Vinorelbine Metronomic Plus Lapatinib for Overexpressing HER-2 Metastatic Breast Cancer

NCT ID: NCT00754702

Last Updated: 2015-09-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2011-03-31

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of metronomic oral vinorelbine taken three times a week plus daily lapatinib without break, as salvage treatment in patients with metastatic breast cancer.

Detailed Description

Continuous administration of oral vinorelbine, given three times a week (metronomic) is feasible and exceptionally well tolerated at doses up to 50 mg. Early results show activity against refractory tumors and provide evidence towards clinical proof of efficacy for metronomic chemotherapy. Recently, lapatinib plus capecitabine was proven superior to capecitabine alone in women with HER2-positive advanced breast cancer that has progressed after treatment with regimens that included an anthracycline, a taxane, and trastuzumab.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Vinorelbine metronomic/Lapatinib

Group Type: EXPERIMENTAL

Vinorelbine

Intervention Type: DRUG

Vinorelbine p.o (50 mg 3 times a week) until disease progression or appearance of unacceptable toxicity

Lapatinib

Intervention Type: DRUG

Lapatinib p.o every day without interruption disease progression or appearance of unacceptable toxicity

Interventions

Vinorelbine

Vinorelbine p.o (50 mg 3 times a week) until disease progression or appearance of unacceptable toxicity

Intervention Type: DRUG

Lapatinib

Lapatinib p.o every day without interruption disease progression or appearance of unacceptable toxicity

Intervention Type: DRUG

Other Intervention Names

Navelbine; Tyverb; Tykerb

Eligibility Criteria

Inclusion Criteria

• Histologically- or cytologically- confirmed metastatic breast adenocarcinoma
• Age 18-75 years
• HER2 status positive according to the local institution reported grade 3+ staining intensity (on a scale of 0 to 3) by means of immunohistochemical analysis or grade 2+ staining intensity by means of immunohistochemical analysis with gene amplification on fluorescence in situ hybridization
• Previous therapies had to include, regimens containing an anthracycline and a taxane
• Previous treatment with trastuzumab, alone or in combination with chemotherapy for locally advanced or metastatic disease, is required
• Measurable disease as defined by the presence of at least one measurable lesion (except bone metastases, ascites or pleural effusions)
• Performance status (WHO) 0-2
• Adequate liver (serum bilirubin <1.5 times the upper normal limit; AST and ALT <2.5 times the upper normal limit in the absence of demonstrable liver metastases, or <5 times the upper normal limit in the presence of liver metastases); adequate renal function (serum creatinine <1.5 times the upper normal limit); and bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L) function
• No radiation of measurable disease (except brain metastases)
• No progressive brain metastases according to clinical or radiological criteria
• No brain metastases without prior radiation therapy
• Written informed consent

Exclusion Criteria

• Patient unable to take oral medication
• Active infection
• History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
• Other invasive malignancy except nonmelanoma skin cancer
• Psychiatric illness or social situation that would preclude study compliance
• Pregnant or lactating women

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of Crete

OTHER

Sponsor Role: lead

Responsible Party

Vassilis Georgoulias, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dimitris Mavrudis, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Crete, Dep of Medical Oncology

Locations

University Hospital of Crete, Dep of Medical Oncology

Heraklion, Crete, Greece

"IASO" General Hospital of Athens, 1st Dep of Medical Oncology

Athens, , Greece

Countries

Greece

Other Identifiers

CT/08.27

Identifier Type: -

Identifier Source: org_study_id