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A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer
Trial Status: active
This study will evaluate the efficacy and safety of the combination of inavolisib plus a
cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole versus placebo plus a
CDK4/6i and letrozole in the first-line setting in participants with endocrine-sensitive
PIK3CA-mutated hormone receptor-positive (HR+), human epidermal growth factor receptor
2-negative (HER2-), advanced breast cancer (ABC).
Inclusion Criteria
Women or men with histologically or cytologically confirmed carcinoma of the breast
Documented ER-positive and/or progesterone receptor-positive tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines
Documented HER2-negative tumor according to ASCO/CAP guidelines
De-novo HR+ , HER2- ABC, or, alternatively, relapsed HR+ , HER2- ABC after at least 2 years of standard neoadjuvant/adjuvant endocrine therapy without disease progression during that treatment and disease-free interval of at least 1 year since the completion of that treatment
Participants who have bilateral breast cancers which are both HR-positive and HER2-negative
Confirmation of biomarker eligibility
Consent to provide fresh or archival tumor tissue specimen
Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Adequate hematologic and organ function within 14 days prior to initiation of study treatment
Exclusion Criteria
Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required
Metaplastic breast cancer
Any prior systemic therapy for locally advanced unresectable or metastatic breast cancer
Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
Any history of leptomeningeal disease or carcinomatous meningitis
Known and untreated, or active CNS metastases. Participants with a history of treated CNS metastases are eligible
Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye
Symptomatic active lung disease
History of or active inflammatory bowel disease
Any active bowel inflammation
Prior hematopoietic stem cell or bone marrow transplantation
Treatment with strong cytochrome P450 (CYP) 3A4 inhibitors or strong CYP3A4 inducers within 4 weeks or 5 drug-elimination half-lives, prior to initiation of study treatment
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06790693.
