Understanding immune changes in breast and ovarian cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.