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

RecruitingPhase 2Ages 18 Years - anyFemaleHoffmann-La Roche
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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, and 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
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What it tests

  • Inavolisib
  • Ribociclib
  • Letrozole
  • Giredestrant
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Where

37 sites
Los Angeles Cancer Network
Los Angeles, United States
Community Clinical Trials
Orange, United States
West Cancer Center
Germantown, United States
Texas Oncology - Central South
Austin, United States
Texas Oncology - Northeast Texas
Flower Mound, United States
West Virginia University
Morgantown, United States
Hospital Aleman de Buenos Aires
Buenos Aires, Argentina
Centro Médico Fleischer
Buenos Aires, Argentina

…and 29 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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