NCT04925856 Immunomonitoring of Breast Cancer Patients During Systemic Treatment
| NCT ID | NCT04925856 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Georges Francois Leclerc |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2020-05-26 |
| Primary Completion | 2030-05-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2020-05-26 with a primary completion date of 2030-05-26.
⚠ 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
This study aims to constitute a most complete biological collection for patients treated for localized or metastatic breast cancer (in different cohorts depending on the type of systemic treatment received), in order to describe the basal immune response of patients treated for a breast cancer according to the stage of the disease, but above all to study how the different systemic treatments used in the management of breast cancer modulate this immune response.
Eligibility Criteria
Inclusion Criteria: 1. Woman aged between 18 and 85. 2. Patient with histologically proven infiltrating breast cancer. 3. Triple negative breast cancer or RH + / HER2- (OR and RP \<10% and HER2 negative (0 or 1+ in IHC or 2+ in IHC and FISH negative) 4. Patient receiving treatment corresponding to one of these cohorts: * In a metastatic situation with establishment of treatment with Paclitaxel regardless of the treatment line * In a metastatic situation with establishment of treatment with Epirubicin - cyclophosphamide (EC) regardless of the treatment line * In a metastatic situation with establishment of treatment with Eribulin regardless of the line of treatment * In a 1st line metastatic situation with initiation of treatment with Palbociclib or Abemaciclib, or Ribociclib in combination with hormone therapy (aromatase inhibitor) 5. Patient who signed the informed consent for the study. 6. Patient fit and able to adhere to protocol for the duration of the study, including visits, scheduled specimens and follow-up. 7. Patient affiliated to the social security system. Exclusion Criteria: 1. Patient unable to understand, read and / or sign informed consent. 2. Presence of cerebral or meningeal metastasis 3. Current or previous use of an immunosuppressive drug in the 14 days preceding inclusion (except intranasal corticosteroids, systemic corticosteroids at physiological doses not exceeding 10 mg per day of prednisone or its equivalent, corticosteroids for antiemetic purposes, corticosteroids used as premedication for hypersensitivity reactions (injected CT scan, taxanes, etc.) 4. Patient participating in another research that may modify the systemic treatment administered in the framework of the cohort in which she will be included. 5. Pregnant or breastfeeding woman. 6. HIV and / or HBV and / or HCV serology positive. 7. Life expectancy estimated at less than 3 months. 8. Patient's refusal. 9. Person benefiting from a protection system for adults (including tutorship and curatorship). 10. Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons.
Contact & Investigator
Sylvain LADOIRE, PU-PH
PRINCIPAL INVESTIGATOR
Centre Georges François Leclerc
Frequently Asked Questions
Who can join the NCT04925856 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 85 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04925856 currently recruiting?
Yes, NCT04925856 is actively recruiting participants. Contact the research team at sladoire@cgfl.fr for enrollment information.
Where is the NCT04925856 trial being conducted?
This trial is being conducted at Besançon, France, Dijon, France.
Who is sponsoring the NCT04925856 clinical trial?
NCT04925856 is sponsored by Centre Georges Francois Leclerc. The principal investigator is Sylvain LADOIRE, PU-PH at Centre Georges François Leclerc. The trial plans to enroll 150 participants.
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