Study of Apatinib Combined With Oral Vinorelbine in Metastatic HER2 Negative Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02768415|
Recruitment Status : Active, not recruiting
First Posted : May 11, 2016
Last Update Posted : June 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Apatinib Drug: Oral Vinorelbine||Phase 2|
Apatinib is an orally administered second-generation blocker of the phosphorylation of the tyrosine residues within the intracellular domain of VEGF receptor 2 (VEGFR2). A prospective, open label, phase II multicenter trial of apatinib in heavily pretreated patients with metastatic triple-negative breast cancer demonstrated that the daily dose of apatinib 500 mg/day is active in pretreated metastatic TNBC with encouraging rates of disease stabilization and PFS.
Vinorelbine is a highly active drug in the treatment of MBC, both as a single agent or in combination regimens, and is well tolerated, with a low incidence of severe toxicity. Clinical trials demonstrated oral NVB provided comparable effectiveness to iv NVB. and oral availability allows using different schedules.
The NCCN guideline introduces that combination chemotherapy is one of the standard treatment options in metastatic breast cancer, especially in patients with visceral metastases and/or need of rapid symptom or disease control.
Theoretically, anti-angiogenesis regimen combined with chemotherapy may present increasing therapeutic effect. Related researches are urgently needed to find optimal combined therapy.
The hypothesis of this study is to discover if the all-oral therapy with apatinib plus oral vinorelbine can shrink or slow the growth of pretreated HER2 negative breast cancer. The safety of the combination will also be studied. Patients physical state, symptoms, changes in the size of the tumor, and laboratory findings obtained while on-study will help the research team decide if this combination is safe and effective in pretreated HER2 negative metastatic breast cancer patients.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Apatinib Combined With Oral Vinorelbine in Pretreated Metastatic HER2 Negative Breast Cancer|
|Actual Study Start Date :||June 2016|
|Actual Primary Completion Date :||January 2018|
Experimental: lapatinib+oral vinorelbine
apatinib 425/500mg qd, 21days/cycle
oral vinorelbine 60mg/m2 d1, 8, 15 21days/cycle*3cycles, after 3 cycles: 80mg/m2 d1, 8, 15 21days/cycle
Drug: Oral Vinorelbine
- Progression free survival (PFS) among metastatic HER2 negative breast cancer treated with apatinib and oral vinorelbine [ Time Frame: up to 1 year after the last patient enrolled ]
- remission rate (RR) among metastatic HER2 negative breast cancer treated with apatinib and oral vinorelbine [ Time Frame: up to 1 year after the last patient enrolled ]
- overall survival (OS) among metastatic HER2 negative breast cancer treated with apatinib and oral vinorelbine [ Time Frame: up to 1 year after the last patient enrolled ]
- overall response rate (ORR) among metastatic HER2 negative breast cancer treated with apatinib and oral vinorelbine [ Time Frame: up to 1 year after the last patient enrolled ]
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: up to 1 year after the last patient enrolled ]
- Potential biomarkers to predict efficacy, drug resistance and side effects of anti-angiogenic therapy plus chemotherapy in advanced breast cancer. [ Time Frame: up to 1 year after the last patient enrolled ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02768415
|Cancer Institute and Hospital, Chinese Academy of Medical Sciences|
|Beijing, Beijing, China|