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Circulating Tumor DNA After Neoadjuvant Chemotherapy (ALIENOR)

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ClinicalTrials.gov Identifier: NCT03357120
Recruitment Status : Recruiting
First Posted : November 29, 2017
Last Update Posted : November 29, 2017
Sponsor:
Collaborator:
Fondation Bergonié
Information provided by (Responsible Party):
Institut Bergonié

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Other: Follow-up after neoadjuvant chemotherapy Not Applicable

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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Detection of Circulating Tumoral DNA Mutations (Sequential Assessment) Following Neoadjuvant Chemotherapy for Breast Cancer: Clinical Validity (ALIENOR Study)
Actual Study Start Date : October 6, 2017
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
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).
 Other: 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).


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. Prognostic value of the presence of ctDNA mutation(s) on overall survival (OS) at 3 years. [ Time Frame: 3 years ]
  2. Prognostic value of the presence of ctDNA mutation(s) on distant-metastasis-free interval (DRFI) at 3 years. [ Time Frame: 3 years ]
  3. Prognostic value of the presence of ctDNA mutation(s) on OS at 5 years. [ Time Frame: 5 years ]
  4. Prognostic value of the presence of ctDNA mutation(s) on DRFI at 5 years. [ Time Frame: 5 years ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03357120


Contacts
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Contact: Hervé BONNEFOI, MD, PhD +33 5 56 33 32 69 h.bonnefoi@bordeaux.unicancer.fr
Contact: Simone MATHOULIN-PELISSIER, MD, PhD s.mathoulin@bordeaux.unicancer.fr

Locations
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France
Institut Bergonie Recruiting
Bordeaux, France, 33076
Contact: Hervé BONNEFOI, MD, PhD    +33 5 56 33 32 69    h.bonnefoi@bordeaux.unicancer.fr   
Contact: Camille CHAKIBA, MD       c.chakiba@bordeaux.unicancer.fr   
Sponsors and Collaborators
Institut Bergonié
Fondation Bergonié
Investigators
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Study Chair: Hervé BONNEFOI, MD, PhD Institut Bergonié
More Information
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Responsible Party: Institut Bergonié
ClinicalTrials.gov Identifier: NCT03357120    
Other Study ID Numbers: IB 2017-02
ID-RCB number : 2017-A00939-44 ( Other Identifier: ANSM )
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Bergonié:
Breast Cancer
Neoadjuvant chemotherapy
Circulating tumor DNA
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases