Clinical trial · Observational

Studying Changes in Breast Density in Patients With Early-Stage Breast Cancer Treated With Metformin Hydrochloride or Placebo on CAN-NCIC-MA.32

Change in Mammographic Density With Metformin Use: A Companion Study to NCIC Study MA.32

NCT01666171CI-TRIAL-00011290unknownClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

RATIONALE: Learning about the effect of metformin hydrochloride in breast density of women with early-stage breast cancer may help plan treatment. PURPOSE: This trial studies changes in breast density in patients with early-stage breast cancer treated with metformin hydrochloride or placebo on CAN-NCIC-MA.32.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Breast Cancer	Malignant Breast Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (6)

Intervention	Type	Mapped drug	Match
clinical observation	Other	—	UNRESOLVED
diagnostic laboratory biomarker analysis	Other	—	UNRESOLVED
digital mammography	Procedure	—	UNRESOLVED
imaging biomarker analysis	Other	—	UNRESOLVED
medical chart review	Other	—	UNRESOLVED
metformin hydrochloride	Drug	Metformin	ALIAS

Design

Arms and outcomes

Arms (0)

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Primary outcomes (1)

measure
Change in percent mammographic breast density in contralateral (unaffected) breast from baseline to 1 year using two-sample t-test or Wilcoxon rank-sum test

Secondary outcomes (4)

measure
Change in percent mammographic breast density in contralateral (unaffected) breast from baseline to 2 years using two-sample t-test
measure
Correlation between baseline mammographic density and baseline plasma fasting insulin, glucose levels, and HOMA using a scatter plot, correlation-coefficient estimation, and linear-regression method
measure
Correlation of changes in dense area in response to metformin therapy from pre-treatment to on treatment (at year 1 and year 2) with plasma fasting insulin, glucose levels, and HOMA using simple linear-regression method
measure
Correlation between mammographic density and the incidence of second primary breast cancer using correlation coefficient and scatter plot

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years
Maximum age: 74 Years

Show eligibility criteria text

DISEASE CHARACTERISTICS:

* Patients must either be concurrently enrolling or previously enrolled to Canada (CAN) National Cancer Institute of Canada (NCIC) study MA.32 (CAN-NCIC-MA.32) (MA.32); eligible patients may be either pre- or post-menopausal
* Patients must have hormone receptor-negative breast cancer
* Patients must have breast density ≥ 25% (correlating with the Breast Imaging-Reporting and Data \[BIRAD\]-2 category of "scattered fibroglandular densities" or greater)
* Baseline digital mammograms taken within 12 months prior to registration to MA.32, with at least a craniocaudal (CC) view used for enrollment to MA.32 must be available for submission; if the patient has previously enrolled to MA.32 and one year has elapsed from baseline mammograms, one-year mammograms must also be available for submission
* Contralateral unaffected breast in place (with no prior cancer or radiation, no implants, and no plan for breast surgery on contralateral breast over the course of the study); women with a prior biopsy on the unaffected breast are eligible

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* Women receiving endocrine therapy (e.g., tamoxifen, aromatase inhibitors) are not eligible

References

Publications (0)

Data not yet available

No reference posted for this study.