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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

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
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).
  • 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

Los Angeles Cancer Network
Los Angeles, California 90017-4803

Community Clinical Trials
Orange, California 92868

West Cancer Center
Germantown, Tennessee 38138

West Virginia University
Morgantown, West Virginia 26506

More Details

Status
Recruiting
Sponsor
Hoffmann-La Roche

Study Contact

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

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.