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Preoperative Epirubicin Paclitaxel Aranesp Study (PREPARE)
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: German Breast Group
Pharmacia
Amgen
Bristol-Myers Squibb
Information provided by: German Breast Group
ClinicalTrials.gov Identifier: NCT00544232
  Purpose

The present clinical trial will investigate the efficacy of a sequential interval-shortened and dose-intensified preoperative use of epirubicin, paclitaxel and CMF with preoperative sequential administration of epirubicin and cyclophosphamide followed by paclitaxel in breast cancer. In addition, the influence of darbepoetin alfa on the response rate and quality of life is to be investigated in both treatment arms.

Arm A: Sequential treatment in standard doses with Epirubicin (90 mg/m2)/cyclophosphamide (600 mg/m2) d1, q21d - 4× followed by paclitaxel (175 mg/m2) d1, q21d - 4×.

Pegfilgratim should be used as secondary preventive after febrile neutropenia in the standard arm of the study, or in exceptional cases also after severe febrile neutropenia necessitating postponement of the treatment by more than one week ± Darbepoetin alfa 1 × 4.5 µg/kg of body weight every two weeks with the start of the first epirubicin dose (day 1) until 14 days after the last dose of paclitaxel Daily oral intake of 200 mg iron unless there complications occur with taking iron

Arm B: sequential dose-intensified, interval-shortened treatment with Epirubicin (150 mg/m2) d1, q14d - 3× followed by paclitaxel (225 mg/m2) d1, q14d - 3×, followed by CMF (600/40/600 mg/m2) d1/d8, q28d - 3× Obligatory pegfilgratim 6 mg after epirubicin and/or paclitaxel: subcutaneous injection on day 2. After CMF pegfilgrastim should be used as a secondary preventive measure

± Darbepoetin alfa 1 × 4.5 µg/kg of body weight every two weeks with the start of the first dose of epirubicin (day 1) until 14 days after the last dose of CMF Daily oral dose of 200 mg iron unless complications occur in taking iron.

Primary goal: Determining the relapse-free survival time and overall survival after dose-intensified sequential preoperative chemotherapy including anthracycline and taxan and/or after preoperative chemotherapy including anthracycline followed by taxan in a standard dose


Condition Intervention Phase
Breast Cancer
Drug: Epirubicin
Drug: Paclitaxel
Drug: Cyclophosphamide
Drug: Darbepoetin
Phase III

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Cyclophosphamide Paclitaxel Epirubicin hydrochloride Epirubicin Darbepoetin alfa
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Official Title: Randomized Comparison of a Preoperative, Dose-Intensified, Interval-Shortened, Sequential Chemotherapy With Epirubicin, Paclitaxel and CMF ± Darbepoetin Alfa Versus a Preoperative, Sequential Chemotherapy With Epirubicin and Cyclophosphamide Followed by Paclitaxel in Standard Dosage ± Darbepoetin Alfa in Patients With Primary Breast Cancer

Further study details as provided by German Breast Group:

Primary Outcome Measures:
  • Relapse-free survival time and overall survival [ Time Frame: 2007 ]

Enrollment: 720
Study Start Date: August 2002
Estimated Study Completion Date: June 2008
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed breast cancer: at least three fast biopsies.
  • Primary tumor ≥2 cm acc. to clinical measurement or manifestation of an inflammatory breast cancer.
  • No systemic metastasis, exclusion by chest x-ray, sonogram of the upper abdomen and skeletal scintiscan.
  • Age ≥18 years and ≤65 years.
  • ECOG < 2/WHO 0-1
  • Adequate organ function defined as SGOT and bilirubin ≤ 1.5× upper limit WBC ≥ 3000 /µL Neutrophils ≥ 1000 /µL Platelets ≥ 100,000 /µL Serum creatinine < 2.0 mg/dL
  • Unremarkable heart echo
  • No florid hepatitis
  • Written consent to participate in the treatment optimization protocol

Exclusion Criteria:

  • Multicentricity in various quadrants (contact the study office)
  • Known allergy to E. coli-produced medication
  • Known allergy to medication containing cremophor (e.g., cyclosporin A)
  • Patients receiving immunosuppressant therapy
  • Lack of consent after informing the patient
  • Lack of willingness to keep and disclose personal medical data as part of the study
  • Pregnancy, nursing
  • Secondary malignancy, excluding basalioma of the skin or carcinoma in situ of the cervix that has received curative therapy
  • Pre-existing treatment-resistant cardiac disease, coronary heart disease, arrhythmias, cardiac insufficiency
  • Patients with uncontrolled hypertension (diastolic >95 mmHg)
  • A history of convulsions
  • Known hypersensitivity to darbepoetin alfa or any of its other ingredients or a known hypersensitivity to r-HuEPO
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00544232

Sponsors and Collaborators
German Breast Group
Pharmacia
Amgen
Bristol-Myers Squibb
Investigators
Principal Investigator: M. Untch, MD Clinic of the Ludwig-Maximilian-University, München
  More Information

Related Info  This link exits the ClinicalTrials.gov site

Study ID Numbers: GBG 49
Study First Received: October 15, 2007
Last Updated: October 15, 2007
ClinicalTrials.gov Identifier: NCT00544232  
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by German Breast Group:
Breast Cancer
neoadjuvant therapy
pCR rates

Study placed in the following topic categories:
Skin Diseases
Paclitaxel
Darbepoetin alfa
Breast Neoplasms
Cyclophosphamide
Epirubicin
Breast Diseases

Additional relevant MeSH terms:
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Antimitotic Agents
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Tubulin Modulators
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Alkylating Agents

ClinicalTrials.gov processed this record on January 14, 2009