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NCT07405801 | RECRUITING | Breast Cancer

A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer
Sponsor:

Hoffmann-La Roche

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) with chromosome 8p loss (chr8p loss) and without PIK3CA mutation.

Condition or disease

Breast Cancer

Intervention/treatment

Inavolisib

Ribociclib

Fulvestrant

Placebo

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 80 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Patients With Endocrine- Resistant Hormone-Receptor-Positive, HER2-Negative Advanced Breast Cancer With Chromosome 8P Loss and Without a PIK3CA Mutation
Actual Study Start Date : 2026-03-31
Estimated Primary Completion Date : 2028-12-19
Estimated Study Completion Date : 2030-12-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer

Location Details

NCT07405801

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

Brazil, São Paulo

Research Clinic and Study Center for Gynecological and Breast Oncology Ltda

São Paulo, São Paulo, Brazil, 01317-000

RECRUITING

Canada, Quebec

CIUSSS du Saguenay Lac-Saint-Jean, Chicoutimi Hospital

Chicoutimi, Quebec, Canada, G7H 5H6

RECRUITING

Canada, Quebec

McGill University

Montreal, Quebec, Canada, H4A 3J1

RECRUITING

South Korea,

Soon Choon Hyang University Cheonan Hospital

My friend, Cheonan-si, South Korea, 31151

RECRUITING

South Korea,

Gachon University Gil Medical Center

Nam Dong-GU, South Korea, 21565

RECRUITING

South Korea,

Seoul National University Bundang Hospital

Seongnam-si, South Korea, 13605

RECRUITING

South Korea,

Seoul National University Hospital

Seoul, South Korea, 03080