Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01905046
Study type Interventional
Source Alliance for Clinical Trials in Oncology
Contact
Status Active, not recruiting
Phase Phase 3
Start date November 23, 2015
Completion date November 2025

See also
  Status Clinical Trial Phase
Completed NCT02314156 - Transdermal or Oral Telapristone Acetate in Treating Patients Undergoing Mastectomy Phase 2
Completed NCT01874184 - Group-Based Lifestyle Intervention in Measuring Biomarker Levels in Participants at High Risk for Breast Cancer N/A
Completed NCT01869764 - Omega-3 Fatty Acid in Treating Patients With Stage I-III Breast Cancer Phase 2
Completed NCT02587663 - Extent of Breast Cancer and the Role of Pre-Operative Sonography and MRI N/A
Active, not recruiting NCT04537312 - Prospective Pilot Study of Robot-assisted Nipple Sparing Mastectomy (RNSM) N/A
Active, not recruiting NCT01245712 - Radiation Therapy in Treating Patients With Stage 0-II Breast Cancer Phase 2
Recruiting NCT02993159 - Testing an Active Form of Tamoxifen (4-hydroxytamoxifen) Delivered Through the Breast Skin to Control Ductal Carcinoma in Situ (DCIS) of the Breast Phase 2
Completed NCT01753908 - Broccoli Sprout Extract in Treating Patients With Breast Cancer Early Phase 1
Terminated NCT02023008 - Interactive Gentle Yoga in Improving Quality of Life in Patients With Stage I-III Breast Cancer Undergoing Radiation Therapy N/A
Terminated NCT01754519 - Radiation Therapy in Treating Post-Menopausal Women With Early Stage Breast Cancer Undergoing Surgery Phase 2
Completed NCT01849250 - Study of Docosahexaenoic Acid (DHA) in Triple Negative Breast Cancer Survivors Phase 2
Completed NCT01819233 - Caloric Restriction in Treating Patients With Stage 0-I Breast Cancer Undergoing Surgery and Radiation Therapy N/A
Active, not recruiting NCT03077841 - Hypofractionated Partial Breast Irradiation in Treating Patients With Early Stage Breast Cancer Phase 2/Phase 3
Active, not recruiting NCT02352883 - MRI and Gene Expression in Diagnosing Patients With Ductal Breast Cancer In Situ N/A
Recruiting NCT03909282 - Surgical Excision vs Neoadjuvant Radiotherapy+Delayed Surgical Excision of Ductal Carcinoma N/A
Completed NCT01723943 - Educational Counseling in Improving Communication and Quality of Life in Spouses and Breast Cancer Patients N/A
Completed NCT00637481 - A Phase I Prevention Study of Atorvastatin in Women at Increased Risk for Breast Cancer Phase 1
Completed NCT01975363 - Pilot Study of Curcumin for Women With Obesity and High Risk for Breast Cancer N/A
Active, not recruiting NCT03391388 - 3D-CRT, Proton, or Brachytherapy APBI in Treating Patients With Invasive and Non-invasive Breast Cancer Phase 2
Completed NCT02526498 - Accelerated Partial Breast Radiation Therapy Using High-Dose Rate Brachytherapy in Treating Patients With Early Stage Breast Cancer After Surgery Phase 2