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

NCT ID: NCT00424606

Last Updated: 2015-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 658 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-06-30
• Study Completion Date: 2013-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

Docetaxel

Intervention Type: DRUG

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

Epirubicin

Intervention Type: DRUG

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

2

Group Type: EXPERIMENTAL

Epirubicin

Intervention Type: DRUG

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

Docetaxel

Intervention Type: DRUG

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

Interventions

Docetaxel

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

Intervention Type: DRUG

Epirubicin

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

Intervention Type: DRUG

Epirubicin

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

Intervention Type: DRUG

Docetaxel

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

Intervention Type: DRUG

Other Intervention Names

Taxotere; Farmorubicin; Farmorubicin; Taxotere

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of Crete

OTHER

Sponsor Role: collaborator

Hellenic Oncology Research Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dimitris Mavrudis, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Heraklion Dept. of Medical Oncology

Locations

University Hospital of Heraklion

Heraklion, Crete, Greece

University Hospital of Alexandroupolis Dept. of Medical Oncology

Alexandroupoli, , 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

State General Hospital of Larissa

Larissa, , Greece

"AXEPA" General Hospital of Thessaloniki

Thessaloniki, , Greece

"Theagenion" Anticancer Hospital of Thessaloniki

Thessaloniki, , Greece

Countries

Greece

Other Identifiers

CT/01.04

Identifier Type: -

Identifier Source: org_study_id