Clinical trial · Interventional
Validity of HER2-amplified Circulating Tumor Cells to Select Metastatic Breast Cancer Considered HER2-negative for Trastuzumab-emtansine (T-DM1) Treatment.
NCT01975142CI-TRIAL-00097784completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer, HER2 Negative Primary Tumor | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Trastuzumab - Emtansine | Drug | Trastuzumab Emtansine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TDM-1
- interventionNames
- Drug: Trastuzumab - Emtansine
Primary outcomes (1)
- measure
- Tumor response rate to T-DM1 in patients with HER2 amplified circulating tumor cells
- timeFrame
- Until disease progression (estimated duration : 1 year)
- description
- Assessment every 6 weeks.
Secondary outcomes (9)
- measure
- Detection rate of HER2 amplified circulating tumor cells, heterogeneity rate between circulating tumor cells and correlations with patient characteristics
- timeFrame
- 1 month
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDJacot W, Cottu P, Berger F, Dubot C, Venat-Bouvet L, Lortholary A, Bourgeois H, Bollet M, Servent V, Luporsi E, Espie M, Guiu S, D'Hondt V, Dieras V, Sablin MP, Brain E, Neffati S, Pierga JY, Bidard FC. Actionability of HER2-amplified circulating tumor cells in HER2-negative metastatic breast cancer: the CirCe T-DM1 trial. Breast Cancer Res. 2019 Nov 14;21(1):121. doi: 10.1186/s13058-019-1215-z. PMID 31727113