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 @ 8:03 PM
Ignite Modification Date:
2025-12-24 @ 8:03 PM
NCT ID:
NCT02115204
Eligibility Criteria:
Inclusion Criteria:
* Female patients
* Age 18-65 years
* Eastern Cooperative Oncology Group (ECOG) status \< 2
* Surgery: R0-resection and \>= 10 removed axillary lymph nodes
* M0 by chest x-ray, bone scintigraphy and liver sonography
Exclusion Criteria:
* Polyneuropathy
* Creatinin (serum) \> 1,4 mg/dl; Bilirubin (serum) \> 2,0 mg/dl
* Cardia dysfunction, ejection fraction \< lower normal value of each institution
* Hematopoeitic insufficiency: leucocytes \< 3,5 G/l, thrombocytes \< 100 G/l
* second malignant neoplasia, except curatively treated basalioma of the skin
* Surgery before more the six weeks (42 days)
* Concurrent pregnancy; patients of childbearing potential must implement a highly effective (less than 1% failure rate) non-hormonal contraceptive measures during the study treatment
* Breast feeding woman
* Sequential breast cancer
* Reasons indicating risk of poor compliance
* Patients not able to consent
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02115204
Study Brief:
Protocol Section:
NCT02115204