NCT01975142

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: Institut Curie · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Breast Cancer, HER2 Negative Primary Tumor

Interventions

Type	Name	Description
DRUG	Trastuzumab - Emtansine

Timeline

• Start date: 2013-11-07
• Primary completion: 2018-02-13
• Completion: 2019-01-21
• First posted: 2013-11-04
• Last updated: 2025-11-24

Locations

10 sites across 1 country: France