Vinorelbine and Gemcitabine Versus Capecitabine in Pretreated Metastatic Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Multicenter Randomized Phase III Study of Combination Treatment With Vinorelbine and Gemcitabine Versus Capecitabine Monotherapy in Metastatic Breast Cancer Patients Following Treatment Failure With the Combination of a Taxane and an Anthracycline

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00431106
• Other study ID #: CT/02.11
• Status: Completed
• Phase: Phase 3
• First received: February 2, 2007
• Last updated: September 25, 2009
• Start date: April 2002
• Est. completion date: January 2009

Study information

• Verified date: September 2009
• Source: Hellenic Oncology Research Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial Summary

The combination of vinorelbine and gemcitabine seems to be an important part of the chemotherapy regimens used in metastatic breast cancer patients following treatment failure with the combination of a taxane and an anthracycline. Capecitabine rescue monotherapy in metastatic breast cancer patients following treatment failure with the combination of a taxane and an anthracycline, also seems to be an important part of the chemotherapy regimens used in metastatic breast cancer patients. Whether the combination of vinorelbine and gemcitabine or capecitabine administration is preferable is not yet known, especially in patients with metastatic disease.

Description:

This trial will compare the efficacy of combination treatment with Vinorelbine and Gemcitabine versus Capecitabine monotherapy in metastatic breast cancer patients following treatment failure with the combination of a taxane and an anthracycline.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age 19-75 years.

• Performance status World Health Organization (WHO) 0-2.

• Histologically confirmed breast adenocarcinoma.

• Clinical or radiological evidence of metastatic disease that has progressed after combination treatment of a taxane and an anthracycline (Taxotere + Mitoxantrone or Taxotere + Farmorubicine).

• Measurable disease.

• No metastatic central nervous system (CNS) disease.

• Less than 25% of myeloproductive bone marrow irradiated.

• Adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count > 100000/mm^3, hemoglobin > 9 gr/mm^3).

• Adequate liver (bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times upper limit of normal) and renal function (creatinine < 2 mg/dl).

• Informed consent.

Exclusion Criteria:

• Pregnancy or nursing.

• Positive pregnancy test.

• Psychiatric illness or social situation that would preclude study compliance.

• Other concurrent uncontrolled illness.

• Other invasive malignancy within the past 5 years except nonmelanoma skin cancer.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Gemcitabine
Gemcitabine at the dose of 1000 mg/m2 intravenously (IV) every 2 weeks for 12 consecutive cycles
• Capecitabine
Capecitabine at the dose of 1250 mg/m2 twice daily orally (os), from day 1 to day 14, every 3 weeks for 6 consecutive cycles
• Vinorelbine
Vinorelbine at the dose of 25 mg/m2 IV on day 1 every 2 weeks for 12 consecutive cycles

Locations

Country	Name	City	State
Greece	University General Hospital of Alexandroupolis, Dept. of Medical Oncology	Alexandroupolis
Greece	"IASO" General Hospital of Athens, 1st Dept. of Medical Oncology	Athens
Greece	"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dept. of Internal Medicine	Athens
Greece	"Marika Iliadis" Hospital of Athens, Dept. of Medical Oncology	Athens
Greece	401 Military Hospital of Athens	Athens
Greece	Air Forces Military Hospital of Athens	Athens
Greece	University Hospital of Crete	Heraklion	Crete
Greece	State General Hospital of Larissa, Dept. of Medical Oncology	Larissa
Greece	"Metaxa's" Anticancer Hospital of Piraeus, 1st Dept. of Medical Oncology	Piraeus
Greece	"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dept. of Medical Oncology	Thessaloniki

Sponsors (2)

Lead Sponsor	Collaborator
Hellenic Oncology Research Group	University Hospital of Crete

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to tumor progression between the two treatment arms		1 year	No
Secondary	Overall survival		1 year	No