A 300-patient feasibility trial will test whether women with lymph-node-positive breast cancer can safely skip chemotherapy based on a genetic test result. The problem is that multi-parameter tests like Oncotype DX already help guide chemotherapy decisions for women whose cancer has not spread to lymph nodes, but the evidence is weaker for those with involved nodes. Without better data, many women receive chemotherapy they may not need, while others who would benefit might be undertreated. OPTIMA prelim directly addresses this gap by randomising patients with ER-positive, HER2-negative, node-positive tumours to either standard chemotherapy or test-directed treatment, where the Oncotype DX result determines whether chemotherapy is given. If the feasibility phase succeeds, the main trial will compare five-year relapse-free survival between test-directed and conventional treatment. If test-directed care proves non-inferior, the NHS could adopt a more precise approach that spares many women the side effects of unnecessary chemotherapy while still catching those who need it. The study also evaluates alternative multi-parameter tests against Oncotype DX, using cost-effectiveness analysis to select a candidate suitable for routine NHS use.
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"Multi-parameter" prognostic tests such as Oncotype DX are increasingly used to identify women with ER +ve HER2 -ve early breast cancer treated with endocrine therapy who are unlikely to benefit meaningfully from chemotherapy. The supporting evidence for predictive testing is retrospective and is strongest for women without nodal involvement. More evidence is needed, especially for patients with node positive disease. There is early evidence that other multi-parameter tests in development also have a predictive utility. OPTIMA will assess the value of multi-parameter tests in the NHS. OPTIMA prelim, the feasibility phase, will recruit 300 patients (with a 200 patient bridging extension to the main study). Eligible patients will have ER +ve HER2 -ve tumours with involved nodes (pN1-2). Patients will be randomised to standard treatment with chemotherapy or to have "test-directed treatment" with either the same chemotherapy or no chemotherapy, assigned according to the result of an Oncotype DX test. All patients will receive endocrine therapy. OPTIMA prelim has 3 objectives. (1) To establish whether randomisation to test-directed treatment is acceptable to patients and clinicians. This will be done through qualitative research by recording and analysing consultations when the trial is discussed with potential participants and with in-depth interviews with OPTIMA researchers and participants. (2) Alternative multi-parameter tests will be evaluated on all patients’ tumours and their performance will be compared to Oncotype DX using statistical and cost-effectiveness analysis to select a candidate test(s) appropriate for NHS use to be evaluated in the main trial. (3) The success of the main trial depends on efficient tumour sample collection and analysis to avoid treatment delays. The obstacles to this will be analysed in detail using a sample tracking database. The main study is an efficacy trial of 2-3 arms. It will compare 5-year relapse free survival of test-directed vs. conventional treatment with a non-inferiority hypothesis.
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