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 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT00674557
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed breast cancer
* Recurrent disease after 2-3 years of adjuvant treatment with an anti-estrogen (documented by imaging techniques)
* Advanced disease that has recurred during or after anti-estrogen therapy
* Measurable or evaluable disease by conventional techniques, with ≥ 1 lesion that can be followed for response
* Bone metastases only are eligible provided they have ≥ 1 lytic lesion (not previously irradiated or planned for irradiation) that can be followed by X-ray or CT scanning
* Cutaneous skin metastases only are eligible provided the skin lesions are \> 10 mm and can be followed by good quality photography with a ruler included in the photograph
* No clinically apparent brain metastases
* Hormone receptor status must meet 1 of the following criteria:
* Estrogen receptor-positivity
* Score ≥ 3 on a scale (range of 0 to 8), or equivalent score from other grading methods, representing the intensity and percentage of positive-staining tumor cells by immunohistochemistry
* Greater than or equal to 5 fmol/mg protein by ligand binding assay or ELISA
* Progesterone receptor-positivity
* Score ≥ 3 on a scale (range of 0 to 8) or equivalent score from other grading methods, representing the intensity and percentage of positive-staining tumor cells by immunohistochemistry
* No HER-2 overexpression, defined as gene amplification by fluorescence in situ hybridization \[FISH\] OR 3+ overexpression by IHC)
PATIENT CHARACTERISTICS:
* Postmenopausal as defined by any of the following:
* Surgical or radiation-induced
* No menstrual periods for 12 consecutive months with no other biological or physiological cause in women with an intact uterus
* Age ≥ 55 years
* WHO performance status 0-2
* Life expectancy ≥ 6 months
* Hemoglobin ≥ 9.0 g/dL
* ANC ≥ 1.5 x 10\^9/L
* Platelet count ≥100 x 10\^9/L
* Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
* ALT and/or AST ≤ 2.5 times ULN (5 times ULN if due to tumor)
* Creatinine clearance ≥ 50 mL/min
* No history of malabsorption syndromes or other gastrointestinal disorders that may affect SOD1 inhibitor ATN-224 absorption, including any of the following:
* Bowel obstruction
* Celiac disease
* Sprue
* Cystic fibrosis
* No history of allergic reactions attributed to compounds of similar chemical or biologic composition to SOD1 inhibitor ATN-224, omeprazole (or other proton pump inhibitor), or exemestane
* No non-malignant systemic disease including active uncontrolled infection
* No serologic positivity for hepatitis B, hepatitis C, or HIV
* No concurrent congestive heart failure
* No history of NYHA class III-IV cardiac disease
* No other concurrent malignancy, except adequately treated cone-biopsied carcinoma in situ of the uterine cervix, basal cell or squamous cell carcinoma of the skin
* Cancer survivors who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for 5 years, and are deemed at low risk for recurrence are eligible
* No other condition which, in the investigator's opinion, would not make the patient a good candidate for this study
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Recovered from all prior therapy (alopecia allowed)
* At least 1 year since prior bilateral oophorectomy
* Prior adjuvant or neoadjuvant treatment with tamoxifen allowed
* Prior adjuvant therapy with a non-steroidal aromatase inhibitor allowed
* More than 4 weeks since prior immunotherapy or chemotherapy (6 weeks for nitrosoureas and mitomycin-C)
* More than 4 weeks since prior major thoracic and/or abdominal surgery
* More than 3 weeks since prior endocrine therapy
* More than 4 weeks since prior and no concurrent radiotherapy (except to control pain or prevent fracture)
* No prior exemestane
* Concurrent iron-containing vitamins or supplements are allowed
* No concurrent luteinizing hormone-releasing hormone analog
* No concurrent oral bisphosphonates (IV bisphosphonates allowed)
* No concurrent chronic steroid therapy for concurrent illness or cancer (short-term steroid use for concurrent illness allowed \[e.g., for acute asthma\])
* No concurrent copper- or zinc-containing vitamins or supplements
* No concurrent participation in another interventional clinical study (participation in an observational study allowed)
* No other concurrent copper-binding drug (e.g., penicillamine or trientine)
* No other concurrent anticancer therapy or investigational agent
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00674557
Study Brief:
Protocol Section:
NCT00674557