Recruiting
Phase 2

Inavolisib Combinations

Sponsor:

Hoffmann-La Roche

Code:

NCT07054190

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Inavolisib

Ribociclib

Letrozole

Giredestrant

Study Details

Brief summary:

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).

Conditions

Breast Cancer

Study ID

NCT07054190

Start date

Sep 9, 2025

Status verified date

Aug, 2026

Completion date

Sep 28, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Histologically confirmed operable or inoperable invasive Stage II-III BC according to American Joint Committee on Cancer (AJCC) TNM staging classification
  • Candidate for neoadjuvant treatment and considered appropriate for endocrine combination therapy
  • Willingness to undergo breast surgery (mastectomy or breast-conserving surgery) after neoadjuvant treatment (unless inoperable)
  • Documented ER-positive tumor in accordance with current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
  • Documented HER2-negative tumor in accordance with current ASCO/CAP guidelines
  • Documented Ki-67 score >=5% as per local assessment
  • Confirmed PIK3CA mutation

Exclusion Criteria:

  • Stage IV (metastatic) BC
  • Inflammatory BC (cT4d)
  • Bilateral invasive BC
  • History of ductal carcinoma in situ or lobular carcinoma in situ if they have received any systemic therapy for treatment or radiation therapy to the ipsilateral breast
  • Previous systemic or local treatment for the primary BC currently under investigation (including excisional biopsy or any other surgery of the primary tumor and/or axillary lymph nodes, and sentinel lymph node biopsy, radiotherapy, cytotoxic, and endocrine treatments)
  • Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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).

experimental: Arm D (non-randomized)

Participants will receive inavolisib and letrozole PO 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 E

Participants will receive inavolisib and giredestrant PO 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 giredestrant will be administered PO QD on days 1-21 (each cycle=21 days).

experimental: Arm F

Participants will receive a starting regimen of inavolisib and giredestrant 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 + giredestrant as follows: inavolisib and giredestrant 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 giredestrant will be administered PO QD on days 1-21 (each cycle=21 days).

experimental: Arm G

Participants will receive a starting regimen of ribociclib PO QD from Day 1 to 21 and giredestrant 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 + giredestrant as follows: inavolisib and giredestrant 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 giredestrant will be administered PO QD on days 1-21 (each cycle=21 days).

Interventions

Inavolisib

Inavolisib will be administered as per the schedule specified in the arms

Ribociclib

Ribociclib will be administered as per the schedule specified in the arms

Letrozole

Letrozole will be administered as per the schedule specified in the arms

Giredestrant

Giredestrant will be administered as per the schedule specified in the arms

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 and Locations

Central contacts

Reference Study ID Number: BO45853 https://forpatients.roche.com/ No attachments to email below.

888-662-6728 (U.S. and Canada)global-roche-genentech-trials@gene.com

Locations

Los Angeles Cancer Network

Recruiting

Los Angeles, California, United States, 90017-4803

Community Clinical Trials

Recruiting

Orange, California, United States, 92868

West Cancer Center

Recruiting

Germantown, Tennessee, United States, 38138

West Virginia University

Recruiting

Morgantown, West Virginia, United States, 26506

BC Cancer - Vancouver

Recruiting

Vancouver, British Columbia, Canada, V5Z 4E6

Sunnybrook Odette Cancer Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Centre Hospitalier de l'Universite de Montreal (CHUM)

Recruiting

Montreal, Quebec, Canada, H2X 0C2

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T1E2

McGill University Health Center

Recruiting

Montreal, Quebec, Canada, H4A 3J1

More Information

Sponsor

Hoffmann-La Roche

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-04. This information was provided to ClinicalTrials.gov by Hoffmann-La Roche on 2026-08-31.