Randomized Phase III Trial With Docetaxel Plus Epirubicine Versus Docetaxel Plus Capecitabine for Metastatic Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00429871
• Other study ID #: CT/02.09
• Status: Completed
• Phase: Phase 3
• First received: January 31, 2007
• Last updated: May 28, 2009
• Start date: May 2002
• Est. completion date: November 2007

Study information

• Verified date: May 2009
• Source: Hellenic Oncology Research Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial Summary

The combination of docetaxel+epirubicin is highly effective and well tolerated as first line treatment in patients with metastatic breast cancer (MBC). Capecitabine is an active drug in women with MBC pretreated with taxane and anthracycline. Docetaxel increases the intracellular levels of thymidilate phosphorylase and thus is synergistic with capecitabine. The combination of docetaxel plus capecitabine is highly active and superior to docetaxel monotherapy in women with MBC pretreated with an anthracycline

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 272
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Docetaxel
Docetaxel at the dose of 75mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles
• Capecitabine
Capecitabine 950 mg/m2 orally twice a day on days 1-14 every 3 weeks for 6 consecutive cycles
• Epirubicin
Epirubicin at the dose of 75mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles
• Docetaxel
Docetaxel at the dose of 75mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles

Locations

Country	Name	City	State
Greece	University General Hospital of Alexandroupolis, Dep of Medical Oncology	Alexandroupolis
Greece	"IASO" General Hospital of Athens, 1st Dep of Medical Oncology	Athens
Greece	"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine	Athens
Greece	"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology	Athens
Greece	401 Military Hospital of Athens	Athens
Greece	Air Forces Military Hospital of Athens	Athens
Greece	University Hospital of Heraklion	Heraklion	Crete
Greece	State General Hospital of Larissa, Dep of Medical Oncology	Larissa
Greece	"Metaxa's" Anticancer Hospital of Piraias	Piraeus
Greece	"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology	Thessaloniki

Sponsors (2)

Lead Sponsor	Collaborator
Hellenic Oncology Research Group	University Hospital of Crete

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the time to tumor progression between the two treatment arms		1 year	No
Secondary	Overall survival		1 year	No
Secondary	Toxicity profile between the two treatment arms		1 year	Yes