Breast Cancer
Conditions
Keywords
breast cancer
Brief summary
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
Interventions
DRUGSHR-1316 at a dose 20mg/kg q3w
Combination of SBRT and SHR1316, followed by SHR1316 plus nab-paclitaxel and carboplatin or cisplatin
DRUGSHR6390 at a dose of 150mg orally, daily
SHR6390 plus exemestane with/without ovarian function suppression/ablation (OFS) after SBRT
RADIATIONSBRT
radiation therapy for breast cance before surgery.
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Shengjing Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological complete response (pCR) for TNBC group | Up to11 months | 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. |
| Residual cancer burden (RCB) 0-I index for HER2-/HR+BC group | Up to11 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pathological complete response (pCR) forHER2-/HR+BC group | Up to11 months | 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. |
| Residual cancer burden (RCB) 0-I index for TNBC group | Up to11 months | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate(ORR) | Up to11 months | ORR by investigator using RECIST Guideline (Version 1.1) |
| Adverse reactions（AE） and Serious adverse reactions （SAE) | Through study completion, an average of 15 months | Adverse reactions（AE） and Serious adverse reactions during the study |
Countries
China
Outcome results
None listed