Clinical trial NCT00431106: Vinorelbine and Gemcitabine Versus Capecitabine in Pretreated Metastatic Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Breast cancer
Chemotherapy
Vinorelbine
Gemcitabine
Capecitabine
Lead sponsor: Hellenic Oncology Research Group
Sponsor class: OTHER
Collaborators: name: University Hospital of Crete
First posted: 2007-02-05
Enrollment: 144
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time to tumor progression between the two treatment arms
timeFrame: 1 year
Secondary outcomes:
measure: Overall survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Heraklion
country: Greece
facility: University Hospital of Crete
state: Crete
city: Alexandroupolis
country: Greece
facility: University General Hospital of Alexandroupolis, Dept. of Medical Oncology
city: Athens
country: Greece
facility: "IASO" General Hospital of Athens, 1st Dept. of Medical Oncology
city: Athens
country: Greece
facility: "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dept. of Internal Medicine
city: Athens
country: Greece
facility: "Marika Iliadis" Hospital of Athens, Dept. of Medical Oncology
city: Athens
country: Greece
facility: 401 Military Hospital of Athens
city: Athens
country: Greece
facility: Air Forces Military Hospital of Athens
city: Larissa
country: Greece
facility: State General Hospital of Larissa, Dept. of Medical Oncology
city: Piraeus
country: Greece
facility: "Metaxa's" Anticancer Hospital of Piraeus, 1st Dept. of Medical Oncology
city: Thessaloniki
country: Greece
facility: "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dept. of Medical Oncology
Study officials:
affiliation: University Hospital of Crete
name: Dimitris Mavrudis, MD
role: PRINCIPAL_INVESTIGATOR
References: