NCT05654623Source recordAI-normalized
A PHASE 3, RANDOMIZED, OPEN-LABEL, MULTICENTER TRIAL OF ARV-471 (PF-07850327) VS FULVESTRANT IN PARTICIPANTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED BREAST CANCER WHOSE DISEASE PROGRESSED AFTER PRIOR ENDOCRINE BASED TREATMENT FOR ADVANCED DISEASE (VERITAC-2)
ARV-471 (PF-07850327) is being evaluated against fulvestrant in a pivotal Phase 3 trial for ER+/HER2- advanced breast cancer patients who have progressed after prior endocrine therapy. The market for advanced breast cancer treatments is significant, with a growing demand for novel therapies that can overcome resistance to existing treatments. If successful, ARV-471 could capture a substantial share of the market, particularly given the limitations of current therapies like fulvestrant. Competitive implications include positioning against other SERDs and emerging therapies targeting similar patient populations. Diligence should focus on the trial's primary and secondary endpoints, safety profile, and potential market entry timelines.
AI analysis
Indication: Advanced Breast Cancer
Modality: small molecule
Target: Estrogen Receptor (ER) degradation via PROTAC mechanism (specifically targeting ER+ breast cancer).
Sponsor: Pfizer
Source URL: ClinicalTrials.gov
Source updated: Mar 18, 2026
Ingested: Jun 12, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by conditions: Advanced Breast Cancer
View original source fields
Condition raw: Advanced Breast Cancer
Condition normalized: Advanced Breast Cancer
Modality raw: small molecule
Modality normalized: small molecule
Target raw: Estrogen Receptor (ER) degradation via PROTAC mechanism (specifically targeting ER+ breast cancer).
Target normalized: Estrogen Receptor (ER) degradation via PROTAC mechanism (specifically targeting ER+ breast cancer).
Open reportNCT05573555Source recordAI-normalized
TACTIVE-U: AN INTERVENTIONAL SAFETY AND EFFICACY PHASE 1B/2, OPEN-LABEL UMBRELLA STUDY TO INVESTIGATE TOLERABILITY, PK, AND ANTITUMOR ACTIVITY OF VEPDEGESTRANT (ARV-471/PF-07850327), AN ORAL PROTEOLYSIS TARGETING CHIMERA, IN COMBINATION WITH OTHER ANTICANCER TREATMENTS IN PARTICIPANTS AGED 18 YEARS AND OVER WITH ER+ ADVANCED OR METASTATIC BREAST CANCER, SUB-STUDY B (ARV-471 IN COMBINATION WITH RIBOCICLIB)
The TACTIVE-U study, sponsored by Pfizer, is investigating the safety and efficacy of ARV-471, an oral proteolysis targeting chimera, in combination with ribociclib for the treatment of advanced or metastatic ER+ breast cancer. The study is particularly relevant given the increasing prevalence of breast cancer and the need for effective therapies in patients who have exhausted prior treatment options. The combination therapy could provide a competitive edge in the oncology market, especially as CDK4/6 inhibitors like ribociclib have established their role in breast cancer treatment. Pfizer's collaboration with Arvinas enhances its portfolio in targeted therapies, potentially positioning it favorably against competitors in the rapidly evolving oncology landscape.
AI analysis
Indication: Breast Cancer
Modality: small molecule
Target: Estrogen Receptor Positive (ER+) signaling pathway, specifically targeting estrogen receptor degradation via proteolysis targeting chimera (PROTAC) mechanism.
Sponsor: Pfizer
Source URL: ClinicalTrials.gov
Source updated: Mar 09, 2026
Ingested: Jun 12, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by conditions: Breast Cancer
View original source fields
Condition raw: Breast Cancer
Condition normalized: Breast Cancer
Modality raw: small molecule
Modality normalized: small molecule
Target raw: Estrogen Receptor Positive (ER+) signaling pathway, specifically targeting estrogen receptor degradation via proteolysis targeting chimera (PROTAC) mechanism.
Target normalized: Estrogen Receptor Positive (ER+) signaling pathway, specifically targeting estrogen receptor degradation via proteolysis targeting chimera (PROTAC) mechanism.
Open reportNCT04606446Source recordAI-normalized
A PHASE 1/2A DOSE ESCALATION AND EXPANSION STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETIC, PHARMACODYNAMIC, AND ANTI-TUMOR ACTIVITY OF PF-07248144 IN PARTICIPANTS WITH ADVANCED OR METASTATIC SOLID TUMORS
PF-07248144, developed by Pfizer, is currently undergoing a Phase 1/2A clinical trial targeting advanced or metastatic solid tumors, specifically focusing on ER+HER2- breast cancer, castration-resistant prostate cancer (CRPC), and non-small cell lung cancer (NSCLC). The trial's design includes both monotherapy and combination therapy approaches, which may enhance its market potential by addressing treatment-resistant cancers. The competitive landscape includes established therapies such as CDK4/6 inhibitors and endocrine therapies, necessitating a strong efficacy and safety profile to differentiate PF-07248144. Given the increasing prevalence of these cancers and the demand for novel treatment options, successful outcomes could position PF-07248144 favorably within a lucrative oncology market. The estimated enrollment of 320 participants indicates a robust commitment to generating significant clinical data, which could attract interest from investors and stakeholders in the oncology space.
AI analysis
Indication: Locally Advanced or Metastatic ER+ HER2- Breast Cancer
Modality: small molecule
Target: KAT6 Inhibitor
Sponsor: Pfizer
Source URL: ClinicalTrials.gov
Source updated: Apr 16, 2026
Ingested: Jun 12, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by conditions: Locally Advanced or Metastatic ER+ HER2- Breast Cancer
View original source fields
Condition raw: Locally Advanced or Metastatic ER+ HER2- Breast Cancer, Locally Advanced or Metastatic Castration-resistant Prostate Cancer, Locally Advanced or Metastatic Non-small Cell Lung Cancer
Condition normalized: Locally Advanced or Metastatic ER+ HER2- Breast Cancer, Locally Advanced or Metastatic Castration-resistant Prostate Cancer, Locally Advanced or Metastatic Non-small Cell Lung Cancer
Modality raw: small molecule
Modality normalized: small molecule
Target raw: KAT6 Inhibitor
Target normalized: KAT6 Inhibitor
Open reportNCT04362826Source recordAI-normalized
A Randomized, Double-blind, Placebo Controlled, Parallel Study to Investigate Efficacy of a Novel Probiotic on the Bacteriome and Mycobiome of Breast Cancer Patients
The study, sponsored by Case Comprehensive Cancer Center, aims to evaluate the efficacy of BIOHM, a novel probiotic, in altering the microbiome profiles of breast cancer patients. Given the increasing interest in the role of the microbiome in cancer treatment and prevention, successful outcomes could position BIOHM as a complementary therapy in breast cancer management. The market for probiotics is growing, with a focus on personalized medicine and microbiome research. If proven effective, this could lead to significant commercial opportunities for BIOHM Health LLC, particularly in oncology. The competitive landscape includes other microbiome-focused therapies, necessitating a robust differentiation strategy. Due diligence should consider regulatory pathways, potential market access challenges, and the need for further studies to establish clinical utility.
AI analysis
Indication: Breast Cancer
Modality: protein therapy
Target: Bacteriome and Mycobiome modulation in breast cancer patients
Sponsor: Case Comprehensive Cancer Center
Source URL: ClinicalTrials.gov
Source updated: Apr 09, 2026
Ingested: Jun 12, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by conditions: Breast Cancer
View original source fields
Condition raw: Breast Cancer
Condition normalized: Breast Cancer
Modality raw: protein therapy
Modality normalized: protein therapy
Target raw: Bacteriome and Mycobiome modulation in breast cancer patients
Target normalized: Bacteriome and Mycobiome modulation in breast cancer patients
Open reportNCT04387630Source recordAI-normalized
Neoadjuvant Chemotherapy With or Without Metformin in Early Breast Cancer.
Metformin is a widely used anti-diabetic drug. Several studies have pointed out a potentially beneficial effect of metformin therapy in diabetic cancer patients. Several studies are investigating the anti-tumor effect of metformin in early breast cancer. However, the enhancing effect of metformin on anti-tumor immunity has only been demonstrated in animal models. This study examines the immune effect of metformin in breast cancer patients treated with preoperative chemotherapy.
AI analysis
Indication: Breast Cancer
Modality: small molecule
Target: Metformin, Placebo oral tablet
Sponsor: Mansoura University
Source URL: ClinicalTrials.gov
Source updated: Jun 11, 2020
Ingested: Jun 11, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by conditions: Breast Cancer
View original source fields
Condition raw: Breast Cancer
Condition normalized: Breast Cancer
Modality raw: small molecule
Modality normalized: small molecule
Target raw: Metformin, Placebo oral tablet
Target normalized: Metformin, Placebo oral tablet
Open reportNCT02980341Source recordAI-normalized
Phase 1/2, Multicenter, Open-label, Multiple-Dose First-in-human Study of U3-1402, in Subjects With HER3 Positive Metastatic Breast Cancer
This is an open-label, three-part, multiple-dose study to evaluate safety, tolerability, and efficacy of U3-1402 in patients with HER3-positive metastatic breast cancer. HER3 is a unique member of the human epidermal growth factor receptor, which defines a certain type of cancer. The number of patients and treatment cycles are not fixed in this study. Subjects who continue to derive clinical benefit from the study treatment in the absence of withdrawal of consent, progressive disease (PD), unacceptable toxicity, or death may continue the study treatment until the end of the trial.
AI analysis
Indication: Metastatic Breast Cancer
Modality: small molecule
Target: Patritumab Deruxtecan
Sponsor: Daiichi Sankyo Co., Ltd.
Source URL: ClinicalTrials.gov
Source updated: Oct 30, 2024
Ingested: Jun 11, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by conditions: Metastatic Breast Cancer
View original source fields
Condition raw: Metastatic Breast Cancer
Condition normalized: Metastatic Breast Cancer
Modality raw: small molecule
Modality normalized: small molecule
Target raw: Patritumab Deruxtecan
Target normalized: Patritumab Deruxtecan
Open reportNCT01498588Source recordAI-normalized
Phase II Neoadjuvant Trial of Eribulin Followed by Dose Dense Doxorubicin and Cyclophosphamide for Her2-negative, Locally Advanced Breast Cancer
Previous studies have shown that chemotherapy has the same effect on treating breast cancer whether you receive it before or after surgery. Receiving chemotherapy before surgery, rather than after surgery, may allow the patient to have less extensive surgery. The purpose of this study is to identify new treatment regimens with better response rates and to find out if the combination of eribulin followed by doxorubicin and cyclophosphamide can shrink the size of the patient's breast tumor and allow you to preserve your breast. Additionally, by receiving chemotherapy before surgery, the investigators will be able to determine if your cancer is responsive to chemotherapy.
AI analysis
Indication: Breast Neoplasms
Modality: small molecule
Target: Eribulin, Doxorubicin, Cyclophosphamide, Pegfilgrastim
Sponsor: Emory University
Source URL: ClinicalTrials.gov
Source updated: Oct 03, 2016
Ingested: Jun 11, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by conditions: Breast Neoplasms
View original source fields
Condition raw: Breast Neoplasms, Breast Cancer, Breast Tumors, Cancer of the Breast, Neoplasms, Breast, Tumors, Breast
Condition normalized: Breast Neoplasms, Breast Cancer, Breast Tumors, Cancer of the Breast, Neoplasms, Breast, Tumors, Breast
Modality raw: small molecule
Modality normalized: small molecule
Target raw: Eribulin, Doxorubicin, Cyclophosphamide, Pegfilgrastim
Target normalized: Eribulin, Doxorubicin, Cyclophosphamide, Pegfilgrastim
Open reportNCT01501487Source recordAI-normalized
MINT I Multi- Institutional Neo-adjuvant Therapy MammaPrint Project I
Genomics assays that measure specific gene expression patterns in a patient's primary tumor have become important prognostic tools for breast cancer patients. This study is designed to test the ability of MammaPrint® in combination with TargetPrint®, BluePrint®, and TheraPrint®, as well as traditional pathologic and clinical prognostic factors, to predict responsiveness to neo-adjuvant chemotherapy in patients with locally advanced breast cancer (LABC).
AI analysis
Indication: Breast Cancer
Modality: small molecule
Target: TAC chemotherapy, TC chemotherapy, Dose Dense AC or FEC100 followed by paclitaxel or docetaxel chemotherapy, TCH chemotherapy, T + trastuzumab followed by CEF + trastuzumab, Dose dense AC followed by T + trastuzumab, Dose dense AC followed by T + trastuzumab + pertuzumab, PTH followed by dose dense AC of FEC
Sponsor: Agendia
Source URL: ClinicalTrials.gov
Source updated: Jun 28, 2018
Ingested: Jun 11, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by conditions: Breast Cancer
View original source fields
Condition raw: Breast Cancer
Condition normalized: Breast Cancer
Modality raw: small molecule
Modality normalized: small molecule
Target raw: TAC chemotherapy, TC chemotherapy, Dose Dense AC or FEC100 followed by paclitaxel or docetaxel chemotherapy, TCH chemotherapy, T + trastuzumab followed by CEF + trastuzumab, Dose dense AC followed by T + trastuzumab, Dose dense AC followed by T + trastuzumab + pertuzumab, PTH followed by dose dense AC of FEC
Target normalized: TAC chemotherapy, TC chemotherapy, Dose Dense AC or FEC100 followed by paclitaxel or docetaxel chemotherapy, TCH chemotherapy, T + trastuzumab followed by CEF + trastuzumab, Dose dense AC followed by T + trastuzumab, Dose dense AC followed by T + trastuzumab + pertuzumab, PTH followed by dose dense AC of FEC
Open reportNCT07020117Source recordAI-normalized
NECTINIUM-2: A Phase 1b, 2 Part, Multicenter, Single Arm, Open Label Study to Evaluate the Safety and Efficacy of a Nectin-4 Radiopharmaceutical ([225Ac]Ac-AKY-1189) in Patients With Previously Treated Locally Advanced or Metastatic Solid Tumors
This is a first-in-human Phase 1b, 2-part, multicenter open-label clinical study to evaluate safety and efficacy of a Nectin-4 radiopharmaceutical (\[225Ac\]Ac-AKY-1189) in patients with locally advanced or metastatic solid tumors and to establish the maximum tolerated dose (MTD) or maximum administered dose (MAD) and the recommended Phase 2 dose.
AI analysis
Indication: Urothelial Carcinoma Bladder
Modality: small molecule
Target: [225Ac]Ac-AKY-1189 (therapeutic), [64Cu]Cu-AKY-1189 (imaging)
Sponsor: Aktis Oncology, Inc.
Source URL: ClinicalTrials.gov
Source updated: Apr 21, 2026
Ingested: Jun 11, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by conditions: Triple Negative Breast Cancer (TNBC)
View original source fields
Condition raw: Urothelial Carcinoma Bladder, Triple Negative Breast Cancer (TNBC), Hormone Receptor Positive Breast Adenocarcinoma, Non Small Cell Lung Cancer, Cervical Adenocarcinoma, Colorectal Adenocarcinoma, Head and Neck Cancer
Condition normalized: Urothelial Carcinoma Bladder, Triple Negative Breast Cancer (TNBC), Hormone Receptor Positive Breast Adenocarcinoma, Non Small Cell Lung Cancer, Cervical Adenocarcinoma, Colorectal Adenocarcinoma, Head and Neck Cancer
Modality raw: small molecule
Modality normalized: small molecule
Target raw: [225Ac]Ac-AKY-1189 (therapeutic), [64Cu]Cu-AKY-1189 (imaging)
Target normalized: [225Ac]Ac-AKY-1189 (therapeutic), [64Cu]Cu-AKY-1189 (imaging)
Open reportNCT01427400Source recordAI-normalized
The Use of Botulinum Toxin-A in Two-stage Tissue Expander/Implant Breast Reconstruction: A Prospective, Randomized, Double-Blind Placebo Controlled Trial
Breast reconstruction is a common procedure with over 86,000 breast reconstruction procedures performed in the United States in 2009. This is a 1.5-fold increase since 2007. Of these breast reconstructions, 65% use a tissue expander/implant technique. Although satisfactory results can be achieved with a single-stage technique, a two-stage approach is considered more reliable, allowing for precise positioning of the inframammary fold and an opportune time to perform a capsulotomy to increase the breast skin flap by releasing the soft tissue. The placement of the tissue expander and implant under the chest muscles is thought to minimize the incidence of capsular contracture, expander exposure, and in addition, produce acceptable aesthetic results. However, discomfort is often associated with this submuscular placement of a tissue expander or implant, specifically during the expansion phase. Patients undergoing immediate reconstruction using submuscular implants have been shown to have higher analgesic requirements and to have higher pain scores post-operatively, compared to non-reconstructed patients. An uncomfortable reconstruction can lead to under-filling of the expander, a longer expansion process, abandonment of reconstruction, and a compromised quality of life. The use of Botulinum Toxin A (Botox) injections into the chest muscles at the time of surgery may help ease the discomfort that is often associated with this procedure. The investigators propose a prospective double-blind randomized placebo-controlled trial of patients undergoing tissue expander/implant reconstruction. The information gathered from this analysis will provide a greater understanding of the effects of Botox in the setting of two-stage tissue expander/implant breast reconstruction, with the goal to improve patient satisfaction and quality of life.
AI analysis
Indication: Breast Neoplasms
Modality: small molecule
Target: Botulinum Toxin-A, Saline
Sponsor: University of British Columbia
Source URL: ClinicalTrials.gov
Source updated: Jul 29, 2016
Ingested: Jun 11, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by conditions: Breast Neoplasms
View original source fields
Condition raw: Breast Neoplasms, Neoplasms by Site, Neoplasms, Breast Diseases, Skin Diseases
Condition normalized: Breast Neoplasms, Neoplasms by Site, Neoplasms, Breast Diseases, Skin Diseases
Modality raw: small molecule
Modality normalized: small molecule
Target raw: Botulinum Toxin-A, Saline
Target normalized: Botulinum Toxin-A, Saline
Open reportNCT00104650Source recordAI-normalized
A Randomized, Open Label, Active Controlled Study of AMG 162 in Subjects With Advanced Cancer Currently Being Treated With Intravenous Bisphosphonates
The purpose of this trial is to determine the effectiveness of AMG 162 in reducing urinary N-telopeptide in advanced cancer subjects with bone metastases.
AI analysis
Indication: Bone Metastases in Men With Hormone-Refractory Prostate Cancer
Modality: gene therapy
Target: AMG 162 180 mg (SC) q 12 weeks, IV Bisphosphonate q 4 weeks, AMG 162- 180 mg q 4 weeks
Sponsor: Amgen
Source URL: ClinicalTrials.gov
Source updated: Jan 24, 2011
Ingested: Jun 11, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by conditions: Bone Metastases in Subjects With Advanced Breast Cancer
View original source fields
Condition raw: Bone Metastases in Men With Hormone-Refractory Prostate Cancer, Bone Metastases in Subjects With Advanced Breast Cancer, Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma
Condition normalized: Bone Metastases in Men With Hormone-Refractory Prostate Cancer, Bone Metastases in Subjects With Advanced Breast Cancer, Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma
Modality raw: gene therapy
Modality normalized: gene therapy
Target raw: AMG 162 180 mg (SC) q 12 weeks, IV Bisphosphonate q 4 weeks, AMG 162- 180 mg q 4 weeks
Target normalized: AMG 162 180 mg (SC) q 12 weeks, IV Bisphosphonate q 4 weeks, AMG 162- 180 mg q 4 weeks
Open reportNCT03761914Source recordAI-normalized
A Phase 1/2 Study of Galinpepimut-S in Combination With Pembrolizumab (MK 3475) in Patients With Selected Advanced Cancers
To evaluate the safety, tolerability, and anti-tumor activity of galinpepimut-S in combination with pembrolizumab in patients with selected advanced cancers.
AI analysis
Indication: Acute Myelogenous Leukemia
Modality: monoclonal antibody
Target: galinpepimut-S, pembrolizumab, Montanide, GM-CSF
Sponsor: Sellas Life Sciences Group
Source URL: ClinicalTrials.gov
Source updated: Nov 19, 2024
Ingested: Jun 09, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by conditions: Triple-negative Breast Cancer
View original source fields
Condition raw: Acute Myelogenous Leukemia, Ovarian Cancer, Colorectal Cancer, Triple-negative Breast Cancer, Small-cell Lung Cancer
Condition normalized: Acute Myelogenous Leukemia, Ovarian Cancer, Colorectal Cancer, Triple-negative Breast Cancer, Small-cell Lung Cancer
Modality raw: monoclonal antibody
Modality normalized: monoclonal antibody
Target raw: galinpepimut-S, pembrolizumab, Montanide, GM-CSF
Target normalized: galinpepimut-S, pembrolizumab, Montanide, GM-CSF
Open reportNCT05755048Source recordAI-normalized
A Multicenter, Open-label, Randomized Controlled Phase III Clinical Study to Compare the Efficacy and Safety of FS-1502 Versus T-DM1 in Patients With HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer
This study is designed to compare the anti-tumor activity as well as the safety and efficacy of FS-1502 versus T-DM1 in HER2-positive, unresectable locally advanced or metastatic breast cancer subjects previously treated with trastuzumab and taxane.
AI analysis
Indication: Breast Cancer
Modality: small molecule
Target: Investigational drug: Recombinant Anti-HER2 Humanized Monoclonal Antibody - Monomethyl Auristatin F Conjugates for Injection (FS-1502), Control drug: Trastuzumab emtansine (Kadcyla, T-DM1)
Sponsor: Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Source URL: ClinicalTrials.gov
Source updated: Sep 01, 2023
Ingested: Jun 08, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by conditions: Breast Cancer
View original source fields
Condition raw: Breast Cancer
Condition normalized: Breast Cancer
Modality raw: small molecule
Modality normalized: small molecule
Target raw: Investigational drug: Recombinant Anti-HER2 Humanized Monoclonal Antibody - Monomethyl Auristatin F Conjugates for Injection (FS-1502), Control drug: Trastuzumab emtansine (Kadcyla, T-DM1)
Target normalized: Investigational drug: Recombinant Anti-HER2 Humanized Monoclonal Antibody - Monomethyl Auristatin F Conjugates for Injection (FS-1502), Control drug: Trastuzumab emtansine (Kadcyla, T-DM1)
Open reportNCT04675827Source recordAI-normalized
De-Escalation of Adjuvant Chemotherapy in HER2-positive, Estrogen Receptor-negative, Node-negative Early Breast Cancer Patients Who Achieved Pathological Complete Response After Neoadjuvant Chemotherapy and Dual HER2 Blockade
DECRESCENDO is a multicentre, open-label, dual-phase single-arm phase II de-escalation study evaluating neoadjuvant treatment with 12 administrations of weekly IV paclitaxel 80 mg/m2 (or IV docetaxel 75 mg/m2 every 3 weeks for 4 cycles) combined with subcutaneous (SC) fixed dose combination (FDC) of pertuzumab and trastuzumab (loading dose of 1200 mg pertuzumab and 600 mg trastuzumab, followed by 600 mg pertuzumab and 600 mg trastuzumab) every 3 weeks for 4 cycles. Surgery will be performed according to local guidelines in all subjects after neoadjuvant treatment. After surgery, subjects who achieve a pCR (defined as pT0/Tis pN0) will receive adjuvant pertuzumab and trastuzumab FDC SC for additional 14 cycles. Subjects with residual invasive disease will receive salvage adjuvant trastuzumab emtansine (T-DM1, 3.6 mg/kg, IV every 3 weeks) for 14 cycles. In subjects whose residual invasive disease is classified per RCB score as ≥2, 3 to 4 cycles of anthracycline-based chemotherapy may be administered, at the investigator's discretion, before the 14 cycles of T-DM1. If histopathological analysis finds that the surgical specimen from a subject with residual disease is ER-positive and/or PR-positive, adjuvant endocrine therapy may be administered concomitantly with study treatment, at the investigator's discretion and according to local guidelines. Adjuvant radiotherapy will be mandatory after breast-conserving surgery, whereas it will be performed according to local guidelines after mastectomy, and it will be administered concomitantly with pertuzumab and trastuzumab FDC SC in subjects who achieve a pCR, and concomitantly with T-DM1 in subjects with residual invasive disease (after anthracycline-based chemotherapy in subjects assigned to receive this treatment).
AI analysis
Indication: HER2-positive Breast Cancer
Modality: monoclonal antibody
Target: Pertuzumab and tratuzumab fixed dose combination, Trastuzumab emtansine
Sponsor: Jules Bordet Institute
Source URL: ClinicalTrials.gov
Source updated: Dec 04, 2024
Ingested: Jun 08, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by conditions: HER2-positive Breast Cancer
View original source fields
Condition raw: HER2-positive Breast Cancer, ER-Negative Breast Cancer, PR-Negative Breast Cancer, Node-negative Breast Cancer
Condition normalized: HER2-positive Breast Cancer, ER-Negative Breast Cancer, PR-Negative Breast Cancer, Node-negative Breast Cancer
Modality raw: monoclonal antibody
Modality normalized: monoclonal antibody
Target raw: Pertuzumab and tratuzumab fixed dose combination, Trastuzumab emtansine
Target normalized: Pertuzumab and tratuzumab fixed dose combination, Trastuzumab emtansine
Open reportNCT03529110Source recordAI-normalized
A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of DS-8201a (Trastuzumab Deruxtecan), an Anti-HER2 Antibody Drug Conjugate (ADC), Versus Ado Trastuzumab Emtansine (T-DM1) for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane
This study is designed to compare the anti-tumor activity as well as the safety and efficacy of DS-8201a versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane.
AI analysis
Indication: Breast Cancer
Modality: monoclonal antibody
Target: Trastuzumab deruxtecan (T-DXd), Ado-trastuzumab emtansine (T-DM1)
Sponsor: Daiichi Sankyo
Source URL: ClinicalTrials.gov
Source updated: Oct 21, 2025
Ingested: Jun 08, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by conditions: Breast Cancer
View original source fields
Condition raw: Breast Cancer
Condition normalized: Breast Cancer
Modality raw: monoclonal antibody
Modality normalized: monoclonal antibody
Target raw: Trastuzumab deruxtecan (T-DXd), Ado-trastuzumab emtansine (T-DM1)
Target normalized: Trastuzumab deruxtecan (T-DXd), Ado-trastuzumab emtansine (T-DM1)
Open reportNCT03894007Source recordAI-normalized
Improving Pre-operative Systemic Therapy for Human Epidermal Growth Factor Receptor 2 (HER2) Amplified Breast Cancer Part of a Platform of Translational Phase II Trials Based on Molecular Subtypes
This is a phase 2 study evaluating medical treatment before surgery in HER2-amplified early breast cancer patients. Patients receive chemotherapy with HER2-targeted antibodies and are randomised to receive the checkpoint inhibitor atezolizumab or not.
AI analysis
Indication: Early-stage Breast Cancer
Modality: small molecule
Target: Docetaxel, Carboplatin, Trastuzumab, Pertuzumab, Epirubicin, Cyclophosphamide, Atezolizumab, Trastuzumab emtansine, Paclitaxel
Sponsor: Renske Altena
Source URL: ClinicalTrials.gov
Source updated: Sep 23, 2021
Ingested: Jun 08, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by conditions: Early-stage Breast Cancer
View original source fields
Condition raw: Early-stage Breast Cancer, HER2-positive Breast Cancer
Condition normalized: Early-stage Breast Cancer, HER2-positive Breast Cancer
Modality raw: small molecule
Modality normalized: small molecule
Target raw: Docetaxel, Carboplatin, Trastuzumab, Pertuzumab, Epirubicin, Cyclophosphamide, Atezolizumab, Trastuzumab emtansine, Paclitaxel
Target normalized: Docetaxel, Carboplatin, Trastuzumab, Pertuzumab, Epirubicin, Cyclophosphamide, Atezolizumab, Trastuzumab emtansine, Paclitaxel
Open reportNCT01196052Source recordAI-normalized
A Multicenter, Multinational Phase II Study to Assess the Clinical Safety and Feasibility of Trastuzumab Emtansine Sequentially With Anthracycline-based Chemotherapy, as Adjuvant or Neoadjuvant Therapy for Patients With Early Stage HER2-positive Breast Cancer
This single-arm open-label study assessed the safety, feasibility, and efficacy of trastuzumab emtansine (T-DM1) after the completion of anthracycline-based adjuvant/neoadjuvant chemotherapy in patients with early HER2-positive breast cancer. Patients received T-DM1 3.6 mg/kg intravenously on Day 1 of each 3-week cycle, for up to 17 cycles.
AI analysis
Indication: Breast Cancer
Modality: monoclonal antibody
Target: Trastuzumab emtansine
Sponsor: Hoffmann-La Roche
Source URL: ClinicalTrials.gov
Source updated: Oct 06, 2014
Ingested: Jun 08, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by conditions: Breast Cancer
View original source fields
Condition raw: Breast Cancer
Condition normalized: Breast Cancer
Modality raw: monoclonal antibody
Modality normalized: monoclonal antibody
Target raw: Trastuzumab emtansine
Target normalized: Trastuzumab emtansine
Open reportNCT05107388Source recordAI-normalized
AAREN: Continuous Glucose Monitoring Profile Description Under Alpelisib treAtment in Patients With Advanced bREast Cancer
The purpose of this study is to describe the glycemic profile of postmenopausal women treated with alpelisib plus fulvestrant using a continuous blood sugar monitoring device (FreeStyle Libre Pro) over 14 days
AI analysis
Indication: Breast Cancer
Modality: medical device
Target: FreeStyle Libre Pro
Sponsor: Centre Hospitalier Universitaire de Besancon
Source URL: ClinicalTrials.gov
Source updated: Nov 04, 2021
Ingested: Jun 07, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by conditions: Breast Cancer
View original source fields
Condition raw: Breast Cancer, Diabetes
Condition normalized: Breast Cancer, Diabetes
Modality raw: medical device
Modality normalized: medical device
Target raw: FreeStyle Libre Pro
Target normalized: FreeStyle Libre Pro
Open reportNCT02073916Source recordAI-normalized
Phase Ib Trial of Trastuzumab Emtansine In Combination With Lapatinib Plus Abraxane In Metastatic Her 2 Neu Over-Expressed Breast Cancer Patients
This clinical trial evaluated the safety and tolerability of a combination therapy involving trastuzumab emtansine (T-DM1), Lapatinib, and Abraxane in patients with metastatic HER2-positive breast cancer. The study was conducted by The Methodist Hospital Research Institute and completed in December 2018 with 24 participants.
AI analysis
Indication: Metastatic Breast Cancer
Modality: small molecule
Target: HER2-positive metastatic breast cancer
Sponsor: Jenny C. Chang, MD
Source URL: ClinicalTrials.gov
Source updated: Apr 16, 2019
Ingested: Jun 05, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by conditions: Metastatic Breast Cancer
View original source fields
Condition raw: Metastatic Breast Cancer
Condition normalized: Metastatic Breast Cancer
Modality raw: small molecule
Modality normalized: small molecule
Target raw: T-DM1, Lapatinib, Abraxane
Target normalized: HER2-positive metastatic breast cancer
Open reportNCT02658734Source recordAI-normalized
A Multicenter, Open-Label, Single-Arm, Phase IV Study of Trastuzumab Emtansine in Indian Patients With HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Treatment With Trastuzumab and a Taxane
This study evaluated the safety of trastuzumab emtansine in Indian patients with HER2-positive breast cancer who had prior treatment with trastuzumab and a taxane. Conducted by Hoffmann-La Roche, it involved 70 participants across 13 centers in India.
AI analysis
Indication: HER2 Positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer
Modality: monoclonal antibody
Target: HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer
Sponsor: Hoffmann-La Roche
Source URL: ClinicalTrials.gov
Source updated: Apr 02, 2021
Ingested: Jun 05, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by conditions: HER2 Positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer
View original source fields
Condition raw: HER2 Positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer
Condition normalized: HER2 Positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer
Modality raw: monoclonal antibody
Modality normalized: monoclonal antibody
Target raw: Trastuzumab emtansine
Target normalized: HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer
Open reportNCT02213744Source recordAI-normalized
A Randomized, Multicenter, Open Label Study of MM-302 Plus Trastuzumab vs. Chemotherapy of Physician's Choice Plus Trastuzumab in Anthracycline Naive Patients With Locally Advanced/Metastatic HER2-Positive Breast Cancer
The clinical trial aimed to evaluate the efficacy of MM-302 combined with trastuzumab compared to physician's choice chemotherapy plus trastuzumab in patients with HER2-positive locally advanced or metastatic breast cancer. The study was terminated due to a lack of demonstrated benefit over the control group as determined by the Data Monitoring Committee (DMC).
AI analysis
Indication: Breast Cancer
Modality: small molecule
Target: HER2-Positive Breast Cancer
Sponsor: Merrimack Pharmaceuticals
Source URL: ClinicalTrials.gov
Source updated: Jan 06, 2017
Ingested: Jun 05, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by conditions: Breast Cancer
View original source fields
Condition raw: Breast Cancer, HER2 Positive Breast Cancer
Condition normalized: Breast Cancer, HER2 Positive Breast Cancer
Modality raw: small molecule
Modality normalized: small molecule
Target raw: MM-302, Gemcitabine, Capecitabine, Vinorelbine, Trastuzumab
Target normalized: HER2-Positive Breast Cancer
Open reportNCT01772472Source recordAI-normalized
A Randomized, Multicenter, Open-Label Phase III Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy for Patients With HER2-Positive Primary Breast Cancer Who Have Residual Tumor Present Pathologically in the Breast or Axillary Lymph Nodes Following Preoperative Therapy
This 2-arm, randomized, open-label study will evaluate the efficacy and safety of trastuzumab emtansine versus trastuzumab as adjuvant therapy in patients with HER2-positive breast cancer who have residual tumor present in the breast or axillary lymph nodes following preoperative therapy. Eligible patients will be randomized to receive either trastuzumab emtansine 3.6 mg/kg or trastuzumab 6 mg/kg intravenously every 3 weeks for 14 cycles. Radiotherapy and/or hormone therapy will be given in addition if indicated.
AI analysis
Indication: Breast Cancer
Modality: monoclonal antibody
Target: trastuzumab, trastuzumab emtansine
Sponsor: Hoffmann-La Roche
Source URL: ClinicalTrials.gov
Source updated: Jul 22, 2025
Ingested: Jun 05, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by conditions: Breast Cancer
View original source fields
Condition raw: Breast Cancer
Condition normalized: Breast Cancer
Modality raw: monoclonal antibody
Modality normalized: monoclonal antibody
Target raw: trastuzumab, trastuzumab emtansine
Target normalized: trastuzumab, trastuzumab emtansine
Open reportNCT01835236Source recordAI-normalized
A Randomized Phase II Trial of Pertuzumab in Combination With Trastuzumab With or Without Chemotherapy, Both Followed by T-DM1 in Case of Progression, in Patients With HER2-positive Metastatic Breast Cancer
This clinical trial evaluates a novel treatment strategy for HER2-positive metastatic breast cancer, comparing a chemotherapy-free regimen of trastuzumab and pertuzumab followed by T-DM1 against a chemotherapy-inclusive regimen. The study aims to determine if the new strategy offers similar or improved efficacy and tolerability compared to standard treatments.
AI analysis
Indication: Metastatic Breast Cancer
Modality: monoclonal antibody
Target: HER2-positive Metastatic Breast Cancer
Sponsor: Swiss Cancer Institute
Source URL: ClinicalTrials.gov
Source updated: Mar 30, 2021
Ingested: Jun 05, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by conditions: Metastatic Breast Cancer
View original source fields
Condition raw: Metastatic Breast Cancer
Condition normalized: Metastatic Breast Cancer
Modality raw: monoclonal antibody
Modality normalized: monoclonal antibody
Target raw: Trastuzumab, Pertuzumab, Paclitaxel, Vinorelbine, T-DM1
Target normalized: HER2-positive Metastatic Breast Cancer
Open reportNCT02144012Source recordAI-normalized
A Randomized, Multicenter, Open-Label Phase III Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus the Combination of Trastuzumab Plus Docetaxel as First-Line Treatment of Patients With Her2-Positive Progressive Or Recurrent Locally Advanced Or Metastatic Breast Cancer.
This terminated clinical trial aimed to evaluate the efficacy and safety of trastuzumab emtansine compared to trastuzumab plus docetaxel in patients with HER2-positive metastatic breast cancer. The study enrolled only 49 participants out of the planned 561, leading to its termination.
AI analysis
Indication: Metastatic Breast Cancer
Modality: monoclonal antibody
Target: HER2-positive Breast Cancer
Sponsor: Hoffmann-La Roche
Source URL: ClinicalTrials.gov
Source updated: Mar 07, 2017
Ingested: Jun 05, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by conditions: Metastatic Breast Cancer
View original source fields
Condition raw: Metastatic Breast Cancer
Condition normalized: Metastatic Breast Cancer
Modality raw: monoclonal antibody
Modality normalized: monoclonal antibody
Target raw: Trastuzumab, Trastuzumab Emtansine, Docetaxel
Target normalized: HER2-positive Breast Cancer
Open reportNCT02721433Source recordAI-normalized
A Pragmatic Randomised, Multicentre Trial Comparing 4-weekly Versus 12-weekly Administration of Bone-targeted Agents in Patients With Bone Metastases From Either Castration-resistant Prostate Cancer or Breast Cancer - The REaCT-BTA Study
The REaCT-BTA study evaluates the efficacy of 4-weekly versus 12-weekly administration of bone-targeted agents (BTAs) in improving quality of life and reducing skeletal-related events in patients with bone metastases from castration-resistant prostate cancer or breast cancer. The trial was conducted by the Ottawa Hospital Research Institute and completed in April 2020 with 263 enrolled participants.
AI analysis
Indication: Breast Cancer
Modality: monoclonal antibody
Target: Pamidronate, Denosumab, Zoledronate
Sponsor: Ottawa Hospital Research Institute
Source URL: ClinicalTrials.gov
Source updated: Dec 02, 2020
Ingested: Jun 04, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by conditions: Breast Cancer
View original source fields
Condition raw: Breast Cancer, Prostate Cancer, Metastasis
Condition normalized: Breast Cancer, Prostate Cancer, Metastasis
Modality raw: small molecule
Modality normalized: monoclonal antibody
Target raw: Pamidronate, Denosumab, Zoledronate
Target normalized: Pamidronate, Denosumab, Zoledronate
Open reportNCT03731845Source recordAI-normalized
Evaluation of Individual Sensitivity to the Gonadotoxicity of Chemotherapy in Young Patients With Breast Cancer
The ESIGON trial evaluates the genetic factors influencing ovarian reserve decline in young breast cancer survivors post-chemotherapy. With rising survival rates, understanding fertility preservation is crucial for improving quality of life in this demographic.
AI analysis
Indication: Breast Cancer
Modality: gene therapy
Target: Breast Cancer
Sponsor: Assistance Publique - Hôpitaux de Paris
Source URL: ClinicalTrials.gov
Source updated: Nov 20, 2025
Ingested: May 30, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by conditions: Breast Cancer
View original source fields
Condition raw: Breast Cancer
Condition normalized: Breast Cancer
Modality raw: Breast Cancer
Modality normalized: gene therapy
Target raw: Breast Cancer
Target normalized: Breast Cancer
Open reportNCT05016349Source recordAI-normalized
Why Antiprogestrone (Mifepristone) and Cyp 26 Inhibitor Must be Combined With Tamoxifen or ( Tamoxifen and Retinoic Acid) for Treating Early Breast Cancer
This clinical trial investigates a novel quadrate combination therapy involving Mifepristone, Tamoxifen, Retinoic Acid, and Cannabidiol for treating early breast cancer. The study aims to evaluate the anti-tumor activity of this combination and its effects on CK5-expressing cells, addressing therapy resistance in ERα-positive breast cancer.
AI analysis
Indication: Breast Cancer Female
Modality: small molecule
Target: Breast Cancer
Sponsor: Mahmoud Ramadan mohamed Elkazzaz
Source URL: ClinicalTrials.gov
Source updated: Aug 23, 2021
Ingested: May 30, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by conditions: Breast Cancer Female
View original source fields
Condition raw: Breast Cancer Female
Condition normalized: Breast Cancer Female
Modality raw: Breast Cancer Female
Modality normalized: small molecule
Target raw: Breast Cancer
Target normalized: Breast Cancer
Open reportNCT06076772Source recordAI-normalized
Palbociclib Induced Neutropenia; Risk Factors and Treatment Outcome in Metastatic Breast Cancer Patients
This study aims to assess the risk factors and treatment outcomes associated with neutropenia induced by Palbociclib in patients with hormone receptor-positive, HER2-negative metastatic breast cancer. The study will evaluate progression-free survival (PFS) and overall survival (OS) over a two-year period, providing insights into the pharmacodynamics of Palbociclib and potential dose optimization strategies.
AI analysis
Indication: Metastatic Breast Cancer
Modality: monoclonal antibody
Target: Palbociclib-induced neutropenia in metastatic breast cancer patients
Sponsor: Assiut University
Source URL: ClinicalTrials.gov
Source updated: Oct 11, 2023
Ingested: May 30, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by conditions: Metastatic Breast Cancer
View original source fields
Condition raw: Metastatic Breast Cancer
Condition normalized: Metastatic Breast Cancer
Modality raw: Metastatic Breast Cancer
Modality normalized: monoclonal antibody
Target raw: Palbociclib-induced neutropenia in metastatic breast cancer patients
Target normalized: Palbociclib-induced neutropenia in metastatic breast cancer patients
Open reportNCT01266213Source recordAI-normalized
Randomized Phase II Study OF Goserelin (G) Plus Fulvestrant (F) vs. G Plus Anastrozole (A)vs. G Alone for HR+, Tamoxifen Pretreated, Premenopausal Woman
This clinical trial evaluates the efficacy of high-dose Fulvestrant combined with Goserelin compared to Anastrozole with Goserelin and Goserelin alone in premenopausal women with recurrent or metastatic hormone receptor-positive breast cancer who have previously been treated with Tamoxifen. The study aims to determine the best treatment approach for this patient population.
AI analysis
Indication: Metastatic Breast Cancer
Modality: small molecule
Target: Estrogen Receptor Positive Tumor
Sponsor: Samsung Medical Center
Source URL: ClinicalTrials.gov
Source updated: May 01, 2017
Ingested: May 23, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by conditions: Metastatic Breast Cancer
View original source fields
Condition raw: Metastatic Breast Cancer
Condition normalized: Metastatic Breast Cancer
Modality raw: Metastatic Breast Cancer
Modality normalized: small molecule
Target raw: Estrogen Receptor Positive Tumor
Target normalized: Estrogen Receptor Positive Tumor
Open reportNCT06268327Source recordAI-normalized
Adding Adjuvant Cisplatin and Gemicitabine Versus Capecitabine in Triple-negative Breast Cancer Patients in Non pCR After Neoadjuvant Standard Chemotherapy
This clinical trial aims to evaluate the efficacy and toxicity of adjuvant cisplatin and gemcitabine compared to capecitabine in patients with triple-negative breast cancer who have not achieved a pathological complete response after neoadjuvant chemotherapy. The study is sponsored by Assiut University and is set to begin recruiting in April 2024.
AI analysis
Indication: Breast Cancer
Modality: small molecule
Target: Triple-negative breast cancer
Sponsor: Assiut University
Source URL: ClinicalTrials.gov
Source updated: Feb 20, 2024
Ingested: May 23, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by conditions: Breast Cancer
View original source fields
Condition raw: Breast Cancer
Condition normalized: Breast Cancer
Modality raw: Breast Cancer
Modality normalized: small molecule
Target raw: Triple-negative breast cancer
Target normalized: Triple-negative breast cancer
Open reportNCT02658084Source recordAI-normalized
A Phase I/II Study to Evaluate the Safety and Efficacy of Vinorelbine With Trastuzumab Emtansine in Pre-Treated HER2-Positive Metastatic Breast Cancer
The study proposes to evaluate the safety and efficacy of the combination of trastuzumab emtansine (T-DM1) and vinorelbine in HER2+ metastatic breast cancer patients.
AI analysis
Indication: Breast Cancer
Modality: monoclonal antibody
Target: Vinorelbine, Trastuzumab Emtansine
Sponsor: University of Miami
Source URL: ClinicalTrials.gov
Source updated: Apr 17, 2019
Ingested: May 23, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by conditions: Breast Cancer
View original source fields
Condition raw: Breast Cancer
Condition normalized: Breast Cancer
Modality raw: Breast Cancer
Modality normalized: monoclonal antibody
Target raw: Vinorelbine, Trastuzumab Emtansine
Target normalized: Vinorelbine, Trastuzumab Emtansine
Open reportNCT06663787Source recordAI-normalized
Personalized Detection of ctDNA for Patients With HER2-Positive Metastatic Breast Cancer Who Achieved Durable Response by Anti-HER2 Treatment
This clinical trial aims to evaluate the status of circulating tumor DNA (ctDNA) in patients with HER2-positive metastatic breast cancer who have achieved a durable response to anti-HER2 treatment. The study utilizes the Signatera™ ctDNA assay to assess minimal residual disease (MRD) and explore potential new therapeutic strategies, including the possibility of de-escalating treatment in ctDNA-negative patients.
AI analysis
Indication: Breast Cancer, Metastatic
Modality: monoclonal antibody
Target: HER2-positive metastatic breast cancer
Sponsor: Nagoya City University
Source URL: ClinicalTrials.gov
Source updated: May 13, 2026
Ingested: May 23, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by conditions: Breast Cancer, Metastatic
View original source fields
Condition raw: Breast Cancer, Metastatic, HER2 + Breast Cancer
Condition normalized: Breast Cancer, Metastatic, HER2 + Breast Cancer
Modality raw: monoclonal antibody
Modality normalized: monoclonal antibody
Target raw: Trastuzumab (Herceptin), SIgnatera
Target normalized: HER2-positive metastatic breast cancer
Open reportNCT01513083Source recordAI-normalized
A Phase I, Open Label, Parallel Group, Pharmacokinetic Study of Trastuzumab Emtansine in Patients With HER2-Positive Metastatic Breast Cancer and Normal or Reduced Hepatic Function
This open-label, parallel group study will evaluate the pharmacokinetics and safety of trastuzumab emtansine in patients with HER2-positive metastatic breast cancer and normal or reduced hepatic function. Patients will receive trastuzumab emtansine intravenously on Day 1 of each 3-week cycle. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
AI analysis
Indication: Breast Cancer
Modality: monoclonal antibody
Target: trastuzumab emtansine
Sponsor: Hoffmann-La Roche
Source URL: ClinicalTrials.gov
Source updated: Nov 02, 2016
Ingested: May 23, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by conditions: Breast Cancer
View original source fields
Condition raw: Breast Cancer
Condition normalized: Breast Cancer
Modality raw: Breast Cancer
Modality normalized: monoclonal antibody
Target raw: trastuzumab emtansine
Target normalized: trastuzumab emtansine
Open reportNCT01853748Source recordAI-normalized
A Randomized Phase II Study of Trastuzumab Emtansine (T-DM1) vs. Paclitaxel in Combination With Trastuzumab for Stage I HER2-Positive Breast Cancer (ATEMPT Trial)
This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it-such as the safest dose to use, the side effects it may cause, and if the drug is effective for treating different types of cancer. It also means that the FDA has not approved this drug for use patients undergoing adjuvant treatment for HER2+ breast cancer. Trastuzumab emtansine (T-DM1) is a drug that may stop cancer cells from growing. This drug has been used in other research studies and information from those other research studies suggests that this drug may help to prevent the recurrence of breast cancer in this research study. The use of T-DM1 in this research study is experimental, which means it is not approved by any regulatory authority for the adjuvant treatment of HER2-positive breast cancer. However, it FDA-approved for metastatic HER2-positive breast cancer. T-DM1 has caused cancer cells to die in laboratory studies. In preclinical studies, this drug has prevented or slowed the growth of breast cancer. The breast cancer treatments (paclitaxel and Trastuzumab) used in this study are considered part of standard-of-care regimens in early breast cancer. A standard treatment means that this is a treatment that would be accepted by the majority of the medical community as a suitable treatment for your type of breast cancer. In this research study, the investigators are looking to see if the study drug T-DM1 will have less side effects than traditional HER2-positive breast cancer treatment of trastuzumab and paclitaxel. The investigators are also hoping to learn about the long term benefits and disease-free survival of participants who take the study drug T-DM1 in comparison to those participants to take the combination of trastuzumab and paclitaxel.
AI analysis
Indication: Breast Cancer
Modality: monoclonal antibody
Target: Trastuzumab, Paclitaxel, Trastuzumab emtansine
Sponsor: Dana-Farber Cancer Institute
Source URL: ClinicalTrials.gov
Source updated: Feb 19, 2026
Ingested: May 23, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by conditions: Breast Cancer
View original source fields
Condition raw: Breast Cancer
Condition normalized: Breast Cancer
Modality raw: Breast Cancer
Modality normalized: monoclonal antibody
Target raw: Trastuzumab, Paclitaxel, Trastuzumab emtansine
Target normalized: Trastuzumab, Paclitaxel, Trastuzumab emtansine
Open reportNCT00679341Source recordAI-normalized
A Randomized, Multicenter, Phase ii Study of the Efficacy and Safety of Trastuzumab-MCC-DM1 vs. Trastuzumab (Herceptin®) and Docetaxel (Taxotere®) in Patients With Metastatic HER2-positive Breast Cancer Who Have Not Received Prior Chemotherapy for Metastatic Disease
This was a Phase II, randomized, multicenter, international, 2-arm, open-label clinical trial designed to explore the efficacy and safety of trastuzumab emtansine (T-DM1) relative to the combination of trastuzumab and docetaxel in patients with human epidermal growth factor receptor 2 (HER2)-positive, unresectable, locally advanced breast cancer and/or metastatic breast cancer who have not received prior chemotherapy for metastatic disease.
AI analysis
Indication: Breast Cancer
Modality: monoclonal antibody
Target: Trastuzumab emtansine [Kadcyla], Trastuzumab, Docetaxel
Sponsor: Hoffmann-La Roche
Source URL: ClinicalTrials.gov
Source updated: Jan 09, 2014
Ingested: May 23, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by conditions: Breast Cancer
View original source fields
Condition raw: Breast Cancer
Condition normalized: Breast Cancer
Modality raw: Breast Cancer
Modality normalized: monoclonal antibody
Target raw: Trastuzumab emtansine [Kadcyla], Trastuzumab, Docetaxel
Target normalized: Trastuzumab emtansine [Kadcyla], Trastuzumab, Docetaxel
Open reportNCT04769050Source recordAI-normalized
A Phase II, Single-center, Dynamic Observational Study With PET of 68Ga-HER2-affibody in Anti-HER2 Treatment
Dynamic observationaL study with PET of 68Ga-HER2-affibody in anti-HER2 treatment
AI analysis
Indication: Breast Cancer
Modality: monoclonal antibody
Target: Docetaxel combined with Trastuzumab±Pertuzumab, T-DM1 or Capecitabine combined with Pyrotinib regimen.
Sponsor: Fudan University
Source URL: ClinicalTrials.gov
Source updated: Apr 20, 2022
Ingested: May 23, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by conditions: Breast Cancer
View original source fields
Condition raw: Breast Cancer
Condition normalized: Breast Cancer
Modality raw: Breast Cancer
Modality normalized: monoclonal antibody
Target raw: Docetaxel combined with Trastuzumab±Pertuzumab, T-DM1 or Capecitabine combined with Pyrotinib regimen.
Target normalized: Docetaxel combined with Trastuzumab±Pertuzumab, T-DM1 or Capecitabine combined with Pyrotinib regimen.
Open reportNCT02682693Source recordAI-normalized
Investigating Denosumab as an add-on Neoadjuvant Treatment for RANK-positive or RANK-negative Primary Breast Cancer and Two Different Nab-Paclitaxel Schedules ; 2x2 Factorial Design (GeparX)
The GeparX trial investigated denosumab as an adjunct to neoadjuvant chemotherapy in patients with RANK-positive breast cancer. Conducted by GBG Forschungs GmbH in collaboration with Amgen and Celgene, the study aimed to enhance pathological complete response (pCR) rates and improve patient outcomes. The trial enrolled 780 participants and was completed in December 2020.
AI analysis
Indication: Breast Cancer Female NOS
Modality: monoclonal antibody
Target: RANK-positive or RANK-negative Primary Breast Cancer
Sponsor: GBG Forschungs GmbH
Source URL: ClinicalTrials.gov
Source updated: Feb 02, 2021
Ingested: May 23, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by conditions: Breast Cancer Female NOS
View original source fields
Condition raw: Breast Cancer Female NOS
Condition normalized: Breast Cancer Female NOS
Modality raw: Breast Cancer Female NOS
Modality normalized: monoclonal antibody
Target raw: RANK-positive or RANK-negative Primary Breast Cancer
Target normalized: RANK-positive or RANK-negative Primary Breast Cancer
Open reportNCT05823623Source recordAI-normalized
A Phase II Single-arm Clinical Trial of Inetetamab Combined With Pyrotinib Plus Oral Vinorelbine for the Treatment of Patients With HER2-positive Metastatic Breast Cancer
A Phase II Single-arm Clinical Trial of Inetetamab Combined With Pyrotinib Plus Oral Vinorelbine for the Treatment of Patients With HER2-positive Metastatic Breast Cancer is a PHASE2 clinical asset sponsored by The First Affiliated Hospital with Nanjing Medical University in Breast Cancer. SEO and diligence focus: Inetetamab, Pyrotinib, Oral Vinorelbine Tartrate, endpoint relevance, enrollment feasibility, competitive positioning, readout timing and IP durability.
AI analysis
Indication: Breast Cancer
Modality: monoclonal antibody
Target: Inetetamab, Pyrotinib, Oral Vinorelbine Tartrate
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Source URL: ClinicalTrials.gov
Source updated: Sep 14, 2023
Ingested: May 23, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by conditions: Breast Cancer
View original source fields
Condition raw: Breast Cancer
Condition normalized: Breast Cancer
Modality raw: breast cancer
Modality normalized: monoclonal antibody
Target raw: Inetetamab, Pyrotinib, Oral Vinorelbine Tartrate
Target normalized: Inetetamab, Pyrotinib, Oral Vinorelbine Tartrate
Open reportNCT04740918Source recordAI-normalized
A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase III Study of the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo in Patients With HER2-Positive and PD-L1-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab- (+/- Pertuzumab) and Taxane-Based Therapy (KATE3)
This study will evaluate the efficacy, safety and patient-reported outcomes of trastuzumab emtansine plus atezolizumab compared with trastuzumab emtansine plus placebo in participants with HER2-positive and PD-L1-positive LABC or MBC.Participants must have progressed either during or after prior trastuzumab- (+/- pertuzumab) and taxane-based therapy for LABC/MBC; or during (or within 6 months after completing) trastuzumab- (+/-pertuzumab) and taxane-based therapy in the neoadjuvant and/or adjuvant setting.
AI analysis
Indication: Metastatic Breast Cancer
Modality: monoclonal antibody
Target: Trastuzumab Emtansine, Atezolizumab, Placebo
Sponsor: Hoffmann-La Roche
Source URL: ClinicalTrials.gov
Source updated: Aug 08, 2025
Ingested: May 22, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by conditions: Metastatic Breast Cancer
View original source fields
Condition raw: Metastatic Breast Cancer
Condition normalized: Metastatic Breast Cancer
Modality raw: monoclonal antibody
Modality normalized: monoclonal antibody
Target raw: Trastuzumab Emtansine, Atezolizumab, Placebo
Target normalized: Trastuzumab Emtansine, Atezolizumab, Placebo
Open reportNCT00833963Source recordAI-normalized
An Observational Study of Pregnancy and Pregnancy Outcomes in Women With Breast Cancer Treated With Herceptin, Perjeta in Combination With Herceptin, or Kadcyla During Pregnancy or Within 7 Months Prior to Conception
The MotHER Pregnancy Registry is a United States (U.S.)-based, prospective, observational cohort study in women with breast cancer who have been or are being treated with a trastuzumab (herceptin)-containing regimen with or without pertuzumab (perjeta) or ado-trastuzumab emtansine (kadcyla) during pregnancy or within 7 months prior to conception (regardless of cancer stage at the time of trastuzumab, pertuzumab, or ado-trastuzumab emtansine exposure).
AI analysis
Indication: Breast Cancer
Modality: monoclonal antibody
Target: Trastuzumab, Pertuzumab, Ado-Trastuzumab Emtansine
Sponsor: Genentech, Inc.
Source URL: ClinicalTrials.gov
Source updated: May 16, 2019
Ingested: May 21, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by conditions: Breast Cancer
View original source fields
Condition raw: Breast Cancer, Pregnancy
Condition normalized: Breast Cancer, Pregnancy
Modality raw: monoclonal antibody
Modality normalized: monoclonal antibody
Target raw: Trastuzumab, Pertuzumab, Ado-Trastuzumab Emtansine
Target normalized: Trastuzumab, Pertuzumab, Ado-Trastuzumab Emtansine
Open report