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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 CDK4/6i on either Days 1-21 or Days 1-28 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 CDK4/6i on either Days 1-21 or Days 1-28 of each 28-day cycle.
  • Drug: Letrozole
    Participants will receive oral letrozole QD.

Recruiting Locations

Disney Family Cancer Center
Burbank, California 91505

Scripps Health
La Jolla, California 92040

Cancer and Blood Specialty Clinic
Los Alamitos, California 90720

Ellison Institute of Technology
Los Angeles, California 90064

Palo Alto Medical Foundation Research Center
Palo Alto, California 94301

Kaiser Permanente - San Marcos
San Marcos, California 92069

Palo Alto Medical Foundation Research Center
San Mateo, California 94401

Palo Alto Medical Foundation Research Center
Sunnyvale, California 94086

Cancer Specialists of North Florida - Jacksonville
Jacksonville, Florida 32207

Tallahassee Memorial HealthCare
Tallahassee, Florida 32308

Moffitt Cancer Center-McKinley Campus
Tampa, Florida 33612

Northwest Georgia Oncology Centers PC - Marietta
Marietta, Georgia 30060

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

Springfield Clinic
Springfield, Illinois 62702

Carle Cancer Center
Urbana, Illinois 61801

Baptist Health Lexington
Lexington, Kentucky 40503

Baptist Health Hamburg
Lexington, Kentucky 40509

University of Kentucky - Markey Cancer Center
Lexington, Kentucky 40536

University of Louisville Hospital
Louisville, Kentucky 40202

Baptist Health Louisville
Louisville, Kentucky 40207

Velocity Clinical Research
Annapolis, Maryland 21401

Henry Ford Health System
Detroit, Michigan 48202

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

University of Minnesota Medical Center
Minneapolis, Minnesota 55455

HCA Midwest Health
Kansas City, Missouri 64132

Nebraska Cancer Specialists
Grand Island, Nebraska 68803

Nebraska Cancer Specialists
Omaha, Nebraska 68130-2042

Astera Cancer Care East Brunswick
East Brunswick, New Jersey 08816

Summit Medical Group
Florham Park, New Jersey 07932

Icahn School of Medicine at Mount Sinai
New York, New York 10029

Memorial Sloan Kettering Cancer Center
New York, New York 10065

Fairview Hospital
Cleveland, Ohio 44111

Cleveland Clinic Foundation
Cleveland, Ohio 44915

Hillcrest Hospital
Mayfield Heights, Ohio 44124

Providence Portland Medical Center
Portland, Oregon 97213

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

Bon Secours - St. Francis Hospital
Greenville, South Carolina 29607

West Cancer Center
Germantown, Tennessee 38138

Community Clinical Trials
Kingwood, Texas 77339

Swedish Cancer Institute - Edmonds Campus
Edmonds, Washington 98026

Providence Regional Cancer Partnership
Everett, Washington 98201-1621

Swedish Cancer Institute - Issaquah
Seattle, Washington 98104

Swedish Cancer Institute
Seattle, Washington 98104

Northwest Medical Specialties
Tacoma, Washington 98405

PanOncology Trials
San Juan, Puerto Rico 00935

More Details

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.