Understanding immune changes in breast and ovarian cancer patients
Prospective Study of Immune Alterations in Operable Breast and Ovarian Carcinoma
This study looks at how the immune system changes in women with breast and ovarian cancer to find ways to make treatments work better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Centre Leon Berard Academic / other |
| Drugs / interventions | chemotherapy, methotrexate, prednisone |
| Locations | 1 site (Lyon, France) |
| Trial ID | NCT04562623 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify immune alterations and predictive biomarkers in patients with operable breast and ovarian carcinoma. It focuses on understanding the mechanisms of immune response inhibition that contribute to tumor progression and resistance to treatments. By characterizing specific immune cell populations, the study seeks to uncover actionable targets for improving treatment efficacy in these cancers. The research will involve a cohort of female patients undergoing surgery for high-grade serous ovarian carcinoma or breast carcinoma.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 18 and older with operable high-grade serous ovarian carcinoma or breast carcinoma.
Not a fit: Patients with constitutional BRCA1/2 mutations or those previously treated with immunomodulators may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with breast and ovarian cancers by identifying new targets for immunotherapy.
How similar studies have performed: Other studies have shown promise in understanding immune mechanisms in cancer, but this specific approach is novel in its focus on operable breast and ovarian carcinoma.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * I1. Female patients aged ≥ 18 tears at time of inform consent signature. * I2. Patient with planned primitive tumor surgery listed below : High grade serous ovarian carcinoma (cohort A), Breast carcinoma SBR grade II or III \> 3 cm (cohort B), Extended breast carcinoma In situ associated with invasive nodule carcinoma macroscopically visible and eligible to mastectomy (cohort C). Note : Patients previously treated by neoadjuvant chemotherapy are eligible and all chemotherapies are authorized. * I3. Patient should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures and should be willing to comply procedures required per protocol. * I4. Patient must be covered by a medical insurance. Exclusion Criteria: * E1. Patient under guardianship or trusteeship. * E2. Cancer with constitutional BRCA1/2 mutation. * E3. Previously treated by immunomodulators (PD1/PDL1, CTLA4). * E4. Systemic treatment by an immunosuppressor (including, but not limited to, corticosteroids, azathioprine, methotrexate, thalidomide and anti-TNF-alpha) or by an immunostimulant within 2 weeks before inclusion, except corticosteroids listed below: inhaled corticosteroids, intranasal corticosteroids, topic corticosteroids, and systemic corticosteroids with prednisone or equivalent physiological dose ≤ 10 mg/day. * E5. Patient with known history of autoimmune disease including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis,systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipids syndrome, Wegener syndrome , Sjögren syndrome, Guillain-Barré syndrome, multiple sclerosis, vascularitis, or glomerulonephritis, B or C hepatitis infection, HIV infection. * E6. Patient with other active tumor except if the tumor is considered not to interfere with outcome measures following sponsor approval such as basal or squamous cell skin cancer. Patient previously treated for an other cancer and without relapse for at least one year are eligible. * E7. Pregnant or breastfeeding woman.
Where this trial is running
Lyon, France
- Centre Léon Bérard — Lyon, France, France (Recruiting)
Study contacts
- Study coordinator: Nicolas Chopin
- Email: nicolas.chopin@lyon.unicancer.fr
- Phone: + 33 (0)4 78 78 28 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.