Neoadjuvant adebrelimab plus chemotherapy for high-risk ER-positive/HER2-negative breast cancer

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 is a single-arm Phase 2 neoadjuvant trial combining adebrelimab with nab‑paclitaxel followed by epirubicin and cyclophosphamide in patients with early or locally advanced high‑risk ER+/HER2− breast cancer. Eligible participants must have measurable unilateral disease, provide core biopsy tissue for PD‑L1 and biomarker testing, and have ECOG 0–1 with adequate organ function. The primary objective is to increase pathologic complete response (pCR) rates at surgery while characterizing safety, and secondary analyses will explore biomarkers associated with response. All treatment and surgical care are planned at Ruijin Hospital in Shanghai.

Why it matters

Who can join: the full rules

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 therapy within the past 2 years;
* Severe systemic infections or other serious medical conditions;
* Other malignant tumors in the past 5 years, except for cured carcinoma in situ of the cervix and skin cancer without melanoma;
* History of HIV infection;
* Active HBV or HCV infection;
* Known allergies or intolerance to the therapeutic drug or its excipients;
* History of application of any immunotherapy targeting PD-1/PD-L1/T cell receptors;
* Judged by the investigator to be unsuitable to participate in this study.

Where it's running

• Ruijin Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Haoyu Wang
• Email: meredithwhy@163.com
• Phone: 86 021-64370045

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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.