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Trial record 2 of 3 for:    BR004

Paclitaxel, Trastuzumab, and Pertuzumab With or Without Atezolizumab in Treating Patients With Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03199885
Recruitment Status : Recruiting
First Posted : June 27, 2017
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
This randomized phase III trial studies how well paclitaxel, trastuzumab, and pertuzumab with or without atezolizumab works in treating patients with breast cancer that has spread to other parts of the body. Drugs used in chemotherapy, such as paclitaxel, 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. Immunotherapy with trastuzumab, pertuzumab, and atezolizumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving paclitaxel, trastuzumab, and pertuzumab with or without atezolizumab may kill more tumor cells.

Condition or disease Intervention/treatment Phase
Breast Adenocarcinoma HER2/Neu Positive Metastatic Breast Carcinoma Recurrent Breast Carcinoma Stage III Breast Cancer AJCC v7 Stage IIIA Breast Cancer AJCC v7 Stage IIIB Breast Cancer AJCC v7 Stage IIIC Breast Cancer AJCC v7 Stage IV Breast Cancer AJCC v6 and v7 Drug: Atezolizumab Drug: Paclitaxel Biological: Pertuzumab Other: Placebo Other: Quality-of-Life Assessment Biological: Trastuzumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Phase III Trial of Paclitaxel/Trastuzumab/Pertuzumab With Atezolizumab or Placebo in First-Line HER2-Positive Metastatic Breast Cancer
Actual Study Start Date : March 12, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm I (pertuzumab, trastuzumab, paclitaxel, atezolizumab)
Patients receive pertuzumab IV over 30-60 minutes on days 1 and 22, trastuzumab IV over 30-90 minutes on days 1 and 22, paclitaxel IV over 60 minutes on days 1, 8, 15, 22, 29, and 36, and atezolizumab IV over 60 minutes on days 1 and 22. Cycles for pertuzumab, trastuzumab and atezolizumab repeat every 6 weeks and treatment with paclitaxel repeats every 6 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients may receive additional 3 cycles of paclitaxel in the absence of progression at the investigator's discretion.
Drug: Atezolizumab
Given IV
Other Names:
  • MPDL 3280A
  • MPDL 328OA
  • MPDL-3280A
  • MPDL3280A
  • MPDL328OA
  • RG7446
  • RO5541267
  • Tecentriq

Drug: Paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol
  • Taxol Konzentrat

Biological: Pertuzumab
Given IV
Other Names:
  • 2C4
  • 2C4 Antibody
  • MoAb 2C4
  • Monoclonal Antibody 2C4
  • Omnitarg
  • Perjeta
  • rhuMAb2C4
  • RO4368451

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Biological: Trastuzumab
Given IV
Other Names:
  • ABP 980
  • ALT02
  • Anti-c-ERB-2
  • Anti-c-erbB2 Monoclonal Antibody
  • Anti-ERB-2
  • Anti-erbB-2
  • Anti-erbB2 Monoclonal Antibody
  • Anti-HER2/c-erbB2 Monoclonal Antibody
  • Anti-p185-HER2
  • c-erb-2 Monoclonal Antibody
  • HER2 Monoclonal Antibody
  • Herceptin
  • Herceptin Biosimilar PF-05280014
  • Herceptin Trastuzumab Biosimilar PF-05280014
  • Herzuma
  • MoAb HER2
  • Monoclonal Antibody c-erb-2
  • Monoclonal Antibody HER2
  • Ogivri
  • Ontruzant
  • PF-05280014
  • rhuMAb HER2
  • RO0452317
  • Trastuzumab Biosimilar ABP 980
  • Trastuzumab Biosimilar ALT02
  • trastuzumab biosimilar EG12014
  • Trastuzumab Biosimilar HLX02
  • Trastuzumab Biosimilar PF-05280014
  • Trastuzumab-dkst
  • Trastuzumab-DTTB
  • Trastuzumab-pkrb
  • Trastuzumab-QYYP
  • Trazimera

Active Comparator: Arm II (pertuzumab, trastuzumab, paclitaxel, placebo)
Patients receive pertuzumab, trastuzumab, and paclitaxel as in Arm I. Patients also receive placebo IV over 60 minutes on days 1 and 22. Cycles for pertuzumab, trastuzumab, and placebo repeat every 6 weeks and treatment with paclitaxel repeats every 6 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients may receive additional 3 cycles of paclitaxel in the absence of progression at the investigator's discretion.
Drug: Paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol
  • Taxol Konzentrat

Biological: Pertuzumab
Given IV
Other Names:
  • 2C4
  • 2C4 Antibody
  • MoAb 2C4
  • Monoclonal Antibody 2C4
  • Omnitarg
  • Perjeta
  • rhuMAb2C4
  • RO4368451

Other: Placebo
Given IV
Other Names:
  • placebo therapy
  • PLCB
  • sham therapy

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Biological: Trastuzumab
Given IV
Other Names:
  • ABP 980
  • ALT02
  • Anti-c-ERB-2
  • Anti-c-erbB2 Monoclonal Antibody
  • Anti-ERB-2
  • Anti-erbB-2
  • Anti-erbB2 Monoclonal Antibody
  • Anti-HER2/c-erbB2 Monoclonal Antibody
  • Anti-p185-HER2
  • c-erb-2 Monoclonal Antibody
  • HER2 Monoclonal Antibody
  • Herceptin
  • Herceptin Biosimilar PF-05280014
  • Herceptin Trastuzumab Biosimilar PF-05280014
  • Herzuma
  • MoAb HER2
  • Monoclonal Antibody c-erb-2
  • Monoclonal Antibody HER2
  • Ogivri
  • Ontruzant
  • PF-05280014
  • rhuMAb HER2
  • RO0452317
  • Trastuzumab Biosimilar ABP 980
  • Trastuzumab Biosimilar ALT02
  • trastuzumab biosimilar EG12014
  • Trastuzumab Biosimilar HLX02
  • Trastuzumab Biosimilar PF-05280014
  • Trastuzumab-dkst
  • Trastuzumab-DTTB
  • Trastuzumab-pkrb
  • Trastuzumab-QYYP
  • Trazimera




Primary Outcome Measures :
  1. Progression free survival [ Time Frame: The time from randomization to the first documented progressive disease assessed up to 7 years ]
    Will be determined using the current Response Evaluation Criteria in Solid Tumors 1.1 criteria. Analysis will be based on the intent to treat population. The stratified log-rank test will be used to compare the progression free survival between the two treatment arms with the following stratification factors: prior neoadjuvant or adjuvant therapy with trastuzumab (no prior trastuzumab; prior trastuzumab and no pertuzumab; prior trastuzumab and pertuzumab), estrogen receptor status (positive; negative), and disease sites (any visceral without brain metastasis; non-visceral only without brain metastasis; brain metastasis). The Kaplan-Meier estimates will be calculated by treatment arms. Stratified Cox proportional hazards models to estimate the hazard ratio.


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: The time from randomization to death from any cause, assessed up to 7 years ]
    Analysis will be based on the intent to treat population. The Kaplan-Meier estimates will be calculated by treatment arms. Stratified Cox proportional hazards models to estimate the hazard ratio.

  2. Overall objective response [ Time Frame: Up to 7 years ]
    Defined as complete response or partial response. Will be determined using Response Evaluation Criteria in Solid Tumors 1.1 criteria.

  3. Duration of objective response [ Time Frame: From the date of initial confirmed partial response or complete response until the date of progressive disease or death from any cause assessed up to 7 years ]
    Tumor responses will be based on the current Response Evaluation Criteria in Solid Tumors 1.1 criteria.

  4. Cumulative incidence of brain metastases [ Time Frame: The time from randomization to documentation of brain metastases, assessed up to 7 years ]
    Analysis will be based on the intent to treat population. The Kaplan-Meier estimates will be calculated by treatment arms. Stratified Cox proportional hazards models to estimate the hazard ratio.

  5. Frequency of adverse events, including late immune-related toxicities [ Time Frame: Up to 7 years ]
    Will be categorized using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient must have signed and dated an Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines
  • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Histologically confirmed adenocarcinoma of the breast with locally recurrent, unresectable disease or metastatic disease confirmed as described below; eligible patients include those with either:

    • De novo metastatic disease presenting without prior history of HER2-positive breast cancer:

      • Diagnosis should have been made from a biopsy of a metastatic disease site, but biopsy from the breast primary or involved regional lymph nodes is acceptable if biopsy of the metastatic sites was thought to carry excessive risk for the patient
    • Locally recurrent or metastatic disease following prior therapy for early breast cancer:

      • Diagnosis must have been made from the biopsy of the locally recurrent or metastatic disease
      • There must be an interval of >= 6 months between completion of neoadjuvant/adjuvant HER2-targeted therapy and documentation of locally recurrent or metastatic HER2-positive disease by biopsy
  • Patients must have measurable disease based on RECIST 1.1, as determined by the site, to be eligible
  • The tumor specimen obtained at the time of diagnosis of locally recurrent or metastatic disease must have been determined to be HER2-positive based on central testing according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines (Wolff 2018); HER2 status will initially be assessed using a Food and Drug Administration (FDA)-cleared IHC assay; positive is defined as IHC 3+ staining intensity; if HER2 IHC results are equivocal (2+), then HER2 status will be determined using a FDA-cleared HER2 in situ hybridization (ISH) test according to ASCO/CAP guidelines; sites can send biopsy specimens for central testing which have been determined to be HER2-positive or initially equivocal by either IHC or ISH on local testing
  • The tumor specimen obtained at the time of diagnosis used for HER2 testing must also have central testing for PD-L1 status; patients will be eligible irrespective of PD-L1 testing result including PD-L1 indeterminant
  • The tumor specimen obtained at the time of diagnosis used for HER2 and PD-L1 testing should also have central testing for estrogen receptor (ER) and progesterone receptor (PgR) according to current ASCO/CAP guideline recommendations for hormone receptor testing; patients with , 1% ER and PgR staining by IHC will be classified as negative; if sufficient material for central confirmation of ER and PgR is unavailable, local testing results for ER and PgR may be used for eligibility
  • Localized palliative radiation therapy is allowed for symptom management if completed >= 14 days prior to randomization
  • Patients must have imaging of the chest/abdomen/pelvis, preferably with a computed tomography (CT) scan, and a bone scan within 4 weeks prior to randomization; (NOTE: if a patient is unable to receive CT contrast, a magnetic resonance imaging [MRI] of the abdomen/pelvis and non-contrast chest CT should be performed; positron emission tomography/computed tomography [PET/CT] is not an acceptable alternative)
  • MRI of the brain (or contrast CT scan of the brain if patients are unable to undergo MRI) must be obtained in patients with symptoms suggesting possible central nervous system (CNS) metastatic disease; neuroimaging is recommended but not required in asymptomatic patients
  • Absolute neutrophil count (ANC) must be >= 1200/mm^3 (within 14 days prior to randomization)
  • Platelet count must be >= 100,000/mm^3 (within 14 days prior to randomization)
  • Hemoglobin must be >= 8 g/dL (within 14 days prior to randomization)
  • Total bilirubin must be =< 1.5 x upper limit of normal (ULN) for the lab or direct bilirubin =< ULN for patients with bilirubin levels > 1.5 x ULN (within 14 days prior to randomization)
  • Aspartate aminotransferase (AST) and alanine aminotransaminase (ALT) must be =< 2.5 x ULN for the lab or =< 5 x ULN for patients with liver metastases (within 14 days prior to randomization)
  • Serum creatinine =< 1.5 x ULN or measured or calculated creatinine clearance >= 50 mL/min using the Cockroft-Gault formula for patients with creatinine levels > 1.5 x ULN for the lab (within 14 days prior to randomization)
  • Patients not receiving anti-coagulant therapy must have prothrombin time (PT) and international normalized ratio (INR) =< 1.5 x ULN within 14 days prior to randomization; for laboratories that do not report an ULN for the INR assay, use =< 1.5 as the value for the ULN; patients receiving anti-coagulants should have a baseline INR assessed, but the value does not affect eligibility
  • A serum thyroid-stimulating hormone (TSH), free T4, and AM (morning) cortisol must be obtained within 14 days prior to randomization to obtain a baseline value and be within normal limits for the local laboratory
  • Left ventricular ejection fraction (LVEF) assessment must be performed within 6 weeks prior to randomization; (LVEF assessment performed by echocardiogram is preferred; however, multigated acquisition scan (MUGA) scan may be substituted based on institutional preferences); the LVEF must be >= 55% regardless of the cardiac imaging facility's lower limit of normal
  • Administration of atezolizumab may have an adverse effect on pregnancy and poses a risk to the human fetus, including embryo-lethality; women of child-bearing potential and men must agree to use adequate contraception (non-hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 5 months (150 days) after the last dose of atezolizumab/placebo and 7 months after the last dose of trastuzumab and pertuzumab; 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

Exclusion Criteria:

  • Patients with known primary central nervous system (CNS) malignancy or symptomatic CNS metastases are excluded, with the following exceptions:

    • Patients with asymptomatic untreated CNS disease may be enrolled, provided all of the following criteria are met:

      • Evaluable or measurable disease outside the CNS
      • No metastases to brain stem, midbrain, pons, medulla, cerebellum, or within 10 mm of the optic apparatus (optic nerves and chiasm)
      • No history of intracranial hemorrhage or spinal cord hemorrhage
      • No ongoing requirement for dexamethasone for CNS disease; patients on a stable dose of anticonvulsants are permitted
      • No neurosurgical resection or brain biopsy within 28 days prior to randomization
    • Patients with asymptomatic treated CNS metastases may be enrolled, provided all the criteria listed above are met as well as the following:

      • Radiographic demonstration of improvement upon the completion of CNS directed therapy and no evidence of interim progression between the completion of CNS directed therapy and the screening radiographic study
      • No stereotactic radiation or whole-brain radiation within 4 weeks prior to randomization
      • Screening CNS radiographic study 4 weeks from completion of radiotherapy and 2 weeks from discontinuation of corticosteroids
  • Known leptomeningeal carcinomatosis
  • Patients with metastatic disease limited to the CNS
  • History of systemic anti-cancer therapy (e.g., chemotherapy, targeted therapy) for metastatic breast cancer (MBC) with the exception of administration of trastuzumab or lapatinib concurrently with radiation therapy for brain metastases; toxicities related to lapatinib should be =< grade 1, per the CTCAE version (v)5.0 and must have been completed at least 2 weeks prior to randomization
  • History of exposure to cumulative doses of doxorubicin greater than 360 mg per square meter of body-surface area or its equivalent
  • Prior treatment with mTOR inhibitors or CDK 4/6 inhibitors in combination with endocrine therapy for treatment of metastatic disease
  • Prior treatment with CD137 agonists or immune checkpoint-blockade therapies, including anti-CD40, anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
  • 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
  • Uncontrolled hypertension defined as sustained systolic blood pressure (BP) > 150 mmHg or diastolic BP > 90 mmHg; (patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria)
  • History of asymptomatic LVEF decline to < 40% during or after prior HER2-targeted therapy
  • 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; or
      • Symptomatic pericarditis
    • History of cardiac disease

      • Prior myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular (LV) function;
      • History of documented congestive heart failure (CHF) defined as symptomatic heart failure with an LVEF < 40%; or
      • Documented cardiomyopathy
  • Nervous system disorder (paresthesia, peripheral motor neuropathy, or peripheral sensory neuropathy) >= grade 2, per the Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
  • Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or other recombinant antibodies
  • Known allergy or hypersensitivity to the components of the atezolizumab formulation or to any of the study drugs or excipients, (e.g., Cremophor EL)
  • History or risk of autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis

    • Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible
    • Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible
    • Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:

      • Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations
      • Rash must cover less than 10% of body surface area (BSA)
      • Disease is well controlled at baseline and only requiring low-potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, flucinolone 0.01%, desonide 0.05%, aclometasone dipropionate 0.05%)
      • No acute exacerbations of underlying conditions within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)
  • Treatment with systemic immunosuppressive medications (including but not limited to interferons, IL-2) within 4 weeks or 5 half-lives of the drug, whichever is longer, prior to randomization
  • Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti−tumor necrosis [anti-TNF] factor agents) within 14 days prior to randomization or anticipation of need for systemic immunosuppressive medications during the study; Note: Intranasal and inhaled corticosteroids or systemic corticosteroids at doses that do not exceed 10 mg/day of prednisone or an equivalent corticosteroid are allowed
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 2 weeks prior to randomization
  • Active hepatitis B virus (HBV) infection, defined as having a positive hepatitis B surface antigen (HBsAg) test at screening; patients with a past or resolved HBV infection, defined as having a negative HBsAg test and a positive total hepatitis B core antibody (HBcAb) test at screening, are eligible for the study if active HBV infection is ruled out on the basis of HBV deoxyribonucleic acid (DNA) viral load per local guidelines
  • Active hepatitis C virus (HCV) infection, defined as having a positive HCV antibody test at screening confirmed by a polymerase chain reaction (PCR) positive for HCV ribonucleic acid (RNA)
  • Patients with clinically active tuberculosis
  • Patients known to be human immunodeficiency virus (HIV) positive are eligible if they meet the following criteria within 4 weeks prior to randomization:

    • A stable regimen of highly active anti-retroviral therapy (HAART) and;
    • No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections; and
    • A CD4 count above 250 cells/mcL and an undetectable HIV viral load on standard PCR-based tests
  • Severe infection within 4 weeks prior to randomization, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
  • Prior allogeneic stem cell or solid organ transplantation
  • Symptomatic peripheral ischemia
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis or >= grade 1 pulmonary fibrosis, per the CTCAE v5.0, on screening chest CT scan
  • Administration of a live, attenuated vaccine within 4 weeks prior to randomization or anticipation that such vaccine will be required during the study

    • Patients must agree not to receive live, attenuated influenza vaccine (e.g., FluMist) within 4 weeks prior to randomization, during treatment or within 5 months following the last dose of atezolizumab/placebo
  • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a diseas

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199885


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Locations
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United States, Delaware
Helen F Graham Cancer Center Recruiting
Newark, Delaware, United States, 19713
Contact: Site Public Contact    302-623-4450    KDempsey@christianacare.org   
Principal Investigator: Gregory A. Masters         
Medical Oncology Hematology Consultants PA Recruiting
Newark, Delaware, United States, 19713
Contact: Site Public Contact    302-623-4450    KDempsey@christianacare.org   
Principal Investigator: Gregory A. Masters         
Beebe Health Campus Recruiting
Rehoboth Beach, Delaware, United States, 19971
Contact: Site Public Contact    302-645-3100    Dmiskin@Beebehealthcare.org   
Principal Investigator: Gregory A. Masters         
United States, Florida
UF Cancer Center at Orlando Health Recruiting
Orlando, Florida, United States, 32806
Contact: Site Public Contact    321-841-7246    CancerClinicalTrials@orlandohealth.com   
Principal Investigator: Ana E. Cuesta Fernandez         
United States, Georgia
Northside Hospital Recruiting
Atlanta, Georgia, United States, 30342
Contact: Site Public Contact    404-303-3355    ClinicalTrials@northside.com   
Principal Investigator: Gena H. Volas-Redd         
United States, Idaho
Saint Alphonsus Cancer Care Center-Boise Recruiting
Boise, Idaho, United States, 83706
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Benjamin T. Marchello         
Saint Alphonsus Cancer Care Center-Caldwell Recruiting
Caldwell, Idaho, United States, 83605
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Benjamin T. Marchello         
Saint Alphonsus Medical Center-Nampa Recruiting
Nampa, Idaho, United States, 83686
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Benjamin T. Marchello         
United States, Illinois
Illinois CancerCare-Bloomington Recruiting
Bloomington, Illinois, United States, 61704
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Canton Recruiting
Canton, Illinois, United States, 61520
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Carthage Recruiting
Carthage, Illinois, United States, 62321
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Cancer Care Specialists of Illinois - Decatur Recruiting
Decatur, Illinois, United States, 62526
Contact: Site Public Contact    217-876-4740      
Principal Investigator: Bryan A. Faller         
Crossroads Cancer Center Recruiting
Effingham, Illinois, United States, 62401
Contact: Site Public Contact    217-876-4740    rhamrick@dmhhs.org   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Eureka Recruiting
Eureka, Illinois, United States, 61530
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Galesburg Recruiting
Galesburg, Illinois, United States, 61401
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Ingalls Memorial Hospital Recruiting
Harvey, Illinois, United States, 60426
Contact: Site Public Contact    708-915-4673    clinicaltrials@ingalls.org   
Principal Investigator: Mark F. Kozloff         
Joliet Oncology-Hematology Associates Limited Recruiting
Joliet, Illinois, United States, 60435
Contact: Site Public Contact    815-730-3098    maureenc@jolietoncology.com   
Principal Investigator: Nafisa D. Burhani         
Illinois CancerCare-Kewanee Clinic Recruiting
Kewanee, Illinois, United States, 61443
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Macomb Recruiting
Macomb, Illinois, United States, 61455
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Ottawa Clinic Recruiting
Ottawa, Illinois, United States, 61350
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Pekin Recruiting
Pekin, Illinois, United States, 61554
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Peoria Recruiting
Peoria, Illinois, United States, 61615
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Peru Recruiting
Peru, Illinois, United States, 61354
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Princeton Recruiting
Princeton, Illinois, United States, 61356
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Southern Illinois University School of Medicine Recruiting
Springfield, Illinois, United States, 62702
Contact: Site Public Contact    217-545-7929      
Principal Investigator: Bryan A. Faller         
Springfield Clinic Recruiting
Springfield, Illinois, United States, 62702
Contact: Site Public Contact    800-444-7541      
Principal Investigator: Bryan A. Faller         
United States, Indiana
Memorial Hospital of South Bend Recruiting
South Bend, Indiana, United States, 46601
Contact: Site Public Contact    800-284-7370      
Principal Investigator: Thomas J. Reid         
United States, Iowa
Mary Greeley Medical Center Recruiting
Ames, Iowa, United States, 50010
Contact: Site Public Contact    515-956-4132      
Principal Investigator: Debra M. Prow         
McFarland Clinic PC - Ames Recruiting
Ames, Iowa, United States, 50010
Contact: Site Public Contact    515-956-4132      
Principal Investigator: Debra M. Prow         
McFarland Clinic PC-Boone Recruiting
Boone, Iowa, United States, 50036
Contact: Site Public Contact    515-956-4132      
Principal Investigator: Debra M. Prow         
Mercy Hospital Recruiting
Cedar Rapids, Iowa, United States, 52403
Contact: Site Public Contact    319-365-4673      
Principal Investigator: Deborah W. Wilbur         
Oncology Associates at Mercy Medical Center Recruiting
Cedar Rapids, Iowa, United States, 52403
Contact: Site Public Contact    319-363-2690      
Principal Investigator: Deborah W. Wilbur         
Iowa Methodist Medical Center Recruiting
Des Moines, Iowa, United States, 50309
Contact: Site Public Contact    515-241-6727      
Principal Investigator: Robert J. Behrens         
Medical Oncology and Hematology Associates-Des Moines Recruiting
Des Moines, Iowa, United States, 50309
Contact: Site Public Contact    515-282-2921      
Principal Investigator: Robert J. Behrens         
Broadlawns Medical Center Suspended
Des Moines, Iowa, United States, 50314
McFarland Clinic PC-Trinity Cancer Center Recruiting
Fort Dodge, Iowa, United States, 50501
Contact: Site Public Contact    515-956-4132      
Principal Investigator: Debra M. Prow         
Trinity Regional Medical Center Recruiting
Fort Dodge, Iowa, United States, 50501
Contact: Site Public Contact    515-574-8302      
Principal Investigator: Robert J. Behrens         
McFarland Clinic PC-Jefferson Recruiting
Jefferson, Iowa, United States, 50129
Contact: Site Public Contact    515-956-4132      
Principal Investigator: Debra M. Prow         
McFarland Clinic PC-Marshalltown Recruiting
Marshalltown, Iowa, United States, 50158
Contact: Site Public Contact    515-956-4132      
Principal Investigator: Debra M. Prow         
United States, Louisiana
LSU Health Baton Rouge-North Clinic Recruiting
Baton Rouge, Louisiana, United States, 70805
Contact: Site Public Contact    225-215-1353    clinicalresearch@marybird.com   
Principal Investigator: David S. Hanson         
Louisiana Hematology Oncology Associates LLC Recruiting
Baton Rouge, Louisiana, United States, 70809
Contact: Site Public Contact    225-215-1353    clinicalresearch@marybird.com   
Principal Investigator: David S. Hanson         
Mary Bird Perkins Cancer Center Recruiting
Baton Rouge, Louisiana, United States, 70809
Contact: Site Public Contact    225-215-1353    clinicalresearch@marybird.com   
Principal Investigator: David S. Hanson         
Our Lady of the Lake Physicians Group - Medical Oncology Recruiting
Baton Rouge, Louisiana, United States, 70809
Contact: Site Public Contact    225-757-0343    clinicalresearch@marybird.com   
Principal Investigator: David S. Hanson         
Woman's Hospital Recruiting
Baton Rouge, Louisiana, United States, 70817
Contact: Site Public Contact    412-339-5294    Roster@nrgoncology.org   
Principal Investigator: David S. Hanson         
Northshore Oncology Associates-Covington Recruiting
Covington, Louisiana, United States, 70433
Contact: Site Public Contact    225-215-1353    clinicalresearch@marybird.com   
Principal Investigator: David S. Hanson         
Oncology Center of The South Incorporated Recruiting
Houma, Louisiana, United States, 70360
Contact: Site Public Contact    225-215-1353    clinicalresearch@marybird.com   
Principal Investigator: David S. Hanson         
United States, Maine
Lafayette Family Cancer Center-EMMC Recruiting
Brewer, Maine, United States, 04412
Contact: Site Public Contact    800-987-3005      
Principal Investigator: Thomas H. Openshaw         
United States, Massachusetts
Lahey Hospital and Medical Center Recruiting
Burlington, Massachusetts, United States, 01805
Contact: Site Public Contact    781-744-8027      
Principal Investigator: Corrine L. Zarwan         
United States, Michigan
Saint Joseph Mercy Hospital Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Christopher M. Reynolds         
IHA Hematology Oncology Consultants-Brighton Recruiting
Brighton, Michigan, United States, 48114
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Christopher M. Reynolds         
Saint Joseph Mercy Brighton Recruiting
Brighton, Michigan, United States, 48114
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Christopher M. Reynolds         
IHA Hematology Oncology Consultants-Canton Recruiting
Canton, Michigan, United States, 48188
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Christopher M. Reynolds         
Saint Joseph Mercy Canton Recruiting
Canton, Michigan, United States, 48188
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Christopher M. Reynolds         
Caro Cancer Center Recruiting
Caro, Michigan, United States, 48723
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Christopher M. Reynolds         
IHA Hematology Oncology Consultants-Chelsea Recruiting
Chelsea, Michigan, United States, 48118
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Christopher M. Reynolds         
Saint Joseph Mercy Chelsea Recruiting
Chelsea, Michigan, United States, 48118
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Christopher M. Reynolds         
Genesee Cancer and Blood Disease Treatment Center Recruiting
Flint, Michigan, United States, 48503
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Christopher M. Reynolds         
Genesee Hematology Oncology PC Recruiting
Flint, Michigan, United States, 48503
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Christopher M. Reynolds         
Genesys Hurley Cancer Institute Recruiting
Flint, Michigan, United States, 48503
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Christopher M. Reynolds         
Hope Cancer Clinic Recruiting
Livonia, Michigan, United States, 48154
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Christopher M. Reynolds         
Saint Mary Mercy Hospital Recruiting
Livonia, Michigan, United States, 48154
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Christopher M. Reynolds         
Saint Mary's Oncology/Hematology Associates of Marlette Recruiting
Marlette, Michigan, United States, 48453
Contact: Site Public Contact    989-343-2487      
Principal Investigator: Christopher M. Reynolds         
Ascension Saint Mary's Hospital Recruiting
Saginaw, Michigan, United States, 48601
Contact: Site Public Contact    412-339-5294    Roster@nrgoncology.org   
Principal Investigator: Christopher M. Reynolds         
Oncology Hematology Associates of Saginaw Valley PC Recruiting
Saginaw, Michigan, United States, 48604
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Christopher M. Reynolds         
Ascension Saint Joseph Hospital Recruiting
Tawas City, Michigan, United States, 48764
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Christopher M. Reynolds         
Saint Mary's Oncology/Hematology Associates of West Branch Recruiting
West Branch, Michigan, United States, 48661
Contact: Site Public Contact    989-343-2487      
Principal Investigator: Christopher M. Reynolds         
IHA Hematology Oncology Consultants-Ann Arbor Recruiting
Ypsilanti, Michigan, United States, 48197
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Christopher M. Reynolds         
United States, Minnesota
Park Nicollet Clinic - Saint Louis Park Recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: Richard T. Zera         
United States, Missouri
Parkland Health Center-Bonne Terre Recruiting
Bonne Terre, Missouri, United States, 63628
Contact: Site Public Contact    314-996-5569      
Principal Investigator: Bryan A. Faller         
Saint Francis Medical Center Recruiting
Cape Girardeau, Missouri, United States, 63703
Contact: Site Public Contact    573-334-2230    sfmc@sfmc.net   
Principal Investigator: Bryan A. Faller         
Capital Region Southwest Campus Recruiting
Jefferson City, Missouri, United States, 65109
Contact: Site Public Contact    573-632-4814    swooden@mail.crmc.org   
Principal Investigator: Bryan A. Faller         
Missouri Baptist Medical Center Recruiting
Saint Louis, Missouri, United States, 63131
Contact: Site Public Contact    314-996-5569      
Principal Investigator: Bryan A. Faller         
Sainte Genevieve County Memorial Hospital Recruiting
Sainte Genevieve, Missouri, United States, 63670
Contact: Site Public Contact    314-996-5569      
Principal Investigator: Bryan A. Faller         
Missouri Baptist Sullivan Hospital Recruiting
Sullivan, Missouri, United States, 63080
Contact: Site Public Contact    314-996-5569      
Principal Investigator: Bryan A. Faller         
Missouri Baptist Outpatient Center-Sunset Hills Recruiting
Sunset Hills, Missouri, United States, 63127
Contact: Site Public Contact    314-996-5569      
Principal Investigator: Bryan A. Faller         
United States, Montana
Bozeman Deaconess Hospital Recruiting
Bozeman, Montana, United States, 59715
Contact: Site Public Contact    406-969-6060    mccinfo@mtcancer.org   
Principal Investigator: Benjamin T. Marchello         
United States, Nebraska
Nebraska Methodist Hospital Recruiting
Omaha, Nebraska, United States, 68114
Contact: Site Public Contact    402-354-5144      
Principal Investigator: Kirsten M. Leu         
United States, New Hampshire
New Hampshire Oncology Hematology PA-Concord Recruiting
Concord, New Hampshire, United States, 03301
Contact: Site Public Contact    603-224-2556      
Principal Investigator: Douglas J. Weckstein         
New Hampshire Oncology Hematology PA-Hooksett Recruiting
Hooksett, New Hampshire, United States, 03106
Contact: Site Public Contact    800-339-6484      
Principal Investigator: Douglas J. Weckstein         
United States, New Jersey
The Valley Hospital-Luckow Pavilion Recruiting
Paramus, New Jersey, United States, 07652
Contact: Site Public Contact    201-634-5792      
Principal Investigator: Eleonora Teplinsky         
United States, New Mexico
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87102
Contact: Site Public Contact    505-925-0366    LByatt@nmcca.org   
Principal Investigator: Bernard Tawfik         
New Mexico Oncology Hematology Consultants Recruiting
Albuquerque, New Mexico, United States, 87109
Contact: Site Public Contact    505-272-0530    CLee@nmcca.org   
Principal Investigator: Bernard Tawfik         
Presbyterian Kaseman Hospital Recruiting
Albuquerque, New Mexico, United States, 87110
Contact: Site Public Contact    505-559-6113    WBurman@phs.org   
Principal Investigator: Bernard Tawfik         
Memorial Medical Center - Las Cruces Recruiting
Las Cruces, New Mexico, United States, 88011
Contact: Site Public Contact    575-556-6545    Kim.Hoffman@lpnt.net   
Principal Investigator: Bernard Tawfik         
Presbyterian Rust Medical Center/Jorgensen Cancer Center Recruiting
Rio Rancho, New Mexico, United States, 87124
Contact: Site Public Contact    505-559-6113    WBurman@phs.org   
Principal Investigator: Bernard Tawfik         
United States, Ohio
Strecker Cancer Center-Belpre Recruiting
Belpre, Ohio, United States, 45714
Contact: Site Public Contact    800-523-3977    sheree@columbusccop.org   
Principal Investigator: Timothy D. Moore         
Adena Regional Medical Center Recruiting
Chillicothe, Ohio, United States, 45601
Contact: Site Public Contact    877-779-7585    sheree@columbusccop.org   
Principal Investigator: Timothy D. Moore         
MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Contact: Site Public Contact    216-778-8526    dstrater@metrohealth.org   
Principal Investigator: Bruce J. Averbook         
Columbus Oncology and Hematology Associates Inc Recruiting
Columbus, Ohio, United States, 43214
Contact: Site Public Contact    614-488-2118    sheree@columbusccop.org   
Principal Investigator: Timothy D. Moore         
Grant Medical Center Recruiting
Columbus, Ohio, United States, 43215
Contact: Site Public Contact    614-566-4475    sheree@columbusccop.org   
Principal Investigator: Timothy D. Moore         
The Mark H Zangmeister Center Recruiting
Columbus, Ohio, United States, 43219
Contact: Site Public Contact    614-488-2118    sheree@columbusccop.org   
Principal Investigator: Timothy D. Moore         
Doctors Hospital Recruiting
Columbus, Ohio, United States, 43228
Contact: Site Public Contact    614-566-3275    sheree@columbusccop.org   
Principal Investigator: Timothy D. Moore         
Delaware Health Center-Grady Cancer Center Recruiting
Delaware, Ohio, United States, 43015
Contact: Site Public Contact    740-615-0227    sheree@columbusccop.org   
Principal Investigator: Timothy D. Moore         
OhioHealth Mansfield Hospital Recruiting
Mansfield, Ohio, United States, 44903
Contact: Site Public Contact    419-526-8018    sheree@columbusccop.org   
Principal Investigator: Timothy D. Moore         
Marietta Memorial Hospital Recruiting
Marietta, Ohio, United States, 45750
Contact: Site Public Contact    800-523-3977    sheree@columbusccop.org   
Principal Investigator: Timothy D. Moore         
OhioHealth Marion General Hospital Recruiting
Marion, Ohio, United States, 43302
Contact: Site Public Contact    614-488-2118    sheree@columbusccop.org   
Principal Investigator: Timothy D. Moore         
Licking Memorial Hospital Recruiting
Newark, Ohio, United States, 43055
Contact: Site Public Contact    740-348-4000    sheree@columbusccop.org   
Principal Investigator: Timothy D. Moore         
Southern Ohio Medical Center Recruiting
Portsmouth, Ohio, United States, 45662
Contact: Site Public Contact    614-488-2118    sheree@columbusccop.org   
Principal Investigator: Timothy D. Moore         
Genesis Healthcare System Cancer Care Center Recruiting
Zanesville, Ohio, United States, 43701
Contact: Site Public Contact    740-454-5232    sheree@columbusccop.org   
Principal Investigator: Timothy D. Moore         
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Site Public Contact    405-271-8777    ou-clinical-trials@ouhsc.edu   
Principal Investigator: Wajeeha Razaq         
Oklahoma Cancer Specialists and Research Institute-Tulsa Recruiting
Tulsa, Oklahoma, United States, 74146
Contact: Site Public Contact    918-505-3200      
Principal Investigator: Wajeeha Razaq         
United States, Oregon
Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213
Contact: Site Public Contact    503-215-2614    CanRsrchStudies@providence.org   
Principal Investigator: Dan S. Zuckerman         
United States, Pennsylvania
Saint Luke's University Hospital-Bethlehem Campus Recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: Site Public Contact    412-339-5294    Roster@nrgoncology.org   
Principal Investigator: Hikaru Nakajima         
UPMC Pinnacle Cancer Center/Community Osteopathic Campus Recruiting
Harrisburg, Pennsylvania, United States, 17109
Contact: Site Public Contact    717-724-6765    klitchfield@PINNACLEHEALTH.org   
Principal Investigator: Adam M. Brufsky         
University of Pittsburgh Cancer Institute (UPCI) Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Site Public Contact    412-647-8073      
Principal Investigator: Adam M. Brufsky         
Guthrie Medical Group PC-Robert Packer Hospital Recruiting
Sayre, Pennsylvania, United States, 18840
Contact: Site Public Contact    800-836-0388      
Principal Investigator: Philip A. Lowry         
Reading Hospital Recruiting
West Reading, Pennsylvania, United States, 19611
Contact: Site Public Contact    610-988-9323      
Principal Investigator: Terrence P. Cescon         
UPMC Susquehanna Recruiting
Williamsport, Pennsylvania, United States, 17701
Contact: Site Public Contact    800-598-4282      
Principal Investigator: Adam M. Brufsky         
Abington Memorial Hospital-Asplundh Cancer Pavilion Recruiting
Willow Grove, Pennsylvania, United States, 19090
Contact: Site Public Contact    215-481-2402      
Principal Investigator: Willard G. Andrews         
United States, South Carolina
Lexington Medical Center Recruiting
West Columbia, South Carolina, United States, 29169
Contact: Site Public Contact    803-936-8050      
Principal Investigator: Steven A. Madden         
United States, Virginia
Bon Secours Memorial Regional Medical Center Recruiting
Mechanicsville, Virginia, United States, 23116
Contact: Site Public Contact    804-893-8611    Melissa_Godsey@bshsi.org   
Principal Investigator: William J. Irvin         
Bon Secours Saint Francis Medical Center Recruiting
Midlothian, Virginia, United States, 23114
Contact: Site Public Contact    804-893-8611    Melissa_Godsey@bshsi.org   
Principal Investigator: William J. Irvin         
Bon Secours Saint Mary's Hospital Recruiting
Richmond, Virginia, United States, 23226
Contact: Site Public Contact    412-339-5294    Roster@nrgoncology.org   
Principal Investigator: William J. Irvin         
Virginia Cancer Institute Recruiting
Richmond, Virginia, United States, 23230
Contact: Site Public Contact    804-287-3000    david.trent@comcast.net   
Principal Investigator: Hetal R. Vachhani         
Virginia Commonwealth University/Massey Cancer Center Recruiting
Richmond, Virginia, United States, 23298
Contact: Site Public Contact       mwellons@vcu.edu   
Principal Investigator: Hetal R. Vachhani         
VCU Community Memorial Health Center Recruiting
South Hill, Virginia, United States, 23970
Contact: Site Public Contact    434-774-2442    sherman.baker@vcuhealth.org   
Principal Investigator: Hetal R. Vachhani         
Shenandoah Oncology PC Recruiting
Winchester, Virginia, United States, 22601
Contact: Site Public Contact    540-662-1108    William.Houck@usoncology.com   
Principal Investigator: Hetal R. Vachhani         
United States, Wisconsin
Langlade Hospital and Cancer Center Recruiting
Antigo, Wisconsin, United States, 54409
Contact: Site Public Contact    715-623-9869    Juli.Alford@aspirus.org   
Principal Investigator: Harish G. Ahuja         
Aspirus Regional Cancer Center Recruiting
Wausau, Wisconsin, United States, 54401
Contact: Site Public Contact    877-405-6866      
Principal Investigator: Harish G. Ahuja         
Aspirus UW Cancer Center Recruiting
Wisconsin Rapids, Wisconsin, United States, 54494
Contact: Site Public Contact    715-422-7718      
Principal Investigator: Harish G. Ahuja         
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Charles E Geyer NRG Oncology

Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT03199885     History of Changes
Other Study ID Numbers: NCI-2017-01119
NCI-2017-01119 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
NRG-BR004 ( Other Identifier: NRG Oncology )
NRG-BR004 ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page
URL: https://grants.nih.gov/policy/sharing.htm

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Breast Neoplasms
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Trastuzumab
Atezolizumab
Pertuzumab
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs