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 |
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.
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.
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
172
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Seneca, South Carolina 29672
Principal Investigator: Jeffrey K. Giguere
Phone: 864-241-6251
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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
Dallas, Texas 75246
1.800.422.9567
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3551 Roger Brooke Dr
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200 North Park Street
Kalamazoo, Michigan 49007
Kalamazoo, Michigan 49007
(269) 382-2500
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4805 Northeast Glisan Street
Portland, Oregon 97213
Portland, Oregon 97213
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593 Eddy Street
Providence, Rhode Island 02903
Providence, Rhode Island 02903
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60 Crittenden Blvd # 70
Rochester, New York 14642
Rochester, New York 14642
(585) 275-2121
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Phone: 585-275-5830
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Ames, Iowa 50010
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Phone: 515-956-4132
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5301 McAuley Drive
Ann Arbor, Michigan 48197
Ann Arbor, Michigan 48197
734-712-3456
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Phone: 734-712-3671
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Antioch, California 94531
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Phone: 877-642-4691
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Appleton, Wisconsin 54911
Principal Investigator: Honnie R. Bermas
Phone: 800-574-3872
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Appleton, Wisconsin 54911
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Phone: 920-380-1500
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Appleton, Wisconsin 54911
Principal Investigator: Honnie R. Bermas
Phone: 844-510-3600
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Arlington Heights, Illinois 60005
Principal Investigator: Stephen S. Nigh
Phone: 847-618-4968
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401 North Broadway
Baltimore, Maryland 21287
Baltimore, Maryland 21287
410-955-5000
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Principal Investigator: Kelly S. Myers
Phone: 410-955-8804
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Baltimore, Maryland 21229
Principal Investigator: Diana H. Griffiths
Phone: 410-368-2910
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8901 Rockville Pike
Bethesda, Maryland 20889
Bethesda, Maryland 20889
(301) 295-4000
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Principal Investigator: Jeremy G. Perkins
Phone: 301-319-2100
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
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Bethlehem, Pennsylvania 18015
Principal Investigator: Lee B. Riley
Phone: 888-823-5923
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Boise, Idaho 83706
Principal Investigator: Tareq Al Baghdadi
Phone: 734-712-3671
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Bryn Mawr Hospital Bryn Mawr Hospital, a nationally recognized community teaching hospital, is conveniently located...
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Carbondale, Illinois 62902
Principal Investigator: Bryan A. Faller
Phone: 618-457-5200
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Carmel, Indiana 46032
Principal Investigator: Kandice K. Ludwig
Phone: 317-278-5632
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Cedar Rapids, Iowa 52403
Principal Investigator: Deborah W. Wilbur
Phone: 319-363-2690
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5841 S Maryland Ave
Chicago, Illinois 60637
Chicago, Illinois 60637
1-773-702-6180
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Principal Investigator: Hiroyuki Abe
Phone: 773-834-7424
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1200 West Harrison Stree
Chicago, Illinois 60607
Chicago, Illinois 60607
(312) 996-4350
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Principal Investigator: Alejandra M. Perez-Tamayo
Phone: 312-355-3046
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Chico, California 95926
Principal Investigator: Karen Beatrice S. Ching-Tismal
Phone: 530-332-3808
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Coeur d'Alene, Idaho 83814
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
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Cookeville, Tennessee 38501
Principal Investigator: Jonas V. Sidrys
Phone: 931-783-2714
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Decatur, Georgia 30033
Principal Investigator: Sharad A. Ghamande
Phone: 404-501-2738
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Derby, Connecticut 06418
Principal Investigator: Brigid K. Killelea
Phone: 203-785-5702
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4160 John R St #2122
Detroit, Michigan 48201
Detroit, Michigan 48201
(313) 833-1785
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Principal Investigator: David H. Gorski
Phone: 313-576-9790
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2799 W Grand Blvd
Detroit, Michigan 48202
Detroit, Michigan 48202
(313) 916-2600
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Principal Investigator: Jessica M. Bensenhaver
Phone: 313-916-1784
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Detroit, Michigan 48236
Principal Investigator: Tareq Al Baghdadi
Phone: 734-712-3671
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2301 Erwin Rd
Durham, North Carolina 27710
Durham, North Carolina 27710
919-684-8111
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Principal Investigator: Jeffrey Crawford
Phone: 888-275-3853
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Easley, South Carolina 29640
Principal Investigator: Jeffrey K. Giguere
Phone: 864-241-6251
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Elkhart Clinic, LLC Informed participation in the management of your health care maximizes your Elkhart...
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Michiana Hematology-Oncology The Advanced Center for Cancer Care in Plymouth is part of the Cancer...
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Emeryville, California 94608
Principal Investigator: James H. Feusner
Phone: 510-835-9900
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Emeryville, California 94608
Principal Investigator: James H. Feusner
Phone: 510-629-6682
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302 Kensington Ave
Flint, Michigan 48503
Flint, Michigan 48503
(810) 762-8490
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Phone: 734-712-3671
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2200 Randallia Drive
Fort Wayne, Indiana 46805
Fort Wayne, Indiana 46805
Principal Investigator: Brian K. Chang
Phone: 260-373-8888
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Fort Wayne, Indiana 46845
Principal Investigator: Brian K. Chang
Phone: 877-784-4673
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39400 Paseo Padre Parkway
Fremont, California 94538
Fremont, California 94538
(510) 248-3000
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Principal Investigator: Samantha A. Seaward
Phone: 877-642-4691
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Fresno, California 93720
Principal Investigator: Samantha A. Seaward
Phone: 877-642-4691
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Gaithersburg, Maryland 20879
Principal Investigator: Leon C. Hwang
Phone: 301-816-7218
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Gilbert, Arizona 85234
Principal Investigator: Julie Billar
Phone: 602-747-9738
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Grafton, Wisconsin 53024
Principal Investigator: Judy A. Tjoe
Phone: 414-302-2304
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Grand Rapids, Michigan 49503
Principal Investigator: Kathleen J. Yost
Phone: 773-702-9171
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100 Michigan St NE
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
(616) 391-1774
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Principal Investigator: Kathleen J. Yost
Phone: 616-391-1230
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2845 Greenbrier Rd
Green Bay, Wisconsin 54311
Green Bay, Wisconsin 54311
(920) 288-8000
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Principal Investigator: Judy A. Tjoe
Phone: 414-302-2304
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Greenville, South Carolina 29605
Principal Investigator: Jeffrey K. Giguere
Phone: 864-241-6251
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Greenville, South Carolina 29605
Principal Investigator: Jeffrey K. Giguere
Phone: 864-241-6251
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Greenville, South Carolina 29615
Principal Investigator: Jeffrey K. Giguere
Phone: 864-241-6251
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701 Grove Rd
Greenville, South Carolina 29605
Greenville, South Carolina 29605
(864) 455-7000
![Greenville Memorial Hospital](/wp-content/uploads/logos/greenville-memorial-hospital.png)
Principal Investigator: Jeffrey K. Giguere
Phone: 864-679-3966
Greenville Memorial Hospital Greenville Memorial Medical Campus is a regional referral center for the diagnosis...
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Greer, South Carolina 29650
Principal Investigator: Jeffrey K. Giguere
Phone: 864-241-6251
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111 Goose Lane
Guilford, Connecticut 06437
Guilford, Connecticut 06437
Principal Investigator: Brigid K. Killelea
Phone: 203-785-5702
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1 Ingalls Dr
Harvey, Illinois 60426
Harvey, Illinois 60426
(708) 333-2300
![Ingalls Memorial Hospital](/wp-content/uploads/logos/ingalls-memorial-hospital.jpg)
Principal Investigator: Mark F. Kozloff
Phone: 708-915-4673
Ingalls Memorial Hospital As the area's only independent not-for-profit healthcare system, Ingalls has the ability...
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500 University Dr
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
(717) 531-6955
![Penn State Milton S. Hershey Medical Center](/wp-content/uploads/logos/penn-state-milton-s-hershey-medical-center.jpg)
Principal Investigator: Claudia J. Kasales
Phone: 717-531-3779
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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Houston, Texas 77030
Principal Investigator: Isabelle Bedrosian
Phone: 877-312-3961
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535 Barnhill Dr
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
(888) 600-4822
![Indiana University Melvin and Bren Simon Cancer Center](/wp-content/uploads/logos/indiana-university-melvin-and-bren-simon-cancer-center.jpg)
Principal Investigator: Kandice K. Ludwig
Phone: 317-278-5632
Indiana University Melvin and Bren Simon Cancer Center At the IU Simon Cancer Center, more...
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Jacksonville, Florida 32207
Principal Investigator: Beth A. Lesnikoski
Phone: 904-202-7051
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Jonesboro, Arkansas 72401
Principal Investigator: Carroll D. Scroggin
Phone: 870-936-7067
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Laredo, Texas 78041
Principal Investigator: Gary W. Unzeitig
Phone: 773-702-9171
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Lexington, Kentucky 40503
Principal Investigator: Karabeth B. Moore
Phone: 859-260-6425
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1441 Eastlake Ave
Los Angeles, California 90033
Los Angeles, California 90033
(323) 865-3000
![U.S.C./Norris Comprehensive Cancer Center](/wp-content/uploads/logos/u-s-c-norris-comprehensive-cancer-center.jpg)
Phone: 323-865-3226
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
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600 Highland Ave
Madison, Wisconsin 53792
Madison, Wisconsin 53792
(608) 263-6400
![University of Wisconsin Hospital and Clinics](/wp-content/uploads/logos/university-of-wisconsin-hospital-and-clinics.jpg)
Principal Investigator: Lee G. Wilke
Phone: 800-622-8922
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
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2500 Alhambra Ave
Martinez, California 94553
Martinez, California 94553
(925) 370-5000
![Contra Costa Regional Medical Center](/wp-content/uploads/logos/contra-costa-regional-medical-center.png)
Principal Investigator: James H. Feusner
Phone: 925-957-5400
Contra Costa Regional Medical Center Contra Costa Health Services is the largest department of County...
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2160 South 1st Avenue
Maywood, Illinois 60153
Maywood, Illinois 60153
(888) 584-7888
![Loyola University Medical Center](/wp-content/uploads/logos/loyola-university-medical-center.jpg)
Principal Investigator: Claudia B. Perez
Phone: 773-702-9171
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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Meadowbrook, Pennsylvania 19046
Principal Investigator: Sheena K. Jain
Phone: 215-938-3551
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Milwaukee, Wisconsin 53215
Principal Investigator: Judy A. Tjoe
Phone: 773-702-9171
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9200 W Wisconsin Ave
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
(414) 805-3666
![Froedtert and the Medical College of Wisconsin](/wp-content/uploads/logos/froedtert-and-the-medical-college-of-wisconsin.jpg)
Principal Investigator: Tina W. Yen
Phone: 414-805-4380
Froedtert and the Medical College of Wisconsin Froedtert Health combines with the Medical College of...
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Milwaukee, Wisconsin 53201
Principal Investigator: Judy A. Tjoe
Phone: 414-302-2304
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5340 Holy Cross Pkwy
Mishawaka, Indiana 46545
Mishawaka, Indiana 46545
(574) 237-1328
![Michiana Hematology Oncology PC-Mishawaka](/wp-content/uploads/logos/michiana-hematology-oncology-pc-mishawaka.jpg)
Michiana Hematology Oncology PC-Mishawaka Michiana Hematology Oncology's Advanced Centers for Cancer Care include the largest...
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Modesto, California 95356
Principal Investigator: Samantha A. Seaward
Phone: 877-642-4691
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Morgantown, West Virginia 26505
Principal Investigator: Ginger P. Layne
Phone: 304-293-7374
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Neenah, Wisconsin 54956
Principal Investigator: Honnie R. Bermas
Phone: 920-725-4527
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New Haven, Connecticut 6520
(203) 432-4771
![Yale University](/wp-content/uploads/logos/yale-university.jpg)
Principal Investigator: Brigid K. Killelea
Phone: 203-785-5702
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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1275 York Ave
New York, New York 10021
New York, New York 10021
(212) 639-2000
![Memorial Sloan Kettering Cancer Center](/wp-content/uploads/logos/memorial-sloan-kettering-cancer-center.jpg)
Principal Investigator: Andrea V. Barrio
Phone: 212-639-7592
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, New York 10032
Principal Investigator: Bret Taback
Phone: 212-305-6361
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New York, New York 10016
Principal Investigator: Linda Moy
Phone: 212-263-4434
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Newark, Delaware 19713
Principal Investigator: Diana Dickson-Witmer
Phone: 302-623-4450
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4755 Ogletown-Stanton Road
Newark, Delaware 19718
Newark, Delaware 19718
302-733-1000
![Christiana Care Health System - Christiana Hospital](/wp-content/uploads/logos/christiana-care-health-system---christiana-hospital.gif)
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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Sentara Norfolk General Hospital Sentara Norfolk General Hospital is recognized as the number one ranked...
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