Preoperative Epirubicin Paclitaxel Aranesp Study (PREPARE)

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: German Breast Group
• Collaborators: Amgen; Bristol-Myers Squibb; Pharmacia
• Treatments: Albumin-Bound Paclitaxel; Cyclophosphamide; Darbepoetin alfa; Epirubicin; Methotrexate; Paclitaxel

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