Compare Apatinib Plus Capecitabine Versus Capecitabine in Maintenance Therapy for Patients With Advanced Triple-negative Breast Cancer
NCT ID: NCT03775928
Last Updated: 2018-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
80 participants
INTERVENTIONAL
2018-12-18
2021-10-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Apatinib + Capecitabine
Apatinib 425mg d1-21+ capecitabine 1000mg/m2 bid d1-14, q21d
Apatinib
apatinib 425mg qd po
capecitabine
capecitabine 1000mg/m2 bid d1-d14
Capecitabine
capecitabine 1000mg/m2 bid d1-14, q21d
capecitabine
capecitabine 1000mg/m2 bid d1-d14
Interventions
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Apatinib
apatinib 425mg qd po
capecitabine
capecitabine 1000mg/m2 bid d1-d14
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
FEMALE
No
Sponsors
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
OTHER
Responsible Party
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Ma Fei，MD
clinical professor
Principal Investigators
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Binghe Xu
Role: PRINCIPAL_INVESTIGATOR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Locations
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Cancer hospital, ChineseAMS
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Binghe Xu, PhD
Role: primary
Bo Lan, PhD
Role: backup
Other Identifiers
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LB
Identifier Type: -
Identifier Source: org_study_id