Inclusion criteria, exclusion criteria and study summary
The HER2-RADiCAL study is for patients with HER2-positive breast cancer who: -started their course of drug treatment (chemotherapy + trastuzumab + pertuzumab) before surgery; -have had breast surgery; -and have been found to have the best possible response to treatment (a “pathological complete response” or “pCR”). A pCR means that there were no remaining living cancer cells in tissue removed at surgery. We already know that such patients have good outcomes with only a small chance of the cancer returning, and so it is possible that the side effects and risks of continuing all of these treatments in combination could outweigh any benefit. The study will investigate whether a more personalised treatment plan can be offered, with the aim of allowing patients with a pCR to safely receive less drug treatment after surgery. Study participants will continue treatment with trastuzumab to complete 9 cycles (rather than 18), including the cycles given before surgery. No more pertuzumab or any type of chemotherapy will be given after surgery. Some patients may avoid receiving a type of drug called an anthracycline (where the anthracycline-containing chemotherapy component is deferred after surgery). Any other treatment that might have been recommended (like hormone therapy or radiotherapy) will be given as normal. Patients will be asked to donate tissue samples removed during routine biopsy procedures or surgery. No new tissue samples will be taken for research purposes. The HER2-RADiCAL study aims to recruit around 720 patients with HER2-positive breast cancer and a pCR, to test whether these patients can safely receive less trastuzumab, pertuzumab and chemotherapy after surgery. This reduction of drug treatment may not only benefit the patient, but also save NHS resources. Data from routine NHS records on all patients with HER2-positive breast cancer in the UK will be collected in addition to the study data to assess the cost-effectiveness of this response-adapted approach.