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Testing Whether Treating Breast Cancer Metastases With Surgery or High-Dose Radiation Improves Survival

Sponsor
NRG Oncology (Other)
Overall Status
Suspended
CT.gov ID
NCT02364557
Collaborator
National Cancer Institute (NCI) (NIH)
360
Enrollment
164
Locations
2
Arms
96.2
Anticipated Duration (Months)
2.2
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This randomized phase II/III trial studies how well standard of care therapy with stereotactic radiosurgery and/or surgery works and compares it to standard of care therapy alone in treating patients with breast cancer that has spread to one or two locations in the body (limited metastatic) that are previously untreated. Standard of care therapy comprising chemotherapy, hormonal therapy, biological therapy, and others may help stop the spread of tumor cells. Radiation therapy and/or surgery is usually only given with standard of care therapy to relieve pain; however, in patients with limited metastatic breast cancer, stereotactic radiosurgery, also known as stereotactic body radiation therapy, may be able to send x-rays directly to the tumor and cause less damage to normal tissue and surgery may be able to effectively remove the metastatic tumor cells. It is not yet known whether standard of care therapy is more effective with stereotactic radiosurgery and/or surgery in treating limited metastatic breast cancer.

Condition or Disease Intervention/Treatment Phase
  • Other: Laboratory Biomarker Analysis
  • Radiation: Stereotactic Radiosurgery
  • Procedure: Therapeutic Conventional Surgery
 Phase 2/Phase 3

Detailed Description

PRIMARY OBJECTIVES:
  1. To determine whether ablation (through stereotactic body radiation therapy [SBRT] [stereotactic radiosurgery] and/or surgical resection of all known metastases) in oligometastatic breast cancer patients provides a sufficient signal for improved progression-free survival (PFS) to warrant full accrual to the Phase III portion of the trial. (Phase II-R) II. To determine whether ablation (through SBRT and/or surgical resection of all known metastases) in oligometastatic breast cancer patients significantly improves overall survival (OS). (Phase III)
SECONDARY OBJECTIVES:

  1. To evaluate treated metastasis control according to tumor receptor status (estrogen receptor [ER], progesterone receptor [PR], human epidermal growth factor receptor [HER]-2), use of chemotherapy, surgery versus (vs.) ablative therapy, and number of metastases.

  2. To evaluate whether the addition of ablative metastasis directed therapy significantly reduces the number of distant recurrences (new metastases) in patients who progress according to tumor receptor status (ER, PR, HER-2); use of chemotherapy, and number of metastases.

  3. To evaluate adverse events in patients who receive ablative metastasis-directed therapy to all known metastases in addition to standard medical therapy compared with those treated with standard medical therapy alone.

EXPLORATORY OBJECTIVE:
  1. To explore the most appropriate and clinically relevant technological parameters to ensure quality and effectiveness throughout the radiation therapy processes, including imaging, simulation, target and critical structure definition, treatment planning, image guidance, and delivery.
TRANSLATIONAL RESEARCH OBJECTIVES:

  1. To determine whether < 5 circulating tumor cells (CTCs) (per 7.5 ml of blood) is an independent prognostic (outcome) marker for improved PFS and OS in oligometastatic breast cancer.

  2. To determine whether < 5 CTCs (per 7.5 ml of blood) is an independent predictive (response to therapy) marker for improved PFS and OS in oligometastatic breast cancer.

  3. To determine whether eliminating CTCs (0/7.5 ml of blood in patients with at least 2 CTCs at registration) is both a prognostic and predictive marker for improved PFS and OS.

  4. To evaluate the prognostic and predictive properties of CTC count as a continuous measure of PFS and OS.

  5. To store material for retrospective analysis of circulating tumor deoxyribonucleic acid (ctDNA).

  6. To store material for retrospective analysis of circulating micro-ribonucleic acid (RNA).

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

ARM 1: Patients continue to receive their current planned systemic therapy at the discretion of the treating physician.

ARM 2: Patients continue to receive their current planned systemic therapy at the discretion of the treating physician. Patients also undergo stereotactic radiosurgery in 1, 3, or 5 fractions within 3 weeks and/or surgery at the discretion of the treating physician.

ARM 1: Patients are followed every 3 months from randomization to 2 years. ARM 2: Patients are followed 25-35 days post-ablation, every 3 months from randomization to 2 years, and then yearly thereafter.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
360 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase IIR/III Trial of Standard of Care Therapy With or Without Stereotactic Body Radiotherapy (SBRT) and/or Surgical Ablation for Newly Oligometastatic Breast Cancer
Actual Study Start Date :
Dec 24, 2014
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Arm 1 (standard of care)

Patients continue to receive their current planned systemic therapy at the discretion of the treating physician.
Experimental: Arm 2 (stereotactic radiosurgery, surgery)

Patients continue to receive their current planned systemic therapy at the discretion of the treating physician. Patients also undergo stereotactic radiosurgery in 1, 3, or 5 fractions within 3 weeks and/or surgery at the discretion of the treating physician.

Other: Laboratory Biomarker Analysis
Correlative studies

Radiation: Stereotactic Radiosurgery
Undergo stereotactic radiosurgery
Other Names:
  • Stereotactic External Beam Irradiation
  • stereotactic external-beam radiation therapy
  • Stereotactic Radiation Therapy
  • Stereotactic Radiotherapy
  • stereotaxic radiation therapy
  • stereotaxic radiosurgery

    • Procedure: Therapeutic Conventional Surgery
    Undergo surgery

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free survival (PFS) (failure: progression or death due to any cause) (Phase II-R) [From the date of randomization to the date of first PFS failure or last follow-up]

      Progression-free survival will be estimated by the Kaplan-Meier method, with progression defined as: progression of initial/treated metastases (using the revised Response Evaluation Criteria in Solid Tumors [RECIST] guideline), appearance of new metastases, or death due to any cause. The distribution of PFS estimates between the two arms will be compared using the log rank test.

    2. Overall survival (OS) (failure: death due to any cause) (Phase III) [From the date of randomization to the date of death or last follow-up]

      Overall survival will be estimated by the Kaplan-Meier method. The distribution of OS estimates between the two arms will be compared using the log rank test. The Cox proportional hazard regression model will be used to analyze the effects of factors, in addition to treatment, that may be associated with OS.

    Secondary Outcome Measures

    1. Existing metastasis control [From the date of randomization to the date of death or last follow-up]

    2. Appearance of new metastases [From the date of randomization to the date of the first appearance of any new metastases]

      Failure for this endpoint will be the appearance of any new metastases. The cumulative probability of new metastases in the presence of competing failure events will be estimated by the cumulative incidence method. The cumulative incidence distributions between the two arms will be compared using Gray's test. The Cox proportional hazard regression model will be used to analyze the effects of factors, in addition to treatment, that may be associated with the incidence of new metastases.

    3. Incidence of adverse events [From the date of randomization to the date of death or last follow-up]

      Will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4. The frequencies and severity of adverse events by treatment arm will be analyzed.

    4. Initial presence of circulating tumor cells (CTCs) in blood samples [Baseline]

      The prognostic effect of the initial presence of CTCs at baseline on PFS (OS) will be evaluated using the Cox proportional hazards model, controlling for treatment effect and stratification factors. The hypothesis tests will be two-sided and will use an alpha level of 0.05 to determine significance.

    5. Presence of circulating tumor cells (CTCs) after treatment in blood samples [Up to 3 months]

      The interaction between treatment effect and the initial presence of CTCs at baseline on PFS (OS) will be evaluated in the Cox model, which will include an indicator for treatment group, an indicator for presence of CTCs (>= 5 per 7.5 ml of blood), and their interaction term. The analysis will be adjusted for the stratification factors.

    6. Change in circulating tumor cells (CTC) count in blood samples [Baseline to up to 3 months]

      The effect of change in CTC count from CTC >= 2 per 7.5 ml of blood at baseline to CTC = 0 at follow-up after initial treatment on PFS (OS) will be evaluated using the Cox proportional hazards model, controlling for treatment effect and stratification factors. The analyses will be conditional on a patient's event-free survival up to post-treatment evaluation. The interaction between treatment effect and change in CTC count will be evaluated in the Cox model, which will include an indicator for treatment group, an indicator for change of CTCs, and their interaction term.

    7. Levels of circulating tumor deoxyribonucleic acid (ctDNA) in plasma samples [Up to 3 months]

      The prognostic effect of dichotomized ctDNA on PFS (OS) will be evaluated using the Cox proportional hazards model, controlling for treatment effect and stratification factors. In addition, the presence of the interaction between treatment effect and dichotomized ctDNA will be evaluated (predictive effect). Spearman rank correlation coefficient will be used to correlate the levels of CTCs and ctDNA.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • A patient cannot be considered eligible for this study unless ALL of the following conditions are met.

    • Pathologically confirmed metastatic breast cancer

    • Known estrogen, progesterone, and HER2 status of either primary tumor or metastasis;

    • Note: estrogen, progesterone and HER2 status of metastasis preferred for stratification

    • Number of allowable metastases:

    • =< 4 metastases seen on standard imaging within 60 days prior to registration when all metastatic disease is located within the following sites:

    • Peripheral lung

    • Osseous (bone)

    • Spine

    • Central lung

    • Abdominal-pelvic metastases (lymph node/adrenal gland)

    • Liver

    • Mediastinal/cervical lymph node

    • All known disease amenable to metastasis-directed therapy with either SBRT or resection

    • NOTE: Symptomatic bone metastasis are allowed if ablative therapy can be delivered

    • NOTE: Sites for possible surgical excision include lung, liver, adrenal gland, bone, small intestine, large intestine, ovary, and amenable nodal disease sites

    • NOTE: Surgical stabilization is allowed for a metastasis if it is followed by conventionally fractionated external beam radiotherapy

    • Maximum diameter of individual metastasis in any dimension =< 5 cm

    • There are no restrictions on distance between the metastases

    • Patients must be registered within 365 days of the initial metastatic breast cancer diagnosis; first-line standard systemic therapy (chemotherapy, anti-endocrine therapy, anti-HER2, or other standard targeted therapy) for metastatic breast cancer must be given or planned to be given; if given before study entry, it cannot have exceeded a duration of 12 months at the time of registration (Note: sequencing of ablative therapy [surgery or SBRT] relative to systemic therapy, for patients randomized to Arm 2, is at the discretion of the treating physician)

    • The primary tumor site must be controlled prior to registration

    • For those who present with synchronous primary and oligometastatic disease, primary must be controlled prior to registration

    • The definition of control is definitive surgery by excision or mastectomy (+/- radiotherapy) per institution preference For those who present with local recurrence and oligometastatic disease, local recurrence must be controlled prior to registration

    • The definition of control is definitive surgery by excision or mastectomy (+/- radiotherapy) per institution preference

    • Appropriate stage for study entry based on the following diagnostic workup:

    • History/physical examination within 60 days prior to registration

    • Clinical grade computed tomography (CT) scans of the chest, abdomen, and pelvis with radionuclide bone scan OR whole body positron emission tomography (PET)/CT within 60 days prior to study registration

    • Zubrod performance status =< 2 within 60 days prior to registration

    • Blood cell count (CBC)/differential obtained within 60 days prior to registration on study

    • Absolute neutrophil count (ANC) >= 500 cells/mm^3

    • Platelets >= 50,000 cells/mm^3

    • Hemoglobin >= 8.0 g/dl (note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable)

    • For females of child-bearing potential, negative serum or urine pregnancy test within 14 days prior to study registration

    • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry

    Exclusion Criteria:

    • Patients with any of the following conditions are NOT eligible for this study.

    • Pathologic evidence of active primary disease or local/regional breast tumor recurrence at the time of registration;

    • Co-existing or prior invasive malignancy (except non-melanomatous skin cancer), unless disease free for a minimum of 3 years; previous RT dose, date, fraction size, must be reported

    • Metastases with indistinct borders making targeting not feasible

    • NOTE: A potential issue with bone metastases is that they often are not discrete; since many patients on this protocol will have bone metastases, this will be an important issue; theoretically, Houndsfield units might provide an appropriate measure; however, a sclerotic lesion against dense cortical bone will not have a sharp demarcation based on Houndsfield units (HU); therefore, we acknowledge that such determinations will pose a challenge and thus the physician's judgment will be required

    • Prior palliative radiation treatment for metastatic disease to be treated on the protocol (including radiopharmaceuticals)

    • Metastases located within 3 cm of the previously irradiated structures:

    • Spinal cord previously irradiated to > 40 Gy (delivered in =< 3 Gy/fraction)

    • Brachial plexus previously irradiated to > 50 Gy (delivered in =< 3 Gy/fraction)

    • Small intestine, large intestine, or stomach previously irradiated to > 45 Gy (delivered in =< 3 Gy/fraction)

    • Brainstem previously irradiated to > 50 Gy (delivered in =< 3 Gy/fraction)

    • Whole lung previously irradiated with prior V20Gy > 30% (delivered in =< 3 Gy/fraction)

    • Primary tumor irradiated with SBRT

    • Metastasis irradiated with SBRT

    • Brain metastases

    • Exudative, bloody, or cytological proven malignant effusions

    • Severe, active co-morbidity defined as follows:

    • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months

    • Transmural myocardial infarction within the last 6 months

    • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration

    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration

    • Pregnancy; lactating females must cease expression of milk prior to signing consent to be eligible

    • Human immunodeficiency virus (HIV) positive with cluster of differentiation (CD)4 count < 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to registration; note also that HIV testing is not required for eligibility for this protocol

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Cancer Center Birmingham Alabama United States 35233
    2 CTCA at Western Regional Medical Center Goodyear Arizona United States 85338
    3 Arizona Center for Cancer Care-Peoria Peoria Arizona United States 85381
    4 Alta Bates Summit Medical Center-Herrick Campus Berkeley California United States 94704
    5 UC San Diego Moores Cancer Center La Jolla California United States 92093
    6 Los Angeles County-USC Medical Center Los Angeles California United States 90033
    7 USC / Norris Comprehensive Cancer Center Los Angeles California United States 90033
    8 Cedars Sinai Medical Center Los Angeles California United States 90048
    9 UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California United States 92868
    10 The Permanente Medical Group-Roseville Radiation Oncology Roseville California United States 95678
    11 Sutter Medical Center Sacramento Sacramento California United States 95816
    12 University of California Davis Comprehensive Cancer Center Sacramento California United States 95817
    13 Naval Medical Center -San Diego San Diego California United States 92134
    14 Kaiser Permanente Cancer Treatment Center South San Francisco California United States 94080
    15 Saint Joseph's Medical Center Stockton California United States 95204
    16 Gene Upshaw Memorial Tahoe Forest Cancer Center Truckee California United States 96161
    17 University of Colorado Hospital Aurora Colorado United States 80045
    18 Penrose-Saint Francis Healthcare Colorado Springs Colorado United States 80907
    19 UCHealth Memorial Hospital Central Colorado Springs Colorado United States 80909
    20 Poudre Valley Hospital Fort Collins Colorado United States 80524
    21 McKee Medical Center Loveland Colorado United States 80539
    22 Helen F Graham Cancer Center Newark Delaware United States 19713
    23 University of Florida Health Science Center - Gainesville Gainesville Florida United States 32610
    24 Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood Florida United States 33021
    25 Mayo Clinic in Florida Jacksonville Florida United States 32224-9980
    26 Miami Cancer Institute Miami Florida United States 33176
    27 Orlando Health Cancer Institute Orlando Florida United States 32806
    28 Memorial Hospital West Pembroke Pines Florida United States 33028
    29 Emory University Hospital Midtown Atlanta Georgia United States 30308
    30 Piedmont Hospital Atlanta Georgia United States 30309
    31 Emory University Hospital/Winship Cancer Institute Atlanta Georgia United States 30322
    32 Emory Saint Joseph's Hospital Atlanta Georgia United States 30342
    33 John B Amos Cancer Center Columbus Georgia United States 31904
    34 CTCA at Southeastern Regional Medical Center Newnan Georgia United States 30265
    35 Lewis Hall Singletary Oncology Center Thomasville Georgia United States 31792
    36 Queen's Medical Center Honolulu Hawaii United States 96813
    37 The Cancer Center of Hawaii-Liliha Honolulu Hawaii United States 96817
    38 Northwestern University Chicago Illinois United States 60611
    39 Rush University Medical Center Chicago Illinois United States 60612
    40 University of Illinois Chicago Illinois United States 60612
    41 University of Chicago Comprehensive Cancer Center Chicago Illinois United States 60637
    42 Decatur Memorial Hospital Decatur Illinois United States 62526
    43 Northwestern Medicine Cancer Center Delnor Geneva Illinois United States 60134
    44 Loyola University Medical Center Maywood Illinois United States 60153
    45 Methodist Medical Center of Illinois Peoria Illinois United States 61636
    46 Memorial Medical Center Springfield Illinois United States 62781
    47 Southwest Illinois Health Services LLP Swansea Illinois United States 62226
    48 Carle Cancer Center Urbana Illinois United States 61801
    49 Northwestern Medicine Cancer Center Warrenville Warrenville Illinois United States 60555
    50 Midwestern Regional Medical Center Zion Illinois United States 60099
    51 Saint Vincent Anderson Regional Hospital/Cancer Center Anderson Indiana United States 46016
    52 Parkview Hospital Randallia Fort Wayne Indiana United States 46805
    53 Parkview Regional Medical Center Fort Wayne Indiana United States 46845
    54 IU Health Ball Memorial Hospital Muncie Indiana United States 47303
    55 Memorial Hospital of South Bend South Bend Indiana United States 46601
    56 Ascension Via Christi Hospitals Wichita Wichita Kansas United States 67214
    57 Owensboro Health Mitchell Memorial Cancer Center Owensboro Kentucky United States 42303
    58 MaineHealth Coastal Cancer Treatment Center Bath Maine United States 04530
    59 MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford Biddeford Maine United States 04005
    60 Maine Medical Center-Bramhall Campus Portland Maine United States 04102
    61 MaineHealth Cancer Care Center of York County Sanford Maine United States 04073
    62 MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford Sanford Maine United States 04073
    63 Maine Medical Center- Scarborough Campus Scarborough Maine United States 04074
    64 University of Maryland/Greenebaum Cancer Center Baltimore Maryland United States 21201
    65 Greater Baltimore Medical Center Baltimore Maryland United States 21204
    66 UM Upper Chesapeake Medical Center Bel Air Maryland United States 21014
    67 Central Maryland Radiation Oncology in Howard County Columbia Maryland United States 21044
    68 Lahey Hospital and Medical Center Burlington Massachusetts United States 01805
    69 Lowell General Hospital Lowell Massachusetts United States 01854
    70 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109
    71 Henry Ford Cancer Institute-Downriver Brownstown Michigan United States 48183
    72 GenesisCare USA - Clarkston Clarkston Michigan United States 48346
    73 Henry Ford Macomb Hospital-Clinton Township Clinton Township Michigan United States 48038
    74 Henry Ford Hospital Detroit Michigan United States 48202
    75 GenesisCare USA - Farmington Hills Farmington Hills Michigan United States 48334
    76 West Michigan Cancer Center Kalamazoo Michigan United States 49007
    77 Saint Joseph Mercy Oakland Pontiac Michigan United States 48341
    78 William Beaumont Hospital-Royal Oak Royal Oak Michigan United States 48073
    79 GenesisCare USA - Troy Troy Michigan United States 48098
    80 Henry Ford West Bloomfield Hospital West Bloomfield Michigan United States 48322
    81 Mercy Hospital Coon Rapids Minnesota United States 55433
    82 Saint Luke's Hospital of Duluth Duluth Minnesota United States 55805
    83 Mayo Clinic in Rochester Rochester Minnesota United States 55905
    84 Regions Hospital Saint Paul Minnesota United States 55101
    85 Saint Francis Medical Center Cape Girardeau Missouri United States 63703
    86 Washington University School of Medicine Saint Louis Missouri United States 63110
    87 Mercy Hospital South Saint Louis Missouri United States 63128
    88 Missouri Baptist Medical Center Saint Louis Missouri United States 63131
    89 Benefis Healthcare- Sletten Cancer Institute Great Falls Montana United States 59405
    90 Kalispell Regional Medical Center Kalispell Montana United States 59901
    91 University of Nebraska Medical Center Omaha Nebraska United States 68198
    92 Renown Regional Medical Center Reno Nevada United States 89502
    93 Wentworth-Douglass Hospital Dover New Hampshire United States 03820
    94 Dartmouth Hitchcock Medical Center Lebanon New Hampshire United States 03756
    95 Virtua Memorial Mount Holly New Jersey United States 08060
    96 Community Medical Center Toms River New Jersey United States 08755
    97 Virtua Voorhees Voorhees New Jersey United States 08043
    98 Lovelace Medical Center-Saint Joseph Square Albuquerque New Mexico United States 87102
    99 University of New Mexico Cancer Center Albuquerque New Mexico United States 87102
    100 Lovelace Radiation Oncology Albuquerque New Mexico United States 87109
    101 New Mexico Oncology Hematology Consultants Albuquerque New Mexico United States 87109
    102 Christus Saint Vincent Regional Cancer Center Santa Fe New Mexico United States 87505
    103 Montefiore Medical Center - Moses Campus Bronx New York United States 10467
    104 NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York United States 10032
    105 University of Rochester Rochester New York United States 14642
    106 Dickstein Cancer Treatment Center White Plains New York United States 10601
    107 Rex Hematology Oncology Associates-Cary Cary North Carolina United States 27518
    108 UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina United States 27599
    109 Duke University Medical Center Durham North Carolina United States 27710
    110 Rex Hematology Oncology Associates-Garner Garner North Carolina United States 27529
    111 Rex Cancer Center Raleigh North Carolina United States 27607
    112 Rex Hematology Oncology Associates-Blue Ridge Raleigh North Carolina United States 27607
    113 Rex Cancer Center of Wakefield Raleigh North Carolina United States 27614
    114 NHRMC Radiation Oncology - Supply Supply North Carolina United States 28462
    115 New Hanover Regional Medical Center/Zimmer Cancer Center Wilmington North Carolina United States 28401
    116 NHRMC Radiation Oncology - 16th Street Wilmington North Carolina United States 28401
    117 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157
    118 Sanford Bismarck Medical Center Bismarck North Dakota United States 58501
    119 Cleveland Clinic Akron General Akron Ohio United States 44307
    120 Case Western Reserve University Cleveland Ohio United States 44106
    121 Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210
    122 ProMedica Flower Hospital Sylvania Ohio United States 43560
    123 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    124 Legacy Mount Hood Medical Center Gresham Oregon United States 97030
    125 Legacy Good Samaritan Hospital and Medical Center Portland Oregon United States 97210
    126 Providence Portland Medical Center Portland Oregon United States 97213
    127 Providence Saint Vincent Medical Center Portland Oregon United States 97225
    128 UPMC Pinnacle Cancer Center/Community Osteopathic Campus Harrisburg Pennsylvania United States 17109
    129 University of Pennsylvania/Abramson Cancer Center Philadelphia Pennsylvania United States 19104
    130 Allegheny General Hospital Pittsburgh Pennsylvania United States 15212
    131 UPMC-Shadyside Hospital Pittsburgh Pennsylvania United States 15232
    132 Guthrie Medical Group PC-Robert Packer Hospital Sayre Pennsylvania United States 18840
    133 Reading Hospital West Reading Pennsylvania United States 19611
    134 Self Regional Healthcare Greenwood South Carolina United States 29646
    135 Gibbs Cancer Center-Pelham Greer South Carolina United States 29651
    136 Spartanburg Medical Center Spartanburg South Carolina United States 29303
    137 Texas Oncology-Austin Midtown Austin Texas United States 78705
    138 UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas United States 75390
    139 M D Anderson Cancer Center Houston Texas United States 77030
    140 Ogden Regional Medical Center Ogden Utah United States 84405
    141 Huntsman Cancer Institute/University of Utah Salt Lake City Utah United States 84112
    142 Inova Fairfax Hospital Falls Church Virginia United States 22042
    143 Bon Secours Saint Mary's Hospital Richmond Virginia United States 23226
    144 Legacy Salmon Creek Hospital Vancouver Washington United States 98686
    145 Edwards Comprehensive Cancer Center Huntington West Virginia United States 25701
    146 West Virginia University Healthcare Morgantown West Virginia United States 26506
    147 Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin United States 54301
    148 Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay Wisconsin United States 54303
    149 Gundersen Lutheran Medical Center La Crosse Wisconsin United States 54601
    150 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    151 Marshfield Clinic Stevens Point Center Stevens Point Wisconsin United States 54482
    152 Froedtert West Bend Hospital/Kraemer Cancer Center West Bend Wisconsin United States 53095
    153 Diagnostic and Treatment Center Weston Wisconsin United States 54476
    154 Tom Baker Cancer Centre Calgary Alberta Canada T2N 4N2
    155 Cross Cancer Institute Edmonton Alberta Canada T6G 1Z2
    156 London Regional Cancer Program London Ontario Canada N6A 4L6
    157 Ottawa Hospital and Cancer Center-General Campus Ottawa Ontario Canada K1H 8L6
    158 CHUM - Hopital Notre-Dame Montreal Quebec Canada H2L 4M1
    159 McGill University Department of Oncology Montreal Quebec Canada H2W 1S6
    160 CHUM - Centre Hospitalier de l'Universite de Montreal Montreal Quebec Canada H2X 3E4
    161 The Research Institute of the McGill University Health Centre (MUHC) Montreal Quebec Canada H3H 2R9
    162 Jewish General Hospital Montreal Quebec Canada H3T 1E2
    163 Yonsei University Health System-Severance Hospital Seoul Korea, Republic of 120-752
    164 King Faisal Specialist Hospital and Research Centre Riyadh Saudi Arabia 11211

    Sponsors and Collaborators

    • NRG Oncology
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Steven J Chmura, NRG Oncology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    NRG Oncology
    ClinicalTrials.gov Identifier:
    NCT02364557
    Other Study ID Numbers:
    • NRG-BR002
    • NCI-2014-01810
    • NRG-BR002
    • NRG-BR002
    • NRG-BR002
    • U10CA180868
    First Posted:
    Feb 18, 2015
    Last Update Posted:
    Sep 28, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms
    Neoplasms
    Neoplasms, Second Primary

    Study Results

    No Results Posted as of Sep 28, 2021