A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer (NCT07054190)

🧪 Interventions in This Study

• Inavolisib (DRUG)
• Ribociclib (DRUG)
• Letrozole (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Histologically confirmed operable or inoperable invasive Stage II-III BC according to American Joint Committee on Cancer (AJCC) TNM staging classification
2. Candidate for neoadjuvant treatment and considered appropriate for endocrine combination therapy
3. Willingness to undergo breast surgery (mastectomy or breast-conserving surgery) after neoadjuvant treatment (unless inoperable)
4. Documented ER-positive tumor in accordance with current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
5. Documented HER2-negative tumor in accordance with current ASCO/CAP guidelines
6. Documented Ki-67 score \>=5% as per local assessment
7. Confirmed PIK3CA mutation

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (33 Sites)

Showing the first 25 of 33 sites.

• Los Angeles Cancer Network — Los Angeles, California
• Community Clinical Trials — Orange, California
• West Cancer Center — Germantown, Tennessee
• West Virginia University — Morgantown, West Virginia
• Hospital Aleman de Buenos Aires — Buenos Aires,
• Centro Médico Fleischer — Buenos Aires,
• Centro Oncologico Korben — Ciudad Autonoma Buenos Aires,
• Hospital Araujo Jorge — Goiânia, Goiás
• Hospital do Cancer de Pernambuco - HCP — Recife, Pernambuco
• Irmandade Da Santa Casa de Misericordia de Porto Alegre — Porto Alegre, Rio Grande do Sul
• Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda — São Paulo, São Paulo
• Sunnybrook Odette Cancer Centre — Toronto, Ontario
• Centre Hospitalier de l'Universite de Montreal (CHUM) — Montreal, Quebec
• Jewish General Hospital — Montreal, Quebec
• McGill University Health Center — Montreal, Quebec
• Das Brustzentrum — Berlin,
• HELIOS Klinikum Berlin-Buch — Berlin,
• Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden — Dresden,
• Kliniken Essen-Mitte — Essen,
• Universitätsklinikum Heidelberg — Heidelberg,
• St. Vincenz-Krankenhaus GmbH Paderborn Frauen- und Kinderklinik St. Louise — Paderborn,
• HELIOS Klinikum Schwerin — Schwerin,
• Seoul National University Hospital — Seoul,
• Severance Hospital, Yonsei University Health System — Seoul,
• Asan Medical Center. — Seoul,

📞 Contact the Study Coordinator

Phone: (888) 662-6728

Email: global-roche-genentech-trials@gene.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.