Vinorelbine and Gemcitabine Versus Capecitabine in Pretreated Metastatic Breast Cancer

Hellenic Oncology Research Group

Status and phase

Completed

Phase 3

Conditions

Breast Cancer

Treatments

Drug: Gemcitabine

Drug: Vinorelbine

Drug: Capecitabine

Study type

Interventional

Funder types

Other

Identifiers

NCT00431106

CT/02.11

Details and patient eligibility

About

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.

Full 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.

Enrollment

144 estimated patients

Sex

Female

Ages

19 to 75 years old

Volunteers

No Healthy Volunteers

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.