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

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

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.