Epirubicin and Docetaxel Combination (ET) or Epirubicin Followed by Docetaxel (E/T) for Node Negative (N0) High Risk Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

A Multicenter Randomized Phase III Study of Adjuvant Treatment With Epirubicin Followed by Docetaxel (E/T) Versus Epirubicin and Docetaxel Combination (ET) in High Risk Lymph Node Negative Breast Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00424606
• Other study ID #: CT/01.04
• Status: Completed
• Phase: Phase 3
• First received: January 18, 2007
• Last updated: May 19, 2015
• Start date: June 2001
• Est. completion date: August 2013

Study information

• Verified date: May 2015
• 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 taxanes, and especially docetaxel, with an anthracycline seems to be an important part of the chemotherapy regimens used in the adjuvant setting of patients with early-stage node-positive breast cancer patients. Whether sequential or concurrent administration of these drugs is preferable is not yet known, especially in patients with node-negative high risk tumors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 658
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Histologically or cytologically confirmed breast adenocarcinoma.

• Within 20-45 days after the surgical excision of the primary tumor with tumor-free operation margins; at least 10 axillary lymph nodes have to be removed.

• Absence of lymph node involvement after eclosion and hormone (E&H) staining and light microscopy evaluation.

• Premenopausal or postmenopausal women with at least one of the following tumor characteristics is required in order to characterize the tumor as high risk:

• Estrogen receptor (ER) (-) and progesterone receptor (PR)(-);

• Ki-67 + > 30%; Grade III; HER2 (3+) (after an amendment on 15.05.2008 women with HER2 (3+) were not included); Perineural infiltration or presence of tumor emboli in blood or lymph vessels.

• Postmenopausal women with tumors 1-2 cm are eligible if the tumor has at least 2 of the above mentioned high risk criteria.

• Premenopausal and postmenopausal women with tumors measuring > 2 cm are eligible irrespectively of the expression of the above adverse prognostic tumor criteria.

• Absence of any clinical or radiological evidence of local or metastatic disease.

• Age > 18 years.

• Performance status (WHO) < 3.

• 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).

• Adequate cardiac function (LVEF > 50%).

• Negative pregnancy test.

• Informed consent.

Exclusion Criteria:

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

• Other concurrent uncontrolled illness that could affect compliance with the study.

• Psychiatric illness or social situation that would preclude study compliance.

• Pregnant or nursing women.

• History of allergic reaction attributed to docetaxel.

• Other concurrent investigational agents.

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 75 mg/m2 intravenously (IV) every 3 weeks for 4 consecutive cycles
• Epirubicin
Epirubicin at the dose of 90 mg/m2 IV every 3 weeks for 4 consecutive cycles
• Epirubicin
Epirubicin at the dose of 75 mg/m2 IV every 3 weeks for 6 consecutive cycles
• Docetaxel
Docetaxel at the dose of 75 mg/m2 IV every 3 weeks for 6 consecutive cycles

Locations

Country	Name	City	State
Greece	University Hospital of Alexandroupolis Dept. of Medical Oncology	Alexandroupolis
Greece	"Agios Savvas" Anticancer Hospital of Athens	Athens
Greece	"IASO" General Hospital of Athens	Athens
Greece	"Laikon" General Hospital	Athens
Greece	"Marika Iliadis" Hospital of Athens	Athens
Greece	"Metaxa's" Anticancer Hospital of Pireas	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	Larissa
Greece	"AXEPA" General Hospital of Thessaloniki	Thessaloniki
Greece	"Theagenion" Anticancer Hospital of Thessaloniki	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	Disease-free interval between the two treatment arms		Five years	No
Secondary	Comparison of overall survival and safety between the two treatment arms		Five years	No