Last updated 46 hours ago
A Study to Learn About the Study Medicine Called PF-07248144 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment.
400 patients around the world
Available in Puerto Rico, Argentina, United States, Mexico, Brazil
Pfizer
14Research sites
400Patients around the world
This study is for people with
Breast Cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Confirmed diagnosis of HR-positive HER2-negative breast cancer with evidence of locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent.Prior CDK4/6 inhibitor therapy in combination with endocrine therapy in advance metastatic setting or in adjuvant setting with documented progression during or within 12 months after the last dose of CDK4/6i.Participants are eligible if they previously received CDK4/6i or ET as a monotherapy, or in combination for rechallenge therapy in the advance or metastatic setting; have received prior therapy targeting estrogen receptor 1 (ESR1) or breast cancer gene (BRCA)1/2.Measurable disease evaluable per Response Evaluation Criterion in Solid Tumors (RECIST) v.1.1 or non-measurable bone-only disease.Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
- Documented detectable PIK3CA/AKT1/PTEN alterations in tissue.Received greater than two prior lines of systemic therapy in the advance or metastatic setting.Had received any prior chemotherapy, including antibody drug conjugates (ADCs), in advance or metastatic setting. Participants who have previously received chemotherapy in the (neo)adjuvant setting are not excluded from the study.Any medical or psychiatric condition that may increase the risk of study participation or make the participant inappropriate for the study.Renal impairment, hepatic dysfunction, or hematologic abnormalities.
Sites
Organización Médica de Investigación (OMI)
Fundación Respirar
Hospital Do Cancer de Londrina
Recruiting
ONCOSITE - Centro de Pesquisa Clinica em Oncologia
Recruiting
Hospital Moinhos de Vento
Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul
Ceon+ Centro de Oncologia
Unidade de Tratamento Oncológico - ANIMI
IBCC - Núcleo de Pesquisa e Ensino
CICLO. Centro de Investigación Clínica de Oaxaca - Oaxaca
Recruiting
SponsorPfizer
Study typeInterventional
Conditions
Breast Cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07062965
