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Clinical Trials/NCT03457467
NCT03457467UnknownPhase 2

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

Yan Li0 sites30 target enrollmentStarted: March 15, 2018Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Sponsor
Enrollment
30
Primary Endpoint
Overall survival (OS)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age: ≥ 18 years old women;
  • Histologically confirmed breast cancer; 3 weeks before enrollment ECOG PS score: 0-2 points;
  • systemic metastasis lesions ≤ 5, Stereotactic body radiotherapy before receiving medical treatment to achieve partial relief or stable disease;
  • 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)
  • 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;
  • Renal insufficiency 3 and above patients;
  • Hand-foot syndrome ≥ 3 or more patients;
  • 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;
  • Pregnant or breastfeeding patients, or who have fertility without taking contraceptive measures;
  • A history of malignancy, but disease-free survival of more than 5 years;
  • Concurrent with other anti-cancer therapies or other interventional clinical trials;
  • Patients unable to follow the study due to psychological, family-living social reasons

Arms & Interventions

SBRT+apatinib group

Experimental

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.

Intervention: Apatinib (Drug)

SBRT+apatinib group

Experimental

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.

Intervention: SBRT (Radiation)

Outcomes

Primary Outcomes

Overall survival (OS)

Time Frame: Approximately 3 year

OS is defined as the length of time from random assignment to death or to last contact.

Secondary Outcomes

  • Progression-free Survival (PFS)(Approximately 2 year)
  • Adverse Events(AEs)(Approximately 2 years)

Investigators

Sponsor
Yan Li
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Yan Li

assistant director physician

West China Hospital

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