Clinical study on the treatment of second-line and above HER2 negative advanced breast cancer with anrotinib combined with capecitabine

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000031388

Enrollment

Unknown

Registered

2020-03-29

Start date

2020-06-10

Completion date

Unknown

Last updated

2020-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Interventions

control group:Capecitabine

experimental group:Anrotinib combined with Capecitabine

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) aged > 18 years old, = 7); (1) The standard of blood routine examination should be: HB >= 90g/L (no blood transfusion within 14 days); The ANC acuity 1.5 x 10^9 / L; PLT 60 x 10^9 / L or higher; (2) biochemical examination should meet the following standards: ALB >= 29g/L; TBIL < 1.5 ULN. ALT and AST < 5ULN; Serum Cr 1.5 or less ULN. 10) women of child-bearing age must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment and be willing to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the test drug; 11) the subjects voluntarily joined the study and signed the informed consent, with good compliance and follow-up.

Exclusion criteria

Exclusion criteria: 1) patients in pregnancy or lactation; 2) patients with a variety of factors affecting the oral and absorption of drugs, including deglutition, gastrointestinal resection, chronic diarrhea, inflammatory bowel disease, etc.; 3) patients with unhealed wounds; Patients with traumatic or pathologic fractures; 4) patients with a history of other malignancies; 5) patients with previous arteriovenous embolism events; 6) patients with previous history of myocardial ischemia, myocardial infarction, arrhythmia, or congestive heart failure; 7) patients with symptomatic or unstable brain metastases; 8) urine protein > ++ and 24-hour urine protein quantitative > 1.0g; 9) the cumulative dose of previous doxorubicin exceeds 300mg/m2 or that of epirubicin exceeds 600mg/m2; 10) estimated survival time 1.5ULN, APTT > 1.5ULN), with bleeding tendency (such as active gastrointestinal ulcer); Patients undergoing thrombolytic or anticoagulant therapy; 15) patients with infection who need intravenous anti-infection treatment; 16) patients previously treated with anti-vegf or anti-vegfr monoclonal antibodies or tyrosine kinase inhibitors.

Design outcomes

Primary

Measure	Time frame
PFS;	—

Secondary

Measure	Time frame
ORR;OS;	—

Countries

China

Contacts

Public ContactChang Shichuan

Chongqing University Three Gorges Hospital

285647098@qq.com+86 17323861001

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026