NCI Community Oncology Research Program - Protocol Summary
Wake Forest WF-97415 - "Understanding and Predicting Breast Cancer Events after Treatment (UPBEAT)"
The summary below serves as a brief review of the treatment plan and eligibility for the protocol.
This summary is not intended to be used in place of the full eligibility & treatment information in the protocol.
Please contact NCORP-KC for complete protocol information.
Cancer Control Clinical Trial
CANCER TYPE: Breast
RESEARCH BASE: Wake Forest
NCT NUMBER: NCT02791581
HIPPA FORM: DOWNLOAD HIPPA FORM
Consent Form: VIEW CONSENT FORM
UPDATED ON 07/27/2018 (16:09:41)
Cancer control, stage I-III female breast ca, will receive neo-adj or adj chemo +/- RT, determine risk for long term left ventricular dysfunction, exercise intolerance, progressive fatigue and CV events.
Prior to enrolling their first participant, each participating center will be required to complete the training process by submitting relevant data from a pair of cardiopulmonary exercise (CPX) tests conducted on a healthy volunteer and other background information to the CPX core laboratory for review. The CPX core laboratory (directed by Drs. Kitzman and Brubaker) will evaluate the data and determine if further steps are required before enrolling participants.
840 Stage I-III female breast cancer patients scheduled to receive adjuvant and neo-adjuvant chemo
(+ or - radiation therapy)
160 healthy cancer free women for statistical comparisons
MRI, Labs, Demographic, Nurse Assessments, Questionnaires, Disability Measures,
6-minute walk, 45% will undergo a treadmill or stationary bike cardiopulmonary exercise test (CPET)
MRI, Labs, Nurse Assessment, Questionnaires, Disability Measures, 6-minute walk
: MRI, Labs, Nurse Assessments, Questionnaires, Disability Measures, 6-minute walk
MRI, Labs, Nurse Assessments, Questionnaires, Disability Measures, 6-minute walk, 45% will undergo a treadmill or stationary bike (CPET)
Cardiac event assessment form
- Stage I-III female breast cancer (including inflammatory and newly diagnosed, or locally recurrent but not metastatic breast cancer being treated with curative intent)
- 18 years old
- Scheduled to receive chemotherapy
- Able to hold breath for 10 seconds
- ECOG 0-2
- Participants in other ongoing clinical trials are eligible for this study
- No ferromagnetic cerebral aneurysm clips or other intracranial metal; pacemakers, defibrillators, functioning neurostimulator devices or other implanted non-compatible MRI devices
- If previously measured, no known LVEF < 50%
- Must be able to exercise on a treadmill or stationary cycle
- No symptomatic claustrophobia
- At the beginning of the study, pregnant women and women who are breast feeding will not be enrolled.