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Compare Apatinib Plus Capecitabine Versus Capecitabine in Maintenance Therapy for Patients With Advanced Triple-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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03775928
Recruitment Status : Recruiting
First Posted : December 14, 2018
Last Update Posted : December 14, 2018
Sponsor:
Information provided by (Responsible Party):
Ma Fei,MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Brief Summary:
The purpose of this study is to assess the efficacy and safety of patients who receive apatinib plus capecitabine or capecitabine for maintenance therapy of patients with with advanced triple-negative breast cancer

Condition or disease Intervention/treatment Phase
Triple-negative Breast Cancer Drug: Apatinib Drug: capecitabine Phase 2

Detailed Description:

Triple-negative breast cancer (TNBC) has the characteristics of early onset, high malignancy, less treatment, and resistance to treatment. Advanced patients have shorter survival than other subtypes. Maintenance therapy after combination chemotherapy can prolong the disease control time in patients with advanced TNBC. How to prolong the disease control time of patients with advanced TNBC without affecting the quality of life has become the focus of current research.

Anti-angiogenic drugs are currently one of the few targeted therapies that have achieved some efficacy in TNBC. Apatinib, a targeted inhibitor of VEGF receptor 2 (VEGFR2), shows significant antitumor activity in the patients with breast cancer. The results of this study will help explore the new treatment of small molecule anti-angiogenic drugs for TNBC maintenance therapy, and provide some new ideas for improving individualized treatment options for patients with advanced TNBC.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase Ⅱ Study of Compare Apatinib Plus Capecitabine Versus Capecitabine in Maintenance Therapy for Patients With Advanced Triple-negative Breast Cancer
Estimated Study Start Date : December 18, 2018
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Apatinib + Capecitabine
Apatinib 425mg d1-21+ capecitabine 1000mg/m2 bid d1-14, q21d
Drug: Apatinib
apatinib 425mg qd po

Drug: capecitabine
capecitabine 1000mg/m2 bid d1-d14

Active Comparator: Capecitabine
capecitabine 1000mg/m2 bid d1-14, q21d
Drug: capecitabine
capecitabine 1000mg/m2 bid d1-d14




Primary Outcome Measures :
  1. progression-free survival [ Time Frame: up to 6 months ]
    Time from randomization to disease progression or death for any cause


Secondary Outcome Measures :
  1. overall survival [ Time Frame: up to 6 months ]
    Time from randomization to death for any cause

  2. tine to progress [ Time Frame: up to 6 months ]
    Time from randomization to disease progression

  3. Safety: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: up to 6 months ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0



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 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age:18~75 years;
  2. Triple-negative breast cancer (TNBC) confirmed by histology examination;
  3. patients had received first-line combination chemotherapy for advanced metastatic disease, and had a complete response, partial response or stable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria;
  4. received endocrine therapy for metastatic disease before first-line chemotherapy were allowed;
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
  6. A life expectancy of more than 12 weeks;
  7. Baseline blood routine examination in accordance with the following criteria : ANC≥1.5×109/L,PLT≥90×109/L,Hb≥90g/L;
  8. Liver and renal function in accordance with the following criteria: total bilirubin less than 1.5 times the upper limit of normal value; aspartate aminotransferase (AST), or alanine aminotransferase (ALT) less than 2.5 times the upper limit of normal value, less than 5 times the upper limit of normal value in patients with liver metastases.

    the creatinine clearance rate calculated greater than 60 mL/min;

  9. Females of childbearing potential must be a pregnancy test in 7 days before participating ( including serum or urine), and the results were negative, and they are willing to take effective contraceptive methods During the trial and within 8 weeks after the last dose;
  10. Obtain informed consent from patients before starting any research-related operations and treatments to confirm that patients are willing to participate in this study and comply with research-related requirements.

Exclusion Criteria:

  1. Metastasis/recurrence occurs within 6 months of adjuvant chemotherapy;
  2. controlled high blood pressure, systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100mmHg;
  3. urine routine test with urinary protein more than ++, or 24 hour urinary protein more than 1.0 g;
  4. abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN+4 seconds or APTT >1.5 times the ULN);
  5. Pregnant or lactating woman;
  6. Symptomatic brain parenchymal and/or pia mater metastases without treatment and control;
  7. Patients with Other malignant tumors in the past 5 years, except for fully treated cervical carcinoma in situ, cutaneous squamous cell carcinoma or well-controlled localized basal cell skin cancer;
  8. Mental illness or other condition that affects patient compliance;
  9. serious and uncontrollable systemic diseases (eg clinically significant cardiovascular disease, lung or metabolic disease, arteriovenous thrombosis, etc.) happened recently;
  10. Can not take or absorb oral drugs;
  11. Receiving any other testing drugs, or participating in other clinical trial 30 days before being enrolled in this trial;
  12. The patient has previously received treatment with an anti-angiogenic drug (whether adjuvant or palliative);
  13. Known or suspected to be allergic to any research drug or excipient;
  14. Any other researcher believes that it is not appropriate to participate in this test.

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): NCT03775928


Contacts
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Contact: Binghe Xu 86-87788826 ext 861087788120 xubinghe@medmail.com
Contact: Bo Lan 86-87788114 ext 861087788120 daxiaolanbo@163.com

Locations
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China, Beijing
Cancer hospital, ChineseAMS Recruiting
Beijing, Beijing, China, 100021
Contact: Binghe Xu, PhD    86-10-87788826    xubinghe@medmail.com   
Contact: Bo Lan, PhD    86-10-87788114    daxiaolanbo@163.com   
Principal Investigator: Binghe Xu, PhD         
Sub-Investigator: Fei Ma, PhD         
Sub-Investigator: Bo Lan, PhD         
Sponsors and Collaborators
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Investigators
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Principal Investigator: Binghe Xu Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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Responsible Party: Ma Fei,MD, clinical professor, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT03775928    
Other Study ID Numbers: LB
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: December 14, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Apatinib
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors