Analyzing breast cancer responses to chemotherapy in real time
Real Time Molecular Analysis of Breast Cancer Receiving Neo-adjuvant Chemotherapy: Identification of Preclinical Models Predictive for Therapeutic Resistance
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 type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Institut Paoli-Calmettes Academic / other |
| Drugs / interventions | trastuzumab, chemotherapy |
| Locations | 1 site (Marseille, Marseille) |
| Trial ID | NCT04504747 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are women over 18 with histologically confirmed invasive mammary adenocarcinoma who are eligible for neo-adjuvant chemotherapy.
Not a fit: Patients with metastatic breast cancer at diagnosis or those who have relapsed from breast cancer may not benefit from this study.
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 performed: Other studies have shown promise in using molecular analyses and patient-derived models to understand treatment responses, suggesting this approach has potential for success.
Eligibility criteria
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 this trial is running
Marseille, Marseille
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.