Study of Apatinib Combined With Oral Vinorelbine in Metastatic HER2 Negative Breast Cancer

NCT02768415 | Unknown Phase 2

• 1 other identifier: CH-BC-046
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS) among metastatic HER2 negative breast cancer treated with apatinib and oral vinorelbine

  up to 1 year after the last patient enrolled

Secondary Outcomes (5)

• remission rate (RR) among metastatic HER2 negative breast cancer treated with apatinib and oral vinorelbine

  up to 1 year after the last patient enrolled

• overall survival (OS) among metastatic HER2 negative breast cancer treated with apatinib and oral vinorelbine

  up to 1 year after the last patient enrolled

• overall response rate (ORR) among metastatic HER2 negative breast cancer treated with apatinib and oral vinorelbine

  up to 1 year after the last patient enrolled

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  up to 1 year after the last patient enrolled

• Potential biomarkers to predict efficacy, drug resistance and side effects of anti-angiogenic therapy plus chemotherapy in advanced breast cancer.

  up to 1 year after the last patient enrolled

Study Arms (1)

lapatinib+oral vinorelbine

EXPERIMENTAL

apatinib 425/500mg qd, 21days/cycle oral vinorelbine 60mg/m2 d1, 8, 15 21days/cycle\*3cycles, after 3 cycles: 80mg/m2 d1, 8, 15 21days/cycle

Drug: Apatinib; Drug: Oral Vinorelbine

Interventions

Apatinib DRUG

lapatinib+oral vinorelbine

Oral Vinorelbine DRUG

lapatinib+oral vinorelbine

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 vinorelbine or were allergic to vinorelbine.
• 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 not 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, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

apatinib; Vinorelbine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

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: May 4, 2016
• First Posted: May 11, 2016
• Study Start: June 1, 2016
• Primary Completion: January 1, 2018
• Last Updated: June 19, 2019

Record last verified: 2019-06

Locations

CN (1)