Study of Apatinib in Metastatic Triple-Negative Breast Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01176669
Recruitment Status : Completed
First Posted : August 6, 2010
Last Update Posted : September 9, 2015
Jiangsu HengRui Medicine Co., Ltd.
Information provided by (Responsible Party):
Xichun Hu, Fudan University

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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Apatinib Phase 2

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 study has shown that the drug's toxicity is manageable and the maximum tolerable daily dose is 850 mg. The hypothesis of this clinical research study is to discover if the study drug apatinib can shrink or slow the growth of triple-negative breast cancer. The safety of apatinib will also be studied. Patients physical state, symptoms, changes in the size of the tumor, and laboratory findings obtained while on-study will help the research team decide if apatinib is safe and effective in pretreated metastatic triple-negative breast cancer patients.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-Institutional Phase IIa Trial and A Multi-Institutional Phase IIb Trial of Apatinib in Metastatic Triple-Negative Breast Cancer
Study Start Date : June 2010
Actual Primary Completion Date : June 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Apatinib Drug: Apatinib
Apatinib was administratered at 750 mg/d in Phase IIa. The actual average dose intensity delivered was 525 mg/d due to toxicities. So, in Phase IIb, the starting dose of apatinib will be 500mg/d. Two dose reductions will be allowed to 375 and then 250 mg/d.
Other Name: Target therapy

Primary Outcome Measures :
  1. DCR(Disease control rate) for IIa [ Time Frame: 8 Weeks ]
  2. PFS(Progression free survival) for IIb [ Time Frame: 8 Weeks ]

Secondary Outcome Measures :
  1. PFS(Progression free survival) for IIa [ Time Frame: 8 Weeks ]
  2. OS (Overall survival) [ Time Frame: 8 Weeks ]
  3. ORR (Objective response rate) [ Time Frame: 8 Weeks ]
  4. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 8 weeks ]
  5. QoL (Quality of life) [ Time Frame: 8 Weeks ]
  6. DCR(Disease control rate) for IIb [ Time Frame: 8 Weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • ≥ 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01176669

China, Shanghai
Fudan University Cancer Hospital
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
Jiangsu HengRui Medicine Co., Ltd.
Study Chair: Xichun Hu, Doctorship Fudan University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Xichun Hu, Professor, Fudan University Identifier: NCT01176669     History of Changes
Other Study ID Numbers: Fudan BR2010-03
First Posted: August 6, 2010    Key Record Dates
Last Update Posted: September 9, 2015
Last Verified: September 2015

Keywords provided by Xichun Hu, Fudan University:
Triple-Negative Breast Cancer
Metastatic Breast Cancer
ER/PR Negative
Her2/Neu Negative

Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases