BCTRCG

A National Retrospective Multicentre Audit, of Long Term Trastuzumab use in Metastatic Breast Cancer

Get involved: please email us at ALTRASTUDY2020@gmail.com

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Metastatic breast cancer is currently viewed as an incurable disease with patients requiring palliative treatments to allow them to live with their disease in addition to improving their survival. The addition of targeted anti-HER2 agents has changed the natural history of metastatic breast cancer for many of the 20% of patients with this subtype of disease. 

Currently, NICE guidance recommends continuation of trastuzumab until extra cranial progression or toxicity. However, with increasing evidence of complete remissions beyond 2 years of treatment in a sub population or HER2 positive metastatic breast cancer patients, this may need to be revisited and updated. A long-term responder is defined as achievement of stable disease, partial response or complete response after 2 years of trastuzumab. 

 

Primary Objective

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To identify the characteristics and clinical outcomes of long-term responders to trastuzumab who maintain a durable response.

 

Secondary objectives:

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1. To establish the overall survival of patients who are long-term responders to trastuzumab

2. To establish the progression-free survival of patients who are long-term responders to trastuzumab

3. To assess the frequency of complete radiological response to trastuzumab therapy

4. To assess the proportion of patients in complete remission after 5 years of treatment with trastuzumab

5. To assess the proportion of patients with cardiotoxicity

6. To assess the safety and tolerability of trastuzumab

7. To assess the current practice of trastuzumab in metastatic breast cancer against NICE guidelines

8. To assess the reasons for cessation of trastuzumab in metastatic breast cancer

 

Method

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This is a trainee collaborative project which will be co-ordinated by the ALTRA study steering group with guidance from the Breast Cancer Trainees Research Collaborative Group (BCTRCG).

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• Any breast unit providing trastuzumab for HER2 positive metastatic breast cancer as part of their routine management of breast cancer will be eligible to participate in this audit. Units will be invited to take part through the Association of Cancer Physicians (ACP), Royal College of Radiologists (RCR) and the NCRI Breast Clinical Studies Group (CSG). Identified patients should have been on trastuzumab for a minimum of 2 years.

 

• A local study lead, ideally a senior medical/ clinical oncology trainee will be identified at each centre. In units where no trainee is attached, the unit lead can be any regular member of the oncology team. If the identified lead is a trainee, they will be required to identify a supervising consultant to act as the local Principal Investigator (PI) for the study. Unit leads/PIs will be responsible for obtaining the support of other team members for data collection.

 

• Support will also be sought from the professional associations, including the Association of Cancer Physicians (ACP) and UK Breast Cancer Group (UKBCG). We will ask that the ACP encourage all MDTs where trastuzumab is utilised to support their trainees in this audit.

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