A Study of Apatinib in Non-triple-negative Metastatic Breast Cancer

NCT01653561 | Completed Phase 2 DMC

• 1 other identifier: Fudan BR2012-08
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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 non-triple-negative metastatic breast cancer.

Conditions

Breast Neoplasms

Keywords

Metastatic breast cancer; Apatinib; non-triple-negative

Outcome Measures

Primary Outcomes (1)

• PFS(Progression free survival)

  8 Weeks

Secondary Outcomes (5)

• ORR (Objective response rate)

  8 Weeks

• CBR(Clinical benefit rate)

  8 Weeks

• OS (Overall survival)

  8 Weeks

• QoL (Quality of life)

  8 Weeks

• Toxicity (Number of adverse events)

  8 Weeks

Study Arms (1)

Apatinib

EXPERIMENTAL

Apatinib 500mg/d

Drug: Apatinib

Interventions

Apatinib DRUG

The starting dose of apatinib will be 500mg/d. Two dose reductions will be allowed to 375 and then 250 mg/d.

Apatinib

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.
• 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.
• Written informed consent prior to study specific screening procedures.

You may not qualify if:

• Triple-negative breast cancer (ER-, PR- and HER2-. HER2- is defined as 0 or 1+ staining on immunohistochemistry or FISH/CISH negative for gene amplification. )
• 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.
• 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.

Sponsors & Collaborators

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

Study Sites (2)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Fudan University Cancer Hospital

Shanghai, 200032, China

Location

Related Publications (2)

• 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.

  PMID: 25376790 DERIVED

• 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.

  PMID: 24292957 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

apatinib

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: November 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: December 3, 2013

Record last verified: 2013-08

Locations

CN (2)