Spots Global Cancer Trial Database for Metformin Hydrochloride in Preventing Breast Cancer in Patients With Atypical Hyperplasia or In Situ Breast Cancer
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Trial Identification
Brief Title: Metformin Hydrochloride in Preventing Breast Cancer in Patients With Atypical Hyperplasia or In Situ Breast Cancer
Official Title: Testing for Atypia in Random Periareolar Fine Needle Aspiration (RPFNA) Cytology After 12 Months Metformin (1, 1-Dimethylbiguanide Hydrochloride) Chemoprevention Versus Placebo Control in Premenopausal Women
Study ID: NCT01905046
Study Description
Brief Summary: This randomized phase III trial studies metformin hydrochloride to see how well it works compared to placebo in preventing breast cancer in patients with atypical hyperplasia or in situ breast cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of metformin hydrochloride may prevent breast cancer.
Detailed Description: I. Test for the presence or absence of cytological atypia (as measured by a Masood Cytology Index Score of 14-17) in unilateral or bilateral random periareolar fine needle aspiration (RPFNA) aspirates after 12 and 24 months (24 month is optional for placebo-only group for patients who remain on placebo arm and will not receive metformin \[metformin hydrochloride\]) for women receiving metformin versus placebo control. The presence of cytological atypia means any atypia in any RPFNA specimen. SECONDARY OBJECTIVES: I. Use the Masood Cytology Index Score to test for the presence of cytological atypia or disappearance of cytological atypia in RPFNA aspirates after 12 months for both arms, and 24 months (24 month is optional for placebo-only group for patients who remain on placebo arm and will not receive metformin, and mandatory for crossover patients) for women receiving metformin 850 mg orally (PO) twice daily (BID) (metformin group). II. Compare Masood Cytology Score values at 0 and 12 months in right and left breasts (if both breasts were aspirated) from the same individual in the metformin and placebo group. III. Test the reproducibility of reverse phase protein microarray (RPPM) in duplicate RPPM determinations from individual RPFNA specimens. IV. Correlate baseline RPPM values with presence of atypia (as measured by Masood Cytology Index Score) at month 12 and month 24 (month 24 optional for placebo-only group; for patients who remain on placebo arm and will not receive metformin) RPFNA. TERTIARY OBJECTIVES: I. Test whether metformin alters RPFNA or blood biomarkers associated with breast cancer risk. II. Test whether metformin alters markers associated with obesity and insulin resistance. III. Test other exploratory measures in RPFNA and serum including metformin levels and estrogen/progesterone. IV. Banking: As part of ongoing research for Alliance Cancer Control studies, banking residual blood and RPFNA products for future studies.
Keywords
Eligibility
Minimum Age: 25 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
City of Hope Comprehensive Cancer Center, Duarte, California, United States
Los Angeles County-USC Medical Center, Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
City of Hope South Pasadena, South Pasadena, California, United States
The Community Hospital, Munster, Indiana, United States
University of Kansas Cancer Center, Kansas City, Kansas, United States
Cotton O'Neil Cancer Center / Stormont Vail Health, Topeka, Kansas, United States
Mayo Clinic in Rochester, Rochester, Minnesota, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Mount Sinai Hospital, New York, New York, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
The Christ Hospital, Cincinnati, Ohio, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Prisma Health Cancer Institute - Spartanburg, Boiling Springs, South Carolina, United States
Prisma Health Cancer Institute - Easley, Easley, South Carolina, United States
Greenville Health System Cancer Institute-Andrews, Greenville, South Carolina, United States
Prisma Health Cancer Institute - Butternut, Greenville, South Carolina, United States
Prisma Health Cancer Institute - Faris, Greenville, South Carolina, United States
Prisma Health Greenville Memorial Hospital, Greenville, South Carolina, United States
Prisma Health Cancer Institute - Eastside, Greenville, South Carolina, United States
Prisma Health Cancer Institute - Greer, Greer, South Carolina, United States
Prisma Health Cancer Institute - Seneca, Seneca, South Carolina, United States
M D Anderson Cancer Center, Houston, Texas, United States
Doctor's Hospital of Laredo, Laredo, Texas, United States
University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, United States
Contact Details
Name: Victoria Seewaldt, MD
Affiliation: City of Hope Comprehensive Cancer Center
Role: STUDY_CHAIR
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