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🏛️ Verified NIH Protocol • Sourced via U.S. National Library of Medicine (Last Synced: 2026-07-16)

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

🟢 Recruiting Phase 2 💊 Investigational Drug / Biologic Sponsor: Hoffmann-La Roche

🩺 Protocol 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).

Primary Research Facility: Los Angeles Cancer Network (Los Angeles, California)

📋 Preliminary Self-Screener

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📍 Primary Site Map

Site: Los Angeles Cancer Network — Los Angeles, California

📍 All Participating Trial Locations (33 Sites)

Multi-Center Trial

This protocol is enrolling participants across multiple clinical centers:

1. Los Angeles Cancer Network — Los Angeles, California
2. Community Clinical Trials — Orange, California
3. West Cancer Center — Germantown, Tennessee
4. West Virginia University — Morgantown, West Virginia
5. Hospital Aleman de Buenos Aires — United States
6. Centro Médico Fleischer — United States
7. Centro Oncologico Korben — United States
8. Hospital Araujo Jorge — Goiânia, Goiás
9. Hospital do Cancer de Pernambuco - HCP — Recife, Pernambuco
10. Irmandade Da Santa Casa de Misericordia de Porto Alegre — Porto Alegre, Rio Grande do Sul
11. Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda — São Paulo, São Paulo
12. Sunnybrook Odette Cancer Centre — Toronto, Ontario
13. Centre Hospitalier de l'Universite de Montreal (CHUM) — Montreal, Quebec
14. Jewish General Hospital — Montreal, Quebec
15. McGill University Health Center — Montreal, Quebec
16. Das Brustzentrum — United States
17. HELIOS Klinikum Berlin-Buch — United States
18. Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden — United States
19. Kliniken Essen-Mitte — United States
20. Universitätsklinikum Heidelberg — United States
21. St. Vincenz-Krankenhaus GmbH Paderborn Frauen- und Kinderklinik St. Louise — United States
22. HELIOS Klinikum Schwerin — United States
23. Seoul National University Hospital — United States
24. Severance Hospital, Yonsei University Health System — United States
25. Asan Medical Center. — United States

📄 Print Doctor Discussion Sheet

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💰 Clinical Trial Costs & Insurance Coverage

Coverage for clinical trial participation varies depending on your health insurance policy, state legislation, and whether specific procedures are investigational research or routine medical care. Under federal law (Affordable Care Act § 2709), health insurers generally cannot drop coverage or refuse to pay for routine patient care costs incurred in approved clinical trials.

💡 Always ask the study coordinator for the trial's official Informed Consent Form, which outlines all sponsor-funded research items versus procedures billed to your insurance.

🏛️ Official Government Provenance

NIH ClinicalTrials.gov Protocol Record

NCT Identifier: NCT07054190 • Last Synced: 2026-07-16
View on ClinicalTrials.gov ↗
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