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

• Status: Not yet recruiting
• Trial end date: 2023-10-15
• Target enrollment: 0
• Participant gender: Female

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shengjing Hospital
• Collaborator: Jiangsu HengRui Medicine Co., Ltd.

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.