Metformin Hydrochloride in Preventing Breast Cancer in Patients With Atypical Hyperplasia or In Situ Breast Cancer
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|ClinicalTrials.gov Identifier: NCT01905046|
Recruitment Status : Recruiting
First Posted : July 23, 2013
Last Update Posted : July 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Atypical Ductal Breast Hyperplasia BRCA1 Mutation Carrier BRCA2 Mutation Carrier Ductal Breast Carcinoma in Situ Lobular Breast Carcinoma in Situ||Drug: metformin hydrochloride Other: placebo||Phase 3|
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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||128 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Actual Study Start Date :||February 1, 2015|
|Estimated Primary Completion Date :||June 2022|
Experimental: Arm I: metformin hydrochloride
Patients receive metformin hydrochloride PO QD or BID for 24 months. Patients will continue metformin 850 mg PO BID for months 13-24. Patients will undergo RPFNA at 24 months. Follow up visits will be performed at 36 and 48 months after the start of treatment.
Drug: metformin hydrochloride
Placebo Comparator: Arm II: placebo
Patients receive placebo PO QD or BID for 12 months. Patients may crossover to Arm I for months 13-24.
Other Name: PLCB
- Test for the presence or absence of cytological atypia in unilateral or bilateral 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). [ Time Frame: Up to 24 months ]
- Test for the Masood Score and the presence of atypia or disapperance of atypia in RPFNA after 12 months (for both arms) and 24 months for Metformin arm. [ Time Frame: Up to 24 months ]
- Compare Masood Cytology Score value at 0 and 12 in right and left breast from the same individual in the metformin and non-metformin group. [ Time Frame: Up to 24 months ]
- Test the reproducibility of RPPM in duplicate RPPM determinations from individual RPFNA specimens. [ Time Frame: Up to 12 months ]
- Correlate baseline RPPM values with presence of atypia at Month 12 and Month 24. [ Time Frame: Up to 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01905046
|Contact: Victoria Seewaldt, MD||(626) 471-7321|
|Study Chair:||Victoria Seewaldt, MD||City of Hope Comprehensive Cancer Center|