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
Overview
- Phase
- Not Applicable
- Intervention
- SBRT
- Conditions
- Breast Cancer
- Sponsor
- Shengjing Hospital
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Pathological complete response (pCR) for TNBC group
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
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
Investigators
Caigang Liu
professor
Shengjing Hospital
Eligibility Criteria
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.
Arms & Interventions
HER2-/HR+BC
Intervention: SBRT
TNBC
Intervention: SHR-1316 at a dose 20mg/kg q3w
TNBC
Intervention: SBRT
HER2-/HR+BC
Intervention: SHR6390 at a dose of 150mg orally, daily
Outcomes
Primary Outcomes
Pathological complete response (pCR) for TNBC group
Time Frame: 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
Time Frame: 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 Outcomes
- Residual cancer burden (RCB) 0-I index for TNBC group(Up to11 months)
- Pathological complete response (pCR) forHER2-/HR+BC group(Up to11 months)