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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


Phase 3
18 Years
65 Years
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Relapse-free survival time and overall survival

Outcome Time Frame:

2007

Safety Issue:

No

Principal Investigator

M. Untch, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Clinic of the Ludwig-Maximilian-University, München

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

GBG 49

NCT ID:

NCT00544232

Start Date:

August 2002

Completion Date:

October 2008

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • neoadjuvant therapy
  • pCR rates
  • Breast Neoplasms

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