The purpose of this study is to learn about the safety and how effective the study medicine (PF-07220060) plus fulvestrant is compared to the study doctor's choice of treatment in people with advanced or metastatic breast cancer. Advanced cancer is the one that is unlikely to be cured or taken care of with treatment. Metastatic cancer is the one that has spread to other parts of the body. This study is seeking female and male participants who: * are 18 years of age or older; * are hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative; * have advanced or metastatic breast cancer after taking other treatments before this study; * have not taken or need to take medications that are not allowed by the study protocol; * do not have any medical or mental conditions that may increase the risk of study participation. Half of the participants will take PF-07220060 two times daily by mouth along with fulvestrant. Fulvestrant will be given as a shot into the muscle. The other half will take the study doctor's choice of treatment which can either be: * Fulvestrant alone taken as shot into the muscle. * Everolimus along with exemestane taken once daily by mouth. This study will compare the experiences of participants receiving the study medicine plus fulvestrant to those who are receiving the study doctor's choice of treatment. This will help decide if the study medicine is safe and effective. Participants will receive study treatment and/or will be in the study until: * imaging scans (such as an MRI and/or CT) show that their cancer is getting worse. * the study doctor thinks the participant is no longer benefitting from the study medicine. * has side effects that become too severe. A side effect is a reaction (expected or unexpected) to a medicine or treatment you take. * the participant chooses to stop taking part.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
333
Experimental
Experimental and Active comparator
Active Comparator
Active Comparator
Hoag Health Center Irvine
Irvine, California, United States
Hoag Hospital Irvine
Irvine, California, United States
Keck Hospital of USC
Los Angeles, California, United States
Los Angeles General Medical Center
Los Angeles, California, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Progression-Free Survival (PFS) progression, as determined by investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: From Initiation up to 2 years
Overall Survival (OS)
Time frame: Time from the date of randomization to the date of death due to any cause up to approximately 3 years
OR by investigator per RECIST v1.1
Time frame: Time From randomization date (every 8 weeks during the first 48 weeks and then every 12 weeks) to the date of progression OR death whichever occurs first (up to approximately 2 years)
Duration of Response (DOR) as defined by investigator per RECIST v1.1
Time frame: From the date of the first objective response (every 8 weeks during the first 48 weeks and then every 12 week) up to approximately 2 years.
Number of Participants With Clinical Benefit Response (CBR) by investigator per RECIST v1.1
Time frame: From randomization date (every 8 weeks during the first 48 weeks and then every 12 weeks) up to approximately 2 years
Number or Patients with Adverse Events (AEs) by Type
Time frame: From screening until 28 days after the last dose, to approximately 3 years
Number or Patients with AEs by Incidence
Time frame: From screening until 28 days after the last dose, to approximately 3 years
Number or Patients with AEs by Seriousness
Time frame: From screening until 28 days after the last dose, to approximately 3 years
Number or Patients with AEs by relationship to study interventions
Time frame: From screening until 28 days after the last dose, to approximately 3 years
Number of Participants With Abnormal Electrocardiogram (ECG)
Time frame: From baseline to approximately 2 years
Number of Participants With Laboratory Test Abnormalities
Time frame: From screening until 28 days after the last dose to approximately 2 years
EQ-5D-5L
Time frame: Screening Days 1, 15 of Cycle 1 and 2, Day 1 of Cycles 3-6, then Day 1 of every other subsequent Cycle starting with Cycle 8 (eg, Cycles 8, 10, 12, etc) and EoT. Each Cycle is 28 days.
EORTC QLQ
Time frame: Screening Days 1, 15 of Cycle 1 and 2, Day 1 of Cycles 3-6, then Day 1 of every other subsequent Cycle starting with Cycle 8 (eg, Cycles 8, 10, 12, etc) and EoT. Each Cycle is 28 days.
EORTC QLQ Breast Cancer Module 23 (BR23)
Time frame: Screening Days 1, 15 of Cycle 1 and 2, Day 1 of Cycles 3-6, then Day 1 of every other subsequent Cycle starting with Cycle 8 (eg, Cycles 8, 10, 12, etc) and EoT. Each Cycle is 28 days.
Ctrough of PF-07220060
Time frame: Cycle 1 (Day 15), Cycle 2 (Day 1), and Cycle 3 (Day 1). Each Cycle is 28 days
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Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Keck Medical Center of USC Pasadena
Pasadena, California, United States
Danbury Hospital
Danbury, Connecticut, United States
Norwalk Hospital
Norwalk, Connecticut, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
...and 118 more locations