Clinical trial · Interventional
Breast Cancer Study of Stereotactic Body Radiation Therapy (SBRT) Combined Neoadjuvant Treatment
Study to Evaluate the Efficacy and Safety of Stereotactic Body Radiation Therapy (SBRT) Combined Neoadjuvant Treatment for Patients With Triple-negative and Hormone Receptor-positive, HER2-negative Breast Cancer
NCT05132790CI-TRIAL-00072674active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study is being conducted to evaluate the efficacy and safety of stereotactic body radiation therapy (SBRT) combined neoadjuvant treatment for patients with triple-negative and hormone receptor-positive, HER2-negative breast cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SBRT | Radiation | — | UNRESOLVED |
| SHR-1316 at a dose 20mg/kg q3w | Drug | — | UNRESOLVED |
| SHR6390 at a dose of 150mg orally, daily | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TNBC
- interventionNames
- Drug: SHR-1316 at a dose 20mg/kg q3w
- Radiation: SBRT
- type
- EXPERIMENTAL
- label
- HER2-/HR+BC
- interventionNames
- Drug: SHR6390 at a dose of 150mg orally, daily
- Radiation: SBRT
Primary outcomes (2)
- measure
- Pathological complete response (pCR) for TNBC group
- timeFrame
- Up to11 months
- description
- pCR is defined as the absence of residual invasive cancer on resected breast specimen and the sampled regional lymph nodes as shown by hematoxylin-eosin staining after completion of the neoadjuvant treatment.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed histologic diagnosis of invasive adenocarcinoma of the breast * ER, PR and HER2 testing, and * TNBC patients （ HER2-neu 0-1+ by IHC or FISH-negative by ASCO CAP guidelines） * ER-positive and HER2-negative breast cancer * tumor measuring ≥2 cm in maximal diameter as measured by any available standard of care imaging (mammogram, breast ultrasound, breast MRI) * Any nodal status * ECOG Performance Status of 0 -1 * Screening laboratory values must meet the following criteria: i. Absolute neutrophil count (ANC) ≥1.5 × 109/L ii. Platelets ≥100 × 109/L iii. Hemoglobin ≥ 10.0 g/dl for TNBC, ≥ 10.0 g/dl for HR+/HER2-BC iv. Serum creatinine ≤1.5 x upper limit of normal (ULN) v. AST ≤ 2.5 xULN vi. ALT ≤ 2.5 x ULN vii. Total bilirubin ≤ 2.5 xULN viii left ventricular ejection fraction ≥ 50%. Exclusion Criteria: * Any kind of prior treatment for breast cancer, including chemotherapy, radiotherapy, endocrine therapy and so on * Inflammatory breast cancer * Pregnant and lactating women; * distant metastasis * patients who have participated in other clinical trials.
References
Publications (2)
- DERIVEDZhang Y, Cao S, Niu N, Shan H, Xue J, Chen G, Xu Y, Yin J, Liu C, Sun L, Jiang X, Tang M, Xu Q, Jia M, Zhang X, Zhang Z, Zhang Q, Wang J, Li A, Yang Y, Liu C. Efficacy and safety of neoadjuvant stereotactic body radiation therapy plus dalpiciclib and exemestane for hormone receptor-positive, HER2-negative breast cancer: A prospective pilot study. Elife. 2025 Jul 28;14:RP101583. doi: 10.7554/eLife.101583. PMID 40719174
- DERIVEDChen G, Gu X, Xue J, Zhang X, Yu X, Zhang Y, Li A, Zhao Y, He G, Tang M, Xing F, Yin J, Bian X, Han Y, Cao S, Liu C, Jiang X, Zhang K, Xia Y, Li H, Niu N, Liu C; Northeastern Clinical Research Alliance of Oncology (NCRAO). Effects of neoadjuvant stereotactic body radiotherapy plus adebrelimab and chemotherapy for triple-negative breast cancer: A pilot study. Elife. 2023 Dec 22;12:e91737. doi: 10.7554/eLife.91737. PMID 38131294