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 @ 7:30 PM
Ignite Modification Date:
2025-12-24 @ 7:30 PM
NCT ID:
NCT00248703
Eligibility Criteria:
Inclusion Criteria:
1. Breast cancer with node positive disease or high risk node negative disease (pT1c/T2GII-IIIN0, pT3N0, cT3N0). Patients \< 35 years with pT1a-bN0G2-3.
2. Primary surgery for breast cancer completed
3. Completed 6 cycles of adjuvant (or neoadjuvant) chemotherapy containing anthracycline
4. Age ≥ 18 and \< 70 years
5. Eastern Cooperative Oncology Group or WHO performance status \< 2
6. Written informed consent prior to beginning protocol specific procedures
7. Laboratory requirements (within 5 weeks prior to end of radiation treatment or within 5 weeks prior to completion of baseline examinations):
Neutrophils ≥ 1.1 10\^9/l, Platelets ≥ 100 10\^9/l, Hemoglobin ≥ 10 g/dl, ASAT and ALAT ≤ x 2.5 UNL (If ALP \> 2.5 ≤ x 5 UNL, then ASAT and ALAT ≤ x 1.5 UNL), ALP ≤ x 5 UNL (If ASAT and ALAT \> 1.5 ≤ x 2.5 UNL, then ALP ≤ 2.5 x UNL), Creatinine ≤ 175 umol/l
8. Completed staging analysis including chest X-ray, bone scintigraphy or MRI, liver ultrasound or liver CT scan
Exclusion Criteria:
1. Other (than breast carcinoma) earlier or concomitant carcinoma, except for skin and in situ cervix cancer
2. M1 breast cancer or locoregional recurrence of previously diagnosed breast cancer.
3. Earlier treatment with paclitaxel or docetaxel.
4. Pre-existing motor or sensory neurotoxicity of a severity ≥ grade 2 by NCI criteria (see appendix II)
5. Cardiac disease with symptoms classified as NYHA ≥ 2
6. Definite contraindications for the use of corticosteroids
7. Concurrent treatment with other experimental drugs
8. Concurrent treatment with any other anti-cancer therapy (except for endocrine therapy and trastuzumab)
9. Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00248703
Study Brief:
Protocol Section:
NCT00248703