Determinants of Acquired Endocrine Resistance in Metastatic Breast Cancer: A Pilot Study

Titre officiel

Determinants of Acquired Endocrine Resistance in Metastatic Breast Cancer: A Pilot Study

Sommaire:

Il s’agit d’une étude prospective monocentrique comportant l’analyse de l’ADN tumoral circulant (ADNtc) et du microbiome intestinal chez des patientes atteintes d’un cancer du sein métastatique suivant le traitement endocrinien de référence au moyen d’un inhibiteur de l’aromatase en association avec un inhibiteur de la kinase dépendante des cyclines 4 et 6 (KDC 4/6). Jusqu’à 20 patientes atteintes d’un cancer du sein métastatique à récepteurs des œstrogènes positifs (RO+) et à récepteur 2 du facteur de croissance épidermique humain négatif (HER2-) et présentant un indice fonctionnel de l’Eastern Cooperative Oncology Group (ECOG) de 0 ou 1 seront inscrites. Cette étude comprend la collecte et l’analyse d’échantillons de patientes et ne comporte aucune intervention thérapeutique.

Description de l'essai

Primary Outcome:

• Time to treatment failure

Secondary Outcome:

• Correlation between specific mutations in ctDNA and in archival tissue samples (where available from prior testing) with time to treatment failure
• Diversity and composition of the gut microbiome in patients with ER+ HER2- metastatic breast cancer
• Dietary factors and composition of the gut microbiome
• Overall survival

Endocrine therapies have been associated with an overall survival benefit in breast cancer and are the preferred initial treatment approach in patients with ER+, HER2- metastatic breast cancer. Unfortunately, resistance to endocrine therapies eventually develops in the metastatic setting and metastatic breast cancer remains an incurable disease. Endocrine resistance may develop as a result of alterations in estrogen signaling and metabolism pathways, which may be modulated by gut bacteria. In addition, genomic profiling of archival tissues and circulating tumour DNA (ctDNA) in ER+ breast cancer has identified multiple somatic molecular alterations that may mediate response to endocrine therapies. This study is designed to identify markers of endocrine resistance in ctDNA and the gut microbiome in patients with ER+ HER2- metastatic breast cancer.

Voir cet essai sur ClinicalTrials.gov