🏛️ Verified NIH Record • Updated 2026-08-03

RO7771950 Versus Tucatinib in Combination With Trastuzumab and Capecitabine in People With Locally Advanced or Metastatic Breast Cancer That is Human Epidermal Growth Factor Receptor 2 (HER2)-Positive (NCT07413939)

A Two-part, Seamless, Multicenter, Randomized, Open-label, Adaptive Phase II/III Study of the Blood-brain Barrier Penetrant RO7771950 Versus Tucatinib, Both in Combination With Trastuzumab and Capecitabine, in Patients With Pretreated Unresectable Locally Advanced or Metastatic HER2-Positive Breast Cancer, With or Without Central Nervous System Metastases

🟢 Recruiting Phase2 / Phase3 💊 Investigational Drug / Biologic Sponsor: Hoffmann-La Roche

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

The purpose of this study is to assess the efficacy and safety of RO7771950 in combination with trastuzumab and capecitabine, compared to tucatinib in combination with trastuzumab and capecitabine.

Who can join: Review the eligibility criteria below.

Location: The West Clinic, PC dba West Cancer Center — Germantown, Tennessee

Age range: 18 Years

📋 "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 (152 Sites)

Showing the first 25 of 152 sites.

  • The West Clinic, PC dba West Cancer Center — Germantown, Tennessee
  • Centro Médico Fleischer — Buenos Aires,
  • Investigaciones Clínicas Moleculares — Buenos Aires,
  • Instituto Alexander Fleming — Buenos Aires,
  • Fundación Respirar — CABA,
  • Hospital Provincial del Centenario — Rosario,
  • Centro Oncológico de Excelencia — San Juan,
  • Macquarie University Hospital — Macquarie Park, New South Wales
  • Monash Health — Clayton, Victoria
  • Barwon Health — Geelong, Victoria
  • Peter MacCallum Cancer Centre — Melbourne, Victoria
  • Sunshine Hospital — St Albans, Victoria
  • Lkh-Univ. Klinikum Graz — Graz,
  • Ordensklinikum Linz Barmherzige Schwestern — Linz,
  • Lkh Salzburg - Univ. Klinikum Salzburg — Salzburg,
  • Cliniques Universitaires St-Luc — Brussels,
  • Jessa Zkh (Campus Virga Jesse) — Hasselt,
  • AZ Groeninge — Kortrijk,
  • UZ Leuven Gasthuisberg — Leuven,
  • AZ St Maarten Campus Leopoldstr — Mechelen,
  • Clinique Ste-Elisabeth — Namur,
  • ZAS Sint Augustinus Wilrijk — Wilrijk,
  • Sunnybrook Odette Cancer Centre — Toronto, Ontario
  • Princess Margaret Cancer Center — Toronto, Ontario
  • Hopital Maisonneuve-Rosemont — Montreal, Quebec

📞 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.

💡 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 ↗