Multicenter Phase II Study of Apatinib in Patients With Advanced Breast Cancer(CABC006)

Sponsor
Peking University Cancer Hospital & Institute
Study ID
NCT02878057
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apatinib — DRUG
    Dosing regimen: apatinib tablets: 500 mg, Po, QD; 4 weeks as a cycle, continuous treatment until disease progression, death or intolerable toxicity (giving endocrine therapy simultaneously if hormone receptor positive)

Study Details

The treatment of the patients with recurrent and metastatic breast cancer remains a major problem. There is still a lack of effective targeted therapy for Her-2 negative breast cancer.Based on the present researches on the anti-angiogenesis drugs in advanced breast cancer, the investigators believe that it is necessary to further explore the efficacy and safety of apatinib in advanced breast cancer.

Key Dates

Start date
May 31, 2016
Status verified
Jan 2021
Primary completion
Sep 2, 2020
Completion
Sep 2, 2020

Study Design

Enrollment
30 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Advanced Breast Cancer
    Patients With HER-2 Negative Advanced Breast Cancer With Chest Wall Metastasis; Dosing regimen: apatinib tablets: 500 mg, Po, QD; 4 weeks as a cycle, continuous treatment until disease progression, death or intolerable toxicity (giving endocrine therapy simultaneously if hormone receptor positive)

Primary Outcome Measure

Progression-free Survival [ Time Frame: evaluation per 2 cycles (8 weeks), up to 6 months;From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months ]

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