Anrotinib in Combination With Capecitabine in Advanced Triple Negative Breast Cancer

Last updated: December 18, 2021
Sponsor: Chinese Academy of Medical Sciences
Overall Status: Active - Recruiting

Phase

2

Condition

Metastatic Triple-negative Breast Cancer

Treatment

N/A

Clinical Study ID

NCT05089643
NCC1969
  • Ages 18-70
  • Female

Study Summary

The hypothesis of this study is to discover if the capecitabine plus Anlotinib can shrink or slow the growth of pretreated advanced TNBC.

It is a single-arm phase II clinical study of capecitabine combined with antinib in the treatment of recurrent or metastatic triple-negative breast cancer

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Female aged between 18 and 70;
  2. Recurrence or metastasis OF TNBC confirmed by histological or cytological methods,TNBC definitions of ER, PR and HER-2 are negative, if there is metastasis pathology,the histological pathology of metastasis shall prevail.ER and PR negative were definedas ER < 10% positive and PR < 10% positive.
  3. Disease progression after at least one prior systemic treatment and anthracyclineand/or taxane use;Note: For neoadjuvant/adjuvant therapy, recurrence or diseaseprogression during treatment or within 6 months of discontinuation of treatment shouldbe counted as first-line systemic treatment failure;
  4. There should be at least one measurable lesion according to the efficacy evaluationcriteria for solid tumors (RECIST version 1.1)

Exclusion

Exclusion Criteria:

  1. The number of previous treatment lines (including postoperative adjuvant therapy) >4lines
  2. symptomatic central system metastases.Patients with stable asymptomatic BMS who havereceived brain radiation and who have at least one other evaluable target in additionto the BMS can be enrolled (evaluable target should be at least 4 weeks away from thelast radiotherapy).
  3. New bisphosphonate or dinoselmer treatment for bone metastases was initiated within 28days prior to study initiation.(Subjects are permitted if they have already beentreated with bisphosphonate or dinoselmer for at least 4 weeks of optimal stableadministration prior to study initiation.)Subjects already enrolled in this study maybegin treatment with bisphosphonate or dinoselmer for bone metastases after the firstpost-treatment evaluation

Study Design

Total Participants: 35
Study Start date:
April 11, 2019
Estimated Completion Date:
December 31, 2022

Study Description

It is a single-arm phase II clinical study of capecitabine combined with antinib in the treatment of recurrent or metastatic triple-negative breast cancer.

The hypothesis of this study is to discover if the capecitabine plus Anlotinib can shrink or slow the growth of pretreated advanced TNBC.

Connect with a study center

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing 100021
    China

    Active - Recruiting

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Beijing, 100021
    China

    Active - Recruiting

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