Regional Radiotherapy in Biomarker Low Risk Node Positive Breast Cancer



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:40 - Any
Updated:3/27/2019
Start Date:May 30, 2018
End Date:December 30, 2027
Contact:Wendy Parulekar
Email:wparulekar@ctg.queensu.ca
Phone:613-533-6430

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TAILOR RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive Breast Cancer

The purpose of this study is to compare the effects on low risk breast cancer receiving usual
care that includes regional radiation therapy, with receiving no regional radiation therapy.
Researchers want to see if not giving this type of radiation treatment works as well at
preventing breast cancer from coming back.

Women with node positive breast cancer normally will receive endocrine therapy and some may
receive chemotherapy to help prevent the cancer from coming back. Many women will also
receive radiotherapy to the whole breast/chest area and the surrounding lymph glands (called
regional radiotherapy). No one really knows whether patients with low risk breast cancer need
to receive regional radiotherapy. Some women may be getting regional radiotherapy who do not
need it. These women may be exposed to the side effects of their treatment without benefit.

Inclusion Criteria:

- Patients must have newly diagnosed histologically proven invasive carcinoma of the
breast with no evidence of metastases.

- Patients must have been treated by BCS or mastectomy.

- Patients treated by BCS or mastectomy and axillary dissection must have 1-3 positive
axillary nodes (macrometastases, > 2 mm).

- Patients treated by BCS and SLNB alone must have only 1-2 positive axillary nodes
(macrometastases, > 2 mm).

- Patients treated by mastectomy and SLNB alone must have only 1 positive axillary node
(macrometastases, > 2 mm).

- Patients must be ER ≥ 1% and HER2 negative on local testing

- Patients must have an Oncotype DX recurrence score <18

- Patient must consent to provision of, and investigator(s) must confirm access to and
agree to submit to the CCTG Central Tumour Bank, a representative formalin fixed
paraffin block of tumour tissue in order that the specific correlative marker assays
described in the protocol may be conducted

- Patient must consent to provision of samples of blood in order that the specific
correlative marker assays described in the protocol may be conducted.

- Patients must have had endocrine therapy initiated or planned for ≥ 5 years. Endocrine
therapy can be given concurrently or following RT.

- Patients may or may not have had adjuvant chemotherapy.

- RT must be administered within 12 weeks of definitive surgery if the patient is not
treated with chemotherapy. If adjuvant chemotherapy is given, RT must begin within 2-8
weeks after the last dose.

- Patient's ECOG performance status must be 0, 1 or 2.

- Patient's age must be ≥ 40 years.

- Patient's life expectancy is ≥10 years

- For the first 736 eligible English or French-speaking subjects who have agreed to
optional questionnaire completion: Patient is able (i.e. sufficiently fluent) and
willing to complete the quality of life, health utilities and lost productivity
questionnaires in either English or French

- Patient consent must be appropriately obtained in accordance with applicable local and
regulatory requirements

- Patients must be accessible for treatment and follow-up. Investigators must assure
themselves the patients randomized on this trial will be available for complete
documentation of the treatment, adverse events, and follow-up.

- In accordance with CCTG policy, protocol treatment is to begin within 3 weeks of
patient randomization.

- Women of childbearing potential must have agreed to use an effective contraceptive
method. A woman is considered to be of "childbearing potential" if she has had menses
at any time in the preceding 12 consecutive months.

Exclusion Criteria:

- Patients with nodal disease limited to micrometastases (pN1Mi, > 0.2 mm and ≤ 2 mm) or
isolated tumour cells (pN0i+ < 0.2 mm).

- Any prior history, not including the index cancer, of ipsilateral invasive breast
cancer or ipsilateral DCIS treated with radiation therapy. (Patients with synchronous
or previous ipsilateral LCIS are eligible.)

- Synchronous or previous contralateral invasive breast cancer. (Patients with
contralateral DCIS not treated with radiation are eligible.)

- History of non-breast malignancies except adequately treated non-melanoma skin
cancers, in situ cancers treated by local excision or other cancers curatively treated
with no evidence of disease for ≥ 5 years.

- Patients with pT3 or pT4 disease.

- Patients who are pregnant.

- Patients that have had prior ipsilateral chestwall/thoracic radiation.

- Patients treated with neoadjuvant chemo or endocrine therapy for breast cancer.

- Patients with serious non-malignant disease (e.g. cardiovascular, scleroderma etc.)
which would preclude RT.

- Patients with any serious active or co-morbid medical conditions, laboratory
abnormality, psychiatric illness, active or uncontrolled infections, or serious
illnesses or medical conditions that would prevent the patient from participating or
to be managed according to the protocol (according to investigator's decision).
We found this trial at
83
sites
4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
Principal Investigator: Zheng (Jane) Shi
Phone: 210-450-3800
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
Principal Investigator: David Y. Lee
Phone: 505-925-0366
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
Principal Investigator: Thomas Kim
Phone: 501-686-8274
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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4650 Jefferson Lane Northeast
Albuquerque, New Mexico 87109
Principal Investigator: David Y. Lee
Phone: 505-272-0530
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Albuquerque, New Mexico 87109
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Annapolis, Maryland 21401
Principal Investigator: Mary E. Young
Phone: 443-481-1320
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Antigo, Wisconsin 54409
Principal Investigator: Christopher S. Platta
Phone: 715-623-9869
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Bemidji, Minnesota 56601
Principal Investigator: Preston D. Steen
Phone: 218-333-5000
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Berkeley, California 94704
Principal Investigator: Edmund W. Tai
Phone: 415-209-2686
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300 N. Seventh St.
Bismarck, North Dakota 58501
(701) 323-6000
Principal Investigator: Preston D. Steen
Phone: 701-323-5760
Sanford Bismarck Medical Center Whether your stay in our hospital is one day for same...
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Brewer, Maine 04412
Principal Investigator: Thomas H. Openshaw
Phone: 800-987-3005
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Bronx, New York 10461
Principal Investigator: Jana L. Fox
Phone: 718-379-6866
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Bronx, New York 10467
Principal Investigator: Jana L. Fox
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Burlington, Massachusetts 01805
Principal Investigator: Andrea B. McKee
Phone: 781-744-8027
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Calgary, Alberta
Principal Investigator: Jeffrey Q. Cao
Phone: 403-521-3433
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2600 Sixth St. SW
Canton, Ohio 44710
330.363.4908
Principal Investigator: Shruti Trehan
Phone: 330-363-7274
Aultman Health Foundation The Aultman Foundation will raise and administer funds in order to support...
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211 Saint Francis Drive
Cape Girardeau, Missouri 63703
573-331-3000
Principal Investigator: Bryan A. Faller
Phone: 573-334-2230
Saint Francis Medical Center Saint Francis Medical Center is a 282-bed facility serving more than...
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Eric D. Donnelly
Phone: 312-695-1301
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Chicago, Illinois 60630
Principal Investigator: Santosh V. Yajnik
Phone: 773-296-5360
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Parul N. Barry
Phone: 312-942-5498
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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6001 E Woodmen Rd
Colorado Springs, Colorado 80923
(719) 776-5000
Principal Investigator: Richard L. Deming
Phone: 308-398-6518
Penrose-Saint Francis Healthcare Founded by the Sisters of St. Francis and the Sisters of Charity,...
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3100 Plaza Properties Blvd
Columbus, Ohio 43219
(614) 383-6000
Principal Investigator: Timothy D. Moore
Phone: 614-488-2118
The Mark H. Zangmeister Center At The Zangmeister Center, we appreciate that our patients have...
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Columbus, Ohio 43210
Principal Investigator: Julia R. White
Phone: 800-293-5066
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2300 N Edward St
Decatur, Illinois 62526
(217) 876-8121
Principal Investigator: Bryan A. Faller
Phone: 217-876-4740
Decatur Memorial Hospital An American flag bearing only 48 stars waved above Decatur Memorial Hospital...
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Dover, New Hampshire 03820
Principal Investigator: Amanda J. Walker
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Edgewood, Kentucky 41017
Principal Investigator: Bradley J. Huth
Phone: 859-301-5473
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Fishersville, Virginia 22939
Principal Investigator: David B. Morgan
Phone: 540-245-7106
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1600 S Andrews Ave
Fort Lauderdale, Florida 33316
(954) 355-4400
Principal Investigator: Marshal E. Lieberfarb
Phone: 954-355-5346
Broward Health Medical Center Broward Health, providing service for more than 75 years, is a...
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100 Michigan St NE
Grand Rapids, Michigan 49503
(616) 391-1774
Principal Investigator: Kathleen J. Yost
Phone: 616-391-1230
Spectrum Health at Butterworth Campus Butterworth Hospital is one of four facilities that make up...
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1801 16th St
Greeley, Colorado 80631
(970) 352-4121
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
North Colorado Medical Center NCMC is a fully accredited, private, non-profit facility licensed to operate...
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Greenville, South Carolina 29605
Principal Investigator: Jeffrey K. Giguere
Phone: 864-241-6251
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Greenville, South Carolina 29607
Principal Investigator: Jeremy M. Kilburn
Phone: 864-603-6213
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Greenville, South Carolina 29615
Principal Investigator: Jeffrey K. Giguere
Phone: 864-241-6251
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Greer, South Carolina 29650
Principal Investigator: Jeffrey K. Giguere
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Hamilton, New Jersey 08690
Principal Investigator: Nisha Ohri
Phone: 609-631-6946
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Hollywood, Florida 33021
Principal Investigator: Ignacio Castellon
Phone: 888-823-5923
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Indianapolis, Indiana 46202
Principal Investigator: Richard C. Zellars
Phone: 317-278-5632
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1400 North Ritter Avenue
Indianapolis, Indiana 46219
Principal Investigator: Daniel W. Weed
Phone: 800-777-7775
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Indianapolis, Indiana 46227
Principal Investigator: Daniel W. Weed
Phone: 317-497-2823
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Indianapolis, Indiana 46256
Principal Investigator: Daniel W. Weed
Phone: 317-621-7104
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535 Barnhill Dr
Indianapolis, Indiana 46202
(888) 600-4822
Principal Investigator: Richard C. Zellars
Phone: 317-278-5632
Indiana University Melvin and Bren Simon Cancer Center At the IU Simon Cancer Center, more...
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Jefferson Hills, Pennsylvania 15025
Principal Investigator: James A. Betler
Phone: 412-359-3043
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Lake Forest, Illinois 60045
Principal Investigator: Eric D. Donnelly
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Las Cruces, New Mexico 88011
Principal Investigator: David Y. Lee
Phone: 575-556-6545
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2000 N Boise Ave
Loveland, Colorado 80538
(970) 669-4640
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
McKee Medical Center Through the years, McKee has led the way in health care innovation....
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600 Highland Ave
Madison, Wisconsin 53792
(608) 263-6400
Principal Investigator: Bethany M. Anderson
Phone: 800-622-8922
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
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Memphis, Tennessee 38120
Principal Investigator: Angela H. Wortham
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Muncie, Indiana 47303
Principal Investigator: Yunjie X. Lin
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Muskegon, Michigan 49444
Principal Investigator: Kathleen J. Yost
Phone: 616-391-1230
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New Brunswick, New Jersey 08903
Principal Investigator: Nisha Ohri
Phone: 732-235-8675
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New York, New York 10016
Principal Investigator: Naamit K. Gerber
Phone: 212-263-4434
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Oakland, California 94611
Principal Investigator: Samantha A. Seaward
Phone: 877-642-4691
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Principal Investigator: Andrew O. Wahl
Phone: 402-559-6941
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Pembroke Pines, Florida 33028
Principal Investigator: Ignacio Castellon
Phone: 954-265-4325
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Peoria, Illinois 61637
Principal Investigator: Bryan A. Faller
Phone: 309-243-3605
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111 S 11th St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: Nicole L. Simone
Phone: 215-955-6084
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
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4800 Friendship Avenue
Pittsburgh, Pennsylvania 15206
Principal Investigator: James A. Betler
Phone: 412-578-5000
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320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Principal Investigator: James A. Betler
Phone: 877-284-2000
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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Rancho Cordova, California 95670
Principal Investigator: Samantha A. Seaward
Phone: 877-642-4691
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Rohnert Park, California 94928
Principal Investigator: Samantha A. Seaward
Phone: 877-642-4691
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Roseville, California 95678
Principal Investigator: Samantha A. Seaward
Phone: 877-642-4691
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3015 North Ballas Road
Saint Louis, Missouri 63131
(314) 996-5000
Principal Investigator: Bryan A. Faller
Phone: 314-996-5569
Missouri Baptist Medical Center You just feel it. The smile that greets you. The hand...
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2000 Circle of Hope Dr
Salt Lake City, Utah 84112
(801) 585-0303
Principal Investigator: Matthew M. Poppe
Phone: 888-424-2100
Huntsman Cancer Institute at University of Utah Huntsman Cancer Institute (HCI) is part of the...
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700 Lawrence Expy
Santa Clara, California 95051
(408) 851-1000
Principal Investigator: Samantha A. Seaward
Phone: 877-642-4691
Kaiser Permanente Medical Center - Santa Clara At Kaiser Permanente Santa Clara, members and patients...
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Savannah, Georgia 31405
Principal Investigator: Howard A. Zaren
Phone: 888-823-5923
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Seneca, South Carolina 29672
Principal Investigator: Jeffrey K. Giguere
Phone: 864-241-6251
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1305 W 18th St
Sioux Falls, South Dakota 57117
(605) 333-1000
Principal Investigator: Preston D. Steen
Phone: 605-312-3320
Sanford USD Medical Center - Sioux Falls Sanford
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Somerville, New Jersey 08876
Principal Investigator: Kathleen C. Toomey
Phone: 908-685-2481
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South Jordan, Utah 84095
Principal Investigator: Matthew M. Poppe
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South San Francisco, California 94080
Principal Investigator: Samantha A. Seaward
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7601 Southcrest Parkway
Southhaven, Mississippi 38671
Principal Investigator: Angela H. Wortham
Phone: 901-226-1366
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Spartanburg, South Carolina 29307
Principal Investigator: Jeffrey K. Giguere
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101 Nicolls Rd
Stony Brook, New York 11794
(631) 444-4000
Principal Investigator: Alexander M. Stessin
Phone: 800-862-2215
Stony Brook University Medical Center Stony Brook Medicine expresses our shared mission of research, clinical...
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105 Sixth St
Traverse City, Michigan 49684
(231) 935-5000
Principal Investigator: Kathleen J. Yost
Phone: 616-391-1230
Munson Medical Center There’s no place quite like northern Michigan, and there is no other...
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602 W University Ave
Urbana, Illinois 61801
(217) 383-3010
Principal Investigator: Sinisa Stanic
Phone: 800-446-5532
Carle Cancer Center Carle Cancer Center delivers comprehensive care through leading-edge technology and advanced research,...
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Vallejo, California 94589
Principal Investigator: Edmund W. Tai
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Wausau, Wisconsin 54401
Principal Investigator: Christopher S. Platta
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West Columbia, South Carolina 29169
Principal Investigator: Steven A. Madden
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Wexford, Pennsylvania 15090
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Wheat Ridge, Colorado 80033
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929 N St Francis St
Wichita, Kansas 67214
(316) 268-5775
Principal Investigator: Pavan S. Reddy
Phone: 800-362-0070
Via Christi Regional Medical Center Via Christi Health's rich history of serving the people of...
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Wisconsin Rapids, Wisconsin 54494
Principal Investigator: Bethany M. Anderson
Phone: 715-422-7718
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5900 Byron Center Ave SW
Wyoming, Michigan 49519
(616) 252-7200
Principal Investigator: Kathleen J. Yost
Phone: 616-391-1230
Metro Health Hospital Metro Health is an integrated healthcare system offering expert, award-winning care that
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