Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT03357120

Circulating Tumor DNA After Neoadjuvant Chemotherapy

Led by Institut Bergonié · Updated on 2025-10-02

180

Participants Needed

1

Research Sites

573 weeks

Total Duration

On this page

Sponsors

I

Institut Bergonié

Lead Sponsor

F

Fondation Bergonié

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Circulating Tumor DNA After Neoadjuvant Chemotherapy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Women or men
  • Histologically confirmed invasive breast cancer at diagnosis
  • Locally advanced inoperable tumors: cT4a, b, c, d or cN2 or cN3
  • Operable tumors including cT2cN1, cT3cN0, cT3N1, or cT2cN0 with confirmed lymph node invasion
  • No clinically or radiologically detectable metastases before neoadjuvant chemotherapy
  • Unilateral or bilateral breast cancer; multifocal tumors allowed
  • Received 6 to 8 cycles of neoadjuvant chemotherapy
  • Preoperative radiation therapy is allowed
  • Breast surgery performed with pathology report showing non-complete histological response
  • Signed informed consent
  • Affiliated to French social security according to French law
  • May be included in another interventional research study
Not Eligible

You will not qualify if you...

  • cT2cN0 tumor without confirmed lymph node involvement
  • Cancer progression during neoadjuvant chemotherapy
  • Received only neoadjuvant hormone therapy
  • Complete blood transfusion within 120 days before first sample collection
  • History of invasive cancer including contralateral invasive breast cancer (except in situ breast cancer, basocellular skin cancer, or cervical cancer treated in situ)
  • Unable to comply with study procedures due to geographic, social, or psychological reasons
  • Subject to legal protection measures or deprived of liberty

AI-Screening

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Trial Site Locations

Total: 1 location

1

Institut Bergonie

Bordeaux, France, 33076

Actively Recruiting

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Research Team

H

Hervé BONNEFOI, MD, PhD

CONTACT

S

Simone MATHOULIN-PELISSIER, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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