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

Titre officiel

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

Sommaire:

L’étude a pour but de déterminer si une biopsie de confirmation effectuée à n’importe quel moment au cours d’une maladie métastatique, pas seulement au moment du diagnostic, modifie le traitement des patientes atteintes d’un cancer du sein métastatique. L’étude vise également à évaluer prospectivement les effets d’un traitement palliatif général (traitement endocrinien ou chimiothérapie) sur le degré de divergence en ce qui concerne le statut à l’égard des récepteurs aux œstrogènes, à la progestérone et HER2 dans les tumeurs primitives et métastatiques. Cette étude pourrait changer la méthode de diagnostic et de traitement de la maladie métastatique chez les patientes atteintes du cancer du sein et contribuer à l’élaboration d’une nouvelle norme de pratique de soins pour ces patientes. L’étude permettra de déterminer s’il est possible d’effectuer des biopsies chez toutes les patientes atteintes d’un cancer du sein métastatique et si celles-ci consentent à la biopsie. Elle permettra également aux chercheurs d’étudier les mécanismes fondamentaux de la formation des métastases lorsqu’ils disposeront de tissu non utilisé pour le critère d’évaluation primaire de l’étude.

Description de l'essai

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.