Trial · NCT01905046

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

NCT01905046, Phase 3, Active not recruiting, Alliance for Clinical Trials in Oncology; results first posted 2025-04-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Metformin Hydrochloride in Preventing Breast Cancer in Patients With Atypical Hyperplasia or In Situ Breast Cancer. Trials, record NCT01905046. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01905046

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Metformin Hydrochloride in Preventing Breast Cancer in Patients With Atypical Hyperplasia or In Situ Breast Cancer
NCT number: NCT01905046
Status: Active not recruiting
Phases: Phase 3
Enrollment: 86 participants, actual
Lead sponsor: Alliance for Clinical Trials in Oncology
Conditions: Breast Atypical Ductal Hyperplasia, Breast Ductal Carcinoma In Situ, Breast Lobular Carcinoma In Situ
Interventions: metformin hydrochloride, placebo
First posted: 2013-07-23
Last updated: 2026-10-08
Results first posted: 2025-04-13

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Test for the Presence or Absence of Cytological Atypia in Unilateral or Bilateral RPFNA Aspirates After 12 Months.	12 months	Presence of atypia at 12 months is determined through the average of Masood scores across all evaluable breasts for a patient. If the average score is at least 13.5, then patient will be labeled as having atypia. The primary aim of this study is to compare the presence of atypia at month 12 between two arms using the chi-square test in univariable analysis and regressed on group indicator, age, race, stratification factors, and baseline Masood score using logistic regression in multivariable analysis.
Secondary	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.	Up to 24 months
Secondary	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.	Up to 24 months
Secondary	Test the Reproducibility of RPPM in Duplicate RPPM Determinations From Individual RPFNA Specimens.	Up to 12 months
Secondary	Correlate Baseline RPPM Values With Presence of Atypia at Month 12 and Month 24.	Up to 24 months

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Test for the Presence or Absence of Cytological Atypia in Unilateral or Bilateral RPFNA Aspirates After 12 Months.	12 months	Per protocol, evaluable patients are defined as having a baseline Masood score between 14 and 17 in at least one breast, and all evaluable breasts undergo satisfactory RPFNA at 12 months. At the time of the primary analysis, we had 66 evaluable patients out of 86 randomized patients (32 Placebo, 34 Metformin).	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	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.	Up to 24 months
SECONDARY	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.	Up to 24 months
SECONDARY	Test the Reproducibility of RPPM in Duplicate RPPM Determinations From Individual RPFNA Specimens.	Up to 12 months
SECONDARY	Correlate Baseline RPPM Values With Presence of Atypia at Month 12 and Month 24.	Up to 24 months

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Test for the Presence or Absence of Cytological Atypia in Unilateral or Bilateral RPFNA Aspirates After 12 Months.	Arm I	With Aytpia	20	Participants
Test for the Presence or Absence of Cytological Atypia in Unilateral or Bilateral RPFNA Aspirates After 12 Months.	Arm II	With Aytpia	21	Participants
Test for the Presence or Absence of Cytological Atypia in Unilateral or Bilateral RPFNA Aspirates After 12 Months.	Arm I	Without Aytpia	12	Participants
Test for the Presence or Absence of Cytological Atypia in Unilateral or Bilateral RPFNA Aspirates After 12 Months.	Arm II	Without Aytpia	13	Participants

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Months 0-12	STARTED	Arm I	42
Months 0-12	STARTED	Arm II	44
Months 0-12	COMPLETED	Arm I	42
Months 0-12	COMPLETED	Arm II	44
Months 0-12	NOT COMPLETED	Arm I	0
Months 0-12	NOT COMPLETED	Arm II	0
Months 13-24	STARTED	Arm I	42
Months 13-24	STARTED	Arm II	44
Months 13-24	COMPLETED	Arm I	25
Months 13-24	COMPLETED	Arm II	29

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events162

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anemia	Blood and lymphatic system disorders	Arm I	1	42	1
other	Anemia	Blood and lymphatic system disorders	Arm II Months 0-12: Placebo	0	44	0
other	Anemia	Blood and lymphatic system disorders	Arm II Months 13-24: Metformin	0	57	0
other	Hypothyroidism	Endocrine disorders	Arm I	0	42	0
other	Hypothyroidism	Endocrine disorders	Arm II Months 0-12: Placebo	0	44	0
other	Hypothyroidism	Endocrine disorders	Arm II Months 13-24: Metformin	1	57	1
other	Eye pain	Eye disorders	Arm I	0	42	0
other	Eye pain	Eye disorders	Arm II Months 0-12: Placebo	1	44	1
other	Eye pain	Eye disorders	Arm II Months 13-24: Metformin	0	57	0
other	Photophobia	Eye disorders	Arm I	0	42	0

1 to 10 of 162Source ClinicalTrials.gov

See all 162 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm I	0	42
Total, all-cause mortality	Arm II Months 0-12: Placebo	0	44
Total, all-cause mortality	Arm II Months 13-24: Metformin	0	57
Total, other adverse events	Arm I	24	42
Total, other adverse events	Arm II Months 0-12: Placebo	34	44
Total, other adverse events	Arm II Months 13-24: Metformin	32	57
Total, serious adverse events	Arm I	1	42
Total, serious adverse events	Arm II Months 0-12: Placebo	0	44
Total, serious adverse events	Arm II Months 13-24: Metformin	2	57

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U10CA031946	Cancer and Leukemia Group B	BERTAGNOLLI, MONICA M	BRIGHAM AND WOMEN'S HOSPITAL	NATIONAL CANCER INSTITUTE	1985 to 2013

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01905046

GET https://conductscience.org/api/trials/v1/NCT01905046/events?page=2

API reference For AI assistants