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

Institut Curie

Status and phase: Completed; Phase 2

Conditions: Metastatic Breast Cancer, HER2 Negative Primary Tumor

Treatments: Drug: Trastuzumab - Emtansine

Study type: Interventional

Funder types: Other

Identifiers

NCT01975142

IC 2013-03

Details and patient eligibility

About

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.

Enrollment: 155 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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155 participants in 1 patient group

TDM-1

Experimental group

Treatment:

Drug: Trastuzumab - Emtansine