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 @ 11:30 PM
Ignite Modification Date:
2025-12-24 @ 11:30 PM
NCT ID:
NCT01149356
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of breast cancer
* Locally advanced or metastatic disease for which curative measures are not effective
* Relapsed disease with (or within 6 months of discontinuation of) an adjuvant nonsteroidal aromatase inhibitor or tamoxifen
* Progressive disease during treatment with first- or second-line hormonal therapy that could include a nonsteroidal aromatase inhibitor, tamoxifen, or fulvestrant
* Recurrent disease
* No locally recurrent resectable disease
* Histologically confirmed estrogen receptor-positive (ER+) by IHC
* Must have ≥ 5% strong staining for ER+ or ≥ 10% weak staining
* Measurable disease defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 20 mm by conventional techniques OR as ≥ 10 mm by spiral CT scan
* No HER2/neu-positive disease
* No known brain metastases
* Pre- or postmenopausal status
* ECOG performance status 0-1
* Life expectancy ≥ 6 months
* WBC ≥ 3,500/mm\^3
* ANC ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9 g/dL
* Total bilirubin ≤ 2 mg/dL
* AST and ALT ≤ 2.5 times upper limit of normal
* Creatinine normal OR creatinine clearance ≥ 60 mL/min
* Able to swallow and retain oral medication
* Negative pregnancy test
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for ≥ 12 months after completion of study therapy
* More than 5 years since other invasive cancer except basal or squamous cell cancer of the skin or cervical carcinoma in situ
* No history of allergic reactions attributed to compounds of similar chemical or biologic composition to gamma-secretase inhibitor RO4929097 or other agents used in the study
* No history of torsades de pointes
* No malabsorption syndrome or other condition that would interfere with intestinal absorption (e.g., ulcerative colitis)
* Not serologically positive for hepatitis B or C, have a history of liver disease, other forms of hepatitis, or cirrhosis
* No uncontrolled hypocalcemia, hypomagnesemia, hyponatremia, hypophosphatemia, or hypokalemia
* No uncontrolled intercurrent illness including, but not limited to, any of the following:
* Ongoing or active infection requiring parenteral antibiotics
* Impairment of lung function (e.g., chronic obstructive pulmonary disease or lung conditions requiring oxygen therapy)
* Symptomatic congestive heart failure (NYHA class III-IV heart disease)
* Unstable angina pectoris, angioplasty, stenting, and or myocardial infarction within the past 6 months
* Uncontrolled hypertension (systolic BP \> 180 mm Hg or diastolic BP \> 100 mm Hg on 2 consecutive measurements separated by a 1-week period) despite adequate medical support
* Clinically significant cardiac arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, torsades de pointes, ventricular tachycardia that is symptomatic, or requiring treatment)
* A requirement for antiarrthymics or other medications known to prolong QTC
* Uncontrolled diabetes (hyperosmolar state, ketoacidosis, etc.)
* Psychiatric illness and/or social situations that would limit compliance with study requirements
* No baseline QTcF \> 450 msec (male) or \> 470 msec (female)
* See Disease Characteristics
* Fully recovered from all previous adverse events
* No prior exemestane for metastatic or recurrent breast cancer, or within the past 6 months in the adjuvant setting
* More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
* At least 2 weeks since prior radiotherapy
* At least 2 weeks since prior and no other concurrent investigational agents
* No prior exposure to γ-secretase inhibitors
* No concurrent medications with narrow therapeutic indices that are metabolized by cytochrome P450 (CYP450), including warfarin sodium (Coumadin®)
* No other concurrent CYP3A4 substrates, inducers, or inhibitors
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No other concurrent anticancer agents or therapies, including chemotherapy, radiotherapy, surgery, immunotherapy, hormonal therapy, or biologic therapy
* No concurrent medications or food that may interfere with the metabolism of gamma-secretase inhibitor RO4929097, including ketoconazole and grapefruit juice
* No concurrent antiarrhythmics or other medications known to prolong QTc
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01149356
Study Brief:
Protocol Section:
NCT01149356