Actionability of HER2-amplified circulating tumor cells in HER2-negative metastatic breast cancer: the CirCe T-DM1 trial.

ABSTRACT:

Background

In this prospective phase 2 trial, we assessed the efficacy of trastuzumab-emtansine (T-DM1) in HER2-negative metastatic breast cancer (MBC) patients with HER2-positive CTC.

Methods

Main inclusion criteria for screening were as follows: women with HER2-negative MBC treated with ≥ 2 prior lines of chemotherapy and measurable disease. CTC with a HER2/CEP17 ratio of ≥ 2.2 by fluorescent in situ hybridization (CellSearch) were considered to be HER2-amplified (HER2_amp). Patients with ≥ 1 HER2_amp CTC were eligible for the treatment phase (T-DM1 monotherapy). The primary endpoint was the overall response rate.

Results

In 154 screened patients, ≥ 1 and ≥ 5 CTC/7.5 ml of blood were detected in N = 118 (78.7%) and N = 86 (57.3%) patients, respec

SUBMITTER: Jacot W 

PROVIDER: S-EPMC6854749 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature