Clinical Study of Apatinib Combined With SBRT Therapy in the Treatment of Oligometastasis of Breast Cancer

• Status: Unknown status
• Trial end date: 2020-03-15
• Target enrollment: 0
• Participant gender: Female

Summary

The treatment of the patients with metastatic breast cancer remains a major problem. However, there is an intermediate state between the primary tumor and distant metastases called oligometastasis. Current research indicates that good local control of oligometastasis can be obtained with Stereotactic body radiotherapy (SBRT) Can not prolong the long-term survival of patients. Researchers believe that after SBRT treatment of patients with oligometacosis in breast cancer, it is necessary to explore whether the anti-angiogenic therapy targeted drug apatinib can reduce the occurrence of new lesions and prolong the survival of patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yan Li
• Collaborator: Jiangsu HengRui Medicine Co., Ltd.
• Treatments: Apatinib

Criteria

Inclusion Criteria:

1. Age: ≥ 18 years old women; 2. Histologically confirmed breast cancer; 3 weeks before enrollment ECOG PS score: 0-2 points; 4. systemic metastasis lesions ≤ 5, Stereotactic body radiotherapy before receiving medical treatment to achieve partial relief or stable disease; 5. Appropriate hematological parameters and liver and kidney function: absolute neutrophil ≧ 1.5 × 109 / L; platelet count ≧ 75 × 109 / L; serum total bilirubin ≦ 1.5 × upper limit of normal; AST and ALT ≦ 2.5 × upper limit of normal (if liver dysfunction) 6. Subject voluntarily joined the study and signed the informed consent form.

Exclusion Criteria:

1. After the above image examination of the whole body metastasis lesions ≥ 6;

2. Have received one or more palliative chemotherapy regulators failed;

3. Patients with a high risk of bleeding: active gastric digestive ulcer in the stomach with fecal occult blood (++); those with a history of melena and / or vomiting within 3 months; persons with abnormal coagulation and bleeding tendency; 3-4 grade hypertension patients;

5. Renal insufficiency 3 and above patients; 6. Hand-foot syndrome ≥ 3 or more patients; 7. There are uncontrolled concomitant diseases in the first 6 months of the study, including unstable angina pectoris, acute myocardial infarction, cerebrovascular accident and so on;

8. Pregnant or breastfeeding patients, or who have fertility without taking contraceptive measures; 9. A history of malignancy, but disease-free survival of more than 5 years; 10. Concurrent with other anti-cancer therapies or other interventional clinical trials; 11. Patients unable to follow the study due to psychological, family-living social reasons