Recruiting
Phase 2

Inavolisib, Ribociclib, Fulvestrant

Sponsor:

Hoffmann-La Roche

Code:

NCT07405801

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Inavolisib

Ribociclib

Fulvestrant

Placebo

Study Details

Brief summary:

A study to evaluate the efficacy and safety of triplet combination of inavolisib plus ribociclib and fulvestrant versus placebo plus ribociclib and fulvestrant in the first-line setting in participants with endocrine-therapy-resistant hormone receptor (HR)-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC).

Conditions

Breast Cancer

Study ID

NCT07405801

Start date

Apr 7, 2026

Status verified date

Aug, 2026

Completion date

Feb 26, 2030

Anticipated

Primary completion date

Dec 19, 2028

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 that is locally advanced or metastatic and is not amenable to surgical or radiation therapy with curative intent
  • Documented estrogen receptor (ER)-positive and/or progesterone receptor (PR)-positive tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines, defined as >=1% of tumor cells stained positive based on the most recent tumor biopsy and assessed locally (Allison et al. 2020)
  • Participants must not have received any prior systemic therapy for locally advanced unresectable or metastatic breast cancer (mBC) and must have progressed during adjuvant endocrine-based treatment or within 12 months after completing adjuvant endocrine-based therapy with an aromatase inhibitor or tamoxifen
  • Confirmed biomarker eligibility as documented through central laboratory testing of a tumor tissue sample documenting both the lack of a phosphatidylinositol-4,5-biphosphate 3-kinase catalytic subunit alpha gene (PIK3CA) mutation and the presence of heterozygous loss of chromosome 8p (i.e., PIK3CAnmd and chr8p loss)
  • Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)

Exclusion Criteria:

  • Metaplastic breast cancer
  • Radiotherapy within 2 weeks before randomization
  • Appropriate for treatment with cytotoxic chemotherapy at time of entry into the study, as per national or local treatment guidelines (e.g., participants with visceral crisis)
  • Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
  • Known and untreated, or active Central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control). Participants with a history of treated CNS metastases are eligible
  • Any history of leptomeningeal disease or carcinomatous meningitis

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Inavolisib + Ribociclib + Fulvestrant

Participants will receive inavolisib, ribociclib and fulvestrant.

placebo comparator: Placebo + Ribociclib + Fulvestrant

Participants will receive placebo, ribociclib and fulvestrant.

Interventions

Inavolisib

Inavolisib will be administered as per the schedule mentioned in the protocol.

Ribociclib

Ribociclib will be administered as per the schedule mentioned in the protocol.

Fulvestrant

Fulvestrant will be administered as per the schedule mentioned in the protocol.

Placebo

Placebo will be administered as per the schedule mentioned in the protocol.

Primary outcome measure

  • Percentage of Participants With Confirmed Objective Response (cORR) [ Time Frame: Up to approximately 2 years ]

Central Contacts and Locations

Central contacts

Reference Study ID Number: CO46274 https://forpatients.roche.com/ No attachments to email below.

888-662-6728global-roche-genentech-trials@gene.com

Locations

Los Angeles Cancer Network - Anaheim

Recruiting

Anaheim, California, United States, 92805

Stanford Cancer Institute

Recruiting

Palo Alto, California, United States, 94304

Avera Cancer Institute - Marshall

Recruiting

Marshall, Minnesota, United States, 56258

Avera Cancer Institute - Aberdeen

Recruiting

Aberdeen, South Dakota, United States, 57401

Avera Cancer Institute - Mitchell

Recruiting

Mitchell, South Dakota, United States, 57301

Avera Cancer Institute - Pierre, SD

Recruiting

Pierre, South Dakota, United States, 57501

Avera Cancer Institute

Recruiting

Sioux Falls, South Dakota, United States, 57105

AMG Oncology and Hematology Avera Cancer Institute - Yankton

Recruiting

Yankton, South Dakota, United States, 57078

Ottawa General Hospital

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Sunnybrook Health Science Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

CIUSSS du Saguenay Lac-Saint-Jean, Chicoutimi Hospital

Recruiting

Chicoutimi, Quebec, Canada, G7H 5H6

McGill University

Recruiting

Montreal, Quebec, Canada, H4A 3J1

More Information

Sponsor

Hoffmann-La Roche

Last update posted

Aug 11, 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 2026-08-11.