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

Purpose

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).

Condition

  • Breast Cancer

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 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

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Inavolisib + Ribociclib + Fulvestrant 		Participants will receive inavolisib, ribociclib and fulvestrant.
  • Drug: Inavolisib
    Inavolisib will be administered as per the schedule mentioned in the protocol.
  • Drug: Ribociclib
    Ribociclib will be administered as per the schedule mentioned in the protocol.
  • Drug: Fulvestrant
    Fulvestrant will be administered as per the schedule mentioned in the protocol.
Placebo Comparator
Placebo + Ribociclib + Fulvestrant 		Participants will receive placebo, ribociclib and fulvestrant.
  • Drug: Ribociclib
    Ribociclib will be administered as per the schedule mentioned in the protocol.
  • Drug: Fulvestrant
    Fulvestrant will be administered as per the schedule mentioned in the protocol.
  • Drug: Placebo
    Placebo will be administered as per the schedule mentioned in the protocol.

Recruiting Locations

Avera Cancer Institute - Marshall
Marshall, Minnesota 56258

Avera Cancer Institute - Aberdeen
Aberdeen, South Dakota 57401

Avera Cancer Institute - Mitchell
Mitchell, South Dakota 57301

Avera Cancer Institute - Pierre, SD
Pierre, South Dakota 57501

Avera Cancer Institute
Sioux Falls, South Dakota 57105

AMG Oncology and Hematology Avera Cancer Institute - Yankton
Yankton, South Dakota 57078

More Details

Status
Recruiting
Sponsor
Hoffmann-La Roche

Study Contact

Reference Study ID Number: CO46274 https://forpatients.roche.com/
888-662-6728
global-roche-genentech-trials@gene.com