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

• Status: Completed
• Trial end date: 2019-01-21
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut Curie
• Treatments: Ado-trastuzumab emtansine; Maytansine; Trastuzumab

Criteria

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