Triple Negative Breast Cancer
Conditions
Brief summary
The hypothesis of this study is to discover if the oral Etoposide plus Anlotinib can shrink or slow the growth of pretreated advanced TNBC. It is a single-arm, multicenter phase II clinical study of oral etoposide combined with antinib in the treatment of recurrent or metastatic triple-negative breast cancer
Detailed description
It is a single-arm, multicenter phase II clinical study of oral etoposide combined with antinib in the treatment of recurrent or metastatic triple-negative breast cancer. The hypothesis of this study is to discover if the oral Etoposide plus Anlotinib can shrink or slow the growth of pretreated advanced TNBC.
Interventions
DRUGoral etoposide + anlotinib
anlotinib 12mg qd, d1-14，21days/cycle oral etoposide 75mg qd，d1-10，21days/cycle
Sponsors
Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 and 75 year-old women; TNBC * ECOG score: 0-1, expected survival time ≥ 3months; * Pathologically or cytologically confirmed breast cancer; * Anthracycline- / taxane- pretreated (adjuvant, neoadjuvant) breast cancer patients who have failed from 1-3 standard chemotherapies after recurrence and metastasis; * According to RECIST 1.1, exist at least ≥1 measurable lesion(CT \>1cm，other examination \>2cm); * The patients have enough organ function. The laboratory test indexes must comply with the following requirements: * Blood routine: neutrophil≥1.5G/L, platelet count ≥80G/L, hemoglobin ≥90g/L * Liver function: serum bilirubin ≤ 1.5 times the upper limit of normal value; ALT and AST≤2.5 times the upper limit of normal value; ALT and AST≤5 times the upper limit of normal value when liver metastasis * Renal function: serum creatinine ≤ 1.0times the upper limit of normal value, creatinine clearance \>50ml/min（Cockcroft-Gault formula) * Women of child-bearing age should be carried out pregnancy test (serum or urine) within 7 days before recruit, the results should be negative; and are willing to adopt the appropriate methods of contraception during the trial and 8 weeks after last administration； * Can swallow oral drugs; * The patients have good compliance to the therapy and follow-up to be scheduled and are able to understand the study protocol and sign the Informed Consent Form.
Exclusion criteria
* The patients in pregnancy or lactation growth period and did not take effective contraception; * The patients who received ≥4 chemotherapies after recurrence and metastasis; involved in other clinical trials four weeks prior to the start of the study; * The patients with a variety of factors that affect the oral administration and absorption of drugs; * Prior treatment with etoposide or antiangiogenic TKI (subjects with prior use of antiangiogenic macromolecules such as bevacizumab are allowed to be enrolled); * The patients have uncontrollable mental illness； * Serous cavity effusion (such as pleural effusion and ascites) with clinical symptoms requiring clinical intervention or stable time less than 4 weeks; * The patients who had serious adverse effect to oral etoposide or were allergic to etoposide. * The patients who have only bone metastasis without other measurable lesion; * The patients experience severe cardiovascular diseases; * The patients experience severe upper gastrointestinal ulcer or malabsorption syndrome. * Abnormal bone marrow functions(neutrophil\<1.5G/L, platelet count \<75G/L, hemoglobin \<90g/L); * Abnormal renal function(serum creatinine \> 1.5 times the upper limit of normal value); * Abnormal liver function(serum bilirubin ≤ 1.5 times the upper limit of normal value); * The patients have uncontrollable brain metastasis; * Active or uncontrolled infection requiring systematic treatment (except simple urinary tract infection or upper respiratory tract infection) during the 2 weeks or 2 weeks prior to enrollment; * Previous or concurrent history of other malignant tumors.Except for the cured skin basal cell carcinoma and cervical carcinoma in situ; * The patients do have good compliance to the therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| objective response rate（ORR） | up to 1 year after the last patient enrolled | The 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
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival（PFS） | 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 |
| Incidence and Severity of adverse events | approximately 1.5 years | hematologic，hepatotoxicity，Incidence of hypertension，Incidence of proteinuria |
Countries
China
Contacts
Primary ContactPeng Yuan
Outcome results
None listed