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A Single-Institutional, Phase II, Open-label, Single Arm Trial of Famitinib Malate in in HER2-negative Metastatic Breast Cancer

Phase 2
18 Years
70 Years
Open (Enrolling)
Breast Neoplasms

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Trial Information

A Single-Institutional, Phase II, Open-label, Single Arm Trial of Famitinib Malate in in HER2-negative Metastatic Breast Cancer

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.

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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

ORR (Objective response rate)

Outcome Time Frame:

8 Weeks

Safety Issue:


Principal Investigator

Xi-Chun Hu, Doctor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan Univeristy Cancer Hospital


China: Food and Drug Administration

Study ID:

Fudan BR2012-10



Start Date:

May 2012

Completion Date:

July 2014

Related Keywords:

  • Breast Neoplasms
  • Famitinib Malate
  • Metastatic Breast Cancer
  • HER-2 negative
  • Breast Neoplasms
  • Neoplasms