Breast Cancer Clinical Trial
A Study to Learn About a New Medicine Called ARV-471 (PF-07850327) in People Who Have Advanced Metastatic Breast Cancer.
Summary
A study to learn about a new medicine called ARV-471 (PF-07850327) in people who have advanced metastatic breast cancer.
Full Description
The purpose of this study is to learn about the safety and effects of the study medicine ARV-471 (PF-07850327) compared to fulvestrant (FUL) in participants with advanced breast cancer. FUL is a medicine already used for treatment of breast cancer while ARV-471 is a new medicine.
This study is seeking participants with breast cancer who:
Have a disease that comes back in the place where it started or in the nearby region (locoregional recurrent disease) or have a disease that has spread to other parts of the body (metastatic) and cannot be fully cured by surgery or radiation therapy
Are responsive to hormonal therapy such as tamoxifen (it is called estrogen receptor positive disease)
Have received one line of CDK4/6 inhibitor therapy (for example palbociclib) in combination with endocrine therapy (for example letrozole) for advanced disease.
Allowed up to one additional endocrine therapy (for example exemestane) for advanced disease.
Half of the participants will be given ARV-471 while half of the participants will be given FUL.
Participants will take ARV-471 by mouth with food, one time a day. During the first treatment cycle participants will be given FUL by shots into the muscles on Day 1 and again 2 weeks later. Afterwards, FUL shots will be given on the first day of each new treatment cycle. One treatment cycle is 28 days
Participants will receive the study medicine until their breast cancer worsens or side effects become too severe. Participants will have visits at the study clinic about every 4 weeks.
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
≤ 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
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There are 29 Locations for this study
Encinitas California, 92024, United States
Napa California, 94558, United States
San Marcos California, 92069, United States
Clearwater Florida, 33756, United States
Coconut Creek Florida, 33073, United States
Lakeland Florida, 33805, United States
Lauderdale Lakes Florida, 33313, United States
Orange City Florida, 32763, United States
Plantation Florida, 33313, United States
Plantation Florida, 33322, United States
Tamarac Florida, 33321, United States
East Syracuse New York, 13057, United States
Nyack New York, 10960, United States
Lawton Oklahoma, 73506, United States
Oklahoma City Oklahoma, 73102, United States
Oklahoma City Oklahoma, 73102, United States
Oklahoma City Oklahoma, 73102, United States
Harlingen Texas, 78550, United States
Tyler Texas, 75701, United States
Fredericksburg Virginia, 22408, United States
Birtinya Queensland, 4575, Australia
Hobart Tasmania, 7000, Australia
Moncton New Brunswick, E1C 6, Canada
Chiba-shi Chiba, 260-8, Japan
Kashiwa Chiba, 277-8, Japan
Koto Tokyo, 135-8, Japan
Shinjuku City Tokyo, 162-8, Japan
Kagoshima , 892-0, Japan
Okayama , 700-8, Japan
Rio Piedras , 00935, Puerto Rico
San Juan , 00927, Puerto Rico
Kaohsiung , 80756, Taiwan
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