OncoMatch/Clinical Trials/NCT06627712
SBRT Combined With PD-1 Inhibitor and Chemotherapy in Early-stage TNBC
Is NCT06627712 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments including SBRT+PD-1 Inhibitor + Chemotherapy and PD-1 Inhibitor + Chemotherapy for tnbc - triple-negative breast cancer.
Treatment: SBRT+PD-1 Inhibitor + Chemotherapy · PD-1 Inhibitor + Chemotherapy — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) negative (negative)
Required: ESR1 negative (negative)
Required: PR (PGR) negative (negative)
Disease stage
Required: Stage CT1CN1-2M0, CT2N0-2M0
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Lab requirements
Blood counts
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
Kidney function
creatinine ≤ 1.5× uln or ccr ≥ 50 ml/min calculated using the cockcroft-gault formula corrected for body surface area
Liver function
tbil ≤ 1.5× 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
Cardiac function
baseline left ventricular ejection fraction (lvef) ≥ 50% measured by muga or echo; no severe organic heart disease or arrhythmias
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06627712 currently recruiting?
Yes, this trial is currently recruiting patients.
Does this trial require ERBB2?
Yes, ERBB2 negative is a required biomarker for enrollment.
Does this trial require ESR1?
Yes, ESR1 negative is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR negative is a required biomarker for enrollment.
What disease stage is eligible?
Stage CT1CN1-2M0 or CT2N0-2M0 is required.
Is there an age limit?
Yes. Patients must be 65 years or younger.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify