Monitoring immune responses in breast cancer patients during treatment
Immunomonitoring of Breast Cancer Patients During Systemic Treatment
NA · Centre Georges Francois Leclerc · NCT04925856
This study is testing how different treatments for breast cancer affect the immune system by collecting blood samples from women during their therapy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | Female |
| Sponsor | Centre Georges Francois Leclerc (other) |
| Drugs / interventions | cyclophosphamide, prednisone |
| Locations | 2 sites (Besançon and 1 other locations) |
| Trial ID | NCT04925856 on ClinicalTrials.gov |
What this trial studies
This study aims to collect biological samples from women with localized or metastatic breast cancer to analyze their immune responses based on the type of systemic treatment they receive. It focuses on understanding how different treatments affect the immune system before and during therapy. Blood samples will be taken to evaluate the immune response and its evolution throughout the treatment process.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 85 with histologically proven infiltrating breast cancer, specifically those with triple negative or certain hormone receptor-positive subtypes receiving specific systemic treatments.
Not a fit: Patients with non-infiltrating breast cancer or those not receiving the specified systemic treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding of how breast cancer treatments influence immune responses, potentially guiding more effective therapies.
How similar studies have performed: Other studies have shown promise in understanding immune responses in cancer treatment, suggesting that this approach could yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Besançon and 1 other locations
- CHRU Jean Minjoz — Besançon, France (NOT_YET_RECRUITING)
- Centre Georges Francois Leclerc — Dijon, France (RECRUITING)
Study contacts
- Principal investigator: Sylvain LADOIRE, PU-PH — Centre Georges François Leclerc
- Study coordinator: Sylvain LADOIRE, PU-PH
- Email: sladoire@cgfl.fr
- Phone: 03 80 73 75 28
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.
Conditions: Breast Cancer, immune response, blood samples