MO42319:TDM-1 with Atezolizumab or Placebo in Her2+,PDL1+ mBC patients
Research type
Research Study
Full title
A RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE III STUDY OF THE EFFICACY AND SAFETY OF TRASTUZUMAB EMTANSINE IN COMBINATION WITH ATEZOLIZUMAB OR PLACEBO IN PATIENTS WITH HER2-POSITIVE AND PD-L1-POSITIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER WHO HAVE RECEIVED PRIOR TRASTUZUMAB- (+/- PERTUZUMAB) AND TAXANE-BASED THERAPY (KATE3)
IRAS ID
292475
Contact name
Head, EU/ROW Regulatory Affairs Pharmaceutical Division, PDR
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2020-002818-41
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 10 months, 3 days
Research summary
Breast cancer is the most common cancer among women in the world. While advances in early diagnosis and adjuvant therapy have led to a decrease in mortality rates, the prevalence of metastatic breast cancer (MBC) is still high. MBC is not considered curable and median overall survival (OS) ranges from approximately 1 year to approximately 5 years.
Treatment choices are generally guided by disease characteristics (e.g., HER2/hormone receptor status), location and number of metastatic sites, treatment history and potential toxicity with the main goals of improving quality of life and prolonging survival. There is a significant need for new agents with novel mechanisms of action and acceptable toxicity, which can be combined with established treatments for breast cancer to improve survival.
Trastuzumab emtansine is a drug that combines a chemotherapy drug (DM1) with trastuzumab. Trastuzumab is a man-made antibody that attaches to HER2 on the surface of cancer cells. HER2, or human epidermal growth factor 2, is a protein that is over produced by breast cancer cells and is a prominent target in breast cancer. Trastuzumab emtansine has been globally approved for the treatment of HER2-positive MBC.
Atezolizumab, another man-made antibody affects the immune system by blocking the programmed death-ligand 1 (PD-L1) pathway. By blocking this pathway, atezolizumab may help the immune system to stop or reverse the growth of tumours. Atezolizumab has been globally approved for the treatment of PDL1-positive MBC in combination with chemotherapy (nab-paclitaxel).
This is a Global Phase 3 study to evaluate the efficacy and safety of trastuzumab emtansine combined with atezolizumab or placebo in HER2-positive, PDL1-positive MBC patients.
Approximately 350 patients will be enrolled and receive treatment every 3 weeks until disease progression, intolerable toxicity or withdrawal of consent.
8 UK sites will participate in this study sponsored by F.Hoffmann-La Roche.REC name
London - Brent Research Ethics Committee
REC reference
21/LO/0179
Date of REC Opinion
3 Mar 2021
REC opinion
Favourable Opinion