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Real Time Molecular Analysis of Breast Cancer Receiving Neo-adjuvant Chemotherapy

ConditionBreast Cancer Female
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorInstitut Paoli-Calmettes

About this trial

The present project aims at identifying robust candidates for drug resistance in BC patients eligible for NAC. Its originality lies upon the combination of three different and complementary prospective approaches: from the molecular analyses of biopsies sampled before and after NAC, from in vitro BC Patient-Derived Organoids (PDO) mimicking patient's response to NAC, and from Circulating Tumor Cells (CTCs) isolated before/during/after NAC.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Woman over 18

Signed consent to participate

Invasive mammary adenocarcinoma proven histologically and / or cytologically

Indication of CNA retention by the referring clinical team.

Disqualifiers

Planned therapeutic sequence: CNA, followed by neoadjuvant radiotherapy (HIST-RIC clinical trial for example) before surgery

Metastatic disease at diagnosis

Patient relapsed from breast cancer precede

Other malignant disease in the previous 3 years, with the exception of cervical carcinoma in situ or skin basal cell carcinoma and any other cancerous pathology considered to have been properly treated and at low risk of relapse.

Trial population

Brest cancer females with a non metastatic cancer

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • molecular analysis of blood and tumor

    Other intervention

    RNAseq, DNAseq, CTCs

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: RH+1 intervention
Group B: HER2+1 intervention
Group C: TN1 intervention

Trial outcomes

Primary outcomes

1

Identify robust candidates - "innate, "acquired stable" and/or reversible"

comparison of pre and/or post NAC molecular profiles in tumors, PDO models and CTCs - will be targeted with a drug in relevant models

Time frame
5 years

Secondary outcomes

1

public repertoire of whole transcriptome and targeted-NGS

NAC" database will be constructed from well documented RNAseq and targeted-NGS profiles established from serial HER2+ and TN tumors before/after NAC treatment

Time frame
5 years
2

Identify molecular signatures associated with response to NAC

Comparison of serial molecular profiles

Time frame
5 years
3

Establish PDO samples exposed to NAC

Percentage of PDO exposed to NAC that will parallel the patient's clinical response to NAC

Time frame
5 years
4

Evaluation of CTCs features

phenotype, RNA-seq-based transcriptome

Time frame
5 years

Other outcomes

Sponsors and contacts

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

Institut Paoli-Calmettes

Lead sponsor

Source ClinicalTrials.gov
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