Validity of HER2-amplified Circulating Tumor Cells to Select Metastatic Breast Cancer Considered HER2-negative for Trastuzumab-emtansine (T-DM1) Treatment.

Phase 2CompletedNCT01975142

Institut Curie155 enrolled

Overview

Patients with metastatic breast cancer considered HER2 negative are screened for HER2-amplified circulating tumor cells. If at least HER2-amplified circulating tumor cell is detected, patients are treated by Trastuzumab - Emtansine (T-DM1) in a single arm phase II with an adaptive design.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

155

Conditions

Metastatic Breast Cancer, HER2 Negative Primary Tumor

Interventions

Trastuzumab - EmtansineDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: Inclusion criteria for screening: * Breast adenocarcinoma considered HER2-negative on the primary tumour or unknown status HER2 * A least one metastatic site and/or inoperable loco-regional relapse * Measurable disease (RECIST v1.1) * Age from 18 to 75 years * Performance status of 0-2 * Efficient contraceptive in non-menopause women Inclusion criteria for treatment : * At least 1 (Cohort " L ") or 3 (cohort " H ") HER2 amplified CTC * Performance status of 0-2 * Adequate cardiac function * Adequate hematological and biochemical blood tests Exclusion Criteria: * Life expectancy of less than 3 months * Previous history of any other stage III or IV invasive cancer * Male breast cancer * Uncontrolled brain metastases * Significant cumulated exposure to anthracyclines * Current or previous significant history of cardio-vascular/pulmonary disease * Previous use of trastuzumab

Locations (10)

Clinique Victor Hugo

Le Mans, France

Institut de Cancérologie HARTMANN

Levallois-Perret, France

Centre Oscar Lambret

Lille, France

Chu de Limoges

Limoges, France

Outcomes

Primary Outcomes

Tumor response rate to T-DM1 in patients with HER2 amplified circulating tumor cells

Assessment every 6 weeks.

Time frame: Until disease progression (estimated duration : 1 year)

Secondary Outcomes

Detection rate of HER2 amplified circulating tumor cells, heterogeneity rate between circulating tumor cells and correlations with patient characteristics

Time frame: 1 month

Technical failure rate and reproducibility of HER2 FISH on circulating tumor cells

Time frame: 1 month

Correlation between HER2 FISH and immunofluorescence on circulating tumor cells

Time frame: 1 month

Progression-free survival

Time frame: 4 years

Disease control rate (responses and stable diseases)

Time frame: Until disease progression (estimated duration : 1 year)

Correlation between treatment efficacy and HER2 FISH results (level of amplification, absolute number and percentage of amplified cells)

Time frame: Until disease progression (estimated duration : 1 year)

Changes in CTC numbers during treatment

Time frame: Until disease progression (estimated duration : 1 year)

Circulating tumor DNA before and during treatment

Time frame: Until disease progression (estimated duration : 1 year)

Treatment toxicity

Data from ClinicalTrials.gov

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