A Study to Learn About a New Medicine Called ARV-471 (PF-07850327) in People Who Have Advanced Metastatic Breast Cancer.

• Status: Not yet recruiting
• Trial end date: 2028-05-15
• Target enrollment: 0
• Participant gender: All

Summary

A study to learn about a new medicine called ARV-471 (PF-07850327) in people who have advanced metastatic breast cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Collaborator: Arvinas Estrogen Receptor, Inc.
• Treatments: Fulvestrant

Criteria

Inclusion Criteria:

• Adult participants with loco-regional recurrent or metastatic breast disease not amenable to surgical resection or radiation therapy

• Confirmed diagnosis of ER+/HER2- breast cancer

• Prior therapies for locoregional recurrent or metastatic disease must fulfill all the following criteria:

• One line of CDK4/6 inhibitor therapy in combination with endocrine therapy

• ≤ 1 endocrine therapy in addition to CDK4/6 inhibitor with ET

• Most recent endocrine treatment duration must have been given for ≥6 months prior to disease progression

• Radiological progression during or after the last line of therapy

• Measurable disease evaluable per Response Evaluation Criterion in Solid Tumors (RECIST) v.1.1 or non-measurable bone-only disease

• Eastern Cooperative Oncology Group (ECOG) performance status 0-1

• Participants should be willing to provide blood and tumor tissue

Exclusion Criteria:

• Participants with advanced, symptomatic visceral spread, that are at risk of life-threatening complications in the short term

• Prior treatment with:

• ARV-471, fulvestrant, mTOR, PI3K, AKT pathway inhibitors, PARP inhibitor for any setting

• other investigational novel endocrine therapy (ie, SERD, SERCA, CERAN) for any setting

• prior CDK4/6 inhibitor treatment in the neoadjuvant/ adjuvant setting

• prior chemotherapy for advanced/metastatic disease

• Inadequate liver, kidney and bone marrow function

• Active brain metastases

• Participants with significant concomitant illness