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

May 22, 2026 updated by: Hoffmann-La Roche

A Phase II, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Neoadjuvant Treatment With Inavolisib Combinations in Patients With Untreated, Early-stage, PIK3CA-Mutated Breast Cancer

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1118AAT
        • Recruiting
        • Hospital Aleman de Buenos Aires
      • Buenos Aires, Argentina, C1414DRK
        • Recruiting
        • Centro Medico Fleischer
      • Ciudad Autonoma Buenos Aires, Argentina, C1426AGE
        • Recruiting
        • Centro Oncologico Korben
  • Brazil
    • Goiás
      • Goiânia, Goiás, Brazil, 74605-070
        • Recruiting
        • Hospital Araujo Jorge
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50040-000
        • Recruiting
        • Hospital do Cancer de Pernambuco - HCP
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-074
        • Recruiting
        • Irmandade da Santa Casa de Misericórdia de Porto Alegre
    • São Paulo
      • São Paulo, São Paulo, Brazil, 01317-000
        • Recruiting
        • Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Odette Cancer Centre
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • McGill University Health Center
      • Montreal, Quebec, Canada, H2X 0C2
        • Recruiting
        • Centre Hospitalier de l'Université de Montréal (CHUM)
      • Montreal, Quebec, Canada, H3T1E2
        • Recruiting
        • Jewish General Hospital
  • Germany
      • Berlin, Germany, 13125
        • Recruiting
        • Helios Klinikum Berlin-Buch
      • Berlin, Germany, 12623
        • Recruiting
        • Das Brustzentrum
      • Dresden, Germany, 01307
        • Recruiting
        • Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
      • Essen, Germany, 45136
        • Recruiting
        • Kliniken Essen-Mitte
      • Heidelberg, Germany, 69120
        • Recruiting
        • Universitätsklinikum Heidelberg
      • Paderborn, Germany, 33098
        • Recruiting
        • St. Vincenz-Krankenhaus GmbH Paderborn Frauen- und Kinderklinik St. Louise
      • Schwerin, Germany, 19055
        • Recruiting
        • HELIOS Klinikum Schwerin
  • South Korea
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
      • Seoul, South Korea, 03722
        • Recruiting
        • Severance Hospital, Yonsei University Health System
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center
      • Seoul, South Korea, 05505
        • Recruiting
        • Asan Medical Center.
  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic Barcelona
      • Barcelona, Spain, 08035
        • Recruiting
        • Vall d'Hebron Institute of Oncology (VHIO), Barcelona
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital General Universitario Gregorio Marañon
      • Salamanca, Spain, 37007
        • Recruiting
        • Hospital Clinico Universitario de Salamanca
      • Seville, Spain, 41009
        • Recruiting
        • Hospital Universitario Virgen Macarena
      • Valencia, Spain, 46010
        • Recruiting
        • Hospital Clinico Universitario de Valencia
  • United States
    • California
      • Orange, California, United States, 92868
        • Recruiting
        • Community Clinical Trials

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with Total Pathological Complete Response (pCR)
Time Frame: Up to approximately 8 months
Up to approximately 8 months
Percentage of Participants with Objective Response Rate (ORR), According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST v1.1)
Time Frame: Up to approximately 8 months
Up to approximately 8 months
Change From Baseline in Ki-67 Levels by Immunohistochemistry (IHC)
Time Frame: Baseline, Day 22 of Cycle 1 and at Surgery (up to approximately 8 months). One cycle = 28 days
Baseline, Day 22 of Cycle 1 and at Surgery (up to approximately 8 months). One cycle = 28 days
Percentage of Participants Reporting Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire
Time Frame: Up to approximately 8 months
Up to approximately 8 months
Percentage of Participants Reporting Each Response Option at Each Time Point for the Treatment Side-Effect Bother Item (GP5) From the Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire
Time Frame: Up to approximately 8 months
Up to approximately 8 months
Change from Baseline in Symptomatic Treatment-Related Toxicities as Assessed Through use of the PRO-CTCAE
Time Frame: Baseline, up to approximately 8 months
Baseline, up to approximately 8 months
Change from Baseline in Treatment Side-Effect Bother as Assessed Through use of the FACT-G GP5 Item
Time Frame: Baseline, up to approximately 8 months
Baseline, up to approximately 8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2025

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

September 28, 2027

Study Registration Dates

First Submitted

June 26, 2025

First Submitted That Met QC Criteria

July 7, 2025

First Posted (Actual)

July 8, 2025

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BO45853
  • 2024-518811-20-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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