NCT03357120 Circulating Tumor DNA After Neoadjuvant Chemotherapy
| NCT ID | NCT03357120 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut Bergonié |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2017-10-06 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 180 participants in total. It began in 2017-10-06 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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-complete histological response (i.e. all the different results of ypT0 /is ypN0). 9. Signed informed consent. 10. Patients affiliated to a French social security scheme in accordance with Article 1121-11 of the French Code of Public Health. 11. Possible inclusion in another interventional research (surgical, radiotherapy or drug study). Exclusion Criteria : 1. cT2cN0 tumor without cytological or histological lymph node involvement. 2. Progression during neoadjuvant chemotherapy. 3. Exclusive neoadjuvant hormone therapy. 4. Complete blood transfusion within 120 days prior to 1st sampling. 5. History of invasive cancer regardless of the time elapsed since the diagnosis of this cancer, including a history of contralateral invasive breast cancer. However, patients who have been treated for in situ breast cancer, basocellular skin cancer or cervical cancer treated in situ are eligible. 6. Patient unable to follow and comply with research procedures for geographical, social or psychological reasons. 7. Patient deprived of liberty or subject to a legal protection measure.
Contact & Investigator
Hervé BONNEFOI, MD, PhD
STUDY CHAIR
Institut Bergonié
Frequently Asked Questions
Who can join the NCT03357120 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03357120 currently recruiting?
Yes, NCT03357120 is actively recruiting participants. Contact the research team at h.bonnefoi@bordeaux.unicancer.fr for enrollment information.
Where is the NCT03357120 trial being conducted?
This trial is being conducted at Bordeaux, France.
Who is sponsoring the NCT03357120 clinical trial?
NCT03357120 is sponsored by Institut Bergonié. The principal investigator is Hervé BONNEFOI, MD, PhD at Institut Bergonié. The trial plans to enroll 180 participants.
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