Breast Cancer Study of Stereotactic Body Radiation Therapy (SBRT) Combined Neoadjuvant Treatment

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: SHR-1316 at a dose 20mg/kg q3w
* Drug: SHR6390 at a dose of 150mg orally, daily
* Radiation: SBRT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TNBC<br> | Drug: SHR-1316 at a dose 20mg/kg q3w<br>* Combination of SBRT and SHR1316, followed by SHR1316 plus nab-paclitaxel and carboplatin or cisplatin<br>Radiation: SBRT<br>* radiation therapy for breast cance before surgery.<br>|
| Experimental: HER2-/HR+BC<br> | Drug: SHR6390 at a dose of 150mg orally, daily<br>* SHR6390 plus exemestane with/without ovarian function suppression/ablation (OFS) after SBRT<br>Radiation: SBRT<br>* radiation therapy for breast cance before surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer