Pembrolizumab in Treating Patients With Triple-Negative 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:4/6/2019
Start Date:November 15, 2016

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A Randomized, Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer With ≥ 1 CM Residual Invasive Cancer or Positive Lymph Nodes (ypN+) After Neoadjuvant Chemotherapy

This randomized phase III trial studies how well pembrolizumab works in treating patients
with triple-negative breast cancer. Monoclonal antibodies, such as pembrolizumab, may
interfere with the ability of tumor cells to grow and spread.

PRIMARY OBJECTIVES:

I. To compare invasive disease-free survival (IDFS) of patients with triple-negative breast
cancer (TNBC) who have either >= 1 cm residual invasive breast cancer and/or positive lymph
nodes (> ypN+) after neoadjuvant chemotherapy randomized to receive 1 year of MK-3475
(pembrolizumab) adjuvant therapy compared to no MK-3475 (pembrolizumab), in both the entire
study population and also in the PD-L1 positive subset.

SECONDARY OBJECTIVES:

I. To compare the effects of MK-3475 (pembrolizumab) on overall survival (OS) and distant
recurrence-free survival (DRFS) between the two randomized arms for the PD-L1 positive
patients and then all patients.

II. To assess the toxicity and tolerability of MK-3475 (pembrolizumab) in this patient
population with or without radiation therapy.

TERTIARY OBJECTIVES:

I. To examine the association between biomarkers of inflammation and quality of life and
patient reported outcomes between the two groups during and at the end of therapy.

II. To examine the long-term and late effects of treatment on patient-reported outcomes.

III. To collect tissue and whole blood for processing and banking in anticipation of future
correlative studies in this patient population.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (OBSERVATION): Patients receive no treatment but are monitored at standard clinical
intervals during first year after randomization. Patients are examined every 12 weeks for 1
year, and every 6 months for 4 years, then annually for 5 years.

ARM II (PEMROLIZUMAB): Patients receive pembrolizumab intravenously (IV) over 30 minutes on
days 1 and 22. Courses repeat every 42 days for 52 weeks in the absence of disease
progression or unacceptable toxicity.

All patients may undergo radiation therapy within 12 weeks of last breast cancer operation or
after treatment.

After completion of study treatment, patients are followed up to 10 years.

Inclusion Criteria:

- STEP 1 REGISTRATION

- Patients must have histologically confirmed estrogen receptor (ER)-, progesterone
receptor (PR)- and HER2-negative (triple-negative, TNBC) or ER, PR, and HER2 equivocal
status and must not have received and not be planning to receive adjuvant anti-HER2 or
endocrine therapies after completion of neoadjuvant chemotherapy; patients who are
HER2 positive by American Society of Clinical Oncology (ASCO) College of American
Pathologists (CAP) guidelines are ineligible; HER2 negative and HER2 equivocal cases
as per ASCO CAP guidelines that do not receive HER2-targeted therapy are eligible;
patients with weekly ER or PR positive disease, defined as ER and/or PR < 5% by
immunohistochemistry, are eligible if the treating physician considers the patient not
eligible for adjuvant endocrine therapy; residual disease must be >= 1 cm in greatest
dimension, and/or have positive lymph nodes (ypN+) observed on pathologic exam

- NOTE: Immunohistochemistry (IHC)-positive isolated tumor cells in the lymph node
(N0 [i+]) are not considered node-positive and these patients also must have >= 1
cm residual invasive cancer in the breast in order to be eligible

- Patients must not have metastatic disease (i.e., must be M0); patients must not have
locally recurrent disease

- It is preferred that axillary lymph node sampling is performed after completion of
neoadjuvant chemotherapy to allow more accurate assessment of pathologic response;
patients must have a complete axillary lymph node dissection after neoadjuvant
chemotherapy in the following situations (exceptions will be granted for patients
participating in the Alliance A11202 trial):

- Patients had documented pathologic involvement of the axillary nodes (fine needle
aspiration [FNA] or core biopsy) before neoadjuvant chemotherapy and had sentinel
node biopsy after neoadjuvant chemotherapy with positive sentinel node(s)

- Patient had documented pathologic involvement of the axillary nodes (FNA or core
biopsy) before neoadjuvant chemotherapy and had only 1 sentinel lymph node
removed after neoadjuvant chemotherapy

- NOTE: Patients who undergo sentinel node biopsy before starting neoadjuvant
treatment and do not undergo post neoadjuvant assessment of the axillary
nodes or who have negative axillary nodes on post neoadjuvant assessment
must have >= 1 cm residual invasive cancer in the breast after completion of
neoadjuvant chemotherapy

- Patients must have a minimum of five, available unstained slides from the residual
(post-neoadjuvant) invasive tumor in primary site or lymph node; (these will be
submitted to determine PD-L1 expression) the tumor tissue must be adequate for PD-L1
testing, which typically requires a minimum of 100 cancer cells per slide

- NOTE: Initial order for specimen kits should be placed at least two weeks prior
to registering the first patient at each site

- Patients must be offered the opportunity to participate in specimen banking

- Patients must have had neoadjuvant chemotherapy followed by surgery; the recommended
neoadjuvant treatment should include 16-24 weeks of a third generation chemotherapy
regimen as recommended by National Comprehensive Cancer Network (NCCN) guidelines for
triple negative breast cancer (examples include dose dense adriamycin-cytoxan [AC]
followed by dose-dense paclitaxel; weekly paclitaxel x 12 followed or preceded by
cyclophosphamide-adriamycin-fluorouracil [FAC], fluorouracil-epirubicin-cytoxan [FEC],
AC or dose dense AC; docetaxel either followed or preceded by FEC/FAC or AC;
carboplatin-containing neoadjuvant chemotherapy is also allowed); patients who cannot
complete all planned treatment cycles for any reason are considered high risk and
therefore are eligible for the study if they have residual disease; patients must have
resolution of adverse event(s) of the most recent prior chemotherapy to grade 1 or
less, except alopecia and =< grade 2 neuropathy which are allowed

- Patients may receive post-operative (adjuvant) chemotherapy for up to 24 weeks of
duration (e.g. 8 cycles of capecitabine as in the CREATE-X trial) after completion of
surgery at the discretion of the treating physician; patients must have resolution of
adverse event(s) of the most recent prior chemotherapy to grade 1 or less, except
alopecia and =< grade 2 neuropathy which are allowed; patients that have received
adjuvant chemotherapy must be registered to screening within 35 days after completing
treatment

- Patients must have completed their final breast surgery (rendering them free from
disease) with clear resection margins for invasive cancer and DCIS within the
following timelines:

- 90 days prior to screening registration for patients not receiving post-operative
(adjuvant) chemotherapy OR

- 270 days prior to screening registration for patients who have received
post-operative (adjuvant) chemotherapy Patients who receive postoperative
chemotherapy may receive radiation therapy before or after the chemotherapy; a
short course of reduced dose chemotherapy concomitant with radiation for
radiation sensitization is not considered to be adjuvant chemotherapy; positive
margins are allowed only if the surgical team of the patient deems further
resection impossible

- Patients for whom radiation therapy (RT) to the affected breast or chest wall and
regional nodal areas is clinically indicated as per NCCN treatment guidelines, should
receive RT after randomization when possible, and receive MK-3475 (pembrolizumab)
concurrent with RT, if randomized to the experimental arm; however, RT administered,
or initiated, prior to registration is also allowed; pembrolizumab may be added to
ongoing radiation, or started after its completion, if randomized to the experimental
arm, provided there are no > grade 2 radiation-related skin toxicities; patients who
have not yet started radiation must specify at the time of screening registration
whether or not they will receive RT and the extent of intended RT

- Patients must not have had prior immunotherapy with anti-PD-L1, anti-PD-1, anti-CTLA4
or similar drugs; patients must not be planning to receive any of the prohibited
therapies during the screening or treatment phases of the study

- Patients must not be planning to receive concomitantly other biologic therapy,
hormonal therapy, other chemotherapy, surgery or other anti-cancer therapy except
radiation therapy while receiving treatment on this protocol; however, patients
receiving extended adjuvant endocrine therapy for an earlier ER positive breast cancer
treated with curative intent and without recurrence for at least 5 years may continue
with their endocrine therapy

- Patients must have Zubrod performance status =< 2

- Patients must not have a history of (non-infectious) pneumonitis that required
steroids or evidence of active pneumonitis

- Patients must not have an active infection requiring systemic therapy

- Patients must not have active autoimmune disease that has required systemic treatment
in past 2 years (i.e., with use of disease modifying agents, corticosteroids or
immunosuppressive drugs); replacement therapy (e.g., thyroxine, insulin, or
physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency,
etc.) is not considered a form of systemic treatment

- Patients must not have received live vaccines within 30 days prior to registration;
examples of live vaccines include, but are not limited to, the following: measles,
mumps, rubella, chicken pox, shingles, yellow fever, rabies, Bacillus Calmette-Guerin
(BCG), and typhoid (oral) vaccine; seasonal influenza vaccines for injection are
generally killed virus vaccines and are allowed; however, intranasal influenza
vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed

- Patients must not have known active hepatitis B virus (HBV) or hepatitis C virus (HCV)
infection prior to registration; patients who have completed curative therapy for HCV
are eligible; patients with known human immunodeficiency virus (HIV) infection are
eligible if they meet each of the following 3 criteria:

- CD4 counts >= 350 mm^3

- Serum HIV viral load of < 25,000 IU/ml and

- Treated on a stable antiretroviral regimen

- No other prior invasive malignancy is allowed except for the following: adequately
treated basal (or squamous cell) skin cancer, in situ breast or cervical cancer; stage
I or II invasive cancer treated with a curative intent without evidence of disease
recurrence for at least five years

- Patients must have complete history and physical examination within 28 days prior to
registration

- Patients must be informed of the investigational nature of this study and must sign
and give written informed consent for this protocol in accordance with institutional
and federal guidelines

- As a part of the Oncology Patient Enrollment Network (OPEN) registration process the
treating institution's identity is provided in order to ensure that the current
(within 365 days) date of institutional review board approval for this study has been
entered in the system

- STEP 2 REGISTRATION

- Patients must not be registered to step 2 until receiving confirmation from the
Southwest Oncology Group (SWOG) Statistical Center that the patient's tissue specimen
was adequate for PD-L1 testing; patients must be registered within 7 days of receiving
the e-mail notification confirming submission was evaluable for PD-L1 status

- Absolute neutrophil count (ANC) >= 1,500 microliter (mcL), obtained within 28 days
prior to step 2 registration

- Platelets >= 100,000/mcL, obtained within 28 days prior to step 2 registration

- Hemoglobin >= 9 g/dL, obtained within 28 days prior to step 2 registration

- A serum thyroid-stimulating hormone (TSH) must be obtained within 28 days prior to
step 2 registration to obtain a baseline value

- Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (except Gilbert's
syndrome, who must have a total bilirubin < 3.0 mg/dL), obtained within 28 days prior
to step 2 registration

- Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or
serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 2.5 x
IULN, obtained within 28 days prior to step 2 registration

- Alkaline phosphatase =< 2.5 x IULN, obtained within 28 days prior to step 2
registration

- Serum creatinine =< IULN OR measured or calculated creatinine clearance >= 60 mL/min,
obtained within 28 days prior to step 2 registration

- Women of childbearing potential must have a negative urine or serum pregnancy test
within 28 day prior to registration; women/men of reproductive potential must have
agreed to use an effective contraceptive method for the course of the study through
120 days after the last dose of study medication; should a woman become pregnant or
suspect she is pregnant while she or her partner is participating in this study, she
should inform her treating physician immediately; a woman is considered to be of
"reproductive potential" if she has had menses at any time in the preceding 12
consecutive months; in addition to routine contraceptive methods, "effective
contraception" also includes heterosexual celibacy and surgery intended to prevent
pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy,
bilateral oophorectomy, bilateral tubal ligation, or vasectomy; however, if at any
point a previously celibate patient chooses to become heterosexually active during the
time period for use of contraceptive measures outlined in the protocol, he/she is
responsible for beginning contraceptive measures; patients must not be pregnant or
nursing

- Site must verify that there is no known change in the step 1 eligibility since initial
registration
We found this trial at
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Lake Charles, Louisiana 70601
Principal Investigator: John T. Cole
Phone: 504-842-3708
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
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361 Old Belgrade Road
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666 Elm Street
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1500 E Duarte Rd
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1 Hurley Plaza
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200 North Park Street
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529 West Markham Street
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3181 Southwest Sam Jackson Park Road
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503 494-8311
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Phone: 503-494-1080
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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4805 Northeast Glisan Street
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Phone: 503-215-2614
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401 College Street
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60 Crittenden Blvd # 70
Rochester, New York 14642
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University of Rochester The University of Rochester is one of the country's top-tier research universities....
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1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
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825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
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Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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3900 W Avera Drive
Sioux Falls, South Dakota 57108
(605) 322-4700
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Phone: 888-634-7268
Avera Cancer Institute Avera, the health ministry of the Benedictine and Presentation Sisters, is a...
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1200 Old York Road
Abington, Pennsylvania 19001
(215) 481–2000
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Phone: 215-481-2402
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Albany, Georgia 31701
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Albemarle, North Carolina 28002
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Albuquerque, New Mexico 87109
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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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Albuquerque, New Mexico 87102
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Ames, Iowa 50010
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Phone: 515-956-4132
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Ames, Iowa 50010
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Anaconda, Montana 59711
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
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Anaheim, California 92806
Principal Investigator: Jonathan A. Polikoff
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Anchorage, Alaska 99508
Principal Investigator: Gary E. Goodman
Phone: 907-212-6871
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Anchorage, Alaska 99508
Principal Investigator: Gary E. Goodman
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Anchorage, Alaska 99508
Principal Investigator: Gary E. Goodman
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Anchorage, Alaska 99508
Principal Investigator: Gary E. Goodman
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2000 E Greenville St
Anderson, South Carolina 29621
(864) 512-4640
Principal Investigator: John E. Doster
Phone: 864-512-4651
AnMedical Health Cancer Center Cancer is the general term for a group of more than...
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
Principal Investigator: Anne F. Schott
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5301 McAuley Drive
Ann Arbor, Michigan 48197
734-712-3456
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Phone: 734-712-3671
Saint Joseph Mercy Hospital St. Joseph Mercy Ann Arbor Hospital is a 537-bed teaching hospital...
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Annapolis, Maryland 21401
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Antigo, Wisconsin 54409
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Antioch, California 94531
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Arlington Heights, Illinois 60005
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921 North Oak Park Boulevard
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364 White Oak St
Asheboro, North Carolina 27203
(336) 625-5151
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Asheville, North Carolina 28816
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Asheville, North Carolina 28801
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1000 Johnson Ferry Rd NE
Atlanta, Georgia 30342
(404) 851-8000
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Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
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Auburn, California 95602
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Aurora, Colorado 80012
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12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
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2000 Ogden Ave
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Austin, Texas 78702
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1500 Red River Street
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Austin, Texas 78705
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3325 Pocahontas Road
Baker City, Oregon 97814
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Bakersfield, California 93301
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Baldwin Park, California 91706
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345 St Paul Pl
Baltimore, Maryland 21202
(410) 332-9000
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Baltimore, Maryland 21229
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Phone: 410-368-2910
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6701 N Charles St
Baltimore, Maryland 21204
(443) 849-2000
Principal Investigator: Robert B. Donegan
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Greater Baltimore Medical Center The 255-bed medical center (acute and sub-acute care) is located on...
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22 South Greene Street
Baltimore, Maryland 21201
410-328-7904
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Phone: 800-888-8823
University of Maryland Greenebaum Cancer Center The University of Maryland Marlene and Stewart Greenebaum Cancer...
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401 North Broadway
Baltimore, Maryland 21287
410-955-5000
Principal Investigator: Antonio C. Wolff
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489 State St
Bangor, Maine 04401
(207) 973-7000
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4305 New Shepherdsville Road
Bardstown, Kentucky 40004
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Baton Rouge, Louisiana 70815
Principal Investigator: David S. Hanson
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Baton Rouge, Louisiana 70806
Principal Investigator: Hana F. Safah
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Baton Rouge, Louisiana 70809
Principal Investigator: David S. Hanson
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Baton Rouge, Louisiana 70809
Principal Investigator: John T. Cole
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Baton Rouge, Louisiana 70809
Principal Investigator: David S. Hanson
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Baton Rouge, Louisiana 70805
Principal Investigator: David S. Hanson
Phone: 225-215-1353
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Baton Rouge, Louisiana 70816
Principal Investigator: John T. Cole
Phone: 225-761-5346
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4950 Essen Lane
Baton Rouge, Louisiana 70809
Principal Investigator: David S. Hanson
Phone: 225-757-0343
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Baton Rouge, LA
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265 Fremont St
Battle Creek, Michigan 49017
(269) 245-8166
Principal Investigator: Kathleen J. Yost
Phone: 616-391-1230
Bronson Battle Creek As a proud member of the Battle Creek community, we believe everyone...
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Battle Creek, MI
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Bayamon, 00959
Principal Investigator: Luis Baez-Diaz
Phone: 787-395-7085
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Bayamon,
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Beachwood, Ohio 44122
Principal Investigator: Aaron T. Gerds
Phone: 866-223-8100
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Beachwood, OH
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Beachwood, Ohio 44122
Principal Investigator: Joseph Baar
Phone: 800-641-2422
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Beachwood, OH
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Bel Air, Maryland 21014
Principal Investigator: Ashkan Bahrani
Phone: 443-643-3010
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Bel Air, MD
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118 Northport Avenue
Belfast, Maine 04915
Principal Investigator: Peter Rubin
Phone: 207-338-2500
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Belfast, ME
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Bellflower, California 90706
Principal Investigator: Jonathan A. Polikoff
Phone: 800-398-3996
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Bellflower, CA
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800 Farson Street
Belpre, Ohio 45714
(740) 401-0417
Principal Investigator: Timothy D. Moore
Phone: 800-523-3977
Strecker Cancer Center-Belpre The Memorial Health System's Strecker Cancer Center, Belpre combines the clinical expertise...
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Belpre, OH
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Bemidji, Minnesota 56601
Principal Investigator: Preston D. Steen
Phone: 218-333-5000
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Bemidji, MN
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Berkeley, California 94704
Principal Investigator: Ari D. Baron
Phone: 415-209-2686
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Berkeley, CA
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Berwyn, Illinois 60402
Principal Investigator: Irene Q. Ma
Phone: 708-783-0966
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Berwyn, IL
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Bettendorf, Iowa 52722
Principal Investigator: Mark W. Karwal
Phone: 563-355-7733
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Biddeford, Maine 04005
Principal Investigator: Peter Rubin
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Biddeford, ME
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Billings, Montana 59101
Principal Investigator: Benjamin T. Marchello
Phone: 800-996-2663
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Billings, MT
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Birmingham, Alabama 35233
Principal Investigator: Erica M. Stringer-Reasor
Phone: 205-934-0220
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Birmingham, AL
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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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1505 Eastland Drive
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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Bloomington, IL
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100 E Idaho St
Boise, Idaho 83712
(208) 381-2711
Principal Investigator: Gary E. Goodman
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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Bolivar, Missouri 65613
Principal Investigator: Rakesh Gaur
Phone: 800-328-6010
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Bolivar, MO
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Boone, Iowa 50036
Principal Investigator: Debra M. Prow
Phone: 515-956-4132
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Boston, Massachusetts 02118
Principal Investigator: Lauren J. Oshry
Phone: 617-638-8265
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Boulder, Colorado 80303
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
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915 Highland Blvd
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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Brainerd, Minnesota 56401
Principal Investigator: Bret E. Friday
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Bremerton, Washington 98310
Principal Investigator: Mehmet S. Copur
Phone: 308-398-6518
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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
Principal Investigator: Christopher M. Reynolds
Phone: 734-712-3671
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Brighton, MI
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7575 Grand River Avenue
Brighton, Michigan 48114
Principal Investigator: Christopher M. Reynolds
Phone: 734-712-3671
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Brighton, MI
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Bristol, Virginia 24201
Principal Investigator: Asheesh Shipstone
Phone: 423-578-8538
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Bronx, New York 10467
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 10461
Principal Investigator: Jesus D. Anampa Mesias
Phone: 718-379-6866
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