Short-course SBRT plus toripalimab and chemotherapy for chemo-resistant triple-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, single-center Phase II trial for patients with stage II–III triple-negative breast cancer whose tumors show stable or progressive disease after two cycles of standard neoadjuvant chemotherapy. Participants receive stereotactic body radiotherapy (24 Gy in 3 daily fractions) to the intact breast primary, then start toripalimab with albumin-bound paclitaxel and carboplatin for four 21-day cycles. The primary endpoint is pathologic complete response (no invasive cancer in breast or nodes at surgery), with secondary endpoints including objective radiologic response, changes in tumor-infiltrating lymphocytes, safety, event-free and overall survival, and rate of breast-conserving surgery. Exploratory biomarker studies include whole-exome and RNA sequencing, TCR clonality, PD-L1 and interferon signatures, and circulating tumor DNA dynamics.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Female, age 18-75 years, newly diagnosed invasive breast cancer.
* Histologically confirmed triple-negative phenotype: ER \< 1 %, PR \< 1 % by IHC, HER2 negative (IHC 0/1+ or IHC 2+ with ISH negative).
* Clinical stage II-III (T2-4 or N1-3, M0).
* Completed 2 cycles of standard neoadjuvant chemotherapy (taxane ± anthracycline ± platinum) and assessed as non-responder: stable disease (SD) or progressive disease (PD) by RECIST 1.1.
* ECOG performance status 0 or 1.
* Radiation oncologist confirms suitability for SBRT and subsequent standard post-operative radiotherapy.
* Adequate organ function within 14 days before enrollment: WBC ≥ 2 000/µL, ANC ≥ 1 500/µL, platelets ≥ 100 000/µL, Hb ≥ 9 g/dL; Serum creatinine ≤ 2 mg/dL or GFR ≥ 40 mL/min; AST/ALT ≤ 2.5 × ULN, total bilirubin ≤ ULN (≤ 3 mg/dL if Gilbert syndrome); INR ≤ 1.5 (on anticoagulation allowed if therapeutic range)
* Negative HIV, HBV surface antigen, and HCV antibody (or HBV DNA / HCV RNA negative if false-positive).

Exclusion Criteria:

* Inflammatory breast cancer.
* Any other malignancy requiring treatment within the past 3 years (except adequately treated basal-cell skin carcinoma or cervical CIS).
* Active autoimmune disease, immunodeficiency, or systemic steroids \> 10 mg/day prednisone equivalent within 2 years.
* Clinically significant cardiovascular disease (unstable angina, NYHA III/IV heart failure, recent MI).
* Prior radiotherapy to the breast or chest wall.
* Active infection requiring systemic therapy.
* Known intolerance or hypersensitivity to toripalimab, paclitaxel, or carboplatin.
* Pregnant or lactating women.

Where it's running

• The Department of Radiation Oncology，the Second Affiliated Hospital of Zhejiang University School of Medicine, hangzhou, zhejiang
  Hangzhou, China Recruiting

Study contacts

• Study coordinator: Ting Zhang, phD.
• Email: zezht@zju.edu.cn
• Phone: +86-571-87783521

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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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.