Compare Apatinib Plus Capecitabine Versus Capecitabine in Maintenance Therapy for Patients With Advanced Triple-negative Breast Cancer

NCT03775928 | Unknown Phase 2

• 1 other identifier: LB
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Triple-negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• progression-free survival

  Time from randomization to disease progression or death for any cause

  up to 6 months

Secondary Outcomes (3)

• overall survival

  up to 6 months

• tine to progress

  up to 6 months

• Safety: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  up to 6 months

Study Arms (2)

Apatinib + Capecitabine

EXPERIMENTAL

Apatinib 425mg d1-21+ capecitabine 1000mg/m2 bid d1-14, q21d

Drug: Apatinib; Drug: capecitabine

Capecitabine

ACTIVE COMPARATOR

capecitabine 1000mg/m2 bid d1-14, q21d

Drug: capecitabine

Interventions

Apatinib DRUG

apatinib 425mg qd po

Apatinib + Capecitabine

capecitabine DRUG

capecitabine 1000mg/m2 bid d1-d14

Apatinib + Capecitabine; Capecitabine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age：18\~75 years;
• Triple-negative breast cancer (TNBC) confirmed by histology examination;
• 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;
• received endocrine therapy for metastatic disease before first-line chemotherapy were allowed;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
• A life expectancy of more than 12 weeks;
• Baseline blood routine examination in accordance with the following criteria : ANC≥1.5×109/L，PLT≥90×109/L，Hb≥90g/L;
• 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;
• 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;
• 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.

You may not qualify if:

• Metastasis/recurrence occurs within 6 months of adjuvant chemotherapy;
• controlled high blood pressure, systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100mmHg;
• urine routine test with urinary protein more than ++, or 24 hour urinary protein more than 1.0 g;
• abnormal coagulation function (INR \> 1.5 or prothrombin time (PT) \> ULN+4 seconds or APTT \>1.5 times the ULN);
• Pregnant or lactating woman;
• Symptomatic brain parenchymal and/or pia mater metastases without treatment and control;
• 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;
• Mental illness or other condition that affects patient compliance;
• serious and uncontrollable systemic diseases (eg clinically significant cardiovascular disease, lung or metabolic disease, arteriovenous thrombosis, etc.) happened recently;
• Can not take or absorb oral drugs;
• Receiving any other testing drugs, or participating in other clinical trial 30 days before being enrolled in this trial;
• The patient has previously received treatment with an anti-angiogenic drug (whether adjuvant or palliative);
• Known or suspected to be allergic to any research drug or excipient;
• Any other researcher believes that it is not appropriate to participate in this test.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer hospital, ChineseAMS

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

apatinib; Capecitabine

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Binghe Xu

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Binghe Xu

CONTACT

86-87788826; xubinghe@medmail.com

Bo Lan

CONTACT

86-87788114; daxiaolanbo@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical professor

Study Record Dates

• First Submitted: December 13, 2018
• First Posted: December 14, 2018
• Study Start: December 18, 2018
• Primary Completion: December 1, 2020
• Study Completion: October 1, 2021
• Last Updated: December 14, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)