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 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT00309569
Eligibility Criteria:
Inclusion Criteria:
* Patients with bioptically verified breast cancer
* Estrogen receptor-negative status
* Age: \< 70 years
* WHO Performance Status \< 2
* Laboratory parameters
1. hematopoiesis: \> 3500/mm3 leukocytes, \> 100,000/mm3 thrombocytes
2. renal function: creatinin \< 1.5mg%
3. hepatic function: GOT max. 2.5 x UNL
4. bilirubin: \< 2.0 mg %
5. metabolic parameters: Na, Ca, K in normal range
* \</= 4 weeks interval since surgery
* Informed consent
Exclusion Criteria:
* Patients with locally inoperable cancer, M1
* Other preoperative tumor-specific radiotherapy, chemotherapy or endocrine treatment
* Pregnancy or lactation
* General contraindication against cytostatic treatment
* T4 cancer; inflammatory disease, simultaneous or sequential bilateral breast cancer
* Lacking compliance or understanding of disease
* Serious concomitant disease
* Second carcinoma or status post second carcinoma (except for treated squamous cell carcinoma of the skin or cervical carcinoma in situ)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00309569
Study Brief:
Protocol Section:
NCT00309569