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Circulating Tumor DNA After Neoadjuvant Chemotherapy (ALIENOR)

Primary Purpose

Breast Cancer

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Follow-up after neoadjuvant chemotherapy

About this trial

This is an interventional other trial for Breast Cancer focused on measuring Breast Cancer, Neoadjuvant chemotherapy, Circulating tumor DNA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria :

Age ≥ 18 years (no age limit).
Women or men.
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.
Lack of clinically or radiologically detectable metastases in the initial diagnosis before the neoadjuvant chemotherapy (M0).
Unilateral or bilateral breast cancer. Multifocality is accepted.
Patients who received 6 to 8 cycles of neoadjuvant chemotherapy.
Preoperative radiation therapy allowed.
Breast surgery performed and pathology report of a non-complete histological response (i.e. all the different results of ypT0 /is ypN0).
Signed informed consent.
Patients affiliated to a French social security scheme in accordance with Article 1121-11 of the French Code of Public Health.
Possible inclusion in another interventional research (surgical, radiotherapy or drug study).

Exclusion Criteria :

cT2cN0 tumor without cytological or histological lymph node involvement.
Progression during neoadjuvant chemotherapy.
Exclusive neoadjuvant hormone therapy.
Complete blood transfusion within 120 days prior to 1st sampling.
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.
Patient unable to follow and comply with research procedures for geographical, social or psychological reasons.
Patient deprived of liberty or subject to a legal protection measure.

Sites / Locations

Institut BergonieRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Follow-up after neoadjuvant chemotherapy

Arm Description

Outcomes

Primary Outcome Measures

Prognostic value of the presence of ctDNA mutation(s) measured by dPCR on recurrence-free interval (RFI) at 3 years.

Secondary Outcome Measures

Prognostic value of the presence of ctDNA mutation(s) on overall survival (OS) at 3 years.

Prognostic value of the presence of ctDNA mutation(s) on distant-metastasis-free interval (DRFI) at 3 years.

Prognostic value of the presence of ctDNA mutation(s) on OS at 5 years.

Prognostic value of the presence of ctDNA mutation(s) on DRFI at 5 years.

Prognostic value of the presence of ctDNA mutation(s) on a single sample assessment after surgery (measured by dPCR) on RFI at 3 years.

Prognostic value of the presence of ctDNA mutation(s) on a single sample assessment after surgery (measured by dPCR) on DRFI at 3 years.

Prognostic value of the presence of ctDNA mutation(s) on a single sample assessment after surgery (measured by dPCR) on RFI at 5 years.

Prognostic value of the presence of ctDNA mutation(s) on a single sample assessment after surgery (measured by dPCR) on DRFIat 5 years.

Full Information

NCT ID

NCT03357120

First Posted

November 9, 2017

Last Updated

November 28, 2017

Sponsor

Institut Bergonié

Collaborators

Fondation Bergonié

1. Study Identification

Unique Protocol Identification Number

NCT03357120

Brief Title

Circulating Tumor DNA After Neoadjuvant Chemotherapy

Acronym

ALIENOR

Official Title

Detection of Circulating Tumoral DNA Mutations (Sequential Assessment) Following Neoadjuvant Chemotherapy for Breast Cancer: Clinical Validity (ALIENOR Study)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Recruiting

Study Start Date

October 6, 2017 (Actual)

Primary Completion Date

October 2022 (Anticipated)

Study Completion Date

October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut Bergonié

Collaborators

Fondation Bergonié

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

Breast Cancer, Neoadjuvant chemotherapy, Circulating tumor DNA

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Follow-up after neoadjuvant chemotherapy

Arm Type

Other

Arm Description

Intervention Type

Other

Intervention Name(s)

Follow-up after neoadjuvant chemotherapy

Intervention Description

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).

Primary Outcome Measure Information:

Title

Prognostic value of the presence of ctDNA mutation(s) measured by dPCR on recurrence-free interval (RFI) at 3 years.

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Prognostic value of the presence of ctDNA mutation(s) on overall survival (OS) at 3 years.

Time Frame

3 years

Title

Prognostic value of the presence of ctDNA mutation(s) on distant-metastasis-free interval (DRFI) at 3 years.

Time Frame

3 years

Title

Prognostic value of the presence of ctDNA mutation(s) on OS at 5 years.

Time Frame

5 years

Title

Prognostic value of the presence of ctDNA mutation(s) on DRFI at 5 years.

Time Frame

5 years

Title

Prognostic value of the presence of ctDNA mutation(s) on a single sample assessment after surgery (measured by dPCR) on RFI at 3 years.

Time Frame

3 years

Title

Prognostic value of the presence of ctDNA mutation(s) on a single sample assessment after surgery (measured by dPCR) on DRFI at 3 years.

Time Frame

3 years

Title

Prognostic value of the presence of ctDNA mutation(s) on a single sample assessment after surgery (measured by dPCR) on RFI at 5 years.

Time Frame

5 years

Title

Prognostic value of the presence of ctDNA mutation(s) on a single sample assessment after surgery (measured by dPCR) on DRFIat 5 years.

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria : Age ≥ 18 years (no age limit). Women or men. Invasive breast cancer proven histologically at diagnosis (before neoadjuvant chemotherapy): Locally advanced tumor known to be inoperable from the start: cT4a, b, c, d whatever the cN or cN2 or cN3 whatever the cT. Operable tumors: cT2cN1 or cT3cN0 or cT3N1, or cT2cN0 for which ganglionic invasion has been proven by cytology or histology. Lack of clinically or radiologically detectable metastases in the initial diagnosis before the neoadjuvant chemotherapy (M0). Unilateral or bilateral breast cancer. Multifocality is accepted. Patients who received 6 to 8 cycles of neoadjuvant chemotherapy. Preoperative radiation therapy allowed. Breast surgery performed and pathology report of a non-complete histological response (i.e. all the different results of ypT0 /is ypN0). Signed informed consent. Patients affiliated to a French social security scheme in accordance with Article 1121-11 of the French Code of Public Health. Possible inclusion in another interventional research (surgical, radiotherapy or drug study). Exclusion Criteria : cT2cN0 tumor without cytological or histological lymph node involvement. Progression during neoadjuvant chemotherapy. Exclusive neoadjuvant hormone therapy. Complete blood transfusion within 120 days prior to 1st sampling. 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. Patient unable to follow and comply with research procedures for geographical, social or psychological reasons. Patient deprived of liberty or subject to a legal protection measure.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hervé BONNEFOI, MD, PhD

Phone

+33 5 56 33 32 69

h.bonnefoi@bordeaux.unicancer.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Simone MATHOULIN-PELISSIER, MD, PhD

s.mathoulin@bordeaux.unicancer.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hervé BONNEFOI, MD, PhD

Organizational Affiliation

Institut Bergonié

Official's Role

Study Chair

Facility Information:

Facility Name

Institut Bergonie

City

Bordeaux

ZIP/Postal Code

33076

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hervé BONNEFOI, MD, PhD

Phone

+33 5 56 33 32 69

h.bonnefoi@bordeaux.unicancer.fr

First Name & Middle Initial & Last Name & Degree

Camille CHAKIBA, MD

c.chakiba@bordeaux.unicancer.fr

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Circulating Tumor DNA After Neoadjuvant Chemotherapy

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