HER2CLIMB-05
Research type
Research Study
Full title
A randomized, double-blind, phase 3 study of tucatinib or placebo in combination with trastuzumab and pertuzumab as maintenance therapy for metastatic HER2+ breast cancer (HER2CLIMB-05)
IRAS ID
1004234
Contact name
Melanie Smitt
Contact email
Sponsor organisation
Seagen Inc.
Eudract number
2021-002491-39
Clinicaltrials.gov Identifier
Research summary
We are doing this study to test research how the study medication tucatinib works in combination with trastuzumab and pertuzumab, to treat Human Epidermal Growth Factor Receptor 2 (HER2) positive breast cancer and to identify what the side effects are.
HER2 is a protein involved in cell growth. Some cancers can either make more Human Epidermal Growth Factor Receptor 2 (HER2) than normal cells and so are HER2 positive, or have a different type of HER2 than usual i.e. a gene mutation of HER2. These are called HER2 alterations. The presence of these alterations may mean the cancer grows more quickly, spreads faster, or may affect the cancer’s response to standard treatments.
Standard treatment for advanced HER-2 positive breast cancer comprises chemotherapy alongside pertuzumab and trastuzumab. On completion of chemotherapy which is given for a variable duration pertuzumab and trastuzumab are continued normally indefinitely until they stop working or there are unacceptable side effects this is often referred to as the ‘maintenance’ phase of treatment . This study will be investigating the addition of tucatinib to the ‘maintenance’ phase of treatment.
There are two groups in this study. One group will receive tucatinib plus trastuzumab and pertuzumab whilst the other group will receive placebo plus trastuzumab and pertuzumab. The placebo looks just like tucatinib but does not have any active medication in it. Approximately 650 people will be allocated randomly. We will not know which group each participant belongs to until the end of the study.
The sponsor of this study is Seagen Inc., located in Bothell, Washington, United States of America. The sponsor will organise and pay for this study.
REC name
London - Harrow Research Ethics Committee
REC reference
22/LO/0033
Date of REC Opinion
4 Mar 2022
REC opinion
Further Information Favourable Opinion