Breast Cancer Study of Stereotactic Body Radiation Therapy (SBRT) Combined Neoadjuvant Treatment
NCT05132790 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2024-01-03
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
Conditions
Interventions
- DRUG
-
SHR-1316 at a dose 20mg/kg q3w
Combination of SBRT and SHR1316, followed by SHR1316 plus nab-paclitaxel and carboplatin or cisplatin
- DRUG
-
SHR6390 at a dose of 150mg orally, daily
SHR6390 plus exemestane with/without ovarian function suppression/ablation (OFS) after SBRT
- RADIATION
-
SBRT
radiation therapy for breast cance before surgery.
Sponsors & Collaborators
-
Jiangsu HengRui Medicine Co., Ltd.
collaborator INDUSTRY -
Shengjing Hospital
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-09-25
- Primary Completion
- 2024-12-31
- Completion
- 2028-12-31
Countries
- China
Study Locations
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