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A Multicenter Randomized Comparative Study of Docetaxel Plus Epirubicin Versus Docetaxel Plus Capecitabine Combinations as First Line Treatment of Metastatic Breast Cancer


Phase 3
19 Years
75 Years
Not Enrolling
Female
Breast Cancer

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Trial Information

A Multicenter Randomized Comparative Study of Docetaxel Plus Epirubicin Versus Docetaxel Plus Capecitabine Combinations as First Line Treatment of Metastatic Breast Cancer


This trial will compare the efficacy of docetaxel plus epirubicin versus docetaxel plus
capecitabine combinations as first line treatment in women with MBC


Inclusion Criteria:



- Histologically- or cytologically- confirmed metastatic breast adenocarcinoma.

- No previous chemotherapy treatment for metastatic disease.

- No previous anthracycline treatment except as adjuvant therapy at least one year
before.

- Age 19-75 years old

- Presence of measurable disease

- Performance status 0-2 (WHO)

- Adequate cardiac function (LVEF >50%) without a recent (within 6 months) history of
myocardial infraction and/or unstable or uncontrolled angina.

- Adequate bone marrow(absolute neutrophil count >1500/mm3, platelet count
>100.000/mm3, hemoglobin >10gr/mm3), liver (bilirubin <1.5 times upper limit of
normal and SGOT/SGPT <2 times upper limit of normal) and renal function (creatinine
<2mg/dl).

- No previous radiotherapy to more than 25% of marrow-containing bones.

- Written informed consent

Exclusion Criteria:

- Active brain metastases.

- Psychiatric illness or social situation that would preclude study compliance

- Other concurrent uncontrolled illness.

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

- Positive pregnancy for premenopausal women.

- Concurrent antineoplastic treatment e.g. hormonal therapy

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Compare the 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, Dep of Medical Oncology

Authority:

Greece: National Organization of Medicines

Study ID:

CT/02.09

NCT ID:

NCT00429871

Start Date:

May 2002

Completion Date:

November 2007

Related Keywords:

  • Breast Cancer
  • Metastatic breast cancer;
  • First line chemotherapy;
  • Docetaxel;
  • Epirubicin;
  • Capecitabine
  • Breast Neoplasms

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