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| Name | Class |
|---|---|
| Jiangsu HengRui Medicine Co., Ltd. | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TNBC | Experimental |
| |
| HER2-/HR+BC | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1316 at a dose 20mg/kg q3w | Drug | Combination of SBRT and SHR1316, followed by SHR1316 plus nab-paclitaxel and carboplatin or cisplatin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete response (pCR) for TNBC group | 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. | Up to11 months |
| Residual cancer burden (RCB) 0-I index for HER2-/HR+BC group | Residual cancer burden (RCB) is estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes after the completion of neoadjuvant therapy. 5 variables are included in a calculation formula to evaluate the total index(0-III), the higher scores mean a worse outcome | Up to11 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete response (pCR) forHER2-/HR+BC group | 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. | Up to11 months |
| Residual cancer burden (RCB) 0-I index for TNBC group |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate(ORR) | ORR by investigator using RECIST Guideline (Version 1.1) | Up to11 months |
| Adverse reactions（AE） and Serious adverse reactions （SAE) | Adverse reactions（AE） and Serious adverse reactions during the study |
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shengjing Hospital of China Medical University | Shenyang | Liaoning | 110004 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40719174 | Derived | Zhang 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. | |
| 38131294 |
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Findings from this study will indicate whether stereotactic body radiation therapy (SBRT) combined neoadjuvant treatment for patients with triple-negative and hormone receptor-positive, HER2-negative breast cancer is safe and effective.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| SHR6390 at a dose of 150mg orally, daily | Drug | SHR6390 plus exemestane with/without ovarian function suppression/ablation (OFS) after SBRT |
|
| SBRT | Radiation | radiation therapy for breast cance before surgery. |
|
Residual cancer burden (RCB) is estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes after the completion of neoadjuvant therapy. 5 variables are included in a calculation formula to evaluate the total index(0-III), the higher scores mean a worse outcome |
| Up to11 months |
| Through study completion, an average of 15 months |
| Derived |
| Chen 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. |
| D017437 |
| Skin and Connective Tissue Diseases |