A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer
Recruiting now · Phase 2
Conditions studied: Breast Cancer
In brief
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).
Key facts
- Study ID
- NCT07054190
- Run by
- Hoffmann-La Roche
- People needed
- 60
- Starts
- 2025-09-09
- Expected to finish
- 2027-09-28
- Last updated by the study team
- 2026-07-16
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
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
Where it is running
- Los Angeles Cancer Network — Los Angeles, California, United States (enrolling)
- Community Clinical Trials — Orange, California, United States (enrolling)
- West Cancer Center — Germantown, Tennessee, United States (enrolling)
- West Virginia University — Morgantown, West Virginia, United States (enrolling)
- Hospital Aleman de Buenos Aires — Buenos Aires, Argentina (enrolling)
- Centro Médico Fleischer — Buenos Aires, Argentina (enrolling)
- Centro Oncologico Korben — Ciudad Autonoma Buenos Aires, Argentina (enrolling)
- Hospital Araujo Jorge — Goiânia, Goiás, Brazil (enrolling)
- Hospital do Cancer de Pernambuco - HCP — Recife, Pernambuco, Brazil (enrolling)
- Irmandade Da Santa Casa de Misericordia de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil (enrolling)
- Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda — São Paulo, São Paulo, Brazil (enrolling)
- Sunnybrook Odette Cancer Centre — Toronto, Ontario, Canada (enrolling)
- Centre Hospitalier de l'Universite de Montreal (CHUM) — Montreal, Quebec, Canada (enrolling)
- Jewish General Hospital — Montreal, Quebec, Canada (enrolling)
- McGill University Health Center — Montreal, Quebec, Canada (enrolling)
- Das Brustzentrum — Berlin, Germany (enrolling)
- HELIOS Klinikum Berlin-Buch — Berlin, Germany (enrolling)
- Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden — Dresden, Germany (enrolling)
- Kliniken Essen-Mitte — Essen, Germany (enrolling)
- Universitätsklinikum Heidelberg — Heidelberg, Germany (enrolling)
- St. Vincenz-Krankenhaus GmbH Paderborn Frauen- und Kinderklinik St. Louise — Paderborn, Germany (enrolling)
- HELIOS Klinikum Schwerin — Schwerin, Germany (enrolling)
- Seoul National University Hospital — Seoul, South Korea (enrolling)
- Severance Hospital, Yonsei University Health System — Seoul, South Korea (enrolling)
- Asan Medical Center. — Seoul, South Korea (enrolling)
Full record on ClinicalTrials.gov
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