WO46069- RO7771950 versus Tucatinib in Breast Cancer

• Research type

  Research Study

• Full title

  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

• IRAS ID

  1013386

• Contact name

  N/A N/A

• Contact email

  medinfo.uk@roche.com

• Sponsor organisation

  F. Hoffmann-La Roche AG

• Eudract number

  2025-524498-17

• Clinicaltrials.gov Identifier

  NCT07413939

• Research summary

  Breast cancer is the most common non-cutaneous malignancy diagnosed among females. With 2.3 million new cases and 670,000 deaths due to metastatic progression occurring in 2022, it remains the leading cause of cancer-related death in females and a major contributor to the global cancer. HER2-positive breast cancer is more likely to spread to the brain than HER2-negative breast cancer. Because of this, researchers are looking for better treatment options for people whose cancer has spread to the brain. RO7771950 has a unique property in that is able to cross the blood, brain barrier and achieve significantly higher cerebrospinal fluid (CSF) penetration and efficient retention. Consequently, RO7771950 levels in the CSF can reach plasma comparable concentrations leading to superior tumor suppression in HER2 positive breast cancer.

  The purpose of this study is to compare the effects, good or bad, of two different dose levels of RO7771950 plus trastuzumab and capecitabine, versus tucatinib plus trastuzumab and capecitabine on patients with advanced breast cancer. In particular, the study will assess which dose level of RO7771950 could be used to treat people with HER2-positive breast cancer and whether RO7771950 plus trastuzumab and capecitabine will decrease the chances of breast cancer getting worse compared to tucatinib plus trastuzumab and capecitabine.
  18 participants will take part in this study in the UK and Approximately 234 participants will take part in Stage 1 and 416 participants will take part in Stage 2 of this study worldwide.

  The study is sponsored by F. Hoffmann- La Roche
  
  Research Summary; Version Number 1 and date 6th November 2025

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  26/NE/0016

• Date of REC Opinion

  12 Mar 2026

• REC opinion

  Further Information Favourable Opinion