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:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-25 @ 3:31 AM
NCT ID:
NCT00263705
Eligibility Criteria:
Inclusion Criteria:
1. Women aged ³70 years
2. Histologic diagnosis of early breast cancer for which the treating physician considers adjuvant chemotherapy to be beneficial. Recommended situations are for example:
* endocrine non responsive (ER- and PgR -) and pT\>1 cm, any T if N+ OR
* endocrine responsiveness doubtful (ER and/or PgR- or poor \[3 to-5 according to Harvey score (12) or £ 30% of positive cells by immunohistochemistry) and other risk factors (pT³2 cm or N+ or G3 or Her-2/neu positive, etc.) OR
* endocrine responsive (ER and PgR \> 5 according to Harvey score or \> 30% of positive cells by immunohistochemistry) and at least two risk factors (pT³ 2 cm, N+, G3, Her-2/neu positive, etc.) OR
* Very high risk (N\>3) any ER/PgR.
3. ECOG Performance status £ 1
4. No previous exposition to chemotherapy in the neoadjuvant setting
5. Adequate organ function including:
1. neutrophils ³ 1.5 x 109 /l
2. platelets ³100 x 109 / l
3. bilirubin \< 1.25 x upper normal limit for the institution
4. transaminases \< 2.5 x upper normal limit for the institution
5. calculated creatinine clearance of \> 30ml/min (using the Crockoft and Gault formula)
6. absence of
* symptomatic ventricular arrhythmias;
* clinically significant Congestive Heart Failure;
* clinical and/or ECG evidence of myocardial infarction within the last 12 months;
* Coronary artery disease requiring medication.
6. Absence of any psychological, familial or sociological condition or comorbidities that may affect compliance
7. Written informed consent obtained according to local ethics committee guidelines -
Exclusion Criteria:
N/A-
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
70 Years
Study:
NCT00263705
Study Brief:
Protocol Section:
NCT00263705