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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
500 patients around the world
Available in Argentina, United States
Pfizer
7Research sites
500Patients around the world
This study is for people with
Breast Cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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.Everolimus or investigational anti-cancer agents in any settingPrior 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.
Sites
Centro de Investigaciones Metabólicas (CINME) S.A. - CABA, Buenos Aires
Recruiting
CIPREC Centro de Investigación y Prevención Cardiovascular - CABA
Recruiting
Organización Médica de Investigación (OMI)
Recruiting
Fundación Cori para la Investigación y Prevención del Cáncer - La Rioja
Recruiting
Sanatorio Norte SRL - Santiago del Estero
Recruiting
Fundación Respirar
Recruiting
Fundación CENIT para la Investigación en Neurociencias
Recruiting
SponsorPfizer
Conditions
Breast Cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06105632
