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Clinical Trials (PDQ®)

Clinical Trials (PDQ®)

Chemotherapy With or Without Trastuzumab After Surgery in Treating Women With Invasive Breast Cancer

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIBiomarker/Laboratory analysis, TreatmentActive18 and overNCINCI-2011-02572
CDR0000692574, NSABP B-47, U10CA012027, U10CA180868, NCT01275677

Trial Description

Summary

This randomized phase III clinical trial studies chemotherapy with or without trastuzumab after surgery to see how well they work in treating women with invasive breast cancer. 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 more than one drug (combination chemotherapy) and giving chemotherapy after surgery may kill more tumor cells. Monoclonal antibodies, such as trastuzumab, can block cancer growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether combination chemotherapy is more effective with trastuzumab in treating breast cancer.

Further Study Information

PRIMARY OBJECTIVES:

I. To determine whether the addition of trastuzumab to chemotherapy (TC or AC→WP) improves invasive disease-free survival (IDFS) in women with resected node-positive or high-risk node-negative breast cancer which is reported as human epidermal growth factor receptor (HER)2-low by all HER2 testing performed.

SECONDARY OBJECTIVES:

I. To determine whether the addition of trastuzumab to chemotherapy (TC or AC→WP) improves disease-free survival (DFS)-ductal carcinoma in situ (DCIS) in women with resected node-positive or high-risk node-negative breast cancer which is reported as HER2-low by all HER2 testing performed.

II. To determine whether the addition of trastuzumab to chemotherapy (TC or AC→WP) improves breast cancer-free survival (BCFS) in women with resected node-positive or high-risk node-negative breast cancer which is reported as HER2-low by all HER2 testing performed.

III. To determine whether the addition of trastuzumab to chemotherapy (TC or AC→WP) improves recurrence-free interval (RFI) in women with resected node-positive or high-risk node-negative breast cancer which is reported as HER2-low by all HER2 testing performed.

IV. To determine whether the addition of trastuzumab to chemotherapy (TC or AC→WP) improves distant recurrence-free interval (DRFI) in women with resected node-positive or high-risk node-negative breast cancer which is reported as HER2-low by all HER2 testing performed.

V. To determine whether the addition of trastuzumab to chemotherapy (TC or AC→WP) improves overall survival (OS) in women with resected node-positive or high-risk node-negative breast cancer which is reported as HER2-low by all HER2 testing performed.

VI. To evaluate the associations between amenorrhea and circulating reproductive hormone levels, and the associations between chemotherapy regimen, amenorrhea, and IDFS benefit in premenopausal women eligible at baseline for the menstrual history assessments.

VII. To evaluate the toxicity associated with each of the regimens. VIII. To test the hypothesis that the HER2 messenger ribonucleic acid (mRNA) level is the predictor of the degree of benefit from trastuzumab and the threshold for benefit in the adjuvant setting is lower than defined by current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) Guidelines for HER2 assays (immunohistochemistry [IHC] and fluorescent in situ hybridization [FISH]).

IX. To identify and/or validate molecular predictors of the degree of benefit from the addition of trastuzumab to chemotherapy (TC or AC→WP).

X. To test the alternative hypothesis that the main determinant of trastuzumab response in the adjuvant setting of HER2-low breast cancer is through antibody-dependent cellular cytotoxicity (ADCC) by demonstrating that the polymorphism of the Fcgamma receptor gene is predictive of the degree of benefit from the addition of trastuzumab to chemotherapy (TC or AC→WP).

XI. To examine the relationship between behavioral host factors (obesity, tobacco, alcohol) and comorbid conditions that may influence systemic inflammation and breast cancer outcomes, controlling for tumor/stage characteristics and treatment assignment.

XII. To examine the relationship between medication exposures that may influence systemic inflammation and breast cancer outcomes, controlling for tumor/stage characteristics and treatment assignment.

XIII. To examine the relationship between comorbid conditions, medication exposures, and behavioral host factors together and breast cancer outcomes, controlling for tumor/stage characteristics and treatment assignment.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

NOTE: *Chemotherapy regimen is based on the investigator's preference.

ARM I:

GROUP A: Patients receive docetaxel intravenously (IV) over 60 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 6 courses.

GROUP B: Patients receive doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1.

Treatment repeats every 2 or 3 weeks (at the investigator's discretion) for 4 courses. Patients then receive paclitaxel IV over 60 minutes once weekly for 12 doses.

ARM II:

GROUP A: Patients receive chemotherapy as in Arm IA. Patients also receive trastuzumab IV over 30-90 minutes on day 1. Trastuzumab treatment repeats every 3 weeks for 51 weeks.

GROUP B: Patients receive chemotherapy as in Arm IB. Patients also receive paclitaxel IV over 60 minutes weekly and trastuzumab IV over 30-90 minutes weekly for 12 doses. After completion of paclitaxel, patients receive trastuzumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for 13 courses.

After completion of study treatment, patients are followed up every 6 months for 5 years and then every 12 months for 5 years.

Eligibility Criteria

Inclusion Criteria:

  • Patients should have a life expectancy of at least 10 years, excluding their diagnosis of breast cancer; (comorbid conditions should be taken into consideration, but not the diagnosis of breast cancer)
  • Women of reproductive potential must agree to use an effective non-hormonal method of contraception (for example condoms, some intrauterine devices, diaphragms, tubal ligation, vasectomized partner, or abstinence) during therapy and for at least 6 months after the last dose of study therapy (chemotherapy or trastuzumab)
  • Submission of tumor samples from the breast surgery is required for all patients; therefore, the local pathology department policy regarding release of tumor samples must be considered in the screening process; patients whose tumor samples are located in a pathology department that by policy will not submit any samples for research purposes should not be approached for participation in the B-47 trial
  • The patient must have signed and dated an Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines
  • Eastern Cooperation Oncology Group (ECOG) performance status of 0 or 1
  • The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination
  • All of the following staging criteria (according to the 7th edition of the American Joint Committee on Cancer [AJCC] Cancer Staging Manual) must be met:
  • By pathologic evaluation, primary tumor must be pT1-3
  • By pathologic evaluation, ipsilateral nodes must be pN0, pN1 (pN1mi, pN1a, pN1b, pN1c), pN2a, pN2b, pN3a, or pN3b
  • If pN0, one of the following criteria must be met:
  • pT2 and estrogen receptor (ER) negative and progesterone receptor (PgR) negative; or
  • pT2 and ER positive (PgR status may be positive or negative) and either grade 3 histology or Oncotype DX Recurrence Score of >= 25; or
  • pT3 regardless of hormone receptor status, histologic grade, and Oncotype DX Recurrence Score
  • HER2 status of the primary tumor must be evaluated prior to randomization; all testing performed must indicate that the tumor is HER2-low as defined below
  • IHC must be performed and the IHC staining results must indicate a score of 1+ (in situ hybridization [ISH] testing is not required) or 2+ (ISH must also be performed and must indicate that the tumor is HER2-low as described below)
  • If ISH testing is performed, test results must be as follows and IHC must be 1+ or 2+: the ratio of HER2 to chromosome enumeration probe 17 (CEP17) must be < 2.0 or, if a ratio was not performed, the HER2 gene copy number must be < 4 per nucleus
  • Note: If the IHC staining intensity is reported as a range, e.g., 0 to 1+ or 1+ to 2+, the higher intensity score in the range should be used to determine eligibility
  • The patient must have undergone either a total mastectomy or breast-conserving surgery (lumpectomy); (patients who have had a nipple-sparing mastectomy are eligible)
  • For patients who undergo lumpectomy, the margins of the resected specimen must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS) as determined by the local pathologist; if pathologic examination demonstrates tumor at the line of resection, additional operative procedures may be performed to obtain clear margins; if tumor is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible; (patients with margins positive for lobular carcinoma in situ [LCIS] are eligible without additional resection)
  • For patients who undergo mastectomy, margins must be free of gross residual tumor; (patients with microscopic positive margins are eligible as long as post-mastectomy radiation therapy [RT] of the chest wall will be administered)
  • The patient must have completed one of the procedures for evaluation of pathologic nodal status listed below:
  • Sentinel lymphadenectomy alone:
  • If pathologic nodal staging based on sentinel lymphadenectomy is pN0 or pN1b
  • If pathologic nodal staging based on sentinel lymphadenectomy is pN1mi or pN1a, the primary tumor must be T1 or T2 by pathologic evaluation and the nodal involvement must be limited to 1 or 2 positive nodes
  • Sentinel lymphadenectomy followed by removal of additional non-sentinel lymph nodes if the sentinel node (SN) is positive; or
  • Axillary lymphadenectomy with or without SN isolation procedures
  • The interval between the last surgery for breast cancer (treatment or staging) and randomization must be no more than 84 days
  • The patient must have ER analysis performed on the primary tumor prior to randomization; if ER analysis is negative, then PgR analysis must also be performed (either the core biopsy or surgical resection specimen can be used for ER/PgR testing); patients with a primary tumor that is hormone receptor-positive or receptor-negative are eligible
  • Absolute neutrophil count (ANC) must be >= 1,200/mm^3
  • Platelet count must be >= 100,000/mm^3
  • Hemoglobin must be >= 10 g/dL
  • Total bilirubin must be =< upper limit of normal (ULN) for the lab unless the patient has a bilirubin elevation > ULN to 1.5 x ULN due to Gilbert disease or similar syndrome involving slow conjugation of bilirubin
  • Alkaline phosphatase must be =< 2.5 x ULN for the lab
  • Aspartate aminotransferase (AST) must be =< 1.5 x ULN for the lab (if alanine aminotransferase [ALT] is performed instead of AST [per institution's standard practice], the alanine aminotransferase [ALT] value must be =< 1.5 x ULN; if both were performed, the AST must be =< 1.5 x ULN)
  • Alkaline phosphatase and AST may not both be > the ULN
  • Patients with AST or alkaline phosphatase > ULN are eligible for inclusion in the study if liver imaging (computed tomography [CT], magnetic resonance imaging [MRI], positron emission tomography [PET]-CT, or PET scan) performed within 90 days prior to randomization does not demonstrate metastatic disease and the above requirements are met
  • Patients with alkaline phosphatase that is > ULN but =< 2.5 x ULN or unexplained bone pain are eligible for inclusion in the study if a bone scan, PET-CT scan, or PET scan performed within 90 days prior to randomization does not demonstrate metastatic disease
  • The most recent postoperative serum creatinine performed within 6 weeks prior to randomization must be =< ULN for the lab
  • Left ventricular ejection fraction (LVEF) assessment must be performed within 90 days prior to randomization; LVEF assessment performed by 2-dimensional (D) echocardiogram is preferred, however, multi-gated acquisition (MUGA) scan maybe substituted based on institutional preferences
  • For patients who will receive the TC chemotherapy regimen, the LVEF must be >= 50% regardless of the cardiac imaging facility's lower limit of normal
  • For patients who will receive the AC-->WP chemotherapy regimen, the LVEF must be >= 55% regardless of the cardiac imaging facility's lower limit of normal
  • NOTE: Since the pre-entry LVEF serves as the baseline for comparing subsequent LVEF assessments, it is critical that this baseline study be an accurate assessment; if the baseline LVEF is > 70%, the investigator is encouraged to have the accuracy of the initial LVEF result confirmed and repeat the test if the accuracy is uncertain

Exclusion Criteria:

  • Primary tumor with any of the following HER2 testing results:
  • IHC staining intensity:
  • 0 on all evaluations of specimens
  • 3+ on evaluation of any specimen
  • ISH with a ratio of HER2 to CEP17 >= 2.0 on evaluation of any specimen
  • ISH result indicating HER2 gene copy number >= 4 per nucleus on evaluation of any specimen
  • T4 tumors including inflammatory breast cancer
  • Definitive clinical or radiologic evidence of metastatic disease
  • NOTE: Chest imaging (mandatory for all patients) and other imaging (if required) must have been performed within 90 days prior to randomization
  • Synchronous or previous contralateral invasive breast cancer (patients with synchronous and/or previous contralateral DCIS or LCIS are eligible)
  • Any previous history of ipsilateral invasive breast cancer or ipsilateral DCIS; (patients with synchronous or previous ipsilateral LCIS are eligible)
  • History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to randomization
  • Previous therapy with anthracyclines, taxanes, or trastuzumab for any malignancy
  • Chemotherapy or HER2-targeted therapy administered for the currently diagnosed breast cancer prior to randomization
  • Whole-breast RT prior to randomization or partial-breast RT that cannot be completed on or before the date of randomization
  • Continued endocrine therapy such as raloxifene or tamoxifen (or other selective estrogen receptor modulator [SERM]) or an aromatase inhibitor; patients are eligible if these medications are discontinued prior to randomization
  • Any continued use of sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy; patients are eligible if these medications are discontinued prior to randomization
  • Cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimens; this includes but is not confined to:
  • Active cardiac disease:
  • Angina pectoris that requires the current use of anti-anginal medication
  • Ventricular arrhythmias except for benign premature ventricular contractions
  • Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication
  • Conduction abnormality requiring a pacemaker
  • Valvular disease with documented compromise in cardiac function
  • Symptomatic pericarditis
  • History of cardiac disease:
  • Myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricle (LV) function
  • History of documented congestive heart failure (CHF)
  • Documented cardiomyopathy
  • Hypertension defined according to the following ineligibility criteria:
  • For patients who will receive TC (regardless of the patient's age): uncontrolled hypertension defined as sustained systolic blood pressure (BP) > 150 mm Hg or diastolic BP > 90 mm Hg; (patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria)
  • For patients < 50 years old who will receive AC-->WP: uncontrolled hypertension defined as sustained systolic BP > 150 mm Hg or diastolic BP > 90 mm Hg; patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria
  • For patients >= 50 years old who will receive AC-->WP:
  • Uncontrolled hypertension defined as sustained systolic BP > 150 mm Hg or diastolic BP > 90 mm Hg
  • Controlled hypertension (systolic BP =< 150 mm Hg and diastolic BP =< 90 mmHg), if anti-hypertensive medication(s) are needed
  • NOTE: Patients who are not eligible based on the AC-WP regimen BP criteria but who meet the TC regimen BP criteria are eligible for B-47, if the intended chemotherapy regimen is changed to TC
  • Active hepatitis B or hepatitis C with abnormal liver function tests
  • Intrinsic lung disease resulting in dyspnea
  • Poorly controlled diabetes mellitus
  • Active infection or chronic infection requiring chronic suppressive antibiotics
  • Nervous system disorder (paresthesia, peripheral motor neuropathy, or peripheral sensory neuropathy) >= grade 2, per the Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0
  • Conditions that would prohibit administration of corticosteroids
  • Chronic daily treatment with corticosteroids with a dose of >= 10 mg/day methylprednisol one equivalent (excluding inhaled steroids)
  • Known hypersensitivity to any of the study drugs or excipients, e.g., polysorbate 80 and Cremophor EL
  • Pregnancy or lactation at the time of study entry; (Note: pregnancy testing must be performed within 2 weeks prior to randomization according to institutional standards for women of childbearing potential)
  • Other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up
  • Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements
  • Use of any investigational product within 30 days prior to randomization

Trial Contact Information

Trial Lead Organizations/Sponsors

National Cancer Institute

Louis FehrenbacherPrincipal Investigator

Trial Sites

U.S.A.
Delaware
  Dover
 Kent General Hospital
 Iftekhar A. Khan Ph: 302-744-6755
  Email: mary_ella_quillen@bayhealth.org
  Lewes
 Tunnell Cancer Center at Beebe Medical Center
 David D. Biggs Ph: 302-733-6227
  Newark
 Christiana Gynecologic Oncology, LLC
 David D. Biggs Ph: 302-733-6227
 Delaware Clinical and Laboratory Physicians
 David D. Biggs Ph: 302-733-6227
 Helen F. Graham Cancer Center at Christiana Hospital
 David D. Biggs Ph: 302-733-6227
 David D. Biggs Ph: 302-733-6227
 Medical Oncology Hematology Consultants, PA at Helen F. Graham Cancer Center
 David D. Biggs Ph: 302-733-6227
 Regional Hematology/Oncology, PA - Newark
 David D. Biggs Ph: 302-733-6227
  Rehoboth Beach
 Beebe Health Campus
 David D. Biggs Ph: 302-733-6227
  Seaford
 Nanticoke Memorial Hospital
 David D. Biggs Ph: 302-733-6227
  Wilmington
 Christiana Care Health System-Wilmington Hospital
 David D. Biggs Ph: 302-733-6227
District of Columbia
  Washington
 Kaiser Permanente at Capitol Hill Medical Center
 Leon C. Hwang Ph: 301-816-7446
 Washington Cancer Institute at Washington Hospital Center
 Claudine Isaacs Ph: 202-444-0381
Maryland
  Annapolis
 DeCesaris Cancer Institute at Anne Arundel Medical Center
 Jeanine L. Werner Ph: 443-481-1320
  Email: kbodenhorn@aahs.org
  Baltimore
 Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
 Mayer Gorbaty Ph: 410-601-6120
  Email: pridgely@lifebridgehealth.org
 Greater Baltimore Medical Center Cancer Center
 Madhu Chaudhry Ph: 443-849-3706
 Greenebaum Cancer Center at University of Maryland Medical Center
 Katherine Tkaczuk Ph: 800-888-8823
 Harbor View Cancer Center at Harbor Hospital
 Claudine Isaacs Ph: 202-444-0381
 Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
 Claudine Isaacs Ph: 202-444-0381
 Kaiser Permanente at Woodlawn Medical Center
 Leon C. Hwang Ph: 301-816-7446
 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
 Antonio C. Wolff Ph: 410-955-8804
  Email: jhcccro@jhmi.edu
 St. Agnes Hospital Cancer Center
 Diana H Griffiths Ph: 410-368-2910
  Bel Air
 Upper Chesapeake Medical Center
 Katherine Tkaczuk Ph: 800-888-8823
  Columbia
 Maryland Oncology Hematology PA-Columbia
 Christopher T Stokoe Ph: 888-823-5923
  Email: ctsucontact@westat.com
  Easton
 Shore Regional Cancer Center at Memorial Hospital - Easton
 Mary S. DeShields Ph: 410-820-6800ext108
  Email: srichter@shorehealth.org
  Elkton MD
 Union Hospital of Cecil County
 David D. Biggs Ph: 302-733-6227
  Largo
 Kaiser Permanente Mid-Atlantic Medical Group-Largo Medical Facility
 Leon C. Hwang Ph: 301-816-7446
  Silver Spring
 Holy Cross Hospital
 Cheryl A. Aylesworth Ph: 301-896-2719
  Email: Bsquiller@suburbanhospital.org
New Jersey
  Camden
 Cancer Institute of New Jersey at Cooper University Hospital - Camden
 Robert A Somer Ph: 856-325-6757
  Livingston
 St. Barnabas Medical Center Cancer Center
 Richard Alan Michaelson Ph: 973-322-2470
  Morristown
 Carol G. Simon Cancer Center at Morristown Memorial Hospital
 Bonni L Guerin Ph: 908-522-2043
  Mount Holly
 Virtua Fox Chase Health Cancer Program at Virtua Memorial Hospital Burlington County
 Michael S. Entmacher Ph: 888-847-8823
  Newark
 Newark Beth Israel Medical Center
 Frederick B. Cohen Ph: 973-926-7230
 UMDNJ University Hospital
 Robert Wieder Ph: 732-235-8675
  Sewell
 Radiation Oncology Center at Kennedy Health System - Sewell
 Trina A Poretta Ph: 888-847-8823
  Somerville
 Somerset Medical Center
 Kathleen C Toomey Ph: 908-685-2481
  Sparta
 Frederick R. and Betty M. Smith Cancer Treatment Center
 Allison Zibelli Ph: 215-955-6084
  Summit
 Overlook Hospital
 Bonni L Guerin Ph: 908-522-2043
  Toms River
 J. Phillip Citta Regional Cancer Center at Community Medical Center
 Sudha Kavuru Ph: 732-818-3882
  Vineland
 Frank and Edith Scarpa Regional Cancer Pavillion at South Jersey Healthcare
 Benjamin P Negin Ph: 856-641-7933
  Voorhees
 Cancer Institute of New Jersey at Cooper - Voorhees
 Robert A Somer Ph: 856-325-6757
 Fox Chase Virtua Health Cancer Program at Virtua West Jersey
 Michael S. Entmacher Ph: 888-847-8823
Pennsylvania
  Abington
 Rosenfeld Cancer Center at Abington Memorial Hospital
 Willard G. Andrews Ph: 215-481-2402
  Allentown
 Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
 Alyson F McIntosh Ph: 610-402-2273
  Bethlehem
 Lehigh Valley Hospital - Muhlenberg
 Alyson F McIntosh Ph: 610-402-2273
  Bryn Mawr
 Bryn Mawr Hospital
 Albert S DeNittis Ph: 866-225-5654
  Danville
 Geisinger Cancer Institute at Geisinger Health
 Victor Gerald Vogel Ph: 570-271-5251
  Darby
 Mercy Fitzgerald Hospital
 Allison Zibelli Ph: 215-955-6084
  Doylestown
 Doylestown Hospital Cancer Center
 Mitchell Alden Ph: 215-345-2378
  Email: lheacock@dh.org
  Drexel Hill
 Delaware County Regional Cancer Center at Delaware County Memorial Hospital
 Stephen A. Shore Ph: 610-284-8237
  Email: jolene.garney@crozer.org
  East Stroudsburg
 Dale and Frances Hughes Cancer Center at Pocono Medical Center
 Allison Zibelli Ph: 215-955-6084
  Easton
 Easton Regional Cancer Center at Easton Hospital
 Sonyo Shin Ph: 610-250-4000
  Harrisburg
 PinnacleHealth Regional Cancer Center at Polyclinic Hospital
 Amit C Barochia Ph: 717-724-6765
  Email: klitchfield@PINNACLEHEALTH.org
  Hazleton
 Geisinger Hazleton Cancer Center
 Victor Gerald Vogel Ph: 570-271-5251
  Hershey
 Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
 Harold A. Harvey Ph: 717-531-3779
  Email: CTO@hmc.psu.edu
  Langhorne
 St. Mary Regional Cancer Center
 Robert C. Reilly Ph: 215-710-4585
  Lewisburg
 Geisinger Medical Oncology at Evangelical Community Hospital
 Victor Gerald Vogel Ph: 570-271-5251
  Media
 Riddle Memorial Hospital Cancer Center
 Allison Zibelli Ph: 215-955-6084
  Norristown
 Norristown Regional Cancer Center
 Allison Zibelli Ph: 215-955-6084
  Paoli
 Cancer Center of Paoli Memorial Hospital
 Albert S DeNittis Ph: 866-225-5654
  Philadelphia
 Albert Einstein Cancer Center
 Mark S Morginstin Ph: 215-456-3880
 Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
 Allison Zibelli Ph: 215-955-6084
  Pottstown
 Pottstown Memorial Regional Cancer Center
 Wei Song Ph: 610-327-7544
  Pottsville
 Geisinger Medical Oncology-Pottsville
 Victor Gerald Vogel Ph: 570-271-5251
  Reading
 St. Joseph Medical Center
 Marc Rovito Ph: 610-378-2336
  Email: danielward2@catholichealth.net
  Scranton
 Scranton Hematology Oncology
 Martin B. Hyzinski Ph: 570-558-3020
  Sellersville
 Grand View Hospital
 Anthony J Magdalinski Ph: 215-453-4162
  Email: PParsons@gvh.org
  Upland
 Associates in Hematology-Oncology, PC at Crozer Regional Cancer Center
 Allison Zibelli Ph: 215-955-6084
  West Chester
 Cancer Center of Chester County
 William E. Luginbuhl Ph: 610-431-5297
  West Reading
 McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
 Terrence P. Cescon Ph: 610-988-9323
  Wilkes-Barre
 Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
 Victor Gerald Vogel Ph: 570-271-5251
  Williamsport
 Susquehanna Cancer Center at Divine Providence Hospital
 Warren L Robinson Ph: 800-598-4282
  Wynnewood
 Lankenau Cancer Center at Lankenau Hospital
 Albert S DeNittis Ph: 866-225-5654

See All Trial Sites

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01275677
ClinicalTrials.gov processed this data on September 25, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.