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

Status unconfirmed · Has a placebo group

Conditions studied: Breast Cancer, Depression, Fatigue, Sleep Disorders

In brief

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.

Key facts

Study ID

NCT01286233

Run by

NSABP Foundation Inc

People needed

394

Starts

2011-07-01

Expected to finish

2016-09-01

Last updated by the study team

2015-09-09

Who can join

Age: 18 and older, up to 74. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Kaiser Permanente - Deer Valley — Antioch, California, United States
• Kaiser Permanente Medical Center - Baldwin Park — Baldwin Park, California, United States
• Kaiser Permanente Medical Center - Bellflower — Bellflower, California, United States
• Kaiser Permanente Medical Center - Fontana — Fontana, California, United States
• Kaiser Permanente - Fremont — Fremont, California, United States
• Kaiser Permanente Medical Center - Harbor City — Harbor City, California, United States
• Kaiser Permanente Medical Center - Hayward — Hayward, California, United States
• Kaiser Permanente - Irvine — Irvine, California, United States
• Kaiser Permanente Medical Center - Los Angeles — Los Angeles, California, United States
• Kaiser Foundation Hospital - West Los Angeles — Los Angeles, California, United States
• Kaiser Permanente Medical Center - Oakland — Oakland, California, United States
• Kaiser Permanente - Ontario Vineyard Medical Offices and Ambulatory SurgiCenter — Ontario, California, United States
• Kaiser Permanente Medical Group — Panorama City, California, United States
• Kaiser Permanente Medical Center - Redwood City — Redwood City, California, United States
• Kaiser Permanente Medical Center - Richmond — Richmond, California, United States
• Kaiser Permanente Medical Center - Riverside — Riverside, California, United States
• Kaiser Permanente Medical Center - Roseville — Roseville, California, United States
• South Sacramento Kaiser-Permanente Medical Center — Sacramento, California, United States
• Kaiser Permanente Medical Center - Sacramento — Sacramento, California, United States
• Kaiser Permanente Medical Office -Vandever Medical Office — San Diego, California, United States
• Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego — San Diego, California, United States
• Kaiser Permanente Medical Center - San Francisco Geary Campus — San Francisco, California, United States
• Kaiser Permanente Medical Center - Santa Teresa — San Jose, California, United States
• Kaiser Permanente Health Care — San Marcos, California, United States
• Kaiser Permanente Medical Center - Anaheim/Orange County — Anaheim, California, United States

Full record on ClinicalTrials.gov

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