Actively Recruiting

Phase 3
Age: 18Years - 65Years
FEMALE
NCT06627712

SBRT Combined With PD-1 Inhibitor and Chemotherapy in Early-stage TNBC

Led by West China Hospital · Updated on 2026-01-30

318

Participants Needed

1

Research Sites

365 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Triple-negative breast cancer (TNBC) presents significant challenges due to its limited treatment options and poor efficacy. While neoadjuvant chemotherapy has improved breast-conserving rates and extended survival for TNBC patients, this subtype still faces issues such as restricted treatment modalities, low pathological response rates, and unfavorable prognosis compared to other subtypes. Studies like Keynote522 and IMpassion031 have shown that combining chemotherapy with immunotherapy yields a pCR rate of 64.8% in early-stage high-risk TNBC patients, suggesting that such combinations can offer substantial benefits. However, the low immunogenicity of breast cancer and the lack of clear predictive molecular markers for effective immunotherapy result in suboptimal pCR and objective response rates for this group. Radiotherapy has systemic immune regulatory effects by promoting the release of antigens from tumor cells, enhancing T-cell infiltration, and directly killing tumor cells. Therefore, this study aims to investigate the efficacy and safety of stereotactic radiotherapy combined with PD-1 inhibitors and chemotherapy in the neoadjuvant treatment of TNBC.

CONDITIONS

Official Title

SBRT Combined With PD-1 Inhibitor and Chemotherapy in Early-stage TNBC

Who Can Participate

Age: 18Years - 65Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically or cytologically confirmed triple-negative breast cancer (ER-, PR-, HER2-)
  • Clinical stage cT1cN1-2M0 or cT2N0-2M0 according to AJCC 7th edition
  • ECOG performance status of 0 or 1
  • Adequate bone marrow function: hemoglobin ≥ 9.0 g/dL; absolute neutrophil count ≥ 1,500/mcL; platelets ≥ 100,000/mcL; no recent blood transfusions or growth factor therapy
  • Adequate liver function: total bilirubin ≤ 1.5 times upper limit of normal; AST and ALT ≤ 2.5 times ULN without liver metastases or ≤ 3.0 times ULN with liver metastases; alkaline phosphatase ≤ 1.5 times ULN or ≤ 2 times ULN with liver metastases; serum albumin ≥ 30 g/L
  • Adequate coagulation function: INR, PT, and APTT ≤ 1.5 times ULN; close monitoring if on anticoagulants
  • Adequate renal function: creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 50 mL/min
  • Baseline left ventricular ejection fraction ≥ 50% measured by MUGA or echocardiogram
  • No severe organic heart disease or arrhythmias
  • Women of childbearing potential (age 15-49) must have a negative pregnancy test within 7 days before treatment start
  • Participants of reproductive potential must agree to use effective contraception during the study and for 3 months after treatment ends
  • Voluntary signed informed consent
Not Eligible

You will not qualify if you...

  • History of mental illness or diagnosed mental disorders at enrollment
  • Communication difficulties due to confusion, aphasia, or intellectual disability
  • Poorly controlled tumor-related pain
  • Participation in other clinical studies at the same time
  • Active or past autoimmune diseases or immunodeficiencies such as myasthenia gravis, myositis, autoimmune hepatitis, lupus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, idiopathic pneumonia, or active pneumonia on chest CT at screening
  • Active pulmonary tuberculosis
  • Severe cardiovascular diseases within 3 months prior to treatment start, including NYHA class II or higher heart disease, myocardial infarction, cerebrovascular accident, unstable arrhythmias, or unstable angina
  • Major surgery other than diagnostic procedures within 4 weeks before treatment or expected during the study
  • Other malignancies within 5 years except low-risk cancers like treated cervical carcinoma in situ, non-melanoma skin cancer, ductal carcinoma in situ, or stage I uterine cancer
  • Severe infections requiring hospitalization or active infections within 4 weeks before treatment
  • Previous allogeneic stem cell or solid organ transplants
  • Any other diseases, metabolic problems, physical abnormalities, or lab issues that contraindicate study drugs, affect results, or increase treatment risks

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

West China Hospital, Sichuan University

Sichuan, Chengdu, China

Actively Recruiting

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Research Team

J

Jun Wang, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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