Optimal Personalised Treatment of early breast cancer using Multi-parameter Analysis
Chief Investigator: Professor Rob Stein
Sponsor: UCL (University College London)
Funder: National Institute for Health Research Health Technology Assessment Programme (NIHR HTA)
Registration Number: ISRCTN42400492
Chemotherapy and hormone treatment are currently offered to many people as part of their breast cancer treatment. This is to reduce the chance of the cancer coming back. Chemotherapy is given as an injection, usually every three weeks over a few months. Hormone therapy is a daily tablet taken for five to ten years. Younger women may also have a monthly injection to stop menstrual periods.
Recently however it has been argued that chemotherapy may have little effect on the subtype of breast cancer that is broadly identified as being hormonally responsive without HER2 gene amplification/HER2 protein overexpression and with a low or intermediate grade. Recent research indicates that some people with this subtype of breast cancer may not benefit from chemotherapy, and would do just as well with hormone treatment alone.
The decision to offer chemotherapy, or not, is currently made using simple measurements such as the size of the tumour and the number of lymph nodes affected. These methods are not as good as we would like, which means that some patients may be given chemotherapy unnecessarily.
Tests have been developed to try to predict which people could avoid chemotherapy. The tests are performed on a sample of the tumour removed by the surgeon. There are several of these tests. More research is needed into how best to use all of these tests.
The aim of this study is to investigate whether a personalised decision about chemotherapy using these new tests can be made safely and effectively.
Everyone who takes part in this study will receive hormone therapy. Only some people who take part in this study will receive chemotherapy.
4500 patients (2250 patients per arm)
Invasive disease free survival (IDFS): non-inferiority of test-directed chemotherapy treatment and endocrine therapy compared to chemotherapy followed by endocrine treatment.
Cost effectiveness evaluation of protocol specified multi-parametric assay driven treatment against standard clinical practice.
Recruitment into the study is expected to last for 4 years. Participants will be followed-up for 10 years. The primary outcome analysis will be performed when all participants will have at least 3 years, median 5 years follow-up.