Status:
COMPLETED
Study of Apatinib in Metastatic Triple-Negative Breast Cancer Patients
Lead Sponsor:
Fudan University
Collaborating Sponsors:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief Summary
The hypothesis of this clinical research study is to discover if the study drug apatinib can shrink or slow the growth of pretreated metastatic triple-negative breast cancer.
Detailed Description
Apatinib is a tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor (VEGFR), and its anti-angiogenesis effect has been viewed in preclinical tests. The investigators' phase I...
Eligibility Criteria
Inclusion
- ≥ 18 and ≤ 70 years of age.
- ECOG performance status of 0-1.
- Women diagnosed with triple negative breast cancer (breast cancer is estrogen receptor negative (ER-), progesterone receptor negative (PgR-) and human epidermal growth factor receptor negative (HER2-). HER2- is defined as 0 or 1+ staining on immunohistochemistry or FISH/CISH negative for gene amplification.
- Metastatic breast cancer, confirmed by histological analysis.
- Have failed for at least one chemotherapy regimen, but at most three regimens(including adjuvant and neo-adjuvant setting).
- Duration from the last therapy (chemotherapy, radiotherapy, target therapy and operation) is more than 4 weeks (Duration for nitroso or mitomycin is 6 weeks).
- Have at least one extracranial measurable site of disease according to RECIST 1.1 criteria that has not been previously irradiated. If the patient has had previous radiation to the marker lesion(s), there must be evidence of disease progression since the radiation.
- Life expectancy of more than 3 months.
- If the patients have brain or meninges metastases, the lesions must have been controlled at least 8 weeks.
- Adequate hepatic, renal, heart, and hematologic functions (hemoglobin ≥ 9.0g/dl, neutrophils ≥ 1.5×10\^9/L, platelets ≥ 80×10\^9/L , ALT ≤ 2.5 x upper limit of normal (ULN), AST ≤ 2.5 x ULN, serum bilirubin ≤ 1.5 x ULN, serum creatine ≤ 1.5 x ULN, creatinine clearance rate ≥ 50ml/min, PT, APTT, TT, Fbg normal).
- Written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time without prejudice.
Exclusion
- Pregnant or lactating women.
- Less than 4 weeks from the last clinical trial.
- Have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: Congestive heart failure: New York Heart Association Class III/IV, Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease.
- Any factors that influence the usage of oral administration.
- Receiving the therapy of thrombolysis or anticoagulation.
- Unhealed wound or bone fracture.
- Urine protein ≥++ and confirmed \>1.0 g by the 24h quantity.
- Previous or present history of pulmonary fibrosis,interstitial pneumonia,pneumoconiosis,radiation pneumonitis,drug-related pneumonitis or greatly-impaired pulmonary function.
- Disability of serious uncontrolled intercurrence infection.
- Abuse of alcohol or drugs.
- Have received prior treatment with a VEGFR, PDGFR or s-SRC TKI (Bevacizumab is permitted).
- History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01176669
Start Date
June 1 2010
End Date
September 1 2014
Last Update
September 9 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China, 200032