Clinical trial NCT03457467: Clinical Study of Apatinib Combined With SBRT Therapy in the Treatment of Oligometastasis of Breast Cancer
Official title: Clinical Study of Apatinib Mesylate Combined With Stereotactic Body Radiation Therapy in the Treatment of Oligometastasis of Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Keywords: oligometacosis
anti-angiogenic
apatinib
Lead sponsor: West China Hospital
Sponsor class: OTHER
Collaborators: name: Jiangsu HengRui Medicine Co., Ltd.
First posted: 2018-03-07
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Overall survival (OS)
timeFrame: Approximately 3 year
Secondary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: Approximately 2 year
measure: Adverse Events(AEs)
timeFrame: Approximately 2 years
Other outcomes:
Locations:
Study officials:
affiliation: West China Hospital
name: Yan Li
role: STUDY_CHAIR
References:
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citation: Elson-Schwab I, Lorentzen A, Marshall CJ. MicroRNA-200 family members differentially regulate morphological plasticity and mode of melanoma cell invasion. PLoS One. 2010 Oct 4;5(10):e13176. doi: 10.1371/journal.pone.0013176.
citation: Dykxhoorn DM, Wu Y, Xie H, Yu F, Lal A, Petrocca F, Martinvalet D, Song E, Lim B, Lieberman J. miR-200 enhances mouse breast cancer cell colonization to form distant metastases. PLoS One. 2009 Sep 29;4(9):e7181. doi: 10.1371/journal.pone.0007181.
citation: Wong AC, Watson SP, Pitroda SP, Son CH, Das LC, Stack ME, Uppal A, Oshima G, Khodarev NN, Salama JK, Weichselbaum RR, Chmura SJ. Clinical and molecular markers of long-term survival after oligometastasis-directed stereotactic body radiotherapy (SBRT). Cancer. 2016 Jul 15;122(14):2242-50. doi: 10.1002/cncr.30058. Epub 2016 May 20.