Clinical trial · Interventional

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

NCT00544232CI-TRIAL-00020927completedPhase 3ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Breast Cancer	Malignant Breast Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Epirubicin, Cyclophosphamide, Paclitaxel, dabepoetin alfa	Drug	—	UNRESOLVED
Epirubicin, paclitaxel, cyclophosphamide, Methotrexate, 5 FU, darbepoetin alfa	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
epirubicin, paclitaxel and CMF +/- darbepoetin
description
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
interventionNames
1. Drug: Epirubicin, paclitaxel, cyclophosphamide, Methotrexate, 5 FU, darbepoetin alfa
type
EXPERIMENTAL
label
EC followed by paclitaxel +/- darbepoetin
description
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
interventionNames
1. Drug: Epirubicin, Cyclophosphamide, Paclitaxel, dabepoetin alfa

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years
Maximum age: 65 Years

Show eligibility criteria text

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

References

Publications (3)

RESULTUntch 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. PMID 21385882
RESULTUntch 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. PMID 21382868
DERIVEDvon 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. PMID 22508812