ICORG 11-10/TH v THL
Research type
Research Study
Full title
ICORG 11-10/TH v THL: A phase III randomized study of TH (Paclitaxel and Trastuzumab) versus THL (Paclitaxel, Trastuzumab and Lapatinib) in first line treatment of HER2-positive metastatic breast cancer.
IRAS ID
122834
Contact name
Peter Schmid
Contact email
Sponsor organisation
All Ireland Cooperative Oncology Research Group (ICORG)
Eudract number
2011-005189-39
Clinicaltrials.gov Identifier
Research summary
Patients taking part in this study will have a particular type of breast cancer that is positive for a protein called HER2 and has spread beyond the breast into other parts of the body (ie. advanced disease).
Patients with this type of ’HER2 positive’ advanced breast cancer would normally receive chemotherapy and a drug called trastuzumab. Trastuzumab specifically targets the HER2 protein and slows the growth of this type of cancer. However, not all patients respond to trastuzumab and those who do can develop resistance.
The ICORG 11-10 study will investigate whether a drug called lapatinib, when used in combination with trastuzumab and chemotherapy, will help to slow the progression of advanced HER2 positive breast cancer. Lapatinib also targets the HER2 protein, but in a different way to trastuzumab. The hypothesis of the trial is that the two targeted treatments will work in a complimentary manner.
Patients eligible to take part will be females over the age of 18 who have HER2 positive breast cancer that has spread beyond the breast (advanced disease). All patients in the UK will participate via NHS hospitals.
Patients will be allocated randomly to one of two treatment groups. Patients in Group A will receive trastuzumab in combination with a chemotherapy drug called paclitaxel and patients in Group B will receive trastuzumab, paclitaxel and lapatinib. Once randomised to one of the two groups, patients will take the trial treatments until they no longer benefit from them (ie. their disease progresses) or they experience side effects which requires them to withdraw from the study.
Patients in both groups will visit hospital for administration of drugs (paclitaxel and trastuzumab) intravenously (through a vein) three times a month (weeks 1, 2 and 3). Patients in Group B will also take lapatinib tablets every day.
REC name
London - City & East Research Ethics Committee
REC reference
13/LO/1505
Date of REC Opinion
20 Dec 2013
REC opinion
Further Information Favourable Opinion