Study of Apatinib in Metastatic Triple-Negative Breast Cancer Patients

Sponsor
Fudan University
Study ID
NCT01176669
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jun 30, 2010
Status verified
Sep 2015
Primary completion
Jun 30, 2014
Completion
Sep 30, 2014

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Apatinib

Primary Outcome Measure

DCR(Disease control rate) for IIa [ Time Frame: 8 Weeks ]

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