Metastatic Breast Cancer, HER2 Negative Primary Tumor
Conditions
Keywords
Metastatic breast cancer, HER2 negative primary tumor, CTC HER2 positive
Brief 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.
Interventions
DRUGTrastuzumab - Emtansine
Sponsors
Institut Curie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor response rate to T-DM1 in patients with HER2 amplified circulating tumor cells | Until disease progression (estimated duration : 1 year) | Assessment every 6 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | — |
| 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 | — |
| Progression-free survival | 4 years | — |
| 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 | Until disease progression (estimated duration : 1 year) | Toxicity of the treatment from first intake until disease progression |
| Correlation between HER2 FISH and immunofluorescence on circulating tumor cells | 1 month | — |
Countries
France
Outcome results
None listed