NCT04504747 Real Time Molecular Analysis of Breast Cancer Receiving Neo-adjuvant Chemotherapy
| NCT ID | NCT04504747 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut Paoli-Calmettes |
| Condition | Breast Cancer Female |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2022-11-03 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2022-11-03 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
François BERTUCCI, Pr
PRINCIPAL INVESTIGATOR
Institut Paoli-Calmettes
Frequently Asked Questions
Who can join the NCT04504747 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer Female. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04504747 currently recruiting?
Yes, NCT04504747 is actively recruiting participants. Contact the research team at drci.up@ipc.unicancer.fr for enrollment information.
Where is the NCT04504747 trial being conducted?
This trial is being conducted at Marseille, France.
Who is sponsoring the NCT04504747 clinical trial?
NCT04504747 is sponsored by Institut Paoli-Calmettes. The principal investigator is François BERTUCCI, Pr at Institut Paoli-Calmettes. The trial plans to enroll 150 participants.
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