Preoperative Epirubicin Paclitaxel Aranesp Study (PREPARE)

This study has been completed.
Sponsor:
Collaborators:
Pharmacia
Amgen
Bristol-Myers Squibb
Information provided by (Responsible Party):
German Breast Group
ClinicalTrials.gov Identifier:
NCT00544232
First received: October 15, 2007
Last updated: August 29, 2011
Last verified: August 2011

October 15, 2007
August 29, 2011
August 2002
October 2008   (final data collection date for primary outcome measure)
Relapse-free survival time and overall survival [ Time Frame: 2007 ] [ Designated as safety issue: No ]
Relapse-free survival time and overall survival [ Time Frame: 2007 ]
Complete list of historical versions of study NCT00544232 on ClinicalTrials.gov Archive Site
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Preoperative Epirubicin Paclitaxel Aranesp Study (PREPARE)
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

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: Epirubicin, paclitaxel, cyclophosphamide, Methotrexate, 5 FU, darbepoetin alfa

    Epirubicin (90 mg/m2) d1, q21d - 4× / cyclophosphamide (600 mg/m2) d1, q21d - 4× followed by paclitaxel (175 mg/m2) d1, q21d - 4×

    +/- Darbepoetin alfa 1 × 4.5 μg/kg of body weight every two weeks with the start of the first epirubicin dose (day 1) to 14 days after the last dose of paclitaxel

  • Drug: Epirubicin, Cyclophosphamide, Paclitaxel, dabepoetin alfa

    Epirubicin (150 mg/m2) d1, q14d - 3× followed by paclitaxel (225 mg/m2) d1, q14d - 3×, followed by CMF d1/d8, q28d - 3× Obligatory pegfilgratim 6 mg, subcutaneous injection on day 2 after epirubicin and/or paclitaxel and secondary prophylactic dose after CMF

    +/- 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

  • Experimental: epirubicin, paclitaxel and CMF +/- darbepoetin

    Epirubicin (90 mg/m2) d1, q21d - 4× / cyclophosphamide (600 mg/m2) d1, q21d - 4× followed by paclitaxel (175 mg/m2) d1, q21d - 4×

    +/- Darbepoetin alfa 1 × 4.5 μg/kg of body weight every two weeks with the start of the first epirubicin dose (day 1) to 14 days after the last dose of paclitaxel

    Intervention: Drug: Epirubicin, paclitaxel, cyclophosphamide, Methotrexate, 5 FU, darbepoetin alfa
  • Experimental: EC followed by paclitaxel +/- darbepoetin

    Epirubicin (150 mg/m2) d1, q14d - 3× followed by paclitaxel (225 mg/m2) d1, q14d - 3×, followed by CMF d1/d8, q28d - 3× Obligatory pegfilgratim 6 mg, subcutaneous injection on day 2 after epirubicin and/or paclitaxel and secondary prophylactic dose after CMF

    +/- 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

    Intervention: Drug: Epirubicin, Cyclophosphamide, Paclitaxel, dabepoetin alfa
von Minckwitz G, Untch M, Blohmer JU, Costa SD, Eidtmann H, Fasching PA, Gerber B, Eiermann W, Hilfrich J, Huober J, Jackisch C, Kaufmann M, Konecny GE, Denkert C, Nekljudova V, Mehta K, Loibl S. Definition and impact of pathologic complete response on prognosis after neoadjuvant chemotherapy in various intrinsic breast cancer subtypes. J Clin Oncol. 2012 May 20;30(15):1796-804. doi: 10.1200/JCO.2011.38.8595. Epub 2012 Apr 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
720
October 2008
October 2008   (final data collection date for primary outcome measure)

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
Female
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00544232
GBG 49
Yes
German Breast Group
German Breast Group
  • Pharmacia
  • Amgen
  • Bristol-Myers Squibb
Principal Investigator: M. Untch, MD Clinic of the Ludwig-Maximilian-University, München
German Breast Group
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP