Clinical trial Recruiting at 1 site Observational Ages 18 and up Women only

Analyzing breast cancer responses to chemotherapy in real time

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

Run by Institut Paoli-Calmettes · NCT04504747 · Data updated 2026-11-12

This study is trying to see how breast cancer patients respond to chemotherapy in real time to find out why some might not respond well and improve their treatment.

Quick facts

Study typeObservational
Ages18 Years and up
SexWomen only
Enrollment150 (estimated)
SponsorInstitut Paoli-Calmettes
Academic / other
Drugs / interventionstrastuzumab, chemotherapy
Locations1 site (Marseille, Marseille)
StatusRecruiting
StartedNovember 3, 2022
Main results expectedDecember 2027
Study endsJanuary 2030
Registry record updatedJune 15, 2025
Trial IDNCT04504747 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are women over 18 with histologically confirmed invasive mammary adenocarcinoma who are eligible for neo-adjuvant chemotherapy.

Probably not a fit

Patients with metastatic breast cancer at diagnosis or those who have relapsed from breast cancer may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project focuses on identifying candidates for drug resistance in breast cancer patients undergoing neo-adjuvant chemotherapy (NAC). It employs a combination of molecular analyses of biopsies taken before and after NAC, in vitro patient-derived organoids that mimic individual responses to treatment, and the isolation of circulating tumor cells at various stages of NAC. The goal is to better understand the molecular mechanisms behind chemotherapy resistance and improve treatment outcomes for aggressive breast cancer types.

Why it matters

Potential benefit: If successful, this study could lead to more effective treatment strategies for breast cancer patients, particularly those who are resistant to current chemotherapy options.

How similar studies have gone: Other studies have shown promise in using molecular analyses and patient-derived models to understand treatment responses, suggesting this approach has potential for success.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

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

Exclusion Criteria:

1. Planned therapeutic sequence: CNA, followed by neoadjuvant radiotherapy (HIST-RIC clinical trial for example) before surgery
2. Metastatic disease at diagnosis
3. Patient relapsed from breast cancer precede
4. 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.
5. Woman pregnant or likely to be (without effective contraception) or breastfeeding
6. 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.
7. Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons

Where it's running

  • Institut Paoli-Calmettes
    Marseille, Marseille, France
    Recruiting

Study contacts

  • Principal investigator: François BERTUCCI, Pr — Institut Paoli-Calmettes
  • Study coordinator: j PAKRADOUNI, PharmD,PhD
  • Email: drci.up@ipc.unicancer.fr
  • Phone: 0491223778

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.