Circulating Tumor DNA After Neoadjuvant Chemotherapy
Trial assessing the prognostic value of ctDNA mutations from samples taken sequentially in patients with invasive breast cancer initially treated with neoadjuvant chemotherapy and whose tumor is not in complete histological response.
| Condition(s) | Breast Cancer |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | Trial assessing the prognostic value of ctDNA mutations from samples taken sequentially in patients with invasive breast cancer initially treated with neoadjuvant chemotherapy and whose tumor is not in complete histological response. |
| Who can participate | Inclusion Criteria : 1. Age ≥ 18 years (no age limit). 2. Women or men. 3. Invasive breast cancer proven histologically at diagnosis (before neoadjuvant chemotherapy): 1. Locally advanced tumor known to be inoperable from the start: * cT4a, b, c, d whatever the cN * or cN2 or cN3 whatever the cT. 2. Operable tumors: * cT2cN1 or cT3cN0 or cT3N1, * or cT2cN0 for which ganglionic invasion has been proven by cytology or histology. 4. Lack of clinically or radiologically detectable metastases in the initial diagnosis before the neoadjuvant chemotherapy (M0). 5. Unilateral or bilateral breast cancer. Multifocality is accepted. 6. Patients who received 6 to 8 cycles of neoadjuvant chemotherapy. 7. Preoperative radiation therapy allowed. 8. Breast surgery performed and pathology report of a non-co |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Institut Bergonié |
| Locations | Bordeaux, France |
| Start date | 2017-10-06 |
| NCT ID | NCT03357120 |
| Official listing | https://clinicaltrials.gov/study/NCT03357120 |