MRI and Mammography Before Surgery in Patients With Stage I-II Breast Cancer



Status:Recruiting
Conditions:Breast Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/22/2019
Start Date:February 2014
Contact:Isabelle Bedrosian, MD
Phone:713 563-1872

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Effect of Preoperative Breast MRI on Surgical Outcomes, Costs and Quality of Life of Women With Breast Cancer

The purpose of this study is to test whether patients undergoing a breast MRI (magnetic
resonance imaging) before breast surgery will have better results after the surgery. Breast
tumors are routinely evaluated using mammograms and ultrasound before surgery. This study
would like to find out if using MRI in addition to mammography before surgery improves our
ability to evaluate tumors and decide what kind of surgery is best for the patient.

This is a randomized trial of preoperative breast MRI in patients deemed eligible for breast
conserving surgery by conventional clinical criteria will provide important information about
the clinical and biologic relevance of occult disease identified by MRI alone. Patients will
be assigned to standard pre-operative breast cancer disease assessment without the addition
of MRI prior to breast conserving surgery or standard pre-operative breast cancer disease
assessment with the use of MRI prior to breast conserving surgery.

The primary objective is to compare the rates of local-regional recurrence (LRR) following
attempted breast conserving therapy in a cohort of women with triple negative or HER-2
amplified breast cancer randomized to preoperative staging with mammography (control arm) or
mammography plus breast MRI (MRI arm).

Secondary objectives are:

- To compare the re-operation rates following attempted breast conserving therapy between
women assessed preoperatively with breast MRI to those assessed without the use of
breast MRI

- To compare local recurrence rates between women who undergo BCT on the control arm to
women who undergo BCT on the MRI arm

- To compare the conversion rate to mastectomy secondary to persistent positive margins or
poor cosmesis within the first 6 months of attempting BCT (prior to the administration
of RT) between women assessed preoperatively with breast MRI to those assessed without
the use of breast MRI

- To compare the contralateral breast cancer rates in women randomized to preoperative
breast MRI to those not receiving pre-operative breast MRI

- To compare the disease-free survival rates between women assessed preoperatively with
breast MRI to those assessed without the use of breast MRI

- To compare breast cancer specific and overall survival outcomes of women assessed
preoperatively with breast MRI to those assessed without the use of breast MRI

- To estimate the rate of MRI-guided localization assisted surgery

- To estimate the rate of multi-centric disease in the index breast for women in the MRI
arm

- To evaluate the accuracy of index lesion characteristics and other factors in predicting
multi-centricity in the cohort randomized to breast MRI

- To assess the positive predictive values (PPV) of MRI in detecting ipsilateral
multi-centric disease and contralateral disease in women with breast cancer undergoing
preoperative breast MRI

- To estimate the false positive rate for detection of multiple foci of breast cancer by
MRI

All registered patients will be monitored for relapse and survival for 5 years from the date
of surgery. Patients will be followed a minimum of every 4 months for the first 2 years from
diagnosis and a minimum of every 6 months during years 3-5. Patients will be monitored for
local, regional, distant relapse and vital status.

- Female. Men are excluded from this study because the number of men with breast cancer
is insufficient to provide a statistical basis for assessment of effects in this
subpopulation of people with breast cancer.

- Pathologically confirmed diagnosis of breast cancer, clinical stage I-II (T1-3 N0 M0,
T0-2 N1 M0). Diagnosis must be by needle biopsy; patients diagnosed by surgical
excision are excluded.

- Patients must have either:

- Estrogen receptor (ER) negative/progesterone receptor (PR) negative (< 10% by
immunohistochemistry IHC staining) and HER-2 negative breast cancer OR

- ER negative/PR negative (< 10% by IHC staining) and HER-2 positive tumors

- HER-2 status will be determined as per the 2013 ASCO CAP guidelines:

- HER-2 is considered positive if there is IHC 3+ staining or ISH positive
using either single probe ISH or dual probe ISH

- HER-2 is considered negative if there is IHC 0 or 1+ staining or ISH
negative using either single probe ISH or dual probe ISH

- No patients with previous ipsilateral invasive breast cancer or ductal carcinoma in
situ (DCIS)

- No patients with bilateral breast cancer

- No patients with known deleterious mutations in breast cancer (BRCA) genes

- No current history of receiving hormonal therapy, tamoxifen, and or aromatase
inhibitors for therapeutic measures

- No history of chemotherapy for cancer within 6 months prior to registration

- No patients scheduled to receive neoadjuvant chemotherapy or partial breast
irradiation following breast conserving surgery

- Eligible for BCT based on clinical examination, mammography and, if standard practice
at a given institution, ultrasound and/or tomogram. Women who cannot be appropriately
selected for BCT based on these standard imaging studies, and for whom additional
imaging is recommended to clarify local disease extent, will not be eligible for this
trial.

- No patients with multicentric or multifocal disease scheduled to undergo multiple
lumpectomies. Multifocal disease that can be encompassed in a single operative bed can
be enrolled.

- Suitable to undergo MRI and receive the contrast agent gadolinium (exclusions follow):

- No history of untreatable claustrophobia

- No presence of metallic objects or implanted medical devices in body (i.e.,
cardiac pacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts,
valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or
steel implants)

- No history of sickle cell disease

- No contraindication to intravenous contrast administration

- No known allergy-like reaction to gadolinium or moderate or severe allergic
reactions to one or more allergens as defined by the American College of
Radiology (ACR); patient may be eligible if willing to undergo pre-treatment as
defined by the institution's policy and/or ACR guidance

- No findings consistent with renal failure, as determined by glomerular filtration
rate (GFR) < 30 mL/min/1.73 m^2 based on a creatinine level obtained within 28
days prior to registration

- Weight lower than that allowable by the MRI table

- No prior MRI of study breast within the 12 months prior to registration

- Non-pregnant and non-lactating. Patients of child-bearing potential must have a
negative pregnancy test within 7 days prior to registration. Perimenopausal patients
must be amenorrheic > 12 months to be considered not of child-bearing potential

- ≥ 18 years of age

- Signed study-specific informed consent prior to registration
We found this trial at
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855 N. Westhaven Dr.
Oshkosh, Wisconsin 54904
920-303-8700
Principal Investigator: Judy A. Tjoe
Phone: 414-302-2304
Vince Lombardi Cancer Clinic - Oshkosh When the diagnosis is cancer, one of the most...
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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3500 Gaston Avenue
Dallas, Texas 75246
1.800.422.9567
Principal Investigator: Jeffrey P. Lamont
Phone: 800-422-9567
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3551 Roger Brooke Dr
Fort Sam Houston, Texas 78234
(210) 916-4141
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Brooke Army Medical Center Brooke Army Medical Center (BAMC) is the Flagship of Army Medicine!...
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200 North Park Street
Kalamazoo, Michigan 49007
(269) 382-2500
Principal Investigator: Kathleen J. Yost
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West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
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Phone: 503-215-2614
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Principal Investigator: Ana P. Lourenco
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Kristin A. Skinner
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Ames, Iowa 50010
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5301 McAuley Drive
Ann Arbor, Michigan 48197
734-712-3456
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Appleton, Wisconsin 54911
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Appleton, Wisconsin 54911
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401 North Broadway
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410-955-5000
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8901 Rockville Pike
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Chicago, Illinois 60630
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5841 S Maryland Ave
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1-773-702-6180
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1200 West Harrison Stree
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Decatur, Georgia 30033
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Derby, Connecticut 06418
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4160 John R St #2122
Detroit, Michigan 48201
(313) 833-1785
Principal Investigator: David H. Gorski
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Wayne State University/Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
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Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Detroit, Michigan 48236
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
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Easley, South Carolina 29640
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303 S Nappanee St
Elkhart, Indiana 46514
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Elkhart Clinic, LLC Informed participation in the management of your health care maximizes your Elkhart...
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500 Arcade Blvd, Ste 240
Elkhart, Indiana 46514
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Emeryville, California 94608
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Emeryville, California 94608
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Evanston, Illinois 60201
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801 Broadway North
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302 Kensington Ave
Flint, Michigan 48503
(810) 762-8490
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2200 Randallia Drive
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Fort Wayne, Indiana 46845
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39400 Paseo Padre Parkway
Fremont, California 94538
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Grand Rapids, Michigan 49503
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100 Michigan St NE
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2845 Greenbrier Rd
Green Bay, Wisconsin 54311
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Greenville, South Carolina 29605
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Greenville, South Carolina 29605
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Greenville, South Carolina 29615
Principal Investigator: Jeffrey K. Giguere
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701 Grove Rd
Greenville, South Carolina 29605
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Greer, South Carolina 29651
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111 Goose Lane
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Hampton, Virginia 23666
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1 Ingalls Dr
Harvey, Illinois 60426
(708) 333-2300
Principal Investigator: Mark F. Kozloff
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500 University Dr
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Houston, Texas 77030
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535 Barnhill Dr
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1441 Eastlake Ave
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600 Highland Ave
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(608) 263-6400
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2500 Alhambra Ave
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2160 South 1st Avenue
Maywood, Illinois 60153
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9200 W Wisconsin Ave
Milwaukee, Wisconsin 53226
(414) 805-3666
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Milwaukee, Wisconsin 53201
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5340 Holy Cross Pkwy
Mishawaka, Indiana 46545
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Modesto, California 95356
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Morgantown, West Virginia 26505
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Munster, Indiana 46321
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New Haven, Connecticut 6520
(203) 432-4771
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1275 York Ave
New York, New York 10021
(212) 639-2000
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, New York 10032
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New York, New York 10016
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Newark, Delaware 19713
Principal Investigator: Diana Dickson-Witmer
Phone: 302-623-4450
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Newark, DE
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4755 Ogletown-Stanton Road
Newark, Delaware 19718
302-733-1000
Principal Investigator: Diana Dickson-Witmer
Phone: 302-623-4450
Christiana Care Health System - Christiana Hospital A 913-bed, 1.3-million-square-foot, modern facility in Newark, Delaware,...
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Newark, DE
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Norfolk, Virginia 23502
Phone: 757-446-8950
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Norfolk, VA
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600 Gresham Dr
Norfolk, Virginia 23507
(757) 388-3000
Sentara Norfolk General Hospital Sentara Norfolk General Hospital is recognized as the number one ranked...
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Norfolk, VA
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