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

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.

Trial Details

NCT ID

NCT07405801

Phase

PHASE2

Sponsor

Hoffmann-La Roche

Status

RECRUITING

Cancer Type

HER2 Negative Breast Cancer

Interventions

Inavolisib
Ribociclib
Fulvestrant
Placebo

Locations (sample)

Marshall, Minnesota, United States|44.4469,-95.78835
Aberdeen, South Dakota, United States|45.4647,-98.48648
Mitchell, South Dakota, United States|43.70943,-98.0298
Pierre, South Dakota, United States|44.36832,-100.35097
Sioux Falls, South Dakota, United States|43.54369,-96.72796

Key Eligibility Criteria

Women or men with histologically or cytologically confirmed carcinoma of the breast that is locally advanced or metastatic and is not amenable to s…
Documented estrogen receptor (ER)-positive and/or progesterone receptor (PR)-positive tumor according to American Society of Clinical Oncology/Coll…
Participants must not have received any prior systemic therapy for locally advanced unresectable or metastatic breast cancer (mBC) and must have pr…
Confirmed biomarker eligibility as documented through central laboratory testing of a tumor tissue sample documenting both the lack of a phosphatid…

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find HER2 Negative Breast Cancer Trials on Trialify →