🏛️ Verified NIH Record • Updated 2026-07-15

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

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

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Hoffmann-La Roche

🩺 Plain-English Summary (8th-Grade Level)

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).

Who can join: Review the eligibility criteria below.

Location: Los Angeles Cancer Network — Los Angeles, California

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 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.

Explore by condition: All Breast Cancer clinical trials

💡 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.
🏛️ View Official NIH Record ↗