Clinical trial NCT00429871: Randomized Phase III Trial With Docetaxel Plus Epirubicine Versus Docetaxel Plus Capecitabine for Metastatic Breast Cancer
Official title: A Multicenter Randomized Comparative Study of Docetaxel Plus Epirubicin Versus Docetaxel Plus Capecitabine Combinations as First Line Treatment of Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Metastatic breast cancer;
First line chemotherapy;
Docetaxel;
Epirubicin;
Capecitabine
Lead sponsor: Hellenic Oncology Research Group
Sponsor class: OTHER
Collaborators: name: University Hospital of Crete
First posted: 2007-02-01
Enrollment: 272
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 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

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

Eligibility criteria: 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

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