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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


Phase 3
19 Years
75 Years
Not Enrolling
Female
Breast Cancer

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Time to tumor progression between the two treatment arms

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Dimitris Mavrudis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital of Crete

Authority:

Greece: National Organization of Medicines

Study ID:

CT/02.11

NCT ID:

NCT00431106

Start Date:

April 2002

Completion Date:

January 2009

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • Chemotherapy
  • Vinorelbine
  • Gemcitabine
  • Capecitabine
  • Breast Neoplasms

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