A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer

Part of paid clinical trials in Orange, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT07054190
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Inavolisib — DRUG
    Inavolisib will be administered as per the schedule specified in the arms
  • Ribociclib — DRUG
    Ribociclib will be administered as per the schedule specified in the arms
  • Letrozole — DRUG
    Letrozole will be administered as per the schedule specified in the arms

Study Details

This study will evaluate the safety and efficacy of inavolisib combination therapies in participants with untreated, PIK3CA-mutated, Stage II-III, estrogen receptor (ER)-positive, Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer (BC).

Key Dates

Start date
Sep 9, 2025
Status verified
May 2026
Primary completion
Jul 31, 2027
Completion
Sep 28, 2027

Study Design

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

Arms

  • Experimental: Arm A
    Participants will receive inavolisib and letrozole orally (PO) once a day (QD) from Day 1 to 28 and ribociclib PO QD from Day 1 to 21 in cycles 1-5 (each cycle=28 days). In cycle 6, inavolisib, ribociclib and letrozole will be administered PO QD on days 1-21 (each cycle=21 days).
  • Experimental: Arm B
    Participants will receive a starting regimen of inavolisib and letrozole PO QD from Day 1 to 28 in cycle 1 (each cycle=28 days). Starting on Day 1 of Cycle 2, all participants will receive the triplet regimen inavolisib + ribociclib + letrozole as follows: inavolisib and letrozole PO QD from Day 1 to 28 and ribociclib PO QD from Day 1 to 21 in cycles 2-5 (each cycle=28 days). In cycle 6, inavolisib, ribociclib and letrozole will be administered PO QD on days 1-21 (each cycle=21 days).
  • Experimental: Arm C
    Participants will receive a starting regimen of ribociclib PO QD from Day 1 to 21 and letrozole PO QD from Day 1 to 28 in cycle 1 (each cycle=28 days). Starting on Day 1 of Cycle 2, all participants will receive the triplet regimen inavolisib + ribociclib + letrozole as follows: inavolisib and letrozole PO QD from Day 1 to 28 and ribociclib PO QD from Day 1 to 21 in cycles 2-5 (each cycle=28 days). In cycle 6, inavolisib, ribociclib and letrozole will be administered PO QD on days 1-21 (each cycle=21 days).

Primary Outcome Measure

Percentage of Participants with Adverse Events (AEs) [ Time Frame: From first dose up to 30 days after last dose (approximately 8 months) ]

Central Contacts

  • Reference Study ID Number: BO45853 https://forpatients.roche.com/
    888-662-6728 (U.S. and Canada)
    [email protected]

Locations (1)

FacilityCityStateZIPSite coordinators
Community Clinical TrialsOrangeCalifornia92868-

Find similar trials in Orange, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Community Clinical Trials· Orange, CA

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