Metastatic Breast Cancer, HER2 Negative Primary Tumor Clinical Trial
Official title:
Validity of HER2-amplified Circulating Tumor Cells to Select Metastatic Breast Cancer Considered HER2-negative for Trastuzumab-emtansine (T-DM1) Treatment.
| Verified date | March 2019 |
| Source | Institut Curie |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 155 |
| Est. completion date | January 21, 2019 |
| Est. primary completion date | February 13, 2018 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 75 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Clinique Victor Hugo | Le Mans | |
| France | Institut de Cancérologie HARTMANN | Levallois-perret | |
| France | Centre Oscar Lambret | Lille | |
| France | Chu de Limoges | Limoges | |
| France | Centre Val d'Aurelle - P. Lamarque | Montpellier | |
| France | Chu Saint-Louis | Paris | |
| France | Institut Curie | Paris | |
| France | Institut Curie - Hôpital René HUGENIN | Saint-cloud | |
| France | Centre Catherine de Sienne | Vandoeuvre Les Nancy | |
| France | Institut de Cancérologie de Lorraine | Vandoeuvre Les Nancy |
| Lead Sponsor | Collaborator |
|---|---|
| Institut Curie |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | |
| Secondary | Detection rate of HER2 amplified circulating tumor cells, heterogeneity rate between circulating tumor cells and correlations with patient characteristics | 1 month | ||
| Secondary | Technical failure rate and reproducibility of HER2 FISH on circulating tumor cells | 1 month | ||
| Secondary | Correlation between HER2 FISH and immunofluorescence on circulating tumor cells | 1 month | ||
| Secondary | Progression-free survival | 4 years | ||
| Secondary | Disease control rate (responses and stable diseases) | Until disease progression (estimated duration : 1 year) | ||
| Secondary | 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) | ||
| Secondary | Changes in CTC numbers during treatment | Until disease progression (estimated duration : 1 year) | ||
| Secondary | Circulating tumor DNA before and during treatment | Until disease progression (estimated duration : 1 year) | ||
| Secondary | Treatment toxicity | Toxicity of the treatment from first intake until disease progression | Until disease progression (estimated duration : 1 year) |