CompletedNCT00544232Updated Feb 15, 2016

Preoperative Epirubicin Paclitaxel Aranesp Study (PREPARE)

A Phase 3 interventional study of Epirubicin, paclitaxel, cyclophosphamide, Methotrexate, 5 FU, darbepoetin alfa and Epirubicin, Cyclophosphamide, Paclitaxel, dabepoetin alfa in Breast Cancer, sponsored by German Breast Group. Completed. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-02-15.

Sponsored by German Breast Group · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 720
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: Female

Study summary

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.

Read the detailed description

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

Conditions studied

Breast Cancer

Browse trials for

Breast Neoplasms 12,543

Keywords

Breast Cancer
neoadjuvant therapy
pCR rates

In context

Breast Neoplasms

12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 720 is above the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

German Breast Group is the lead sponsor of 33 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: Female
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 720 participants (actual)

Study arms

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
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
Drug: Epirubicin, Cyclophosphamide, Paclitaxel, dabepoetin alfa

Interventions

DrugEpirubicin, 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
DrugEpirubicin, 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

What researchers measure

Primary outcomes

Relapse-free survival time and overall survival
Time frame: 2007

Study locations

No study locations are listed for this record.

References and documents

Publications

Untch M, Fasching PA, Konecny GE, von Koch F, Conrad U, Fett W, Kurzeder C, Luck HJ, Stickeler E, Urbaczyk H, Liedtke B, Salat C, Harbeck N, Muller V, Schmidt M, Hasmuller S, Lenhard M, Schuster T, Nekljudova V, Lebeau A, Loibl S, von Minckwitz G; Arbeitsgemeinschaft Gynakologische Onkologie PREPARE investigators. PREPARE trial: a randomized phase III trial comparing preoperative, dose-dense, dose-intensified chemotherapy with epirubicin, paclitaxel and CMF versus a standard-dosed epirubicin/cyclophosphamide followed by paclitaxel +/- darbepoetin alfa in primary breast cancer--results at the time of surgery. Ann Oncol. 2011 Sep;22(9):1988-1998. doi: 10.1093/annonc/mdq709. Epub 2011 Mar 8. PubMed 21385882 ↗
Untch M, von Minckwitz G, Konecny GE, Conrad U, Fett W, Kurzeder C, Luck HJ, Stickeler E, Urbaczyk H, Liedtke B, Beckmann MW, Salat C, Harbeck N, Muller V, Schmidt M, Hasmuller S, Lenhard M, Nekljudova V, Lebeau A, Loibl S, Fasching PA; Arbeitsgemeinschaft Gynakologische Onkologie PREPARE investigators. PREPARE trial: a randomized phase III trial comparing preoperative, dose-dense, dose-intensified chemotherapy with epirubicin, paclitaxel, and CMF versus a standard-dosed epirubicin-cyclophosphamide followed by paclitaxel with or without darbepoetin alfa in primary breast cancer--outcome on prognosis. Ann Oncol. 2011 Sep;22(9):1999-2006. doi: 10.1093/annonc/mdq713. Epub 2011 Mar 7. PubMed 21382868 ↗
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. PubMed 22508812 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 15, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00544232
Lead sponsor: German Breast Group
Collaborators: Pharmacia, Amgen, Bristol-Myers Squibb
Responsible party: Sponsor
First posted: Oct 16, 2007
Start date: Aug 2002
Primary completion: Sep 2006
Completion: Sep 2006
Last update: Feb 15, 2016

Study contacts

M. Untch, MD

principal investigator · Clinic of the Ludwig-Maximilian-University, München

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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