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

NCT00429871 | Completed Phase 3

• 1 other identifier: CT/02.09
• Study Type: interventional
• Target: 272
• Locations: 1 country
• Sites: 10

Brief 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

Conditions

Breast Cancer

Keywords

Metastatic breast cancer;; First line chemotherapy;; Docetaxel;; Epirubicin;; Capecitabine

Outcome Measures

Primary Outcomes (1)

• Compare the time to tumor progression between the two treatment arms

  1 year

Secondary Outcomes (2)

• Overall survival

  1 year

• Toxicity profile between the two treatment arms

  1 year

Study Arms (2)

1

EXPERIMENTAL

DF

Drug: Docetaxel; Drug: Epirubicin

2

EXPERIMENTAL

DC

Drug: Capecitabine; Drug: Docetaxel

Interventions

Docetaxel DRUG

Docetaxel at the dose of 75mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles

Also known as: Taxotere

1

Capecitabine DRUG

Capecitabine 950 mg/m2 orally twice a day on days 1-14 every 3 weeks for 6 consecutive cycles

Also known as: Xeloda

2

Epirubicin DRUG

Epirubicin at the dose of 75mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles

Also known as: Farmorubicin

1

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hellenic Oncology Research Group: lead
• University Hospital of Crete: collaborator

Study Sites (10)

University Hospital of Heraklion

Heraklion, Crete, 71110, Greece

Location

University General Hospital of Alexandroupolis, Dep of Medical Oncology

Alexandroupoli, Greece

Location

"IASO" General Hospital of Athens, 1st Dep of Medical Oncology

Athens, Greece

Location

"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine

Athens, Greece

Location

"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology

Athens, Greece

Location

401 Military Hospital of Athens

Athens, Greece

Location

Air Forces Military Hospital of Athens

Athens, Greece

Location

State General Hospital of Larissa, Dep of Medical Oncology

Larissa, Greece

Location

"Metaxa's" Anticancer Hospital of Piraias

Piraeus, Greece

Location

"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology

Thessaloniki, Greece

Location

Related Publications (1)

• Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.

  PMID: 34037241 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel; Capecitabine; Epirubicin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Dimitris Mavrudis, MD

  University Hospital of Crete, Dep of Medical Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 31, 2007
• First Posted: February 1, 2007
• Study Start: May 1, 2002
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: May 29, 2009

Record last verified: 2009-05

Locations

GR (10)