Study of Apatinib in Metastatic Triple-Negative Breast Cancer Patients

NCT01176669 | Completed Phase 2

• 1 other identifier: Fudan BR2010-03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Breast Cancer

Keywords

Apatinib; Triple-Negative Breast Cancer; Metastatic Breast Cancer; ER/PR Negative; Her2/Neu Negative

Outcome Measures

Primary Outcomes (2)

• DCR(Disease control rate) for IIa

  8 Weeks

• PFS(Progression free survival) for IIb

  8 Weeks

Secondary Outcomes (6)

• PFS(Progression free survival) for IIa

  8 Weeks

• OS (Overall survival)

  8 Weeks

• ORR (Objective response rate)

  8 Weeks

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  8 weeks

• QoL (Quality of life)

  8 Weeks

Study Arms (1)

Apatinib

EXPERIMENTAL

Drug: Apatinib

Interventions

Apatinib DRUG

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.

Also known as: Target therapy

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.
• 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.

You may not qualify if:

• 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.

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)

• 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; Triple Negative Breast Neoplasms

Interventions

apatinib

Condition Hierarchy (Ancestors)

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

Study Officials

• Xichun Hu, Doctorship

  Fudan University

  STUDY CHAIR

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: Professor

Study Record Dates

• First Submitted: July 20, 2010
• First Posted: August 6, 2010
• Study Start: June 1, 2010
• Primary Completion: June 1, 2014
• Study Completion: September 1, 2014
• Last Updated: September 9, 2015

Record last verified: 2015-09

Locations

CN (1)