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

Study Overview
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Brief Summary
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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.

Detailed Description
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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. So, through the detection of microRNA in the primary lesion of breast cancer patients with oligometastasis to screen the patients with oligomerization and potential multiple metastases; explore the existing medical treatment, based on the control of local lesions by SBRT, the use of apatinib anti-angiogenic targeted maintenance therapy, with a view to reducing the incidence of new lesions, thereby prolonging the patient's survival.

Official Title
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Clinical Study of Apatinib Mesylate Combined With Stereotactic Body Radiation Therapy in the Treatment of Oligometastasis of Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Apatinib
* Radiation: SBRT


Participation Criteria
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Eligibility Criteria
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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: After the above image examination of the whole body metastasis lesions ≥ 6; Have received one or more palliative chemotherapy regulators failed; 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SBRT+apatinib group<br>Apatinib mesylate tablets: 500mg / day, 28 days / cycle, follow-up to the progress of the disease, toxicity intolerable or patients require withdrawal; SBRT: according to the different treatment sites given the corresponding dose: 1200cGy × 4 times or 800cGy × 7 times, or according to the specific situation dose adjustment. | Drug: Apatinib<br>* Apatinib 500 mg is administered orally daily, until disease progression or untolerable toxicity<br>* Other names: Apatinib Mesylate Tablets;Radiation: SBRT<br>* according to the different treatment sites given the corresponding dose: 1200cGy × 4 times or 800cGy × 7 times, or according to the specific situation dose adjustment<br>* Other names: Stereotactic body radiotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | OS is defined as the length of time from random assignment to death or to last contact. | Approximately 3 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival (PFS) | time from randomization to documented progressive disease or death due to any cause, whichever occurs first | Approximately 2 year | 
| Adverse Events(AEs) | AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0. | Approximately 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oligometacosis, anti-angiogenic, apatinib