Optimal Personalised Treatment of early breast cancer using Multi-parameter Analysis.
It is normal clinical practice to offer several months of adjuvant chemotherapy to women with early breast cancer who have involved axillary lymph nodes. A recommendation for chemotherapy is incorporated into a number of guidelines.Recently however it has been argued that chemotherapy may have little effect on some subtypes of breast cancer which broadly are those which are estrogen receptor positive and HER2 negative with a low or intermediate risk of relapse. These patients already benefit substantially from hormone (or endocrine) therapies and the addition ofchemotherapy may provide no significant additional survival benefit. There is evidence that multiparameter pathologytests such as Oncotype DX may identify a population of patients who do not significantly benefit from chemotherapy despite being at risk of relapse as a result of tumour size or nodal involvement.The OPTIMA trial seeks to advance the development of personalised medicine in breast cancer by using multiparameterpathology tests to identify those women who are likely to benefit from chemotherapy sparing those who are unlikely to benefit. The study population would ordinarily be treated with a combination of chemotherapy and hormonetreatment. The trial compares the testdirected assignment to chemotherapy or not (plus hormone treatment) with standard practice chemotherapy (and hormone therapy) using an adaptive design. OPTIMA prelim is the preliminary phase of the study which will select the testing technology to be used in the main trial and demonstrate whether themain trial is feasible on the basis of: acceptability of randomisation to patients and clinicians; and demonstration that timely sample collection and performance of multiparameter assays is possible. The main study hypotheses are thatthe longterm outcome of test directed treatment is not inferior to standard treatment and is costeffective.
|PI Name||Rea - DW|
|Sponsor||University College London|
|Proposed End Date||30/04/2028|
|Study Run through CRF?||No|
|Target number of patients agreed to recruit||12|
|Recruitment so far||18|