Checking circulating tumor DNA in the blood after neoadjuvant chemotherapy
Detection of Circulating Tumoral DNA Mutations (Sequential Assessment) Following Neoadjuvant Chemotherapy for Breast Cancer: Clinical Validity (ALIENOR Study)
This test will see if tracking tumor DNA in the blood over five years can help predict relapse for people with invasive breast cancer whose tumors did not completely respond to pre-surgery chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut Bergonié Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Bordeaux) |
| Trial ID | NCT03357120 on ClinicalTrials.gov |
What this trial studies
Patients who received neoadjuvant chemotherapy and then surgery are enrolled only if the surgical pathology shows residual invasive disease. Blood samples for circulating tumor DNA (ctDNA) will be taken at the post‑surgery visit (2–5 weeks after surgery) and then every six months (±1 month) for five years to look for tumor-specific mutations. If a patient relapses, they may optionally provide additional blood for ctDNA and a metastatic biopsy when clinically indicated. The project aims to correlate longitudinal ctDNA detection with clinical outcomes to define its prognostic value.
Who should consider this trial
Good fit: Adults with histologically proven invasive breast cancer who received 6–8 cycles of neoadjuvant chemotherapy, have no distant metastases at diagnosis, and whose surgery shows residual (non‑complete) pathological disease are the intended participants.
Not a fit: Patients who achieved a complete pathological response after surgery, those with metastatic disease at baseline, or people who did not receive neoadjuvant chemotherapy are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could give earlier warning of recurrence and help tailor follow-up or additional treatment for patients with residual disease after neoadjuvant chemotherapy.
How similar studies have performed: Previous research has shown that post‑treatment ctDNA can often detect molecular residual disease and predict relapse earlier than imaging, but its routine use to guide care is still being validated.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bordeaux
- Institut Bergonie — Bordeaux, France (Recruiting)
Study contacts
- Study coordinator: Hervé BONNEFOI, MD, PhD
- Email: h.bonnefoi@bordeaux.unicancer.fr
- Phone: +33 5 56 33 32 69
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.