NCT04504747

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
44mo left

Started Nov 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress49%
Nov 2022Jan 2030

First Submitted

Initial submission to the registry

August 5, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2020

Completed
2.2 years until next milestone

Study Start

First participant enrolled

November 3, 2022

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

June 15, 2025

Status Verified

June 1, 2025

Enrollment Period

5.1 years

First QC Date

August 5, 2020

Last Update Submit

June 13, 2025

Conditions

Breast Cancer Female

Outcome Measures

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

    5 years

Secondary Outcomes (4)

  • public repertoire of whole transcriptome and targeted-NGS

    5 years

  • Identify molecular signatures associated with response to NAC

    5 years

  • Establish PDO samples exposed to NAC

    5 years

  • Evaluation of CTCs features

    5 years

Study Arms (3)

RH+

Prospective blood and biopsie analyses

Other: molecular analysis of blood and tumor

HER2+

Prospective blood and biopsie analyses

Other: molecular analysis of blood and tumor

TN

Prospective blood and biopsie analyses

Other: molecular analysis of blood and tumor

Interventions

molecular analysis of blood and tumorOTHER

RNAseq, DNAseq, CTCs

HER2+RH+TN

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Brest cancer females with a non metastatic cancer

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Paoli-Calmettes

Marseille, Marseille, 13009, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Bllod and tumor tissue

MeSH Terms

Interventions

Tumor Burden

Intervention Hierarchy (Ancestors)

Body Weights and MeasuresAnthropometryInvestigative Techniques

Study Officials

  • François BERTUCCI, Pr

    Institut Paoli-Calmettes

    PRINCIPAL INVESTIGATOR

Central Study Contacts

j PAKRADOUNI, PharmD,PhD

CONTACT

0491223778drci.up@ipc.unicancer.fr

Laurie-Anne GOUTY, PhD

CONTACT

33491223778drci.up@ipc.unicancer.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2020

First Posted

August 7, 2020

Study Start

November 3, 2022

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

January 1, 2030

Last Updated

June 15, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)