Metformin Hydrochloride in Preventing Breast Cancer in Patients With Atypical Hyperplasia or In Situ Breast Cancer

Part of paid clinical trials in Duarte, California.

Sponsor
Alliance for Clinical Trials in Oncology
Study ID
NCT01905046
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Atypical Ductal Breast Hyperplasia
  • BRCA1 Mutation Carrier
  • BRCA2 Mutation Carrier
  • Ductal Breast Carcinoma in Situ
  • Lobular Breast Carcinoma in Situ

Eligibility Criteria

Sex
FEMALE
Age
25 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • metformin hydrochloride — DRUG
    given PO
  • placebo — OTHER
    given PO

Study Details

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.

Key Dates

Start date
Nov 23, 2015
Status verified
Apr 2026
Primary completion
Nov 10, 2023
Completion
Nov 30, 2026

Study Design

Enrollment
86 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • 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.
  • 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.

Primary Outcome Measure

Test for the Presence or Absence of Cytological Atypia in Unilateral or Bilateral RPFNA Aspirates After 12 Months. [ Time Frame: 12 months ]

Locations (27)

FacilityCityStateZIPSite coordinators
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010-
Los Angeles County-USC Medical CenterLos AngelesCalifornia90033-
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
City of Hope South PasadenaSouth PasadenaCalifornia91030-
The Community HospitalMunsterIndiana46321-
University of Kansas Cancer CenterKansas CityKansas66160-
Cotton O'Neil Cancer Center / Stormont Vail HealthTopekaKansas66606-
Mayo Clinic in RochesterRochesterMinnesota55905-
Roswell Park Cancer InstituteBuffaloNew York14263-
Mount Sinai HospitalNew YorkNew York10029-
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterNew YorkNew York10032-
Duke University Medical CenterDurhamNorth Carolina27710-
The Christ HospitalCincinnatiOhio45219-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-
Prisma Health Cancer Institute - SpartanburgBoiling SpringsSouth Carolina29316-
Prisma Health Cancer Institute - EasleyEasleySouth Carolina29640-
Greenville Health System Cancer Institute-AndrewsGreenvilleSouth Carolina29601-
Prisma Health Cancer Institute - ButternutGreenvilleSouth Carolina29605-
Prisma Health Cancer Institute - EastsideGreenvilleSouth Carolina29615-
Prisma Health Cancer Institute - FarisGreenvilleSouth Carolina29605-
Prisma Health Greenville Memorial HospitalGreenvilleSouth Carolina29605-
Prisma Health Cancer Institute - GreerGreerSouth Carolina29650-
Prisma Health Cancer Institute - SenecaSenecaSouth Carolina29672-
M D Anderson Cancer CenterHoustonTexas77030-
Doctor's Hospital of LaredoLaredoTexas78041-
University of Wisconsin Carbone Cancer CenterMadisonWisconsin53792-

Related coverage on Hipa.ai

Find similar trials in Duarte, CA

By research site
City of Hope Comprehensive Cancer Center· Duarte, CALos Angeles County-USC Medical Center· Los Angeles, CAUSC / Norris Comprehensive Cancer Center· Los Angeles, CACity of Hope South Pasadena· South Pasadena, CAThe Community Hospital· Munster, INUniversity of Kansas Cancer Center· Kansas City, KS

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