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 @ 11:24 PM
Ignite Modification Date:
2025-12-24 @ 11:24 PM
NCT ID:
NCT00813956
Eligibility Criteria:
Inclusion Criteria:
* invasive breast cancer
* stage I-IIIA disease
* ER, PR, Her2/neu-negative status
* no prior treatment for breast cancer
* age 18 years of greater
* normal renal, liver function
* normal hematologic status
* ECOG Performance status 0, 1
* Evaluation by a surgeon to determine breast conservation eligibility
* Women of childbearing potential must have a documented negative pregnancy test within 2 months of study trial entry and agree to birth control during the duration of the trial therapy
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Metastatic breast cancer
* Inoperable breast cancer, including Stage IIIB and IIIC
* Tumor size less than 1 centimeter
* Prior surgery, systemic therapy, or radiotherapy for the current cancer
* Hormone receptor-positive breast cancer
* Her2/neu-positive breast cancer
* Any concurrent condition which in the investigator's opinion makes it inappropriate for the patient to participate in the trial or which would jeopardize compliance with the protocol
* Pregnant or nursing women
* Receipt of any investigational agents within 30 days prior to commencing study treatment
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00813956
Study Brief:
Protocol Section:
NCT00813956