A Study to Learn About the Study Medicine Called PF-07220060 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment
- Conditions
- Advanced or Metastatic Breast Cancer
- Interventions
- Registration Number
- NCT06105632
- Lead Sponsor
- Pfizer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 333
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A PF-07220060 CDK4 inhibitor PF-07220060 to be taken by mouth as a tablet in combination with fulvestrant (a solution for injection) Arm B Fulvestrant 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. Arm A Fulvestrant PF-07220060 to be taken by mouth as a tablet in combination with fulvestrant (a solution for injection) Arm B Everolimus 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. Arm B Exemestane 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.
- Primary Outcome Measures
Name Time Method Progression-Free Survival (PFS) progression, as determined by investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 From Initiation up to 2 years
- Secondary Outcome Measures
Name Time Method Number of Participants With Laboratory Test Abnormalities From screening until 28 days after the last dose to approximately 2 years EQ-5D-5L 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 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) 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 Cycle 1 (Day 15), Cycle 2 (Day 1), and Cycle 3 (Day 1). Each Cycle is 28 days Overall Survival (OS) 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 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 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 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 From screening until 28 days after the last dose, to approximately 3 years Number or Patients with AEs by Incidence From screening until 28 days after the last dose, to approximately 3 years Number or Patients with AEs by Seriousness From screening until 28 days after the last dose, to approximately 3 years Number or Patients with AEs by relationship to study interventions From screening until 28 days after the last dose, to approximately 3 years Number of Participants With Abnormal Electrocardiogram (ECG) From baseline to approximately 2 years
Related Research Topics
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Trial Locations
- Locations (221)
Highlands Oncology Group
🇺🇸Springdale, Arkansas, United States
UCSF - John Muir Health Cancer Center Berkeley
🇺🇸Berkeley, California, United States
Washington Hospital Healthcare System
🇺🇸Fremont, California, United States
Hoag Health Center Irvine
🇺🇸Irvine, California, United States
Hoag Hospital Irvine
🇺🇸Irvine, California, United States
Eisenhower George and Julia Argyros Health Center
🇺🇸La Quinta, 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
Hoag Memorial Hospital Presbyterian
🇺🇸Newport Beach, California, United States
Scroll for more (211 remaining)Highlands Oncology Group🇺🇸Springdale, Arkansas, United States