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

Breast Cancer Clinical Trial

Official title:

Vinorelbine Metronomic Plus Lapatinib as Salvage Therapy for Patients With Overexpressing HER-2 Metastatic Breast Cancer. A Multicenter Phase II Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00754702
• Other study ID #: CT/08.27
• Status: Terminated
• Phase: Phase 2
• First received: September 17, 2008
• Last updated: September 25, 2015
• Start date: October 2008
• Est. completion date: March 2011

Study information

• Verified date: September 2015
• Source: University Hospital of Crete
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Vinorelbine
Vinorelbine p.o (50 mg 3 times a week) until disease progression or appearance of unacceptable toxicity
• Lapatinib
Lapatinib p.o every day without interruption disease progression or appearance of unacceptable toxicity

Locations

Country	Name	City	State
Greece	"IASO" General Hospital of Athens, 1st Dep of Medical Oncology	Athens
Greece	University Hospital of Crete, Dep of Medical Oncology	Heraklion	Crete

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Crete

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate		3 - 6 month	No
Secondary	Progression Free Survival		1 year	No
Secondary	Toxicity profile		21 days	Yes
Secondary	Overall Survival		1 year	No
Secondary	Quality of life assessment		42 days	No