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:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-26 @ 5:23 PM
NCT ID:
NCT01013506
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed invasive breast carcinoma
* Stage IV disease
* No locally recurrent resectable disease
* No symptomatic brain metastases
* History of brain metastases allowed provided the patient is clinically stable for \> 3 weeks after completion of radiotherapy AND is not taking steroids or therapeutic anticonvulsants that are CYP3A4 modifiers
* Hormone receptor status:
* Estrogen receptor and/or progesterone receptor positive tumor by immunohistochemistry (IHC)
PATIENT CHARACTERISTICS:
* Pre- or post-menopausal
* ECOG performance status 0-1
* Life expectancy ≥ 6 months
* ANC ≥ 1,250/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Creatinine ≤ 1.5 times upper limit of normal (ULN)
* Bilirubin ≤ 1.5 times ULN (≤ 3 times ULN if liver metastasis is present)
* For patients with Gilbert syndrome, direct bilirubin will be measured instead of total bilirubin
* SGOT and SGPT ≤ 1.5 times ULN (≤ 3 times ULN if liver metastasis is present)
* Alkaline phosphatase ≤ 1.5 times ULN (≤ 3 times ULN if liver metastasis is present)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception during and for 3 months after completion of study therapy
* Able to swallow and retain oral medication
* Baseline QTc ≤ 450 msec
* No other invasive cancer within the past 5 years except for completely resected basal cell or squamous cell skin cancer or successfully treated cervical carcinoma in situ
* No malabsorption syndrome significantly affecting gastrointestinal function
* No diabetes, fasting glucose \> 150mg/dL, or receiving ongoing anti-hyperglycemic therapies
* No concurrent uncontrolled illness including, but not limited to, any of the following:
* Ongoing or active infection requiring parenteral antibiotics
* Impaired lung function (i.e., COPD or lung conditions requiring oxygen therapy)
* Symptomatic congestive heart failure (NYHA class III or IV heart disease)
* Unstable angina pectoris, angioplasty, stenting, or myocardial infarction within the past 6 months
* Uncontrolled hypertension, defined as systolic BP \> 180 mm Hg or diastolic BP \> 100 mm Hg on two consecutive measurements taken ≥ 1 week apart, despite adequate medical support
* Clinically significant cardiac arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, or ventricular tachycardia that is symptomatic or requires treatment)
* Psychiatric illness and/or social situation that would compromise patient safety or limit compliance with study requirements, including maintenance of a compliance/pill diary
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Recovered from prior therapy
* At least 2 weeks since prior investigational drugs
* No more than 4 prior chemotherapy treatments in the metastatic setting
* Does not include endocrine therapy or single-agent biologic therapy
* No concurrent CYP3A4 or CYP1A2 modifiers
* No other concurrent anticancer therapy, including chemotherapy, radiotherapy, surgery, immunotherapy, hormonal therapy, or biologic therapy
* Concurrent radiotherapy to painful bone metastases or areas of impeding bone fracture allowed provided radiotherapy is initiated before study therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01013506
Study Brief:
Protocol Section:
NCT01013506