Anrotinib in Combination With Capecitabine in Advanced Triple Negative Breast Cancer
- Conditions
- Metastatic Triple-Negative Breast Cancer
- Interventions
- Registration Number
- NCT05089643
- Lead Sponsor
- Chinese Academy of Medical Sciences
- Brief 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 35
- Female aged between 18 and 70;
- 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.
- 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;
- There should be at least one measurable lesion according to the efficacy evaluation criteria for solid tumors (RECIST version 1.1)
- The number of previous treatment lines (including postoperative adjuvant therapy) >4 lines
- 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).
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CA Anlotinib Anlotinib 10mg Qd D1-14 Capecitabine 1G /m2 Bid D1-14 / Q21D CA Capecitabine Anlotinib 10mg Qd D1-14 Capecitabine 1G /m2 Bid D1-14 / Q21D
- Primary Outcome Measures
Name Time Method Objective Response Rate up to 1 year after the last patient enrolled he ORR will be defined as the proportion of patients in the Efficacy Evaluable patient Set who achieve complete response (CR) and partial response (PR)
- Secondary Outcome Measures
Name Time Method Progression-free survival up to 1 year after the last patient enrolled PFS will be defined as the time from first dose of study drug until documentation of disease progression or death from any cause
adverse events approximately 1.5 years Incidence and Severity of adverse events hematologic，hepatotoxicity，Incidence of hypertension，Incidence of proteinuria
Trial Locations
- Locations (2)
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
🇨🇳Beijing, China
Cancer Hospital Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China