RecruitingNCT04504747

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

Real Time Molecular Analysis of Breast Cancer Receiving Neo-adjuvant Chemotherapy: Identification of Preclinical Models Predictive for Therapeutic Resistance


Sponsor

Institut Paoli-Calmettes

Enrollment

150 participants

Start Date

Nov 3, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria8

  • Woman over 18
  • Signed consent to participate
  • Invasive mammary adenocarcinoma proven histologically and / or cytologically
  • Indication of CNA retention by the referring clinical team.
  • No contraindication to CNA.
  • Selected indication of the post-CNA surgery sequence, then radiotherapy
  • Performance index ≤ 1 (WHO).
  • Affiliation to a social security scheme, or beneficiary of such a scheme

Exclusion Criteria7

  • 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.
  • Woman pregnant or likely to be (without effective contraception) or breastfeeding
  • Person in an emergency situation, adult person subject to a legal protection measure (adult under guardianship, guardianship or legal protection), or unable to express consent.
  • Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons

Interventions

OTHERmolecular analysis of blood and tumor

RNAseq, DNAseq, CTCs


Locations(1)

Institut Paoli-Calmettes

Marseille, Marseille, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04504747


Related Trials