Overview

Anrotinib in Combination With Capecitabine in Advanced Triple Negative Breast Cancer

Status:
Recruiting
Trial end date:
2022-12-31
Target enrollment:
0
Participant gender:
Female
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
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Chinese Academy of Medical Sciences
Treatments:
Capecitabine
Criteria
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 defined
as ER < 10% positive and PR < 10% positive.

3. Disease progression after at least one prior systemic treatment and anthracycline
and/or taxane use;Note: For neoadjuvant/adjuvant therapy, recurrence or disease
progression during treatment or within 6 months of discontinuation of treatment should
be counted as first-line systemic treatment failure;

4. There should be at least one measurable lesion according to the efficacy evaluation
criteria for solid tumors (RECIST version 1.1)

Exclusion Criteria:

1. The number of previous treatment lines (including postoperative adjuvant therapy) >4
lines

2. symptomatic central system metastases.Patients with stable asymptomatic BMS who have
received brain radiation and who have at least one other evaluable target in addition
to the BMS can be enrolled (evaluable target should be at least 4 weeks away from the
last radiotherapy).

3. New bisphosphonate or dinoselmer treatment for bone metastases was initiated within 28
days prior to study initiation.(Subjects are permitted if they have already been
treated with bisphosphonate or dinoselmer for at least 4 weeks of optimal stable
administration prior to study initiation.)Subjects already enrolled in this study may
begin treatment with bisphosphonate or dinoselmer for bone metastases after the first
post-treatment evaluation