Apatinib Combined With Oral Etoposide in Metastatic HER2 Negative Breast Cancer

NCT03535961 | Completed Phase 2

• 1 other identifier: CH-BC-055
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The hypothesis of this study is to discover if the all-oral therapy with apatinib plus oral Etoposide can shrink or slow the growth of pretreated HER2 negative metastatic breast cancer.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• objective response rate(ORR)

  Objective response rate defined as confirmed complete response or partial response under RECIST 1.1 criteria. CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met.

  up to 1 year after the last patient enrolled

Secondary Outcomes (4)

• disease control rate(DCR)

  through study completion, an average of 1 year

• Progression free survival (PFS)

  From date of enrollment until the date of first documented progression, assessed up to 24 months

• overall survival(OS)

  From date of enrollment until death, assessed up to 24 months

• Incidence of Treatment-Emergent Adverse Events

  through study completion, an average of 1 year

Study Arms (1)

apatinib+oral etoposide

OTHER

apatinib 425/500mg qd, 21days/cycle oral etoposide 50mgmg/m2 d1-10 21days/cycle

Drug: apatinib+oral etoposide

Interventions

apatinib+oral etoposide DRUG

apatinib 425/500mg qd, 21days/cycle oral etoposide 50mgmg/m2 d1-10 21days/cycle

apatinib+oral etoposide

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; HER2 negative(immunohistochemistry or fluorescence in situ hybridization);
• 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 1-2 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 ≥3 chemotherapies（Do not include endocrine therapy）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;
• The patients previously received anti-VEFG of anti-VEGFR therapies;
• The patients with rapid progression of viscera invasion(liver lesion \>1/2 viscera area or liver dysfunction);
• The patients have uncontrollable mental illness.
• 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;
• The patients do have good compliance to the therapy.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

Related Publications (1)

• Hu N, Zhu A, Si Y, Yue J, Wang X, Wang J, Ma F, Xu B, Yuan P. A Phase II, Single-Arm Study of Apatinib and Oral Etoposide in Heavily Pre-Treated Metastatic Breast Cancer. Front Oncol. 2021 Feb 15;10:565384. doi: 10.3389/fonc.2020.565384. eCollection 2020.

  PMID: 33659204 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

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: September 10, 2017
• First Posted: May 24, 2018
• Study Start: May 1, 2017
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: December 2, 2020

Record last verified: 2020-12

Locations

CN (1)