A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy
Breast Cancer
Unknown Primary
18 Years and older, Male and Female
WO43919 (primary)
NCI-2023-01628
2022-502322-41-00
Summary
This is a Phase III, multicenter, randomized, open-label, global study designed to evaluate
the efficacy and safety of inavolisib plus fulvestrant compared with alpelisib plus
fulvestrant in patients with hormone receptor (HR)-positive, human epidermal growth factor
receptor 2 (HER2) -negative, PIK3CA-mutated, locally advanced (LA) or metastatic breast
cancer (mBC), who progressed during or after cyclin dependent kinase 4/6i (CDK4/6i)-based
therapy.
Eligibility
- If pre/perimenopausal women and men treatment with luteinizing hormone-releasing hormone (LHRH) agonist therapy beginning at least 2 weeks prior to Day 1 of Cycle 1
- Histologically or cytologically confirmed adenocarcinoma of the breast that is locally advanced or metastatic and is not amenable to surgical or radiation therapy with curative intent
- Documented HR +/ HER2- tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines
- Confirmation of biomarker eligibility: detection of specified mutation(s) of PIK3CA via specified test
- Disease progression after or during treatment with a combination of CDK4/6i and endocrine therapy: <= 2 prior lines of systemic therapy in mBC setting; CDK4/6i based therapy does not need to be the last one received prior study entry; one line of chemotherapy in mBC setting allowed
- 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 at time of entry into the study, as per national or local treatment guidelines
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- Life expectancy of > 6 months
- Adequate hematologic and organ function prior to initiation of study treatment
Treatment Sites in Georgia
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