A Phase II, Randomized, Open-Label Study Evaluating Two Inavolisib Dose Levels in Combination With Fulvestrant in Participants With PIK3CA-Mutated, HR-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
Hoffmann-La Roche
Summary
The purpose of this study is to evaluate the efficacy and safety of inavolisib in combination with fulvestrant compared with inavolisib in combination with fulvestrant in participants with PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer (LA/mBC) in the post-cyclin-dependent kinase inhibitor (CDKi) setting.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Documented ER +/ HER2- tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines * Disease progression after or during treatment with a combination of CDK4/6i and endocrine therapy: \<= 1 prior lines of systemic therapy in the locally advanced (recurrent or progressed) or metastatic setting * Measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) * Participants for whom endocrine-based therapy is recommended and treatment with cytotoxic chemotherapy is not indicated…
Interventions
- DrugInavolisib
Participants will receive Inavolisib as per the schedule given in the protocol.
- DrugFulvestrant
Participants will receive Fulvestrant as per the schedule given in the protocol.
Locations (16)
- Los Angeles Cancer NetworkLos Angeles, California
- Astera Cancer Care East BrunswickEast Brunswick, New Jersey
- Cliniques Universitaires St-LucBrussels
- Jessa Zkh (Campus Virga Jesse)Hasselt
- UZ Leuven GasthuisbergLeuven
- Hospital Universitari Vall d'Hebron;OncologyBarcelona