C4391022
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
Trial 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.
Receptor status / problem studied:
HER2-
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 + ET as the most recent systemic treatment for breast cancer (BC), either as the first line treatment for advanced/mBC or as the adjuvant treatment for early BC. 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:
- Selective estrogen receptor degrader (SERDs), phosphoinositide-3-kinase (PI3K)/protein kinase B (AKT)/mammalian target of rapamycin (mTOR) pathway inhibitors, complete estrogen receptor antagonist (CERANs), PROteolysis Targeting Chimera (PROTACs), or other investigational novel anti-endocrine 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, growth factors, chronic systemic corticosteroids, strong and moderate 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.
Open for recruitment
Trial Title
C4391022
Diagnosis
Breast cancer
Type of trial
Pharmaceutical
Type of treatement
Medical Oncology
Phase
III
Locations
Investigators
Principal Investigator