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NCT05573555ACTIVE_NOT_RECRUITINGanonymous

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)

Sponsor

Source record

Pfizer

Phase

Source record

Phase 1B/2

Modality

AI-normalized

small molecule

Target

AI-normalized

Estrogen Receptor Positive (ER+) signaling pathway, specifically targeting estrogen receptor degradation via proteolysis targeting chimera (PROTAC) mechanism.

Indication / condition

AI-normalized

Breast Cancer

Intervention

Source record

ARV-471, Ribociclib

Source & freshness

Source record

NCT ID

NCT05573555

Original source

ClinicalTrials.gov

Source last updated

Mar 09, 2026

Ingested at

Jun 12, 2026

Internal sync

Jun 12, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

Open original registry record
View original source fields

NCT ID

NCT05573555

Title

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)

Sponsor

Pfizer

Status

ACTIVE_NOT_RECRUITING

Phase

Phase 1B/2

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.

Interventions

ARV-471, Ribociclib

Public preview

Source record

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-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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TrialSignal

Clinical trial intelligence report

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)

Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.

Generated

Jun 13, 2026

NCT ID

NCT05573555

Status

ACTIVE_NOT_RECRUITING

Phase

Phase 1B/2

Sponsor

Pfizer

Executive brief

Investment-Ready Snapshot

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.

Source & freshness

Provenance

SourceClinicalTrials.gov
Source updatedMar 09, 2026
Internal syncJun 12, 2026
Model versiontrialsignal-ai-v1

https://clinicaltrials.gov/study/NCT05573555

Indication

Breast Cancer

Modality

small molecule

Target

Estrogen Receptor Positive (ER+) signaling pathway, specifically targeting estrogen receptor degradation via proteolysis targeting chimera (PROTAC) mechanism.

Intervention

ARV-471, Ribociclib

Source record

Protocol Description

Detailed source ingestion pending.

Source record

Outcome Measures

Detailed source ingestion pending.

Source record

Eligibility

Detailed source ingestion pending.

AI analysis

Known Results And Readout Context

Detailed source ingestion pending.

IP intelligence

Patent And IP Landscape

Detailed source ingestion pending.

Source record

Contacts

Detailed source ingestion pending.