Oral Etoposide Combined With Anlotinib in Advanced Triple Negative Breast Cancer

NCT04452370 | Unknown Phase 2

• 1 other identifier: NCC2225
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Triple Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• objective response rate（ORR）

  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)

  up to 1 year after the last patient enrolled

Secondary Outcomes (2)

• Progression free survival（PFS）

  up to 1 year after the last patient enrolled

• Incidence and Severity of adverse events

  approximately 1.5 years

Study Arms (1)

oral Etoposide+Anlotinib

EXPERIMENTAL

anlotinib 12mg qd, d1-14，21days/cycle oral etoposide 75mg qd，d1-10，21days/cycle

Drug: oral etoposide + anlotinib

Interventions

oral etoposide + anlotinib DRUG

anlotinib 12mg qd, d1-14，21days/cycle oral etoposide 75mg qd，d1-10，21days/cycle

Also known as: there is no other intervention name

oral Etoposide+Anlotinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Institute & Hospital. Chinese Academy of Medical Sciences

Beijing, 100021, China

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Etoposide; anlotinib

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Peng Yuan

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peng Yuan

CONTACT

01087787245; yuanpeng01@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 30, 2020
• Study Start: September 23, 2020
• Primary Completion: July 11, 2022
• Study Completion: July 11, 2023
• Last Updated: July 21, 2021

Record last verified: 2021-07

Locations

CN (1)