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

Purpose

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).

Condition

  • Breast Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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, including 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

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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).
  • Drug: Inavolisib
    Inavolisib will be administered as per the schedule specified in the arms
    Other names:
    • GDC-0077
    • RO7113755
  • Drug: Ribociclib
    Ribociclib will be administered as per the schedule specified in the arms
  • Drug: Letrozole
    Letrozole will be administered as per the schedule specified in the arms
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).
  • Drug: Inavolisib
    Inavolisib will be administered as per the schedule specified in the arms
    Other names:
    • GDC-0077
    • RO7113755
  • Drug: Ribociclib
    Ribociclib will be administered as per the schedule specified in the arms
  • Drug: Letrozole
    Letrozole will be administered as per the schedule specified in the arms
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).
  • Drug: Inavolisib
    Inavolisib will be administered as per the schedule specified in the arms
    Other names:
    • GDC-0077
    • RO7113755
  • Drug: Ribociclib
    Ribociclib will be administered as per the schedule specified in the arms
  • Drug: Letrozole
    Letrozole will be administered as per the schedule specified in the arms

Recruiting Locations

Community Clinical Trials
Orange, California 92868

More Details

Status
Recruiting
Sponsor
Hoffmann-La Roche

Study Contact

Reference Study ID Number: BO45853 https://forpatients.roche.com/
888-662-6728 (U.S. and Canada)
global-roche-genentech-trials@gene.com