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Purpose

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).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Inavolisib + Letrozole + CDK4/6i 		Participants will receive inavolisib, letrozole and CDK4/6i.
  • Drug: Inavolisib
    Participants will receive oral inavolisib once daily (QD).
    Other names:
    • GDC-0077
    • Itovebi
  • Drug: CDK4/6i
    Participants will receive oral palbociclib on Days 1-21 of each 28-day cycle.
  • Drug: Letrozole
    Participants will receive oral letrozole QD.
Placebo Comparator
Placebo + Letrozole + CDK4/6i 		Participants will receive placebo, letrozole and CDK4/6i.
  • Drug: Placebo
    Participants will receive oral placebo QD.
  • Drug: CDK4/6i
    Participants will receive oral palbociclib on Days 1-21 of each 28-day cycle.
  • Drug: Letrozole
    Participants will receive oral letrozole QD.

Recruiting Locations

Disney Family Cancer Center
Burbank 5331835, California 5332921 91505

Scripps Health
La Jolla 5363943, California 5332921 92040

Cancer and Blood Specialty Clinic
Los Alamitos 5368304, California 5332921 90720

Ellison Institute of Technology
Los Angeles 5368361, California 5332921 90064

Palo Alto Medical Foundation Research Center
Palo Alto 5380748, California 5332921 94301

Kaiser Permanente - San Marcos
San Marcos 5392368, California 5332921 92069

Palo Alto Medical Foundation Research Center
San Mateo 5392423, California 5332921 94401

Palo Alto Medical Foundation Research Center
Sunnyvale 5400075, California 5332921 94086

Tallahassee Memorial HealthCare
Tallahassee 4174715, Florida 4155751 32308

Moffitt Cancer Center-McKinley Campus
Tampa 4174757, Florida 4155751 33612

Northwest Georgia Oncology Centers PC - Marietta
Marietta 4207783, Georgia 4197000 30060

Cancer Care Specialists of Central Illinois
O'Fallon 4245926, Illinois 4896861 62269

Springfield Clinic
Springfield 4250542, Illinois 4896861 62702

Carle Cancer Center
Urbana 4914570, Illinois 4896861 61801

Baptist Health Lexington
Lexington 4297983, Kentucky 6254925 40503

Baptist Health Hamburg
Lexington 4297983, Kentucky 6254925 40509

University of Kentucky - Markey Cancer Center
Lexington 4297983, Kentucky 6254925 40536

Baptist Health Louisville
Louisville 4299276, Kentucky 6254925 40207

Velocity Clinical Research
Annapolis 4347242, Maryland 4361885 21401

Henry Ford Health System
Detroit 4990729, Michigan 5001836 48202

Cancer & Hematology Centers of Western Michigan
Grand Rapids 4994358, Michigan 5001836 49503

HCA Midwest Health
Kansas City 4393217, Missouri 4398678 64132

Nebraska Cancer Specialists
Grand Island 5069297, Nebraska 5073708 68803

Nebraska Cancer Specialists
Omaha 5074472, Nebraska 5073708 68130-2042

Astera Cancer Care East Brunswick
East Brunswick 5097402, New Jersey 5101760 08816

Summit Medical Group
Florham Park 5098095, New Jersey 5101760 07932

Memorial Sloan Kettering Cancer Center
New York 5128581, New York 5128638 10065

Fairview Hospital
Cleveland 5150529, Ohio 5165418 44111

Cleveland Clinic Foundation
Cleveland 5150529, Ohio 5165418 44915

Hillcrest Hospital
Mayfield Heights 5162188, Ohio 5165418 44124

Providence Portland Medical Center
Portland 5746545, Oregon 5744337 97213

Providence Oncology and Hematology Cancer Clinic - Westside;Investigation Drug Services Pharmacy
Portland 5746545, Oregon 5744337 97225

West Cancer Center
Germantown 4624601, Tennessee 4662168 38138

Community Clinical Trials
Kingwood 7534469, Texas 4736286 77339

Swedish Cancer Institute - Edmonds Campus
Edmonds 5793427, Washington 5815135 98026

Providence Regional Cancer Partnership
Everett 5793933, Washington 5815135 98201-1621

Swedish Cancer Institute - Issaquah
Seattle 5809844, Washington 5815135 98104

Swedish Cancer Institute
Seattle 5809844, Washington 5815135 98104

Northwest Medical Specialties
Tacoma 5812944, Washington 5815135 98405

PanOncology Trials
San Juan 4568127, Puerto Rico 00935

More Details

NCT ID
NCT06790693
Status
Recruiting
Sponsor
Hoffmann-La Roche

Study Contact

Reference Study ID Number: WO45654 https://forpatients.roche.com/
888-662-6728 (U.S. Only)
global-roche-genentech-trials@gene.com

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