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

NCT05654623

Active Not RecruitingPhase 3

Sponsor: Pfizer

Conditions: Advanced Breast Cancer

Interventions: ARV-471, Fulvestrant

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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. Only one line of CDK4/6 inhibitor is allowed in any setting.
* ≤ 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. This may be the endocrine treatment component of the CDK4/6 inhibitor line of therapy.
* 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, elacestrant, mTOR, PI3K, AKT pathway inhibitors, PARP inhibitor for any setting
* other investigational agents (including novel endocrine therapy any SERDs, SERCAs, CERANs) for any setting
* prior chemotherapy for advanced/metastatic disease
* Inadequate liver, kidney and bone marrow function
* Active brain metastases
* Participants with significant concomitant illness

Locations (312)

Encinitas, California, United States
Fountain Valley, California, United States
Fresno, California, United States
Napa, California, United States
San Marcos, California, United States
Sylmar, California, United States
Fairfield, Connecticut, United States
New Haven, Connecticut, United States
New Haven, Connecticut, United States
North Haven, Connecticut, United States
Trumbull, Connecticut, United States
Altamonte Springs, Florida, United States
Bonita Springs, Florida, United States
Bradenton, Florida, United States
Bradenton, Florida, United States
Brandon, Florida, United States
Cape Coral, Florida, United States
Clearwater, Florida, United States
Clearwater, Florida, United States
Daytona Beach, Florida, United States
Fort Myers, Florida, United States
Fort Myers, Florida, United States
Gainesville, Florida, United States
Lakeland, Florida, United States
Largo, Florida, United States
Lecanto, Florida, United States
N. Venice, Florida, United States
Naples, Florida, United States
North Port, Florida, United States
Ocala, Florida, United States
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