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

China Medical University

Status

Active, not recruiting

Conditions

Breast Cancer

Treatments

Drug: SHR6390 at a dose of 150mg orally, daily

Radiation: SBRT

Drug: SHR-1316 at a dose 20mg/kg q3w

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05132790

BC-NEO-IIT-SHR1316-SHR6390-RT

Details and patient eligibility

About

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

Enrollment

24 estimated patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.