Hormone Therapy With or Without Combination Chemotherapy in Treating Node-Negative Breast Cancer (The TAILORx Trial)



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 75
Updated:3/14/2019
Start Date:April 7, 2006
End Date:September 9, 2030

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Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning Individualized Options for Treatment:The TAILORx Trial

This randomized phase III trial studies the best individual therapy for women who have
node-negative, estrogen-receptor positive breast cancer by using a special test (Oncotype
DX), and whether hormone therapy alone or hormone therapy together with combination
chemotherapy is better for women who have an Oncotype DX recurrence score of 11-25. Estrogen
can cause the growth of breast cancer cells. Hormone therapy may fight breast cancer by
blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the
body makes. Drugs used in chemotherapy work in different ways to stop the growth of tumor
cells, either by killing the cells, by stopping them from dividing, or by stopping them from
spreading. Giving hormone therapy together with more than one chemotherapy drug (combination
chemotherapy) has been shown to reduce the chance of breast cancer recurrence, but the
benefit of adding chemotherapy to hormone therapy for women with node-negative,
estrogen-receptor positive breast cancer is small. New tests may provide information about
which patients are more likely to benefit from chemotherapy.

PRIMARY OBJECTIVES:

I. To determine whether adjuvant hormonal therapy is not inferior to adjuvant chemohormonal
in women whose tumors meet established clinical guidelines for adjuvant chemotherapy and fall
in the "primary study group" category (Oncotype DX Recurrence Score 11-25).

II. To create a tissue and specimen bank for patients enrolled in this trial, including
formalin fixed paraffin embedded tumor specimens, tissue microarrays, plasma, and
deoxyribonucleic acid (DNA) obtained from peripheral blood.

SECONDARY OBJECTIVES:

I. To determine whether adjuvant hormonal therapy is sufficient treatment (i.e. 10 year
distant disease-free survival of at least 95%) for women whose tumors meet established
clinical guidelines for adjuvant chemotherapy and who fall into the "Secondary Study Group-1"
category (Oncotype DX Recurrence Score =< 10).

II. To compare the outcomes projected at 10 years by Adjuvant (with outcomes projected using
classical pathologic information including tumor size, hormone receptor status, and
histologic grade) with those made by the Genomic Health Oncotype DX test. Classical
pathologic information and outcome results will also be used to create and refine models that
would use classical information instead of or in combination with genomic tests.

III. To estimate failure rates as a function of recurrence score (RS) separately in the
chemotherapy (arms C, D) and no chemotherapy (arms A, B) groups. The purpose of the analysis
is to develop more precise estimates of the relationship between recurrence score and
chemotherapy treatment effect, if any, at the upper range of the RS 11 - 25 group.

IV. To determine the prognostic significance of the Oncotype DX recurrence score and of the
individual RS gene groups (proliferation gene group, human epidermal growth factor receptor
[HER]2 gene group, estrogen receptor [ER] gene group, invasion gene group, and other genes).

TERTIARY OBJECTIVES:

I. To evaluate the effects of chemotherapy and hormonal therapy vs hormonal therapy alone on
perceived cognitive impairment, fatigue, fear of recurrence among pre-menopausal patients,
endocrine symptoms and sexual dysfunction, and overall health-related quality of life (HRQL).

II. To determine whether perceived cognitive impairment, fatigue, fear of recurrence,
endocrine symptoms, and overall HRQL are similar for patients receiving chemotherapy plus
hormonal therapy in secondary study group 2 as for those in the primary study group (arm D vs
C).

III. To determine whether perceived cognitive impairment, fatigue, fear of recurrence,
endocrine symptoms, and overall HRQL are similar for patients receiving hormonal therapy
alone in secondary study group 1 as for those in the primary study group (arms A vs B).

IV. To determine whether age will be inversely associated with a fear of recurrence,
independent of treatment assignment.

V. Among participants receiving hormonal treatment alone on arm A and arm B, to determine
whether Oncotype DX Recurrence score will be inversely correlated with fear of recurrence.

VI. To create a biospecimen repository including plasma, serum and CellSearch cassettes
containing circulating tumor cells (CTC) for evaluating determinants of late relapse,
including candidate biomarkers reflecting occult tumor burden (e.g., CTCs and plasma tumor
DNA) and host factors (e.g., estrogen, insulin growth factor-[IGF] axis, inflammation, etc).

VII. To create a biorepository of metastatic tumor samples in patients who have had a late
relapse.

VIII. To determine body mass index (BMI) and comorbidity burden in patients with operable
breast cancer five or more years after diagnosis.

IX. To determine whether there is a relationship between late relapse and BMI at diagnosis
and at 5 years after diagnosis, and whether BMI-associated inflammatory and/or metabolic
biomarkers are associated with early and late recurrence.

OUTLINE: This is a partially randomized study. Patients are assigned to 1 of 3 treatment
groups.

GROUP 1 (SECONDARY STUDY GROUP 1; ONCOTYPE DX RECURRENCE SCORE [ODRS] =< 10): Patients
receive standard hormonal therapy (e.g., tamoxifen alone orally (PO), aromatase inhibitor
[e.g., anastrozole, letrozole, or exemestane] alone PO, or tamoxifen PO followed by aromatase
inhibitor PO) at the discretion of the treating physician for 5 or 10 years (Arm A).

GROUP 2 (PRIMARY STUDY GROUP; ODRS 11-25): Patients are randomized to receive either hormonal
therapy alone (Arm B) or combination chemotherapy and hormonal therapy (Arm C).

Arm B (EXPERIMENTAL): Patients receive hormonal therapy as in Group 1 at the discretion of
the treating physician.

Arm C (STANDARD): Patients receive standard combination chemotherapy at the discretion of the
treating physician. Within 4 weeks after the last dose of chemotherapy, patients receive
hormonal therapy as in Group 1 at the discretion of the treating physician.

GROUP 3 (SECONDARY STUDY GROUP 2; ODRS >= 26): Patients receive combination chemotherapy as
in Group 2, Arm C followed by hormonal therapy as in Group 1. (Arm D)

Patients in all groups who have had breast-conservation surgery are also treated with
radiotherapy. Radiotherapy should begin within 4 weeks of registration for patients receiving
hormonal therapy alone or within 8 weeks after completion of chemotherapy. Patients
participating in National Surgical Adjuvant Breast and Bowel Project (NSABP) and/or Radiation
Therapy Oncology Group (RTOG) partial irradiation trial(s) may receive partial breast
radiation.

PROJECTED ACCRUAL: 11248 patients

FOLLOW UP: After completion of study treatment, patients are followed up every 3-6 months for
5 years and then annually up to 20 years.

Inclusion Criteria:

- Patients with operable histologically confirmed adenocarcinoma of the female breast
who have completed primary surgical treatment and meet the following criteria:

- ER and/or progesterone receptor (PR)-positive: Estrogen and/or progesterone
receptor positive disease (as defined by local pathology laboratory)

- Negative axillary nodes: As assessed by a sentinel lymph node biopsy, an axillary
dissection, or both, and as defined by the Sixth Edition of the American Joint
Committee on Cancer (AJCC) staging criteria

- Tumor size 1.1-5.0 cm (or 5 mm-1.0 cm plus unfavorable histological features):

- Unfavorable features defined as intermediate or poor nuclear and/or
histologic grade, or lymphovascular invasion

- NOTE: Definition of tumor size: The tumor size used for determination of
eligibility is the pathologic tumor size, which is usually determined by the
size of the tumor as measured by inspection of the gross specimen; if the
tumor size is measured microscopically and the tumor includes ductal
carcinoma in-situ, the measurement should include only the invasive
component of the tumor

- The tumor must be human epidermal growth factor receptor 2 (Her2)/neu negative by
either fluorescent in-situ hybridization (FISH) or immunohistochemistry (e.g. 0
or 1+ by DAKO Herceptest)

- The patient and physician must be agreeable to initiate standard chemotherapy and
hormonal therapy as adjuvant therapy

- A tissue specimen from the primary breast cancer has been located and is ready to be
shipped to the appropriate laboratory after consent is obtained and within 3 days
following pre-registration; NOTE: For determination of the Oncotype Recurrence Score,
tissue must be shipped to Genomic Health; if the Oncotype DX Recurrence Score was
previously performed by Genomic Health (prior to pre-registration), tissue must be
submitted to the Eastern Cooperative Oncology Group (ECOG)-American College of
Radiology Imaging Network (ACRIN) Central Biorepository and Pathology Facility upon
randomization

- Leukocyte count >= 3500/mm^3

- Platelets >= 100,000/mm^3

- Serum creatinine =< 1.5 mg/dL

- Serum aspartate transaminase (AST) that is =< 3-fold the upper institutional limits of
normal

- Patients must be disease-free of prior invasive malignancies for >= 5 years with the
exception of curatively-treated basal cell or squamous cell carcinoma of the skin or
carcinoma in situ of the cervix; patients with a previous ipsilateral or contralateral
invasive breast cancer, or with bilateral synchronous cancers, are not eligible;
patients with previous ipsilateral or contralateral ductal in situ carcinoma (DCIS)
are not eligible

- Prior treatment

- Mandatory prior surgery criteria:

- Patient must pre-register within 84 days from the final surgical procedure
required to adequately treat the primary tumor (please note that if margins
are not clear and a resection has to be conducted after pre-registration but
before randomization, the patient will be deemed to be within the 84 day
window allowed by protocol and therefore eligible)

- All tumors should be removed by either a mastectomy or local excision plus
an acceptable axillary procedure (i.e., sentinel lymph node biopsy, axillary
dissection, or both); there must be adequate (at least 1 mm if margin width
specified) tumor-free margins of resection (for invasive and ductal
carcinoma in-situ) in order for the patients to be eligible; patients with
lobular carcinoma in-situ involving the resection margins are eligible

- Criteria re: other prior treatments:

- No prior chemotherapy for this malignancy

- No prior radiation therapy for this malignancy; this includes no prior
MammoSite Brachytherapy radiation therapy (RT)

- Hormonal therapy: Patients who develop breast cancer while receiving a
selective estrogen-receptor modulator (SERM; e.g., tamoxifen, toremifene,
raloxifene) or an aromatase inhibitor (e.g., anastrazole, letrozole,
exemestane) for breast cancer prevention or a SERM for other indications
(e.g., raloxifene for osteoporosis) are not eligible; however, patients may
have received up to 8 weeks of a SERM or aromatase inhibitor for this
malignancy and still be eligible for study entry

- Patients must have an anticipated life expectancy of at least 10 years

- Women must not be pregnant or breast-feeding; all females of childbearing potential
must have a blood test or urine study within 2 weeks prior to pre-registration to rule
out pregnancy

- Women of childbearing potential must be strongly advised to utilize an accepted
and effective form of non-hormonal contraception (e.g. intrauterine device,
condoms, diaphragm, abstinence)

- Patients must not have previously had the Oncotype DX Assay performed, with the
exception of patients who have had the assay performed and have a recurrence score of
11-25

Exclusion Criteria:

- Patients with the following medical conditions should not be enrolled on the study:

- Chronic obstructive pulmonary disease requiring treatment

- Chronic liver disease (e.g., cirrhosis, chronic active hepatitis)

- Previous history of a cerebrovascular accident

- History of congestive heart failure or other cardiac disease that would represent
a contraindication to the use of an anthracycline (e.g., doxorubicin or
epirubicin)

- Chronic psychiatric condition or other condition that would impair compliance
with the treatment regimen
We found this trial at
1161
sites
3601 W 13 Mile Rd
Royal Oak, Michigan 48073
(248) 898-5000
William Beaumont Hospital-Royal Oak The largest Beaumont Hospital is located at 3601 W Thirteen Mile...
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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361 Old Belgrade Road
Augusta, Maine 04330
(207) 621-6100
Harold Alfond Center for Cancer Care MaineGeneral's Harold Alfond Center for Cancer Care (HACCC) is...
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Augusta, ME
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8600 Old Georgetown Road
Bethesda, Maryland 20814
301-896-3100
Suburban Hospital Suburban Hospital is a community-based, not-for-profit hospital serving Montgomery County and the surrounding...
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Boca Raton, Florida 33428
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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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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1 South Prospect Street
Burlington, Vermont 05401
802-656-8990
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1300 Jefferson Park Avenue
Charlottesville, Virginia 22908
434-243-6784
University of Virginia Cancer Center We are fortunate in having state of the art clinical...
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166 Stoneridge Drive
Columbia, South Carolina 29210
803-461-3000
South Carolina Oncology Associates, PA South Carolina Oncology Associates (SCOA) is the only comprehensive cancer...
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7777 Forest Ln # C840
Dallas, Texas 75230
(972) 566-7000
Medical City Dallas Hospital If you have concerns for your health, that of a family...
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1500 E Duarte Rd
Duarte, California 91010
(626) 256-4673
City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
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3300 Gallows Road
Falls Church, Virginia 22042
(703) 776-4001
Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
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1 Hurley Plaza
Flint, Michigan 48503
(810) 262-9000
Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
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4725 North Federal Highway
Fort Lauderdale, Florida 33308
(954) 771-8000
Holy Cross Hospital While spirituality plays an essential role in the way that we minister...
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3551 Roger Brooke Dr
Fort Sam Houston, Texas 78234
(210) 916-4141
Brooke Army Medical Center Brooke Army Medical Center (BAMC) is the Flagship of Army Medicine!...
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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Jupiter, Florida 33458
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524 South Park Street
Kalamazoo, Michigan 49007
(269) 341-7654
Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
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200 North Park Street
Kalamazoo, Michigan 49007
(269) 382-2500
West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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1800 West Charleston Boulevard
Las Vegas, Nevada 89102
(702) 383-2000
University Medical Center of Southern Nevada University Medical Center is dedicated to providing the highest...
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9832 US Highway 441 # 101
Leesburg, Florida 34788
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529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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777 Hemlock Street
Macon, Georgia 31201
(478) 633-1000
Medical Center of Central Georgia Navicent Health is a designated Level I Trauma Center and...
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300 Community Drive
Manhasset, New York 11030
(516) 562-0100
North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
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Norfolk, Virginia 23507
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4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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401 College Street
Richmond, Virginia 23298
(804) 828-0450
Virginia Commonwealth University Massey Cancer Center Founded in 1974, VCU Massey Cancer Center is a...
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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34800 Bob Wilson Dr,
San Diego, California 92134
(619) 532-6400
Naval Medical Center - San Diego We are the largest and most comprehensive military healthcare...
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3900 W Avera Drive
Sioux Falls, South Dakota 57108
(605) 322-4700
Avera Cancer Institute Avera, the health ministry of the Benedictine and Presentation Sisters, is a...
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601 South Sherman Street
Spokane, Washington 99202
(509) 228-1000
Cancer Care Northwest - Spokane South Cancer Care Northwest is the Inland Northwest’s premier cancer...
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808 North 39th Avenue
Yakima, Washington 98902
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98-1079 Moanalua Road
'Aiea, Hawaii 96701
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Aberdeen, South Dakota 57401
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1200 Old York Road
Abington, Pennsylvania 19001
(215) 481–2000
Abington Memorial Hospital Abington Memorial Hospital (AMH) is a 665-bed, regional referral center and teaching...
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818 Riverside Ave.
Adrian, Michigan 49221
(517) 265-0900
Bixby Medical Center ProMedica's Mission is to improve your health and well-being. Which is why,...
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Adrian, Michigan 49221
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1 Akron General Avenue
Akron, Ohio 44307
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Albany, Georgia 31701
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Albuquerque, New Mexico 87106
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Albuquerque, New Mexico 87110
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Albury, New South Wales 2640
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Alexandria, Louisiana 71301
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Alexandria, Minnesota 56308
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Allentown, Pennsylvania 18102
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Allentown, Pennsylvania 18103
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Alton, Illinois 62002
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170 North 1100 East
American Fork, Utah 84003
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Ames, Iowa 50010
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Anchorage, Alaska 99508
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Anchorage, Alaska 99508
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Anderson, South Carolina 29621
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5301 McAuley Drive
Ann Arbor, Michigan 48197
734-712-3456
Saint Joseph Mercy Hospital St. Joseph Mercy Ann Arbor Hospital is a 537-bed teaching hospital...
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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Ann Arbor, Michigan 48106
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Annapolis, Maryland 21401
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Antigo, Wisconsin 54409
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Appleton, Wisconsin 54911
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Arlington Heights, Illinois 60005
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345 South Halcyon Road
Arroyo Grande, California 93420
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921 North Oak Park Boulevard
Arroyo Grande, California 93420
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364 White Oak St
Asheboro, North Carolina 27203
(336) 625-5151
Randolph Hospital Since 1932, Randolph Hospital has been fortunate to employ dedicated and loyal personnel...
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Asheville, North Carolina 28801
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Asheville, North Carolina 28816
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Ashland, Kentucky 41101
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Ashland, Kentucky 41101
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Atlanta, Georgia 30303
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Atlanta, Georgia 30342
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1968 Peachtree Rd NW
Atlanta, Georgia 30309
(404) 605-5000
Piedmont Hospital For more than a century, Piedmont Healthcare has been a recognized leader in...
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1000 Johnson Ferry Rd NE
Atlanta, Georgia 30342
(404) 851-8000
Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
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Atlanta, Georgia 30342
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Attleboro, Massachusetts 02703
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Auburn, Washington 98001
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Augusta, Georgia 30912
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1303 D'Antignac Street
Augusta, Georgia 30901
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1501 S Potomac St
Aurora, Colorado 80012
(303) 695-2600
Medical Center of Aurora At The Medical Center of Aurora and Centennial Medical Plaza patients...
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2000 Ogden Ave
Aurora, Illinois 60504
(630) 978-6200
Rush - Copley Medical Center Rush-Copley is proud to be the leading provider of health...
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Austell, Georgia 30106
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Austin, Texas 78705
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Austin, Texas 78759
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Austin, Texas 78759
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1500 Red River Street
Austin, Texas 78701
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