Tumor: Breast Ratio Study



Status:Completed
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:22 - 70
Updated:11/16/2018
Start Date:April 2014
End Date:October 31, 2018

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A Prospective Trial to AssessTumor:Breast Ratio and Patient Satisfaction in Following Lumpectomy Versus Mastectomy With Reconstruction

This is an observational study of 3 arms: breast conservation therapy (Group A), mastectomy
and reconstruction (Group B), and mastectomy only (Group C).


Inclusion Criteria:

- Patient must be scheduled to undergo breast conservation therapy (BCT), mastectomy or
mastectomy with immediate reconstruction (defined as initiating the reconstructive
process at time of mastectomy) for ductal carcinoma in situ (DCIS), lobular carcinoma
in situ (LCIS), and early stage breast cancer (Clinical Stages IA-IIB). Stage IIB
tumors are 2-5 cm with micrometastases 0.2 to 2.0 cm in lymph nodes; or 2-5 cm tumor
with 1-3 positive axillary or internal mammary lymph nodes, or >5 cm with no lymph
node involvement. Clinical staging, based on imaging and physical exam will be used
for enrollment. Patients that are upstaged due to unexpected findings at the time of
surgery/assessment of surgical pathology will be excluded at that time. For staging
reference please see
http://www.cancer.gov/cancertopics/pdq/treatment/breast/patient/page2#keypoint13

- If multifocal/multicentric disease of the ipsilateral breast is encountered and
patients are still deemed eligible for BCT or mastectomy per standard of care, then
the tumor area will be calculated as the total volumes of the identified foci.

- Patient must be between 22-70 years old

- Patient must be able to understand and willing to sign a written informed consent
document

Exclusion Criteria:

- Cognitive impairment

- History of previous lumpectomy (needle biopsies are eligible)

- History of radiation to the chest wall or breasts

- Patients unable to undergo MRI due to metallic implant or claustrophobia

- Patients that are pregnant since breast MRI is contraindicated

- History of previous breast surgery other than primary cosmetic augmentation

- Identification of a concurrent or synchronous contralateral cancer during the
enrollment period

- Any patient that would not have been considered for BCT or reconstruction

- BCT patients planning to proceed with reconstruction during their study participation
timeline
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Terence M. Myckatyn, M.D.
Phone: 314-996-3873
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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mi
from
Saint Louis, MO
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