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Recruiting NCT05654623

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

Conditions: Advanced Breast Cancer

Sex: All
Ages: 18 Years – N/A
Phase: PHASE3
Enrollment: 560
Sponsor: Pfizer

Location: United States

Summary

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

Eligibility Criteria

Inclusion Criteria:Adult participants with loco-regional recurrent or metastatic breast disease not amenable to surgical resection or radiation therapyConfirmed diagnosis of ER+/HER2- breast cancerPrior 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 ETMost recent endocrine treatment duration must have been given for ≥6 months prior to disease progressionRadiological progression during or after the last line of therapyMeasurable disease evaluable per Response Evaluation Criterion in Solid Tumors (RECIST) v.1.1 or non-measurable bone-only diseaseEastern Cooperative Oncology Group (ECOG) performance status 0-1Participants should be willing to provide blood and tumor tissueExclusion Criteria:Participants with advanced, symptomatic visceral spread, that are at risk of life-threatening complications in the short termPrior treatment with:ARV-471, fulvestrant, mTOR, PI3K, AKT pathway inhibitors, PARP inhibitor for any settingother investigational novel endocrine therapy (ie, SERD, SERCA, CERAN) for any settingprior CDK4/6 inhibitor treatment in the neoadjuvant/ adjuvant settingprior chemotherapy for advanced/metastatic diseaseInadequate liver, kidney and bone marrow functionActive brain metastasesParticipants with significant concomitant illness

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05654623). StuddyBuddy aggregates publicly available trial information.