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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Histological confirmation of breast cancer with evidence of locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent. - Documented estrogen receptor (ER) and/or progesterone receptor (PR)- positive tumor - Documented HER2-negative tumor - Able to provide a sufficient amount of representative formalin fixed, paraffin embedded (FFPE) tumor tissue specimen. - Must have received CDK4/6i plus NSAI defined per study protocol. There must be documented PD during or after CDK4/6i treatment. - Measurable disease or non-measurable bone only disease as defined by RECIST version 1.1. - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤2.

Exclusion Criteria

  • Any medical or psychiatric condition that may increase the risk of study participation or make the participant inappropriate for the study. - In visceral crisis at risk of immediately life-threatening complications in the short term. - Known active uncontrolled or symptomatic central nervous system metastases, carcinomatous meningitis, or leptomeningeal disease. - Prior treatment with any of the following: - Everolimus or investigational anti-cancer agents in any setting - Prior chemotherapy in the advanced setting - Radiation within 2 weeks of randomization - Current use or anticipated need for any prohibited food, supplements or concomitant medication(s) (ie, other anti-cancer therapies, other endocrine therapies, growth factors, chronic systemic corticosteroids, strong cytochrome P450 3A4/5 [CYP3A4/5] or uridine 5' diphosphate-glucuronosyltransferase 2B7 [UGT2B7] inhibitors and inducers, direct oral anticoagulants, proton pump inhibitors). - Inadequate renal function, hepatic dysfunction, or hematologic abnormalities.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A 		PF-07220060 to be taken by mouth as a tablet in combination with fulvestrant (a solution for injection)
  • Drug: PF-07220060 CDK4 inhibitor
    Experimental
  • Drug: Fulvestrant
    Experimental and Active comparator
Active Comparator
Arm B 		Investigator's choice of therapy of either: - Fulvestrant alone (a solution for injection), or - Everolimus in combination with exemestane, both a tablet to be taken by mouth.
  • Drug: Fulvestrant
    Experimental and Active comparator
  • Drug: Everolimus
    Active Comparator
  • Drug: Exemestane
    Active Comparator

Recruiting Locations

Georgetown University Medical Center
Washington, District of Columbia 20007

MedStar Washington Hospital Center
Washington, District of Columbia 20010

More Details

Status
Recruiting
Sponsor
Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.