A Study to Learn About Vepdegestrant When Given With PF-07220060 to People With Advanced or Metastatic Breast Cancer.
- Conditions
- Breast Cancer
- Registration Number
- NCT06206837
- Lead Sponsor
- Pfizer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Histological or cytological diagnosis of breast cancer. At time of enrollment this<br> must not be amenable to surgical resection with curative intent (=1% ER+ stained<br> cells as per local practice on the most recent tumor biopsy HER2- tumor by IHC or<br> in-situ hybridization per ASCO/CAP).<br><br> - prior anticancer therapies: Phase 1b: at least 1 line of SOC for A/MBC; Prior<br> fulvestrant allowed; =1 prior chemotherapy line (no antibody-drug conjugates<br> permitted) for A/MBC setting allowed. Phase 2: At least one and maximum 2 lines of<br> ET in A/MBC setting and most recent ET-based regimen for >6 months.<br><br> 1, and only 1, prior CDK4/6 inhibitor-based regimen required. Up to 1 prior regimen<br> of cytotoxic chemotherapy (no antibody-drug conjugates permitted) in the A/MBC<br> setting; Prior fulvestrant allowed.<br><br> - Participant with only non-measurable lesion (Phase1b) or at least 1 measurable<br> lesion as defined by RECIST v1.1. (Phase2) are eligible.<br><br> - ECOG PS = 0 or 1 (Phase1b) ; =2 (Phase2)<br><br>Exclusion Criteria:<br><br> - visceral crisis at risk of life-threatening complications in the short term.<br><br> - Any condition precluding an adeguate absorption of study interventions.<br><br> - newly diagnosed brain metastases, or symptomatic central nervous system (CNS)<br> metastases, carcinomatous meningitis, or leptomeningeal disease. Participants with a<br> history of CNS metastases or cord compression are eligible if they have been<br> definitively treated, clinically stable and discontinued anti-seizure medications<br> and corticosteroids for at least 28 days prior to enrollment in the of study.<br><br> - history of any other tumor malignancies within the past 3 years, except for the<br> following: (1) adequately treated basal or squamous cell carcinoma of the skin; (2)<br> curatively treated in situ carcinoma of the cervix. Inflammatory breast cancer are<br> excluded<br><br> - impaired cardiovascular function or clinically significant cardiovascular diseases.<br><br> - concurrent administration of medications, food, or herb supplements that are strong<br> inhibitors/inducers of CYP3A or UGT2B7, moderate inducers of CYP34 (Phase1b only)<br> and drugs known to predispose to Torsade de Pointes or QT interval prolongation.<br><br> - renal impairment, not adequate liver function and/or bone marrow function.<br><br> - known active infection
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase 1b: Number of Participants With Dose Limiting Toxicities;Phase 2: Percentage of Participants With Objective Response by investigator assessment
- Secondary Outcome Measures
Name Time Method