Clinical trial NCT04452370: Oral Etoposide Combined With Anlotinib in Advanced Triple Negative Breast Cancer
Official title: Oral Etoposide Combined With Anlotinib in Advanced Triple Negative Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Triple Negative Breast Cancer
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2020-06-30
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: objective response rate（ORR）
timeFrame: up to 1 year after the last patient enrolled
Secondary outcomes:
measure: Progression free survival（PFS）
timeFrame: up to 1 year after the last patient enrolled
measure: Incidence and Severity of adverse events
timeFrame: approximately 1.5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Institute & Hospital. Chinese Academy of Medical Sciences
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Peng Yuan
role: PRINCIPAL_INVESTIGATOR
References: