Palbociclib and Letrozole or Fulvestrant in Treating Patients With Estrogen Receptor Positive, HER2 Negative Metastatic Breast Cancer
Status: | Recruiting |
---|---|
Conditions: | Breast Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 70 - Any |
Updated: | 3/7/2019 |
Start Date: | August 15, 2018 |
End Date: | August 2024 |
Contact: | Mina Sedrak, MD, MS |
Email: | msedrak@coh.org |
Phone: | 626-218-4173 |
A Phase II Trial Assessing the Tolerability of Palbociclib in Combination With Letrozole or Fulvestrant in Patients Aged 70 and Older With Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer
This phase II trial studies the side effects and how well palbociclib and letrozole or
fulvestrant works in treating patients aged 70 years and older with estrogen receptor
positive, HER2 negative breast cancer that has spread to other places in the body.
Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for
cell growth. Drugs used in chemotherapy, such as letrozole or fulvestrant, 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 palbociclib and letrozole or fulvestrant
may work better in treating patients with breast cancer. The trial will explore factors other
than chronologic age that can affect toxicity rates as identified using a cancer-specific
geriatric assessment.
fulvestrant works in treating patients aged 70 years and older with estrogen receptor
positive, HER2 negative breast cancer that has spread to other places in the body.
Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for
cell growth. Drugs used in chemotherapy, such as letrozole or fulvestrant, 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 palbociclib and letrozole or fulvestrant
may work better in treating patients with breast cancer. The trial will explore factors other
than chronologic age that can affect toxicity rates as identified using a cancer-specific
geriatric assessment.
PRIMARY OBJECTIVES:
I. To estimate the safety and tolerability (adverse event rate) of the combination of
palbociclib and letrozole or fulvestrant in adults age 70 or older with estrogen
receptor-positive, HER2-negative metastatic breast cancer.
SECONDARY OBJECTIVES:
I. To describe the full toxicity profile including all grade 2 and higher adverse events (per
National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE]
version [v.] 5.0), specifically estimating the rate of grade 2 and higher myelosuppression
(neutropenia, leukopenia, thrombocytopenia, and anemia), neutropenic fever, gastrointestinal
(GI) side effects (nausea, diarrhea, decreased appetite, vomiting, mucositis-oral), fatigue,
neuropathy, and thromboembolism.
II. To describe rates of dose reductions, dose holds, and hospitalizations. III. To estimate
median time to treatment failure, including progression free survival and overall survival.
IV. To estimate the rate of adherence to palbociclib, letrozole and fulvestrant.
V. To explore factors other than chronologic age that can affect toxicity rates as identified
using a cancer-specific geriatric assessment.
VI. To describe the results of the Overall Treatment Utility (OTU). VII. To determine the
degree of agreement between patient-reported adverse events (AEs) using Patient Reported
Outcomes (PRO)-CTCAE measures and those reported using traditional collections for AEs.
VIII. To examine the association between sarcopenia and the development of toxicity and
adverse events.
OUTLINE:
Patients receive palbociclib orally (PO) once daily (QD) on days 1-21. Patients also receive
letrozole PO QD on days 1-28 or fulvestrant intramuscularly (IM) on days 1 and 15 of course 1
and on day 1 of subsequent courses per Doctor of Medicine (MD) discretion. Courses repeat
every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for up to 5 years.
I. To estimate the safety and tolerability (adverse event rate) of the combination of
palbociclib and letrozole or fulvestrant in adults age 70 or older with estrogen
receptor-positive, HER2-negative metastatic breast cancer.
SECONDARY OBJECTIVES:
I. To describe the full toxicity profile including all grade 2 and higher adverse events (per
National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE]
version [v.] 5.0), specifically estimating the rate of grade 2 and higher myelosuppression
(neutropenia, leukopenia, thrombocytopenia, and anemia), neutropenic fever, gastrointestinal
(GI) side effects (nausea, diarrhea, decreased appetite, vomiting, mucositis-oral), fatigue,
neuropathy, and thromboembolism.
II. To describe rates of dose reductions, dose holds, and hospitalizations. III. To estimate
median time to treatment failure, including progression free survival and overall survival.
IV. To estimate the rate of adherence to palbociclib, letrozole and fulvestrant.
V. To explore factors other than chronologic age that can affect toxicity rates as identified
using a cancer-specific geriatric assessment.
VI. To describe the results of the Overall Treatment Utility (OTU). VII. To determine the
degree of agreement between patient-reported adverse events (AEs) using Patient Reported
Outcomes (PRO)-CTCAE measures and those reported using traditional collections for AEs.
VIII. To examine the association between sarcopenia and the development of toxicity and
adverse events.
OUTLINE:
Patients receive palbociclib orally (PO) once daily (QD) on days 1-21. Patients also receive
letrozole PO QD on days 1-28 or fulvestrant intramuscularly (IM) on days 1 and 15 of course 1
and on day 1 of subsequent courses per Doctor of Medicine (MD) discretion. Courses repeat
every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for up to 5 years.
Inclusion Criteria:
- Documentation of disease: estrogen receptor positive, HER2 negative metastatic breast
cancer; histologic confirmation is required
- Measurable disease or non-measurable disease
- Planning to begin endocrine therapy for metastatic disease; one prior line of
endocrine therapy or chemotherapy for metastatic disease is allowed
- No prior therapy with a CDK inhibitor
- Resolution of all acute toxic effects of prior therapy or surgical procedures to CTCAE
grade =< 1 (except alopecia) prior to registration
- No untreated brain metastases; patients with treated brain metastases must have
completed treatment with steroids to be eligible
- No second malignancies other than non-melanoma skin cancers or cervical carcinoma in
situ
- No active infection requiring treatment with antibiotics
- Patients must be able to swallow and retain oral medication
- Patients must be able to read and comprehend English or Spanish
- Absolute neutrophil count (ANC) >= 1500/mm^3 (1.5 x 10^9/L)
- Platelet count >= 100,000/mm^3 (100 x 10^9/L)
- Creatinine clearance >= 30 ml/min calculated using the Cockcroft-Gault formula
- Total serum bilirubin =< 1.5 upper limit of normal (ULN) (< 3 ULN if Gilbert's
disease)
- Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) =< 3 x ULN (=<
5.0 x ULN if liver metastases present)
- Alkaline phosphatase =< 2.5 x ULN (=< 5 x ULN if bone or liver metastases present)
We found this trial at
252
sites
200 Hemlock
Tawas City, Michigan 48764
Tawas City, Michigan 48764
Principal Investigator: Elie G. Dib
Phone: 734-712-3671
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
Albuquerque, New Mexico 87131
(505) 272-4946
Principal Investigator: Ursa A. Brown-Glaberman
Phone: 505-925-0366
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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2545 Schoenersville Rd
Bethlehem, Pennsylvania 18017
Bethlehem, Pennsylvania 18017
(484) 884-2200
Principal Investigator: Elie G. Dib
Phone: 734-712-3671
Lehigh Valley Hospital - Muhlenberg At Lehigh Valley Health Network, we continually go the extra...
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666 Elm Street
Buffalo, New York 14263
Buffalo, New York 14263
(716) 845-2300
Principal Investigator: Tracey L. O'Connor
Phone: 800-767-9355
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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1 Hurley Plaza
Flint, Michigan 48503
Flint, Michigan 48503
(810) 262-9000
Principal Investigator: Elie G. Dib
Phone: 734-712-3671
Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
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4805 Northeast Glisan Street
Portland, Oregon 97213
Portland, Oregon 97213
(503) 215-1111
Principal Investigator: Alison K. Conlin
Phone: 503-215-2614
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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Seattle, Washington 98104
Principal Investigator: Alison K. Conlin
Phone: 206-215-3086
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Aberdeen, Washington 98520
Principal Investigator: Alison K. Conlin
Phone: 360-412-8958
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Adrian, Michigan 49221
Principal Investigator: Rex B. Mowat
Phone: 517-265-0116
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Albuquerque, New Mexico 87102
Principal Investigator: Ursa A. Brown-Glaberman
Phone: 505-272-0530
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Albuquerque, New Mexico 87110
Principal Investigator: Ursa A. Brown-Glaberman
Phone: 505-559-6113
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Allentown, Pennsylvania 18103
Principal Investigator: Elie G. Dib
Phone: 734-712-3671
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Ames, Iowa 50010
Principal Investigator: Joseph J. Merchant
Phone: 515-956-4132
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Ames, Iowa 50010
Principal Investigator: Joseph J. Merchant
Phone: 515-956-4132
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Anchorage, Alaska 98508
Principal Investigator: Alison K. Conlin
Phone: 907-212-6871
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Anchorage, Alaska 99504
Principal Investigator: Alison K. Conlin
Phone: 907-212-6871
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Anchorage, Alaska 99508
Principal Investigator: Alison K. Conlin
Phone: 907-212-6871
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Anchorage, Alaska 99508
Principal Investigator: Alison K. Conlin
Phone: 907-212-6871
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Anchorage, Alaska 99508
Principal Investigator: Alison K. Conlin
Phone: 773-702-9171
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Anchorage, Alaska 99508
Principal Investigator: Alison K. Conlin
Phone: 907-212-6871
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Anchorage, Alaska 99508
Principal Investigator: Alison K. Conlin
Phone: 907-212-6871
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Anchorage, Alaska 99508
Principal Investigator: Alison K. Conlin
Phone: 907-212-6871
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5301 McAuley Drive
Ann Arbor, Michigan 48197
Ann Arbor, Michigan 48197
734-712-3456
Principal Investigator: Elie G. Dib
Phone: 734-712-3671
Saint Joseph Mercy Hospital St. Joseph Mercy Ann Arbor Hospital is a 537-bed teaching hospital...
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Auburn, New York 13021
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Phone: 315-472-7504
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2000 Ogden Ave
Aurora, Illinois 60504
Aurora, Illinois 60504
(630) 978-6200
Principal Investigator: Pratima Chalasani
Phone: 630-978-6212
Rush - Copley Medical Center Rush-Copley is proud to be the leading provider of health...
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3325 Pocahontas Road
Baker City, Oregon 97814
Baker City, Oregon 97814
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Phone: 734-712-3671
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Ballwin, Missouri 63011
Principal Investigator: Jay W. Carlson
Phone: 314-251-7058
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489 State St
Bangor, Maine 04401
Bangor, Maine 04401
(207) 973-7000
Principal Investigator: Thomas H. Openshaw
Phone: 207-973-4274
Eastern Maine Medical Center Located in Bangor, Eastern Maine Medical Center (EMMC) serves communities throughout...
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440 East Main Street
Bay Shore, New York 11706
Bay Shore, New York 11706
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Phone: 516-734-8896
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Bellingham, Washington 98225
Principal Investigator: Alison K. Conlin
Phone: 360-715-4133
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Bemidji, Minnesota 56601
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Phone: 218-333-5000
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Bend, Oregon 97701
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Phone: 541-706-2909
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300 N. Seventh St.
Bismarck, North Dakota 58501
Bismarck, North Dakota 58501
(701) 323-6000
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Phone: 701-323-5760
Sanford Bismarck Medical Center Whether your stay in our hospital is one day for same...
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1505 Eastland Drive
Bloomington, Illinois 61701
Bloomington, Illinois 61701
309-662-2102
Principal Investigator: Bryan A. Faller
Phone: 309-243-3605
Illinois CancerCare-Bloomington Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood diseases. Our...
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100 E Idaho St
Boise, Idaho 83712
Boise, Idaho 83712
(208) 381-2711
Principal Investigator: Alison K. Conlin
Phone: 773-702-9171
Saint Luke's Mountain States Tumor Institute For more than 100 years, St. Luke
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Boise, Idaho 83706
Principal Investigator: Benjamin T. Marchello
Phone: 734-712-3671
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Bonne Terre, Missouri 63628
Principal Investigator: Bryan A. Faller
Phone: 314-996-5569
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Boone, Iowa 50036
Principal Investigator: Joseph J. Merchant
Phone: 515-956-4132
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450 Brookline Ave
Boston, Massachusetts 2215
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Rachel A. Freedman
Phone: 877-442-3324
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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915 Highland Blvd
Bozeman, Montana 59715
Bozeman, Montana 59715
(406) 414-5000
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
Bozeman Deaconess Hospital Bozeman Deaconess Hospital is a Joint Commission certified, licensed Level III trauma...
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Brewer, Maine 04412
Principal Investigator: Thomas H. Openshaw
Phone: 800-987-3005
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7575 Grand River Avenue
Brighton, Michigan 48114
Brighton, Michigan 48114
Principal Investigator: Elie G. Dib
Phone: 734-712-3671
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7575 Grand River Avenue
Brighton, Michigan 48114
Brighton, Michigan 48114
Principal Investigator: Elie G. Dib
Phone: 734-712-3671
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Bronx, New York 10461
Principal Investigator: Jesus D. Anampa Mesias
Phone: 718-379-6866
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Bronx, New York 10461
Principal Investigator: Jesus D. Anampa Mesias
Phone: 718-379-6866
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Bronx, New York 10467
Principal Investigator: Jesus D. Anampa Mesias
Phone: 718-379-6866
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Burbank, California
Principal Investigator: Alison K. Conlin
Phone: 818-847-4793
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201 E Nicollet Blvd
Burnsville, Minnesota 55337
Burnsville, Minnesota 55337
(952) 892-2000
Principal Investigator: Daniel M. Anderson
Phone: 952-993-1517
Fairview Ridges Hospital Fairview Ridges Hospital is a 150-bed, Level III Trauma Care facility, offering...
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3123 Medical Dr
Caldwell, Idaho 83605
Caldwell, Idaho 83605
Principal Investigator: Benjamin T. Marchello
Phone: 734-712-3671
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210 W Walnut St
Canton, Illinois 61520
Canton, Illinois 61520
309-647-5240
Principal Investigator: Bryan A. Faller
Phone: 309-243-3605
Illinois CancerCare - Canton Illinois CancerCare is one of the largest private oncology and hematology...
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1600 South Canton Center Road
Canton, Michigan 48188
Canton, Michigan 48188
Principal Investigator: Elie G. Dib
Phone: 734-712-3671
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1600 South Canton Center Road
Canton, Michigan 48188
Canton, Michigan 48188
Principal Investigator: Elie G. Dib
Phone: 734-712-3671
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211 Saint Francis Drive
Cape Girardeau, Missouri 63703
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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401 North Hooper Street
Caro, Michigan 48723
Caro, Michigan 48723
Principal Investigator: Elie G. Dib
Phone: 734-712-3671
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160 S Adams St
Carthage, Illinois 62321
Carthage, Illinois 62321
(217) 357-6877
Principal Investigator: Bryan A. Faller
Phone: 309-243-3605
Illinois CancerCare - Carthage Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood...
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Cedar Rapids, Iowa 52403
Principal Investigator: Deborah W. Wilbur
Phone: 319-365-4673
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Cedar Rapids, Iowa 52403
Principal Investigator: Deborah W. Wilbur
Phone: 319-363-2690
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Centralia, Illinois 62801
Principal Investigator: Bryan A. Faller
Phone: 217-876-4740
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Centralia, Washington 98531
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Phone: 360-412-8958
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Chadds Ford, Pennsylvania 19317
Principal Investigator: Gregory A. Masters
Phone: 302-623-4450
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Chapel Hill, North Carolina 27599
Principal Investigator: Trevor A. Jolly
Phone: 877-668-0683
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14650 East Old US Highway 12
Chelsea, Michigan 48118
Chelsea, Michigan 48118
Principal Investigator: Elie G. Dib
Phone: 734-712-3671
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775 South Main Street
Chelsea, Michigan 48118
Chelsea, Michigan 48118
Principal Investigator: Elie G. Dib
Phone: 734-712-3671
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5841 S Maryland Ave
Chicago, Illinois 60637
Chicago, Illinois 60637
1-773-702-6180
Principal Investigator: Olwen M. Hahn
Phone: 773-702-8222
University of Chicago Comprehensive Cancer Center The University of Chicago Comprehensive Cancer Center (UCCCC) is...
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9280 SE Sunnybrook Blvd #100
Clackamas, Oregon 97015
Clackamas, Oregon 97015
(503) 513-3300
Principal Investigator: Alison K. Conlin
Phone: 503-215-2614
Clackamas Radiation Oncology Center State-of-the-art technology and compassionate care come together at Clackamas Radiation Oncology...
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Clackamas, Oregon 97015
Principal Investigator: Alison K. Conlin
Phone: 503-215-2614
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4050 Coon Rapids Blvd NW
Coon Rapids, Minnesota 55433
Coon Rapids, Minnesota 55433
(763) 236-6000
Principal Investigator: Daniel M. Anderson
Phone: 952-993-1517
Mercy Hospital Mercy Hospital, located in Coon Rapids, Minnesota, is a 271-bed non-profit hospital that...
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Coos Bay, Oregon 97420
Principal Investigator: Alison K. Conlin
Phone: 541-269-8392
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10 Barnes West Drive
Creve Coeur, Missouri 63141
Creve Coeur, Missouri 63141
Principal Investigator: Lindsay L. Peterson
Phone: 800-600-3606
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Danville, Illinois 61832
Principal Investigator: Pratima Chalasani
Phone: 800-446-5532
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100 North Academy Avenue
Danville, Pennsylvania 17822
Danville, Pennsylvania 17822
570-271-6211
Principal Investigator: Victor G. Vogel
Phone: 570-271-5251
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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210 West McKinley Avenue
Decatur, Illinois 62526
Decatur, Illinois 62526
Principal Investigator: Bryan A. Faller
Phone: 217-876-4740
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2300 N Edward St
Decatur, Illinois 62526
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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Des Moines, Iowa 50309
Principal Investigator: Robert J. Behrens
Phone: 515-282-2921
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Des Moines, Iowa 50314
Principal Investigator: Robert J. Behrens
Phone: 515-282-2200
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1200 Pleasant St
Des Moines, Iowa 50309
Des Moines, Iowa 50309
(515) 241-6212
Principal Investigator: Robert J. Behrens
Phone: 515-241-6727
Iowa Methodist Medical Center Iowa Methodist Medical Center was established in 1901 in a single...
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700 E University Ave
Des Moines, Iowa 50316
Des Moines, Iowa 50316
(515) 263-5612
Principal Investigator: Robert J. Behrens
Phone: 515-241-8704
Iowa Lutheran Hospital Iowa Lutheran Hospital has a long history of serving the Des Moines...
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Detroit, Michigan 48236
Principal Investigator: Elie G. Dib
Phone: 734-712-3671
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17900 23 Mile Road
East China Township, Michigan 48054
East China Township, Michigan 48054
Principal Investigator: Elie G. Dib
Phone: 734-712-3671
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East Stroudsburg, Pennsylvania 18301
Principal Investigator: Elie G. Dib
Phone: 570-422-1700
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East Syracuse, New York 13057
Principal Investigator: Jeffrey J. Kirshner
Phone: 315-472-7504
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6401 France Ave S
Edina, Minnesota 55435
Edina, Minnesota 55435
(952) 924-5000
Principal Investigator: Daniel M. Anderson
Phone: 952-993-1517
Fairview Southdale Hospital Fairview Health Services is an award-winning nonprofit health care system based in...
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Edmonds, Washington 98026
Principal Investigator: Alison K. Conlin
Phone: 206-215-3086
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Effingham, Illinois 62401
Principal Investigator: Bryan A. Faller
Phone: 217-876-4740
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Effingham, Illinois 62401
Principal Investigator: Pratima Chalasani
Phone: 800-446-5532
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1202 East Locust Street
Emmett, Idaho 83617
Emmett, Idaho 83617
Principal Investigator: Benjamin T. Marchello
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Ephrata, Pennsylvania 17522
Principal Investigator: Dan Sotirescu
Phone: 717-721-4840
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Ephrata, Pennsylvania 17522
Principal Investigator: Dan Sotirescu
Phone: 773-702-9171
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101 S Major St
Eureka, Illinois 61530
Eureka, Illinois 61530
309-467-2371
Principal Investigator: Bryan A. Faller
Phone: 309-243-3605
Illinois CancerCare - Eureka Illinois CancerCare is one of the largest private oncology and hematology...
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1717 13th St
Everett, Washington 98201
Everett, Washington 98201
(425) 297-5500
Principal Investigator: Alison K. Conlin
Phone: 425-261-3529
Providence Regional Cancer Partnership Founded in 2007, the Providence Regional Cancer Partnership is the result...
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1720 South University Drive
Fargo, North Dakota 58103
Fargo, North Dakota 58103
Principal Investigator: Preston D. Steen
Phone: 701-234-6161
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801 Broadway North
Fargo, North Dakota 58122
Fargo, North Dakota 58122
Principal Investigator: Preston D. Steen
Phone: 800-437-4010
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801 Broadway
Fargo, North Dakota 58102
Fargo, North Dakota 58102
(701) 234-6175
Principal Investigator: Preston D. Steen
Phone: 800-437-4010
Sanford Medical Center-Fargo Sanford Medical Center Fargo is a major medical center that provides comprehensive,...
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820 4th St N
Fargo, North Dakota 58102
Fargo, North Dakota 58102
(701) 234-6161
Principal Investigator: Preston D. Steen
Phone: 701-234-6161
Roger Maris Cancer Center Sanford Health is an integrated health system headquartered in the Dakotas...
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165 North University Avenue
Farmington, Utah 84025
Farmington, Utah 84025
Principal Investigator: Elizabeth M. Prystas
Phone: 888-424-2100
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Flint, Michigan 48503
Principal Investigator: Elie G. Dib
Phone: 734-712-3671
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302 Kensington Avenue
Flint, Michigan 48503
Flint, Michigan 48503
Principal Investigator: Elie G. Dib
Phone: 734-712-3671
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302 Kensington Ave
Flint, Michigan 48503
Flint, Michigan 48503
(810) 762-8490
Principal Investigator: Elie G. Dib
Phone: 734-712-3671
Genesys Hurley Cancer Institute Bringing the most advanced cancer treatment services, technologies and programs available...
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Fort Dodge, Iowa 50501
Principal Investigator: Joseph J. Merchant
Phone: 515-956-4132
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802 Kenyon Road
Fort Dodge, Iowa 50501
Fort Dodge, Iowa 50501
Principal Investigator: Robert J. Behrens
Phone: 515-574-8302
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550 Osborne Rd NE
Fridley, Minnesota 55432
Fridley, Minnesota 55432
(763) 236-5000
Principal Investigator: Daniel M. Anderson
Phone: 952-993-1517
Unity Hospital Unity Hospital is one of the Twin Cities
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