A Phase 2 interventional study of Trastuzumab - Emtansine in Metastatic Breast Cancer, HER2 Negative Primary Tumor, sponsored by Institut Curie. Completed at 10 sites in France. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-11-24.
Sponsored by Institut Curie · Phase 2, Interventional, and Treatment
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 155 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Institut Curie is the lead sponsor of 134 studies on the registry; 28 are open to participants now.
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Inclusion Criteria:
Inclusion criteria for screening:
Inclusion criteria for treatment :
Exclusion Criteria:
Drug: Trastuzumab - Emtansine
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)
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
Toxicity of the treatment from first intake until disease progression
Time frame: Until disease progression (estimated duration : 1 year)
Plan to share: No
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Institut Curie