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 @ 1:39 PM
Ignite Modification Date:
2025-12-24 @ 1:39 PM
NCT ID:
NCT00496795
Eligibility Criteria:
Inclusion Criteria:
* Primary breast cancer \>4cm in diameter and / or lymph node status N2-3.
* Age 65 years or younger
* "Limited" distant metastases allowed, but patients with massive distant metastases should be excluded
* Willing to participate in the study
Exclusion Criteria:
* Known allergy toward any of the cytotoxic compounds to be administered (epirubicin and doxorubicin)
* Liver enzymes \> 2 times upper normal limit or bilirubin \> 3 times upper normal limit
* Other medical conditions making them unfit for dose-dense therapy
* Cardiac insufficiency; for patients not to receive trastuzumab, decision whether to exclude such patients will be at the physicians discretion. Considering patients with HER-2 positive tumors who should have trastuzumab, exclusion criteria will be according to the NBCG (Norwegian Breast Cancer Group) general guidelines (www.NBCG.net).
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00496795
Study Brief:
Protocol Section:
NCT00496795