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Circulating Tumor DNA After Neoadjuvant Chemotherapy

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut Bergonié

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years (no age limit).

Women or men.

cT4a, b, c, d whatever the cN

or cN2 or cN3 whatever the cT.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Follow-up after neoadjuvant chemotherapy

    Other intervention

    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).

Treatment groups

180 Participants
are divided into 1 treatment group
Group A: Follow-up after neoadjuvant chemotherapyOther 1 intervention

Trial outcomes

Primary outcomes

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 outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institut Bergonié

Lead sponsor

Fondation Bergonié

Collaborator

Source ClinicalTrials.gov
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