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:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-25 @ 5:02 AM
NCT ID:
NCT01372618
Eligibility Criteria:
Inclusion Criteria:
* 21 years of age and older
* Must sign informed consent, witnessed, and dated prior to entry
* The participant has breast biopsy consistent with Ductal Carcinoma in situ (DCIS)
* Performance Status: ECOG 0-1 unless mobility is limited from chronic physical handicap
* No clinical evidence of other malignancies (except Basal Cell carcinoma)
* Complete blood count, differential and platelet count must be WNL or verified by the study chair to be related to conditions not interfering with normal health status
* Adequate hepatic and renal function (these must be WNL or verified by study chair to be related to conditions not interfering with normal health status)
* Normal fasting glucose
* No history of diabetes
* Medically and Psychologically able to comply with all study requirements
* Accessible for Follow up
Exclusion Criteria:
* Less than 21 years of age
* Known invasive breast cancer of any type
* Bilateral prophylactic mastectomy
* Prior malignancy of any type that occurred less than 5 years previously, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
* Existing non-malignant disease that would preclude the administration of pasireotide
* Pregnancy: All subjects will have a beta-hCG serum pregnancy test to rule out pregnancy, a history will also be taken to make certain that recent sexual exposure does not put them at risk for pregnancy. If so a second serum pregnancy test will be done. Volunteers will be asked to use barrier contraception during study.
* Tamoxifen or other preventive measures within 6 months
* Serious Psychiatric condition or addictive disorder
* Diabetes or elevated fasting blood sugar either by history or by HgbA1c greater than 6.5% or fasting serum glucose greater than 100mg/dL on screening labs. If fasting serum glucose is greater than 100mg/dL on screening labs, this test will be repeated to confirm the results
* Inability to inject medication or test for finger stick glucose
* Gall bladder disease
* History of cholecystitis without cholecystectomy
* Electrolyte abnormalities (particularly hypokalemia or hypomagnesemia)
* Contraindication for MRI
* If tumor size is \< 1cm on mammography and all calcifications are removed on core biopsy the patient will be excluded.
QT related exclusion criteria
* QTcF at screening \> 450 msec.
* History of syncope or family history of idiopathic sudden death.
* Sustained or clinically significant cardiac arrhythmias.
* Risk factors for Torsades de Pointes such as hypokalemia, hypomagnesemia, cardiac failure, clinically significant/symptomatic bradycardia, or high-grade AV block.
* Concomitant disease(s) that could prolong QT such as autonomic neuropathy (caused by diabetes, or Parkinson's disease), HIV, cirrhosis, uncontrolled hypothyroidism or cardiac failure
* Concomitant medication(s) known to increase the QT interval.
Hepatic Related Exclusion Criteria
* Baseline Alanine transaminase (ALT) or Aspartate transaminase (AST) \> 2x upper limit of normal (ULN) without known complications of metastatic liver disease or primary hepatic disease (e.g. Cushing's disease and Acromegaly studies).
* Baseline Total Bilirubin \> 1.5x ULN
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
21 Years
Study:
NCT01372618
Study Brief:
Protocol Section:
NCT01372618