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

NCT01653574 | Completed Phase 2 DMC

• 1 other identifier: Fudan BR2012-10
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms

Keywords

Famitinib Malate; Metastatic Breast Cancer; HER-2 negative

Outcome Measures

Primary Outcomes (1)

• ORR (Objective response rate)

  8 Weeks

Secondary Outcomes (5)

• PFS(Progression free survival)

  8 Weeks

• OS (Overall survival)

  8 Weeks

• CBR(Clinical benefit rate)

  8 Weeks

• QoL (Quality of life)

  8 Weeks

• Number of adverse events

  8 Weeks

Study Arms (1)

Famitinib Malate

EXPERIMENTAL

Famitinib 25mg/d

Drug: Famitinib Malate

Interventions

Famitinib Malate DRUG

The starting dose of Famitinib Malate will be 25 mg/d. Two dose reductions will be allowed to 20 and then 15 mg/d.

Famitinib Malate

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ●≥ 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).
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Fudan University: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

• Cao J, Zhang J, Wang Z, Wang B, Lv F, Wang L, Hu X. Hypothyroidism as a potential biomarker of efficacy of famitinib, a novel VEGFR-2 inhibitor in metastatic breast cancer. Cancer Chemother Pharmacol. 2014 Aug;74(2):389-98. doi: 10.1007/s00280-014-2505-x. Epub 2014 Jun 18.

  PMID: 24939214 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Xi-Chun Hu, Doctor

  Fudan Univeristy Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director of department of medical oncology

Study Record Dates

• First Submitted: July 10, 2012
• First Posted: July 31, 2012
• Study Start: May 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: December 3, 2013

Record last verified: 2013-03

Locations

CN (1)