Does Performing a Confirmatory Tumour Biopsy in Patients with Metastatic Breast Cancer Alter their Management?

Official Title

Does Performing a Confirmatory Tumour Biopsy in Patients with Metastatic Breast Cancer Alter their Management? The DESTINY Trial

Summary:

The study aims to determine whether confirmatory biopsy at any point in a patient’s metastatic disease course, not just at diagnosis, alters patient management in women with metastatic breast cancer. It will also prospectively evaluate the impact of intervening lines of palliative systemic therapy (endocrine or chemotherapy) on the degree of discordance between ER, PR, and HER2 receptor status in the primary and metastatic tumours. This study may potentially change the approach to diagnosis and management of metastatic disease in breast cancer patients and may contribute to the development of a new standard of practice in the care of these patients. This study will also aid in determining the feasibility and patient acceptance of performing biopsies in all patients presenting with metastatic disease and allow investigators to explore the fundamental mechanisms of metastasis development where additional tissue is available that is not required for the primary endpoint of the study.

Trial Description

Primary Objective:

• To determine the effect of intervening lines of palliative systemic therapy on ER, PR and HER2 receptor concordance rates between primary and metastatic breast tumours.

Secondary Objectives:

• To determine whether confirmatory tumour biopsy at any time in a patient’s metastatic breast cancer course significantly alters their disease management
• To determine the feasibility and patient acceptance of performing biopsies in all patients presenting with metastatic disease.
• To explore the fundamental mechanisms of metastasis development where additional tissue is available that is not required for the primary endpoint of the study.

Patients with either a new clinical diagnosis of metastatic breast cancer, or who are discontinuing current palliative systemic therapy for MBC will be identified by their primary oncologist. Eligibility will then be assessed by performing medical history, physical examination, and blood tests to ensure the patient's safety in this study. Once patient eligibility and consent has been obtained, the primary oncologist caring for the patient will be surveyed prior to obtaining the tumour biopsy to determine his/her current treatment plan and the reasoning behind it. The patient will then be seen by either a general surgeon or interventional radiologist within one week, and a biopsy of the patient's metastatic lesion(s) will be obtained. The methods by which the biopsy is obtained will depend on its location. Tumour samples will be submitted in 10% formalin to pathology for review. Excess tumour tissue will be frozen for correlative studies exploring the mechanisms of metastasis development. After the biopsy has been completed, the patient will receive a questionnaire to complete about their experience and satisfaction. In addition, the primary oncologist will be surveyed again to determine if their treatment plan had changed based on the results of the biopsy. The patient's records may be accessed by the clinical coordinator of this study over the next one year to determine treatments they received and their progress on these treatments.