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NCT05548127ACTIVE_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 A (ARV-471 in Combination With Abemaciclib)

Sponsor

Source record

Pfizer

Phase

Source record

Phase 1b/2

Modality

AI-normalized

small molecule

Target

AI-normalized

Estrogen Receptor (ER) and CDK4/6 pathway

Indication / condition

AI-normalized

Breast Cancer

Intervention

Source record

ARV-471, Abemaciclib

Source & freshness

Source record

NCT ID

NCT05548127

Original source

ClinicalTrials.gov

Source last updated

Feb 10, 2026

Ingested at

May 19, 2026

Internal sync

May 23, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

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NCT ID

NCT05548127

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 A (ARV-471 in Combination With Abemaciclib)

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 (ER) and CDK4/6 pathway

Target normalized

Estrogen Receptor (ER) and CDK4/6 pathway

Interventions

ARV-471, Abemaciclib

Public preview

Source record

The TACTIVE-U study, sponsored by Pfizer, investigates the combination of ARV-471 (Vepdegestrant) and Abemaciclib for the treatment of ER+ advanced or metastatic breast cancer. This combination therapy targets a significant patient population that has limited treatment options, particularly those who have become resistant to prior therapies. The market for ER+ breast cancer treatments is substantial, with increasing competition from other CDK4/6 inhibitors and novel therapies. Successful outcomes from this trial could position Pfizer favorably in the oncology market, enhancing its portfolio and potentially leading to a competitive edge against existing therapies. Diligence should focus on the safety profile and efficacy data, as well as the regulatory landscape surrounding combination therapies in oncology.

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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