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 @ 3:38 PM
Ignite Modification Date:
2025-12-24 @ 3:38 PM
NCT ID:
NCT00194792
Eligibility Criteria:
Inclusion Criteria:
* Have histologically confirmed, operable ER or PR +, HER2/neu negative, radiographically measurable breast cancer \> 1cm (Operable lesions are T1c - T3 and N0 - N2a; histologic confirmation should be by core needle biopsy only)
* Be chemotherapy naive
* Have an ECOG performance status of =\< 2
* Be assessed for menopausal status (For study purposes, postmenopausal is defined as: a prior documented bilateral oophorectomy, or a history of at least 12 months without spontaneous menstrual bleeding, or age 60 or older with a prior hysterectomy without oophorectomy, or Age less than 60 with a prior hysterectomy without oophorectomy \[or in whom the status of the ovaries is unknown\], with a documented FSH level demonstrating confirmatory elevation in the postmenopausal range for the lab)
* All premenopausal patients must have a baseline FSH and LH
* ANC \>= 1,500
* Platelet count \>= 100,000
* Serum creatinine =\< 1.5 x IULN
* Estimated creatinine clearance \> 50 ml/min
* Have staging studies and tumor assessment prior to registration
* Bone density exam must be done within the first 3 months of complete hormonal blockade
* Have a negative pregnancy test within seven days prior to registration if of childbearing potential
* Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study specific screening procedures
Exclusion Criteria:
* Primary tumor =\< 1 cm, not measurable; inflammatory disease
* Pregnant or lactating; women of childbearing potential with either a positive or no pregnancy test at baseline are excluded (Women of childbearing potential who are not using a reliable and appropriate contraceptive method are excluded; patients must agree to continue contraception for 30 days from the last study drug administration)
* Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil
* Previous enrollment in an investigational drug study within the last 4 weeks
* Evidence of distant metastatic disease
* Prior chemotherapy or hormonal therapy for breast cancer
* Prior malignancy other than adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, other stage I or II cancer from which the patient has been disease free for at least 5 years
* History of uncontrolled seizures, central nervous system disorders, or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance with oral drug intake
* Any other life-threatening illness (e.g. serious, uncontrolled concurrent infection or clinically significant cardiac disease - congestive heart failure, symptomatic coronary artery disease, cardiac arrhythmia not well controlled with medication or myocardial infarction
* Major surgery within four weeks of the start of study treatment without complete recovery
* Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
* Known, existing uncontrolled coagulopathy
* Unwillingness to give informed consent
* Unwillingness to participate or inability to comply with the protocol for the duration of the study
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00194792
Study Brief:
Protocol Section:
NCT00194792