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NCT05501769COMPLETEDanonymous

A Phase 1b Trial of ARV-471 in Combination With Everolimus in Patients With ER+, HER2- Advanced or Metastatic Breast Cancer

Sponsor

Source record

Arvinas Estrogen Receptor, Inc.

Phase

Source record

Phase 1b

Modality

AI-normalized

combination therapy

Target

AI-normalized

Estrogen Receptor (ER) and mTOR pathway

Indication / condition

AI-normalized

Breast Cancer

Intervention

Source record

ARV-471 in combination with Everolimus

Source & freshness

Source record

NCT ID

NCT05501769

Original source

ClinicalTrials.gov

Source last updated

Sep 26, 2025

Ingested at

Jun 18, 2026

Internal sync

Jun 18, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

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View original source fields

NCT ID

NCT05501769

Title

A Phase 1b Trial of ARV-471 in Combination With Everolimus in Patients With ER+, HER2- Advanced or Metastatic Breast Cancer

Sponsor

Arvinas Estrogen Receptor, Inc.

Status

COMPLETED

Phase

Phase 1b

Condition raw

Breast Cancer

Condition normalized

Breast Cancer

Modality raw

combination therapy

Modality normalized

combination therapy

Target raw

Estrogen Receptor (ER) and mTOR pathway

Target normalized

Estrogen Receptor (ER) and mTOR pathway

Interventions

ARV-471 in combination with Everolimus

Public preview

Source record

The Phase 1b trial of ARV-471 in combination with everolimus targets ER+/HER2- advanced or metastatic breast cancer, a significant segment of the oncology market. Given the prevalence of ER+ breast cancer, this combination therapy could address an unmet need for patients who have progressed on standard therapies, including CDK 4/6 inhibitors and endocrine therapies. The collaboration with Pfizer may enhance market access and development capabilities. Competitive analysis indicates that while there are existing therapies targeting similar pathways, the unique mechanism of action of ARV-471 as a PROTAC (proteolysis-targeting chimera) may provide a differentiated therapeutic profile. Diligence considerations include the safety and tolerability data from this trial, which will be critical for future regulatory submissions and market positioning.

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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