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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

NCT06790693

RecruitingPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Breast Cancer

Interventions: Inavolisib, Placebo, CDK4/6i, Letrozole

Countries: United States, Argentina, Australia, Brazil, Canada, China, France, Germany

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (239)

Goodyear, Arizona, United States
Phoenix, Arizona, United States
Burbank, California, United States
Irvine, California, United States
La Jolla, California, United States
Long Beach, California, United States
Los Alamitos, California, United States
Los Angeles, California, United States
Palo Alto, California, United States
San Marcos, California, United States
San Mateo, California, United States
Sunnyvale, California, United States
Jacksonville, Florida, United States
Tallahassee, Florida, United States
Tampa, Florida, United States
Weston, Florida, United States
Marietta, Georgia, United States
O'Fallon, Illinois, United States
Springfield, Illinois, United States
Urbana, Illinois, United States
Zion, Illinois, United States
Lexington, Kentucky, United States
Lexington, Kentucky, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Louisville, Kentucky, United States
Annapolis, Maryland, United States
Baltimore, Maryland, United States
Detroit, Michigan, United States
Grand Rapids, Michigan, United States
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