Study of Biomarkers Associated With Fatigue in Patients With Early-Stage Breast Cancer Treated With Metformin or Placebo on NCIC-CTG-MA.32

• Status: Unknown status
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NSABP Foundation Inc
• Collaborator: National Cancer Institute (NCI)
• Treatments: Metformin

Criteria

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.