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The HER2-RADiCAL study (Response ADaptive CAre pLan) – Tailoring treatment for HER2 positive early breast cancer

Disease site: Breast cancer

Treatment modality: Systemic therapy  

Status: Open to Recruitment

Trial details

HER2-RADiCAL is an interventional cohort study for patients with HER2-positive early breast cancer. The aim of the study is to determine the efficacy of response-adapted (reduced) therapy in patients who are found to have a pathological complete response (pCR) at surgery, following their course of treatment (chemotherapy, trastuzumab and pertuzumab).

What is a pathological complete response?

Tests on tissue removed at surgery can show if a patient's cancer is responding to the treatment in the neoadjuvant setting (i.e. before surgery). If these tests do not find any cancer cells in the breast or lymph glands from the armpit, this predicts a very high chance of cure for the patient, and is called a pathological complete response (pCR).

Eligibility

HER2-RADiCAL is a study for patients with HER2+EBC treated with neoadjuvant chemotherapy, pertuzumab and trastuzumab, who have a pCR at surgery. Eligible patients must not have received an anthracycline as part of their neoadjuvant treatment.

Study treatment

Participants receive less treatment compared with standard care by:

A) Receiving a total of 9 cycles (6 months) of trastuzumab, as opposed to 1 year

B) NOT receiving any further pertuzumab after surgery (if node positive)

C) NOT receiving any further chemotherapy, in particular, not receiving any anthracyclines

720 patients will be recruited from around 40 UK sites over a 3 year period. Patients will continue trastuzumab (initiated prior to surgery) to complete 9 cycles (around 6 months). Patients will not receive chemotherapy or pertuzumab after their surgery, and will be followed up for a further  5 years.

Further information

Chief Investigator: Dr Iain Macpherson, The University of Glasgow and Beatson West of Scotland Cancer Centre

ICR-CTSU Scientific Lead: Professor Judith Bliss

Trial management contact: her2radical-icrctsu@icr.ac.uk

Sponsor: The Institute of Cancer Research

Funding: NIHR HTA programme (NIHR131362)

lay summary in plain English is available from the National Institute for Health Research.

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