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

NCT00424606 | Completed Phase 3

• 1 other identifier: CT/01.04
• Study Type: interventional
• Target: 658
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Breast Cancer

Keywords

High risk node negative

Outcome Measures

Primary Outcomes (1)

• Disease-free interval between the two treatment arms

  Five years

Secondary Outcomes (1)

• Comparison of overall survival and safety between the two treatment arms

  Five years

Study Arms (2)

1

EXPERIMENTAL

Drug: Docetaxel; Drug: Epirubicin

2

EXPERIMENTAL

Drug: Epirubicin; Drug: Docetaxel

Interventions

Docetaxel DRUG

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

Also known as: Taxotere

1

Epirubicin DRUG

Epirubicin at the dose of 90 mg/m2 IV every 3 weeks for 4 consecutive cycles

Also known as: Farmorubicin

1

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (12)

University Hospital of Heraklion

Heraklion, Crete, 71110, Greece

Location

University Hospital of Alexandroupolis Dept. of Medical Oncology

Alexandroupoli, Greece

Location

"Agios Savvas" Anticancer Hospital of Athens

Athens, Greece

Location

"IASO" General Hospital of Athens

Athens, Greece

Location

"Laikon" General Hospital

Athens, Greece

Location

"Marika Iliadis" Hospital of Athens

Athens, Greece

Location

"Metaxa's" Anticancer Hospital of Pireas

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

Larissa, Greece

Location

"AXEPA" General Hospital of Thessaloniki

Thessaloniki, Greece

Location

"Theagenion" Anticancer Hospital of Thessaloniki

Thessaloniki, Greece

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel; 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; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Dimitris Mavrudis, MD

  University Hospital of Heraklion Dept. 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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2007
• First Posted: January 19, 2007
• Study Start: June 1, 2001
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: May 20, 2015

Record last verified: 2015-05

Locations

GR (12)