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

NCT07054190 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: BO458532024-518811-20-00
• Study Type: interventional
• Target: 60
• Locations: 7 countries
• Sites: 30

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants with Adverse Events (AEs)

  From first dose up to 30 days after last dose (approximately 8 months)

Secondary Outcomes (7)

• Percentage of Participants with Total Pathological Complete Response (pCR)

  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)

  Up to approximately 8 months

• Change From Baseline in Ki-67 Levels by Immunohistochemistry (IHC)

  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

  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

  Up to approximately 8 months

Study Arms (3)

Arm A

EXPERIMENTAL

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; Drug: Ribociclib; Drug: Letrozole

Arm B

EXPERIMENTAL

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; Drug: Ribociclib; Drug: Letrozole

Arm C

EXPERIMENTAL

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; Drug: Ribociclib; Drug: Letrozole

Interventions

Inavolisib DRUG

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

Also known as: GDC-0077, RO7113755

Arm A; Arm B; Arm C

Ribociclib DRUG

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

Arm A; Arm B; Arm C

Letrozole DRUG

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

Arm A; Arm B; Arm C

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (30)

Community Clinical Trials

Orange, California, 92868, United States

RECRUITING

Hospital Aleman de Buenos Aires

Buenos Aires, C1118AAT, Argentina

RECRUITING

Centro Médico Fleischer

Buenos Aires, C1414DRK, Argentina

RECRUITING

Centro Oncologico Korben

Ciudad Autonoma Buenos Aires, C1426AGE, Argentina

RECRUITING

Hospital Araujo Jorge

Goiânia, Goiás, 74605-070, Brazil

RECRUITING

Hospital do Cancer de Pernambuco - HCP

Recife, Pernambuco, 50040-000, Brazil

RECRUITING

Irmandade Da Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-074, Brazil

RECRUITING

Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda

São Paulo, São Paulo, 01317-000, Brazil

RECRUITING

Sunnybrook Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec, H2X 0C2, Canada

RECRUITING

Jewish General Hospital

Montreal, Quebec, H3T1E2, Canada

RECRUITING

McGill University Health Center

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

Das Brustzentrum

Berlin, 12623, Germany

RECRUITING

HELIOS Klinikum Berlin-Buch

Berlin, 13125, Germany

RECRUITING

Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden

Dresden, 01307, Germany

RECRUITING

Kliniken Essen-Mitte

Essen, 45136, Germany

RECRUITING

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

RECRUITING

St. Vincenz-Krankenhaus GmbH Paderborn Frauen- und Kinderklinik St. Louise

Paderborn, 33098, Germany

RECRUITING

HELIOS Klinikum Schwerin

Schwerin, 19055, Germany

RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

RECRUITING

Asan Medical Center.

Seoul, 05505, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Vall d'Hebron Institute of Oncology (VHIO), Barcelona

Barcelona, 08035, Spain

RECRUITING

Hospital Clinic Barcelona

Barcelona, 08036, Spain

RECRUITING

Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Hospital Clinico Universitario de Salamanca

Salamanca, 37007, Spain

RECRUITING

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

RECRUITING

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

inavolisib; ribociclib; Letrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: BO45853 https://forpatients.roche.com/

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 8, 2025
• Study Start: September 9, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): September 28, 2027
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1); AR (3); DE (7); ES (7); BR (4); KR (4); CA (4)