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Prospective, Multicenter, Observational Study of Apatinib Single or Combined Capecitabine for Treatment of Patients With Metastatic Her-2 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: NCT03086785
Recruitment Status : Unknown
Verified January 2018 by Hebei Medical University Fourth Hospital.
Recruitment status was:  Recruiting
First Posted : March 22, 2017
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Hebei Medical University Fourth Hospital

Brief Summary:
The purpose of this study is to assess the efficacy and safety of patients who receive apatinib single or combined capecitabine for treatment of patients with metastatic her-2 negative breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Metastatic Drug: Apatinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Multicenter, Observational Study of Apatinib Single or Combined Capecitabine for Treatment of Patients With Metastatic Her-2 Negative Breast Cancer
Actual Study Start Date : November 24, 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: apatinib
apatinib 500mg qd po or combined Capecitabine 1000mg/m2 bid d1-d14 q3w
Drug: Apatinib
apatinib 500mg qd po or combined capecitabine 1000mg/m2 bid d1-14 q3w




Primary Outcome Measures :
  1. Progression free survival [ Time Frame: evaluated in 24 months since the treatment began ]
    Baseline to measured date of progression or death from any cause


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: the first day of treatment to death or last survival confirm date,up to 24 months ]
    Baseline to measured date of death from any cause

  2. Disease control rate [ Time Frame: tumor assessment every 6 weeks since the treatment began,up to 24 months ]
    Baseline to measured progressive disease

  3. Objective response rate [ Time Frame: tumor assessment every 6 weeks since the treatment began,up to 24 months ]
    Baseline to measured stable disease

  4. Side effects [ Time Frame: evaluated in the 24th month since the treatment began according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 ]
    throughout study



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 to 70 years old (female)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Pathologically diagnosed with her-2 negative, ER/PR negative, ER/PR positive after the failure of endocrine treatment, and had not more than three chemotherapy regimens (must include anthracycline-based and yew class), and the final failure of chemotherapy regimens in patients with advanced breast cancer; Note: treatment failure include (1) during or after the completion of six months or less disease progress of neoadjuvant or adjuvant therapy; (2) rescue treatment in progress within 3 months or less
  • Patients with at least one measurable lesions of the advanced breast cancer, measurable lesions has not received radiotherapy or other treatment, unless progress after treatment (measuring≥10mm on spiral CT scan, satisfying the criteria in RECIST1.1 and WHO);
  • Major organ function has to meet the following certeria:

    1. For results of blood routine test (without blood transfusion within 14 days)

      1. HB≥100g/L;
      2. ANC≥1.5×109/L;
      3. PLT≥75×109/L;
    2. For results of blood biochemical test:

      1. TBIL<1.5ULN;
      2. ALTand AST<2.5ULN, but5<ULN if the transferanse elevation is due to liver metastases;
      3. Serum creatinine ≤1.25ULN , or calculated creatinine clearance>45 ml/min(per the Cockcroft-Gault formula); 6.Participants were willing to join in this study, and written informed consent.

Exclusion Criteria:

  1. The patients with the failure of capecitabine treatment;
  2. The patients with chest wall invasion, or chest wall large canker has a tendency to transfer;
  3. Have high blood pressure and antihypertensive drug treatment can not control (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg), with classⅡand above coronary heart disease, unable to control arrhythmia (including QTc lengthened women > 470 ms) and classⅢ-Ⅳcardiac insufficiency; or Left ventricular ejection fraction (LVEF) < 50%;
  4. A variety of factors influencing oral drugs (such as unable to swallow, after resection of the gastrointestinal, chronic diarrhea and intestinal obstruction, etc.);
  5. Has a history of bleeding, the clinical significance of bleeding symptoms, patients with definite bleeding tendency, such as gastrointestinal bleeding, bleeding ulcers, baseline period (+ +)and above of defecate occult blood, vasculitis, etc;
  6. Received a major surgery within 4 weeks or severe traumatic injury, fractures, or has a poor healing wound;
  7. Allergic to apatinib and supplementary material;
  8. Patients with active brain metastases;
  9. Patients with pregnant or planning a pregnancy;
  10. The researchers think inappropriate.

Information from the National Library of Medicine

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): NCT03086785


Contacts
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Contact: cuizhi Geng, archiat 0311-66696310 gengcuizhi@hotmail.com

Locations
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China, Hebei
Fourth Hospital of Hebei Medical University Recruiting
ShiJiazhuang, Hebei, China, 050019
Contact: Cuizhi Geng, archiater    0311-66696310    gengcuizhi@hotmail.com   
Sponsors and Collaborators
Hebei Medical University Fourth Hospital
Investigators
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Principal Investigator: cuizhi Geng, archiat Hebei Medical University Fourth Hospital
Principal Investigator: zefei Jiang, archiat The 307th Hospital of Chinese Peoples' Liberation Army
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Responsible Party: Hebei Medical University Fourth Hospital
ClinicalTrials.gov Identifier: NCT03086785    
Other Study ID Numbers: HB-B001
First Posted: March 22, 2017    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Apatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action