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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TDM-1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trastuzumab - Emtansine | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tumor response rate to T-DM1 in patients with HER2 amplified circulating tumor cells | Assessment every 6 weeks. | Until disease progression (estimated duration : 1 year) |
| Measure | Description | Time Frame |
|---|---|---|
| Detection rate of HER2 amplified circulating tumor cells, heterogeneity rate between circulating tumor cells and correlations with patient characteristics | 1 month | |
| Technical failure rate and reproducibility of HER2 FISH on circulating tumor cells | 1 month |
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Inclusion Criteria:
Inclusion criteria for screening:
Inclusion criteria for treatment :
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Victor Hugo | Le Mans | 72000 | France | |||
| Institut de Cancérologie HARTMANN |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31727113 | Background | Jacot 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. |
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| Correlation between HER2 FISH and immunofluorescence on circulating tumor cells | 1 month |
| Progression-free survival | 4 years |
| Disease control rate (responses and stable diseases) | 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) | Until disease progression (estimated duration : 1 year) |
| Changes in CTC numbers during treatment | Until disease progression (estimated duration : 1 year) |
| Circulating tumor DNA before and during treatment | Until disease progression (estimated duration : 1 year) |
| Treatment toxicity | Toxicity of the treatment from first intake until disease progression | Until disease progression (estimated duration : 1 year) |
| Levallois-Perret |
| 92309 |
| France |
| Centre Oscar Lambret | Lille | 59020 | France |
| Chu de Limoges | Limoges | 87042 | France |
| Centre Val d'Aurelle - P. Lamarque | Montpellier | 34298 | France |
| Institut Curie | Paris | 75005 | France |
| Chu Saint-Louis | Paris | 75475 | France |
| Institut Curie - Hôpital René HUGENIN | Saint-Cloud | SAINT-CLOUD | France |
| Centre Catherine de Sienne | Vandœuvre-lès-Nancy | 54519 | France |
| Institut de Cancérologie de Lorraine | Vandœuvre-lès-Nancy | 54519 | France |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000080044 | Ado-Trastuzumab Emtansine |
| ID | Term |
|---|---|
| D008453 | Maytansine |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D000068878 | Trastuzumab |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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