SBRT plus PD-1 immunotherapy and chemotherapy for early-stage triple-negative breast cancer

Stereotactic Body Radiotherapy (SBRT) Combined With PD-1 Inhibitor and Chemotherapy in Early-stage Treatment-naive Triple-negative Breast Cancer Patients: A Multicenter Phase III Clinical Study

This tests whether adding stereotactic body radiotherapy (SBRT) to a PD-1 drug and chemotherapy helps people with early-stage triple-negative breast cancer get better responses to treatment.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 318 (estimated)
• Ages: 18 Years to 65 Years
• Sex: Female
• Sponsor: West China Hospital (other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Sichuan, Chengdu)
• Trial ID: NCT06627712 on ClinicalTrials.gov

What this trial studies

This phase 3 interventional trial compares SBRT combined with a PD-1 inhibitor and chemotherapy versus a PD-1 inhibitor with chemotherapy alone in patients with early-stage, high-risk triple-negative breast cancer. Eligible participants (cT1cN1-2M0 or cT2N0-2M0, AJCC 7th) with ECOG 0-1 and adequate organ function will receive the assigned neoadjuvant treatment and be followed for response and safety. The trial builds on data showing chemotherapy plus immunotherapy can increase pathological complete response (pCR) rates and tests whether targeted radiotherapy can further boost immune-mediated tumor control. Primary outcomes include pathological response and treatment-related adverse events to determine if adding SBRT improves short-term efficacy and tolerability.

Who should consider this trial

Good fit: Ideal candidates are people with histologically confirmed triple-negative breast cancer staged cT1cN1-2M0 or cT2N0-2M0 (AJCC 7th), with ECOG performance status 0–1 and adequate bone marrow, liver, kidney, and coagulation function per protocol limits.

Not a fit: Patients with metastatic disease, hormone-receptor or HER2-positive tumors, poor performance status, or inadequate organ function by the listed laboratory cutoffs are unlikely to be eligible or to benefit from this approach.

Why it matters

Potential benefit: If successful, adding SBRT could increase pathological complete response rates and broaden effective pre-surgical treatment options for early-stage TNBC patients, which may translate into better long-term outcomes.

How similar studies have performed: Previous trials like Keynote-522 and IMpassion031 showed higher pCR rates when chemotherapy was combined with immunotherapy, but the addition of SBRT to this combination is a newer strategy with limited phase-3 evidence so far.

Eligibility criteria

Inclusion Criteria:

* 1\. Histologically or cytologically confirmed TNBC (ER-, PR-, HER2-)
* 2\. cT1cN1-2M0 or cT2N0-2M0；（AJCC 7th）
* 3\. ECOG performance status of 0-1;
* 4\. Adequate bone marrow function, defined as: Hb ≥ 9.0 g/dL (90 g/L); ANC ≥ 1,500/mcL (1.5 × 10\^9/L); PLT ≥ 100,000/mcL (100 × 10\^9/L) and no blood transfusion within 3 weeks or growth factor (G-CSF, EPO) therapy within 2 weeks prior to dosing;
* 5\. Adequate liver function, defined as: TBIL ≤ 1.5× upper limit of normal (ULN); If no liver metastases, AST and ALT ≤ 2.5× ULN; if liver metastases are present, AST or ALT ≤ 3.0× ULN; ALP ≤ 1.5× ULN; if liver metastases ≤ 2× ULN; Serum albumin ≥ 30g/L;
* 6\. Adequate coagulation function: INR or PT, APTT ≤ 1.5× ULN. Participants on anticoagulant therapy should have these laboratory indices closely monitored;
* 7\. Adequate renal function, defined as creatinine ≤ 1.5× ULN or Ccr ≥ 50 mL/min calculated using the Cockcroft-Gault formula corrected for body surface area;
* 8\. Baseline left ventricular ejection fraction (LVEF) ≥ 50% measured by multiple-gated acquisition (MUGA) or echocardiogram (ECHO);
* 9\. No severe organic heart disease or arrhythmias;
* 10\. Women of childbearing potential (aged 15-49 years) must have a negative pregnancy test within 7 days before starting treatment. Both male and female participants of reproductive potential must agree to use effective contraceptive measures during the study period and for 3 months after discontinuation of treatment;
* 11\. Voluntary signed informed consent by the study participant.

Exclusion Criteria:

* 1\. Patients with a history of mental illness or those diagnosed with mental disorders at the time of enrollment in the clinical trial.
* 2\. Patients with communication barriers due to confusion, aphasia, intellectual disability, or other reasons that prevent them from responding normally.
* 3\. Poorly controlled tumor-related pain.
* 4\. Patients participating in other clinical studies simultaneously.
* 5\. Patients with active or past autoimmune diseases or immunodeficiencies, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis.
* 6\. A history of idiopathic pulmonary fibrosis, organizing pneumonia (such as obliterative bronchiolitis), drug-induced pneumonia, or idiopathic pneumonia, or evidence of active pneumonia on chest CT scans at screening.
* 7\. Active pulmonary tuberculosis.
* 8\. Severe cardiovascular diseases occurring within 3 months prior to the start of study treatment (e.g., NYHA class II or higher heart disease, myocardial infarction, or cerebrovascular accident), unstable arrhythmias, or unstable angina.
* 9\. Patients who underwent significant surgical procedures, other than diagnostic surgeries, within 4 weeks prior to the start of the study treatment, or are expected to require significant surgical procedures during the study period.
* 10\. Patients who had malignant tumors other than breast cancer within the last 5 years, except for malignancies in the study that have negligible risks of metastasis or death (e.g., a 5-year overall survival rate \> 90%), such as adequately treated cervical carcinoma in situ, non-melanoma skin cancer, ductal carcinoma in situ, or stage I uterine cancer.
* 11\. Patients who experienced severe infections within 4 weeks prior to the start of the study treatment, including but not limited to those requiring hospitalization due to infections, bacteremia, severe pneumonia, or any active infection that may impact patient safety.
* 12\. Patients who have previously received allogeneic stem cell or solid organ transplants.
* 13\. Any other diseases, metabolic dysfunctions, physical examination abnormalities, or clinical laboratory abnormalities that contraindicate the use of the study drug, may affect the interpretation of results, or pose a high risk of treatment complications for the patient.

Where this trial is running

Sichuan, Chengdu

• West China Hospital, Sichuan University — Sichuan, Chengdu, China (RECRUITING)

Study contacts

• Study coordinator: Jun Wang, MD

Conditions: TNBC - Triple-Negative Breast Cancer, Triple negative breast cancer, SBRT, Chemotherapy, PD-1 Inhibitor