An Interventional, Open-label, randomized, multicentre Phase3 study of PF-07220060 plus fulvestrant compared to investigatorschoice of therapy in participants over 18 years of age with hormone receptor-positive, HER2-Negative advanced/metastatic breast cancer whose disease progressed after prior CDK 4/6 inhibitor based therapy. - NI

Pfizer Inc.0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年7月22日

试验速览

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•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) less than equal to 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.

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