NCT06500208 Neoadjuvant Adebrelimab and Chemotherapy in High-rish ER+/HER2- BC
| NCT ID | NCT06500208 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shanghai Jiao Tong University School of Medicine |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2025-12-31 |
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.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 48 participants in total. It began in 2024-11-01 with a primary completion date of 2025-12-31.
⚠ 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
Investigators plan to conduct a single-arm clinical study of adebelimab, a novel PD-L1 inhibitor, in the neoadjuvant treatment of early or locally advanced high-risk ER+/HER2- breast cancer, to explore whether the addition of immune checkpoint inhibitors to traditional neoadjuvant chemotherapy can improve the pathologic complete response rate (pCR) of patients, evaluate its therapeutic safety, and further analyze the biomarkers of the efficacy of neoadjuvant immunotherapy for ER+/HER2- breast cancer, so as to support the clinical application of the drug.
Eligibility Criteria
Inclusion Criteria: * pathologically diagnosed as unilateral primary invasive breast cancer with a) cT1c-T2N1-3 or cT3-4N0-3, b) Tumor Grade 3 or Grade 2 with PR- or Ki67 \> 20%; * IHC ER expression ≥1%; IHC HER2 0 or 1+; IHC HER2 2+ and no amplification in FISH test; * At least one measurable lesion according to RECIST 1.1; * Available core needle biopsy samples for PD-L1 status testing; * ECOG 0 or 1 within 10 days prior to initiation of treatment; * Not currently pregnant or breastfeeding, agree to strict contraception during treatment and at least 6 months after last dose; * Intact hematologic, liver, renal and heart functions; * Signed written informed consent. Exclusion Criteria: * Bilateral invasive breast cancer or Stage IV breast cancer; * Severe heart disease; * Diagnosed as immune deficiency or receiving systemic steroid therapy or any form of immuno-suppressive therapy within 7 days prior to the first dose of treatment; * Had active autoimmune diseases requiring systemic
Frequently Asked Questions
Who can join the NCT06500208 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 65 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.
What phase is the NCT06500208 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06500208 currently recruiting?
Yes, NCT06500208 is actively recruiting participants. Visit ClinicalTrials.gov or contact Shanghai Jiao Tong University School of Medicine to inquire about joining.
Where is the NCT06500208 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06500208 clinical trial?
NCT06500208 is sponsored by Shanghai Jiao Tong University School of Medicine. The trial plans to enroll 48 participants.
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