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

Part of paid clinical trials in Anaheim, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT07405801
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Inavolisib — DRUG
    Inavolisib will be administered as per the schedule mentioned in the protocol.
  • Ribociclib — DRUG
    Ribociclib will be administered as per the schedule mentioned in the protocol.
  • Fulvestrant — DRUG
    Fulvestrant will be administered as per the schedule mentioned in the protocol.
  • Placebo — DRUG
    Placebo will be administered as per the schedule mentioned in the protocol.

Study Details

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).

Key Dates

First listed
Feb 12, 2026
Start date
Apr 7, 2026
Status verified
Aug 2026
Primary completion
Dec 19, 2028
Completion
Feb 26, 2030

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Inavolisib + Ribociclib + Fulvestrant
    Participants will receive inavolisib, ribociclib and fulvestrant.
  • Placebo Comparator: Placebo + Ribociclib + Fulvestrant
    Participants will receive placebo, ribociclib and fulvestrant.

Primary Outcome Measure

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

Central Contacts

  • Reference Study ID Number: CO46274 https://forpatients.roche.com/ No attachments to email below.
    888-662-6728
    [email protected]
  • Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Locations (8)

FacilityCityStateZIPSite coordinators
Los Angeles Cancer Network - AnaheimAnaheimCalifornia92805-
Stanford Cancer InstitutePalo AltoCalifornia94304-
Avera Cancer Institute - MarshallMarshallMinnesota56258-
Avera Cancer Institute - AberdeenAberdeenSouth Dakota57401-
Avera Cancer Institute - MitchellMitchellSouth Dakota57301-
Avera Cancer Institute - Pierre, SDPierreSouth Dakota57501-
Avera Cancer InstituteSioux FallsSouth Dakota57105-
AMG Oncology and Hematology Avera Cancer Institute - YanktonYanktonSouth Dakota57078-

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