NCT05089643

Anrotinib in Combination With Capecitabine in Advanced Triple Negative Breast Cancer

Anrotinib in Combination With Capecitabine in the Single-arm, Open Phase II Treatment of Relapsed or Metastatic Triple-negative Breast Cancer Clinical Research

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Metastatic Triple-Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Anlotinib	Before breakfast, anlotinib hydrochloride capsule was taken on an empty stomach, once a day, 1 tablet (10mg) each time.Continuous oral administration for 2 weeks stopped for 1 week, that is, 3 weeks (21 days) as a treatment cycle, until disease progression or adverse reactions become intolerable.In case of missing medication, confirm that the time before the next medication is less than 12 hours, no refill.
DRUG	Capecitabine	Capecitabine tablets 1000 mg/m2, twice a day, within 30min after meals, were taken orally for 2 consecutive weeks and stopped for 1 week, i.e., 3 weeks (21 days) as a treatment cycle until disease progression or adverse reactions became intolerable.

Timeline

• Start date: 2019-04-11
• Primary completion: 2019-04-15
• Completion: 2022-12-31
• First posted: 2021-10-22
• Last updated: 2022-01-10

Locations

2 sites across 1 country: China