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NCT Number: NCT07054190

A Study to Test Inavolisib Treatments in Participants With 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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Centro Médico Fleischer, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inavolisib

Drug

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

Other names: GDC-0077, RO7113755

Ribociclib

Drug

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

letrozole

Drug

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

Primary outcomes

  1. Percentage of Participants with Adverse Events (AEs)

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

Secondary outcomes

  1. Percentage of Participants with Total Pathological Complete Response (pCR)

    Time frame: Up to approximately 8 months

  2. 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

  3. 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

  4. 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

  5. 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

  6. Change from Baseline in Symptomatic Treatment-Related Toxicities as Assessed Through use of the PRO-CTCAE

    Time frame: Baseline, up to approximately 8 months

  7. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

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

CONTACT

[email protected]

888-662-6728 (U.S. and Canada)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 8, 2025
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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