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

Launched by HOFFMANN-LA ROCHE · Jan 22, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment for patients with advanced breast cancer that is hormone receptor-positive (HR+) and HER2-negative, specifically for those whose tumors have a mutation in the PIK3CA gene. Researchers want to find out if a combination of a drug called inavolisib, along with other medications, is more effective and safe than a placebo (a non-active treatment) combined with the same medications. Participants will be adults who have been diagnosed with breast cancer and meet specific criteria regarding their tumor's characteristics.

To be eligible for this study, participants must have been diagnosed with HR+ and HER2-negative breast cancer and either have newly diagnosed advanced disease or have had a recurrence after a certain period of treatment. They will also need to provide a tissue sample for testing. Participants can expect to receive a treatment regimen and will be closely monitored for any side effects and how well the treatment is working. It's important to note that certain health conditions may disqualify someone from participating, so discussing personal health history with a healthcare provider is essential.

Gender

ALL

Eligibility criteria

• 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