Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-24 @ 9:42 PM
NCT ID:
NCT00544232
Eligibility 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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00544232
Study Brief:
Protocol Section:
NCT00544232