Clinical trial · Observational
Study of Biomarkers Associated With Fatigue in Patients With Early-Stage Breast Cancer Treated With Metformin or Placebo on NCIC-CTG-MA.32
Biobehavioral Mechanisms of Fatigue in Patients Treated on NCIC CTG MA.32: A Phase III Randomized Trial of Metformin Versus Placebo on Recurrence and Survival in Early Stage Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Studying samples of blood in the laboratory from patients with breast cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to fatigue. PURPOSE: This research study is studying biomarkers associated with fatigue in patients with early-stage breast cancer treated with metformin or placebo on NCIC-CTG-MA.32.
Conditions
Conditions (4)
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 |
| Depression | — | UNRESOLVED | — |
| Fatigue | — | UNRESOLVED | — |
| Sleep Disorders | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin | Drug | Metformin | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Group 1: Metformin
- description
- 850 mg orally twice a day for 5 years
- interventionNames
- Drug: Metformin
- label
- Group 2: Placebo
- description
- One caplet orally twice a day for 5 years
- interventionNames
- Drug: Placebo
Primary outcomes (5)
- measure
- Questionnaire scores from patient reported outcome battery regarding fatigue, stress, sleep, depression, and general quality of life
- timeFrame
- Collected at baseline and 6, 12, 24, and 36 months from randomization
- measure
- Questionnaire scores from patient reported comorbid conditions and behavioral risks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria * The patient must have consented to participate and must have signed and dated an appropriate IRB-approved consent form that conforms to federal and institutional guidelines for the MA.32.F Study before being enrolled. * The patient must be female. * The patient must reside in the United States or Canada. * The patient must be English-speaking. * The patient must be eligible for randomization in the MA.32 treatment trial. (Participation in the MA.32 QOL study is permitted but not required.) * The patient must not have started taking MA.32 study therapy. * The patient must have completed primary breast radiation therapy at least two weeks prior to enrollment in MA.32.F. Exclusion Criteria * MA.32 study therapy has been initiated. * Currently receiving radiation therapy or additional radiation therapy is planned for initiation after starting MA.32 study therapy.
References
Publications (0)
Data not yet available