Circulating Tumor DNA After Neoadjuvant Chemotherapy (ALIENOR)

Institut Bergonié

Status: Enrolling

Conditions: Breast Cancer

Treatments: Other: Follow-up after neoadjuvant chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03357120

IB 2017-02

ID-RCB number : 2017-A00939-44 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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180 participants in 1 patient group

Follow-up after neoadjuvant chemotherapy

Other group

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).

Treatment:

Other: Follow-up after neoadjuvant chemotherapy