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 @ 12:51 PM
Ignite Modification Date:
2025-12-24 @ 12:51 PM
NCT ID:
NCT00089661
Eligibility Criteria:
* Histologically or cytologically confirmed adenocarcinoma of the breast
* Subjects with early stage disease who are estrogen receptor positive and who have completed their treatment pathway (surgery, chemo-therapy, radiation, and/or hormone therapy) and are currently on or will initiate aromatase inhibitor therapy, and are expected to stay on aromatase inhibitor therapy for the duration of the 24-month study
* All treatment pathway must be completed ≥ 4 weeks prior to study entry, and all acute toxic effect of any above therapy must be resolved to ≤ Grade 1 by National Cancer Institution (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
* Female \> 18 years of age
* ECOG Performance status 0 and 1
* Lumbar spine, total hip or femoral neck BMD equivalent to a t-score classification of -1.0 to -2.5
* Subject is willing and able to provide signed consent before any study-specific procedure
Other criteria also apply.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00089661
Study Brief:
Protocol Section:
NCT00089661