A Study of Apatinib in Non-triple-negative Metastatic Breast Cancer
NCT ID: NCT01653561
Last Updated: 2013-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2011-11-30
2012-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Apatinib
Apatinib 500mg/d
Apatinib
The starting dose of apatinib will be 500mg/d. Two dose reductions will be allowed to 375 and then 250 mg/d.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Apatinib
The starting dose of apatinib will be 500mg/d. Two dose reductions will be allowed to 375 and then 250 mg/d.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* ECOG performance status of 0-1.
* Metastatic breast cancer, confirmed by histological analysis.
* Have experienced at least 1 and at most 4 regimens, and failed from the last chemotherapy regimen. Pretreated anthracycline, taxanes and capecitabine (any rational reason for no use of capecitabine is acceptable) are mandatory.
* Women diagnosed with human epidermal growth factor receptor positive (HER2+) should have failed for at least 1 anti-HER2 therapy (any rational reason for no use of anti-HER2 therapy is acceptable). HER2+ is defined as +++ staining on immunohistochemistry or FISH/CISH positive for gene amplification.
* Women diagnosed with HR+ should have failed for at least 1 hormonal therapy.
* 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 1.0 criteria that has not been previously irradiated.
* Life expectancy of more than 3 months.
* Negative serum or urine pregnancy test taken in all women within 7 days before inclusion. Sexually active women of childbearing potential must use a medically acceptable form of contraception from the beginning of the study to 8 weeks after the last dose of the investigated drug.
* Written informed consent prior to study specific screening procedures.
Exclusion Criteria
* Pregnant or lactating women.
* Less than 4 weeks from the last clinical trial.
* Uncontrolled hypertension with mono-drug therapy (\>140/90 mm Hg)；ischemia of the myocardium （≥ grade 2） or myocardial infarction；arrhythmia（≥ grade 2, QTcF \> 470ms for female patients） or New York Heart Association Class III/IV
* Any factors that influence the usage of oral administration.
* The cumulative doses of doxorubicin and epirubicin before inclusion have surpassed 300 mg/m2 and 600 mg/m2, respectively.
* Duration from the last therapy (chemotherapy, radiotherapy, target therapy and operation) is less than 4 weeks (Duration for nitroso or mitomycin is less than 6 weeks).
* Confirmed brain metastasis.
* Inadequate hepatic, renal, heart, and hematologic functions (hemoglobin \<90g/L, neutrophils \< 1.5×10\^9/L, platelets \< 80×10\^9/L , ALT \> 2.5 x upper limit of normal (ULN)(5x for liver metastasis), AST \> 2.5 x ULN (5x for liver metastasis), serum bilirubin \> 1.5 x ULN, serum creatine \> 1.0 x ULN, creatinine clearance rate ≤ 50ml/min, LVEF \< lower limit of normal (LLN).
* Abnormal coagulative function, inclined to bleeding or is receiving thrombolytictherapy or anticoagulation.
* History of arterial/venous embolic events (such as cerebrovascular accident, TIA, deep vein thrombus,and pulmonary embolism)
* Unhealed wound (\> 30 days) 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).
* Acquired or inherent immunodeficiency； HIV infection； organ transplantation history.
* The active HBV or HCV infection or HBV DNA ≥10\^4/ml.
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix.
* Presence of serious harm to subjects or complication to hinder the completion of the study judged by investigators
18 Years
70 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Fudan University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Xichun Hu
Deputy director of department of medical oncology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Xi-Chun Hu, Doctor
Role: PRINCIPAL_INVESTIGATOR
Fudan Univeristy Cancer Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China
Fudan University Cancer Hospital
Shanghai, , China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Hu X, Cao J, Hu W, Wu C, Pan Y, Cai L, Tong Z, Wang S, Li J, Wang Z, Wang B, Chen X, Yu H. Multicenter phase II study of apatinib in non-triple-negative metastatic breast cancer. BMC Cancer. 2014 Nov 7;14:820. doi: 10.1186/1471-2407-14-820.
Fan M, Zhang J, Wang Z, Wang B, Zhang Q, Zheng C, Li T, Ni C, Wu Z, Shao Z, Hu X. Phosphorylated VEGFR2 and hypertension: potential biomarkers to indicate VEGF-dependency of advanced breast cancer in anti-angiogenic therapy. Breast Cancer Res Treat. 2014 Jan;143(1):141-51. doi: 10.1007/s10549-013-2793-6. Epub 2013 Dec 1.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Fudan BR2012-08
Identifier Type: -
Identifier Source: org_study_id