A Study of Famitinib Malate in HER2-negative Metastatic Breast Cancer

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: NCT01653574
Recruitment Status : Completed
First Posted : July 31, 2012
Last Update Posted : December 3, 2013
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 Famitinib Malate can shrink or slow the growth of pretreated HER2-negative metastatic breast cancer.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: Famitinib Malate Phase 2

Detailed Description:
Famitinib Malate is a tyrosine kinase inhibitor mainly targeting vascular endothelial growth factor receptor 2(VEGFR2), 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 recommended phase II dose is 25 mg. The hypothesis of this clinical research study is to discover if the study drug Famitinib Malate can shrink or slow the growth of pretreated HER2-negative breast cancer. The safety of Famitinib Malate 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 Famitinib Malate is safe and effective in pretreated HER2-negative metastatic breast cancer patients.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-Institutional, Phase II, Open-label, Single Arm Trial of Famitinib Malate in in HER2-negative Metastatic Breast Cancer
Study Start Date : May 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Malic acid

Arm Intervention/treatment
Experimental: Famitinib Malate
Famitinib 25mg/d
Drug: Famitinib Malate
The starting dose of Famitinib Malate will be 25 mg/d. Two dose reductions will be allowed to 20 and then 15 mg/d.

Primary Outcome Measures :
  1. ORR (Objective response rate) [ Time Frame: 8 Weeks ]

Secondary Outcome Measures :
  1. PFS(Progression free survival) [ Time Frame: 8 Weeks ]
  2. OS (Overall survival) [ Time Frame: 8 Weeks ]
  3. CBR(Clinical benefit rate) [ Time Frame: 8 Weeks ]
  4. QoL (Quality of life) [ Time Frame: 8 Weeks ]
  5. Number of adverse events [ 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 HER2-negative breast cancer. 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 from the last chemotherapy regimen, but experienced at most 2 regimens in the relapsed or metastatic setting. Pretreated anthracycline, taxanes and capecitabine (any rational reason for no use of capecitabine is acceptable) are mandatory.
  • Have failed from at least 1 endocrine therapy, if HR positive.
  • 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.
  • 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 ≥ 90g/L, 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 ≤ 1.5 x ULN), serum cholesterol ≤ 1.25 x ULN, serum glycerin trilaurate ≤ 2.0 x ULN, LVEF ≥ lower limit of normal (LLN).
  • 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 (which include oral contraception, injectable or implantable methods, intrauterine devices, or properly used barrier contraception) from the beginning of the study to 8 weeks after the last dose of the investigated drug. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant. This includes women who are using contraceptives or whose sexual partners are either sterile or using contraceptives.
  • 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.
  • Uncontrolled hypertension with mono-drug therapy (>140/90 mm Hg);ischemia of the myocardium (≥ grade 2) or myocardial infarction;arrhythmia(≥ grade 2, QTcF > 480ms for female patients) or New York Heart Association Class III/IV.
  • Abnormal thyroid function history with drug intervention.
  • 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.
  • Brain or meningeal metastases.
  • 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.
  • The active HBV or HCV infection or HBV DNA ≥10^4/ml.
  • Acquired or inherent immunodeficiency; HIV infection; organ transplantation history.
  • Abuse of alcohol or drugs.
  • Have received prior treatment with a VEGFR 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): NCT01653574

China, Shanghai
Fudan University Cancer Hospital
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
Jiangsu HengRui Medicine Co., Ltd.
Principal Investigator: Xi-Chun Hu, Doctor Fudan Univeristy Cancer Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Xichun Hu, Deputy director of department of medical oncology, Fudan University Identifier: NCT01653574     History of Changes
Other Study ID Numbers: Fudan BR2012-10
First Posted: July 31, 2012    Key Record Dates
Last Update Posted: December 3, 2013
Last Verified: March 2013

Keywords provided by Xichun Hu, Fudan University:
Famitinib Malate
Metastatic Breast Cancer
HER-2 negative

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