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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.