Circulating Tumor DNA After Neoadjuvant Chemotherapy

NCT ID: NCT03357120

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-06
• Study Completion Date: 2028-10-31

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.

Detailed Description

Patients with an invasive breast cancer on neoadjuvant chemotherapy (with the exception of cT2cN0 tumors) are preselected before the surgical procedure. They are definitely included during the post-surgery visit following the analysis of the surgical specimen (only patients whose tumor did not achieve a complete pathological response are included).

Sequential plasma samples for ctDNA mutations analysis will be taken during the post-surgery visit (within 2-5 weeks after surgery) and every 6 months (+/- 1 month) thereafter for 5 years.

In case of relapse patients will be proposed to participate to an optional research program with a blood test for ctDNA assessment and biopsies from a metastasis (when these biopsies are clinically indicated).

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Follow-up after neoadjuvant chemotherapy

Patients with an invasive breast cancer on neoadjuvant chemotherapy (with the exception of cT2cN0 tumors) are preselected before the surgical procedure. They are definitely included during the post-surgery visit following the analysis of the surgical specimen (only patients whose tumor did not achieve a complete pathological response are included).

Group Type: OTHER

Follow-up after neoadjuvant chemotherapy

Intervention Type: OTHER

Sequential plasma samples for ctDNA mutations analysis will be taken during the post-surgery visit (within 2-5 weeks after surgery) and every 6 months (+/- 1 month) thereafter for 5 years. In case of relapse patients will be proposed to participate to an optional research program with a blood test for ctDNA assessment and biopsies from a metastasis (when these biopsies are clinically indicated). Next Generation Sequencing (NGS) analysis will be performed on post-neoadjuvant chemotherapy residual tumor tissue samples. The mutations identified by NGS in residual tumor will be tracked in ctDNA using personalized digital PCR (dPCR) or by an NGS technique whose bioinformatics pipeline is adapted to the analysis of ctDNA.

In case of relapse patients will be proposed to participate to an optional research program with a blood test for ctDNA assessment and biopsies from a metastasis (when these biopsies are clinically indicated).

Interventions

Follow-up after neoadjuvant chemotherapy

Sequential plasma samples for ctDNA mutations analysis will be taken during the post-surgery visit (within 2-5 weeks after surgery) and every 6 months (+/- 1 month) thereafter for 5 years. In case of relapse patients will be proposed to participate to an optional research program with a blood test for ctDNA assessment and biopsies from a metastasis (when these biopsies are clinically indicated). Next Generation Sequencing (NGS) analysis will be performed on post-neoadjuvant chemotherapy residual tumor tissue samples. The mutations identified by NGS in residual tumor will be tracked in ctDNA using personalized digital PCR (dPCR) or by an NGS technique whose bioinformatics pipeline is adapted to the analysis of ctDNA.

In case of relapse patients will be proposed to participate to an optional research program with a blood test for ctDNA assessment and biopsies from a metastasis (when these biopsies are clinically indicated).

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Bergonié

UNKNOWN

Sponsor Role: collaborator

Institut Bergonié

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hervé BONNEFOI, MD, PhD

Role: STUDY_CHAIR

Institut Bergonié

Locations

Institut Bergonie

Bordeaux, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Hervé BONNEFOI, MD, PhD

Role: CONTACT

h.bonnefoi@bordeaux.unicancer.fr

+33 5 56 33 32 69

Simone MATHOULIN-PELISSIER, MD, PhD

Role: CONTACT

s.mathoulin@bordeaux.unicancer.fr

Facility Contacts

Hervé BONNEFOI, MD, PhD

Role: primary

h.bonnefoi@bordeaux.unicancer.fr

+33 5 56 33 32 69

Camille CHAKIBA, MD

Role: backup

c.chakiba@bordeaux.unicancer.fr

Other Identifiers

ID-RCB number : 2017-A00939-44

Identifier Type: OTHER

Identifier Source: secondary_id

IB 2017-02

Identifier Type: -

Identifier Source: org_study_id