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 @ 3:28 PM
Ignite Modification Date:
2025-12-24 @ 3:28 PM
NCT ID:
NCT00121992
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent
* Operable breast cancer patients (T1-T3) with negative axillary lymph nodes (10 axillary nodes dissection) and high risk criteria according to St. Gallen consensus criteria.
* Histologically proven breast cancer. Interval between surgery and registration is less than 60 days.
* Definitive surgical treatment must be either mastectomy, or breast conservative surgery. Margins of resected specimen from surgery must be histologically free of invasive adenocarcinoma and ductal carcinoma in-situ (DCIS). Lobular carcinoma in-situ is not considered as positive margin.
* Patients without proven metastatic disease.
* Estrogen and progesterone receptors performed on the primary tumour prior to randomization.
* Age between 18 years and 70 years.
* Karnofsky performance status index \> 80 %.
* Adequate hepatic, renal and heart functions.
* Adequate hematology levels.
* Negative pregnancy test
Exclusion Criteria:
* Prior systemic anticancer therapy for breast cancer (immunotherapy, hormonotherapy, chemotherapy).
* Prior anthracycline therapy or taxoids (paclitaxel, docetaxel) for any malignancy.
* Prior radiation therapy for breast cancer.
* Bilateral invasive breast cancer.
* Pregnant, or lactating patients.
* Patients of childbearing potential must implement adequate non-hormonal contraceptive measures during study treatment .
* Any T4 or N1-3 or M1 breast cancer.
* Pre-existing motor or sensory neurotoxicity of a severity grade 2 by NCI criteria.
* Other serious illness or medical condition
* Past or current history of neoplasm other than breast carcinoma.
* Ipsilateral ductal carcinoma in-situ (DCIS) of the breast.
* Lobular carcinoma in-situ (LCIS) of the breast.
* Chronic treatment with corticosteroids unless initiated \> 6 months prior to study entry and at low dose
* Concurrent treatment with ovarian hormonal replacement therapy. Prior treatment should be stopped before study entry.
* Definite contraindications for the use of corticosteroids.
* Concurrent treatment with other experimental drugs.
* Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry.
* Concurrent treatment with any other anti-cancer therapy.
* Male patients.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00121992
Study Brief:
Protocol Section:
NCT00121992