Recruiting
Phase 3

Inavolisib & CDK4/6 Inhibitor

Sponsor:

Hoffmann-La Roche

Code:

NCT06790693

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Inavolisib

Placebo

CDK4/6i

Letrozole

Study Details

Brief summary:

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).

Conditions

Breast Cancer

Study ID

NCT06790693

Start date

Apr 9, 2025

Status verified date

Aug, 2026

Completion date

May 30, 2032

Anticipated

Primary completion date

May 30, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

450 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Inavolisib + Letrozole + CDK4/6i

Participants will receive inavolisib, letrozole and CDK4/6i.

placebo comparator: Placebo + Letrozole + CDK4/6i

Participants will receive placebo, letrozole and CDK4/6i.

Interventions

Inavolisib

Participants will receive oral inavolisib once daily (QD).

Placebo

Participants will receive oral placebo QD.

CDK4/6i

Participants will receive CDK4/6i on either Days 1-21 or Days 1-28 of each 28-day cycle.

Letrozole

Participants will receive oral letrozole QD.

Primary outcome measure

  • Progression-Free Survival (PFS) [ Time Frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 7 years) ]

Central Contacts and Locations

Central contacts

Reference Study ID Number: WO45654 https://forpatients.roche.com/ No attachments to email below.

888-662-6728 (U.S. Only)global-roche-genentech-trials@gene.com

Locations

City of Hope - Phoenix

Recruiting

Goodyear, Arizona, United States, 85338

The Dignity Health Cancer Institute

Recruiting

Phoenix, Arizona, United States, 85004

Disney Family Cancer Center

Recruiting

Burbank, California, United States, 91505

City of Hope - Lennar Foundation Cancer Center

Recruiting

Irvine, California, United States, 92618

Scripps Health

Recruiting

La Jolla, California, United States, 92040

City Of Hope

Recruiting

Long Beach, California, United States, 90813

Cancer and Blood Specialty Clinic

Recruiting

Los Alamitos, California, United States, 90720

Ellison Institute of Technology

Recruiting

Los Angeles, California, United States, 90064

Palo Alto Medical Foundation Research Center

Recruiting

Palo Alto, California, United States, 94301

Kaiser Permanente - San Marcos

Recruiting

San Marcos, California, United States, 92069

Palo Alto Medical Foundation Research Center

Recruiting

San Mateo, California, United States, 94401

Palo Alto Medical Foundation Research Center

Recruiting

Sunnyvale, California, United States, 94086

Cancer Specialists of North Florida - Jacksonville

Recruiting

Jacksonville, Florida, United States, 32207

Tallahassee Memorial HealthCare

Recruiting

Tallahassee, Florida, United States, 32308

Moffitt Cancer Center-McKinley Campus

Recruiting

Tampa, Florida, United States, 33612

Cleveland Clinic Florida

Recruiting

Weston, Florida, United States, 33331

Northwest Georgia Oncology Centers PC - Marietta

Recruiting

Marietta, Georgia, United States, 30060

Cancer Care Specialists of Central Illinois

Recruiting

O'Fallon, Illinois, United States, 62269

Springfield Clinic

Recruiting

Springfield, Illinois, United States, 62702

Carle Cancer Center

Recruiting

Urbana, Illinois, United States, 61801

City of Hope® Cancer Center Chicago

Recruiting

Zion, Illinois, United States, 60099

Baptist Health Lexington

Recruiting

Lexington, Kentucky, United States, 40503

Baptist Health Hamburg

Recruiting

Lexington, Kentucky, United States, 40509

University of Kentucky - Markey Cancer Center

Recruiting

Lexington, Kentucky, United States, 40536

University of Louisville Hospital

Recruiting

Louisville, Kentucky, United States, 40202

Baptist Health Louisville

Recruiting

Louisville, Kentucky, United States, 40207

Velocity Clinical Research

Recruiting

Annapolis, Maryland, United States, 21401

University of Maryland

Recruiting

Baltimore, Maryland, United States, 21201

Henry Ford Health System

Recruiting

Detroit, Michigan, United States, 48202

Cancer & Hematology Centers of Western Michigan

Recruiting

Grand Rapids, Michigan, United States, 49503

University of Minnesota Medical Center

Recruiting

Minneapolis, Minnesota, United States, 55455

HCA Midwest Health

Recruiting

Kansas City, Missouri, United States, 64132

Nebraska Cancer Specialists

Recruiting

Grand Island, Nebraska, United States, 68803

Nebraska Cancer Specialists

Recruiting

Omaha, Nebraska, United States, 68130-2042

Astera Cancer Care East Brunswick

Recruiting

East Brunswick, New Jersey, United States, 08816

Summit Medical Group

Recruiting

Florham Park, New Jersey, United States, 07932

The Blavatnik Family ? Chelsea Medical Center at Mount Sinai

Recruiting

New York, New York, United States, 10011

Mount Sinai West

Recruiting

New York, New York, United States, 10019

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Duke Cancer Institute

Recruiting

Durham, North Carolina, United States, 27710

Fairview Hospital

Recruiting

Cleveland, Ohio, United States, 44111

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44915

Hillcrest Hospital

Recruiting

Mayfield Heights, Ohio, United States, 44124

Providence Portland Medical Center

Recruiting

Portland, Oregon, United States, 97213

Providence Oncology and Hematology Cancer Clinic - Westside;Investigation Drug Services Pharmacy

Recruiting

Portland, Oregon, United States, 97225

UPMC Hillman Cancer Center - Magee-Women?s Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Bon Secours - St. Francis Hospital

Recruiting

Greenville, South Carolina, United States, 29607

West Cancer Center

Recruiting

Germantown, Tennessee, United States, 38138

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37204

JPS Health Network

Recruiting

Fort Worth, Texas, United States, 76104

Community Clinical Trials

Recruiting

Spring, Texas, United States, 77389

Huntsman Cancer Hospital at the University of Utah

Recruiting

Salt Lake City, Utah, United States, 84113

Swedish Cancer Institute - Edmonds Campus

Recruiting

Edmonds, Washington, United States, 98026

Providence Regional Cancer Partnership

Recruiting

Everett, Washington, United States, 98201-1621

Swedish Cancer Institute - Issaquah

Recruiting

Seattle, Washington, United States, 98104

Swedish Cancer Institute

Recruiting

Seattle, Washington, United States, 98104

Northwest Medical Specialties

Recruiting

Tacoma, Washington, United States, 98405

Arthur J.E. Child Comprehensive Cancer Center

Recruiting

Calgary, Alberta, Canada, T2N 4C2

Cross Cancer Institute

Recruiting

Edmonton, Alberta, Canada, T6G 1Z2

CancerCare Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3E 0V9

The Moncton Hospital

Recruiting

Moncton, New Brunswick, Canada, E1C 6Z8

The Ottawa Hospital Cancer Center

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Sault Area Hospital

Recruiting

Sault Ste. Marie, Ontario, Canada, P6B 0A8

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

St. Joseph's Health Centre

Recruiting

Toronto, Ontario, Canada, M6R 1B5

Centre Hospitalier de l'Universite de Montreal (CHUM)

Recruiting

Montreal, Quebec, Canada, H2X 0C1

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1E2

Hôpital du Sacré-Coeur de Montreal

Recruiting

Montreal, Quebec, Canada, H4J 1C5

Unité de Recherche Clinique du CISSS de Laurentides

Recruiting

Saint-Jérôme, Quebec, Canada, J7Z 2V4

More Information

Sponsor

Hoffmann-La Roche

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-04. This information was provided to ClinicalTrials.gov by Hoffmann-La Roche on 2026-08-05.