Vinorelbine and Gemcitabine Versus Capecitabine in Pretreated Metastatic Breast Cancer

Phase 3

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Gemcitabine; Drug: Capecitabine; Drug: Vinorelbine

• Registration Number: NCT00431106
• Lead Sponsor: Hellenic Oncology Research Group

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2002-04
• Study First Submitted: 2007-02-02
• Study First Submitted QC: 2007-02-02
• Study First Posted: 2007-02-05
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-25
• Last Update Posted: 2009-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 144

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Gemcitabine	Vinorelbine/Gemcitabine (VG)
1	Vinorelbine	Vinorelbine/Gemcitabine (VG)
2	Capecitabine	Capecitabine (Cap)

Primary Outcome Measures

Name	Time	Method
Time to tumor progression between the two treatment arms	1 year

Secondary Outcome Measures

Name	Time	Method
Overall survival	1 year

Trial Locations

Locations (10)

401 Military Hospital of Athens; 🇬🇷 Athens, Greece

University General Hospital of Alexandroupolis, Dept. of Medical Oncology; 🇬🇷 Alexandroupolis, Greece

"IASO" General Hospital of Athens, 1st Dept. of Medical Oncology; 🇬🇷 Athens, Greece

State General Hospital of Larissa, Dept. of Medical Oncology; 🇬🇷 Larissa, Greece

Air Forces Military Hospital of Athens; 🇬🇷 Athens, Greece

University Hospital of Crete; 🇬🇷 Heraklion, Crete, Greece

"Metaxa's" Anticancer Hospital of Piraeus, 1st Dept. of Medical Oncology; 🇬🇷 Piraeus, 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

"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dept. of Medical Oncology; 🇬🇷 Thessaloniki, Greece