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 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT01925651
Eligibility Criteria:
Inclusion Criteria:
* Undergoing mastectomy with or without reconstruction of early breast
* breast malignancy histologically proven
* protocol addended to allow inclusion of men that meet all inclusion criteria
Exclusion Criteria:
* Karnofsky Performance Scale (KPS) \<70%
* Concomitant chemotherapy (only permitted or hormone therapy molecular-targeted)
* Prior ipsilateral thoracic / cervical irradiation
* Proven metastatic disease (excluded from oncologic outcomes analyses)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01925651
Study Brief:
Protocol Section:
NCT01925651