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Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer (SOPHIA)

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ClinicalTrials.gov Identifier: NCT02492711
Recruitment Status : Recruiting
First Posted : July 9, 2015
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
MacroGenics

Brief Summary:
The purpose of this study is to determine whether patients treated with margetuximab plus chemotherapy have longer progression free survival and overall survival than patients treated with trastuzumab plus chemotherapy.

Condition or disease Intervention/treatment Phase
HER-2 Positive Breast Cancer Metastatic Neoplasm Biological: Margetuximab Biological: Trastuzumab Drug: Capecitabine Drug: Eribulin Drug: Gemcitabine Drug: Vinorelbine Phase 3

Expanded Access : An investigational treatment associated with this study is temporarily not available outside the clinical trial.   More info ...

Detailed Description:
An evaluation of efficacy, as measured by progression-free survival (PFS) assessed by independent review and overall survival (OS), of margetuximab plus chemotherapy compared with trastuzumab plus chemotherapy in patients with advanced HER2+ breast cancer who have received at least 2 prior lines of anti-HER2 directed therapy in the metastatic setting, or in case of having received (neo)adjuvant pertuzumab, at least 1 prior line of anti-HER2 directed therapy in the metastatic setting, and who have received at least one, and no more than three, lines of therapy overall in the metastatic setting. A non-randomized sub-study cohort of approximately 78 patients will be enrolled to evaluate the safety of a reduced margetuximab infusion rate in patients receiving margetuximab either as monotherapy or in combination with chemotherapy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 530 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized Study of Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of Patients With HER2+ Metastatic Breast Cancer Who Have Received Prior Anti-HER2 Therapies and Require Systemic Treatment
Actual Study Start Date : August 24, 2015
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Trastuzumab

Arm Intervention/treatment
Experimental: Margetuximab plus chemotherapy
Margetuximab 15 mg/kg every 21 days plus Capecitabine 1000 mg/m2 BID for 14 days in a 21-day cycle or Eribulin 1.4 mg/m2 Day 1 and 8 of a 21-day cycle or Gemcitabine 1000 mg/m2 Day 1 and 8 of a 21-day cycle or Vinorelbine 25-30 mg/m2 Day 1 and 8 of a 21-day cycle
Biological: Margetuximab
15 mg/kg via IV (intravenous) infusion over 120 minutes on day 1 of each 21 day cycle, until progression or unacceptable toxicity develops.

Drug: Capecitabine
1000 mg/m2 BID for 14 days in a 21-day cycle
Other Name: Xeloda®

Drug: Eribulin
1.4 mg/m2 on days 1 and 8 of a 21-day cycle
Other Name: Halaven®

Drug: Gemcitabine
1000 mg/m2 on days 1 and 8 of a 21-day cycle
Other Name: Gemzar ®

Drug: Vinorelbine
25-30 mg/m2 on days 1 and 8 of a 21-day cycle
Other Name: Navelbine®

Active Comparator: Trastuzumab plus chemotherapy
Trastuzumab 8 mg/kg loading dose then 6 mg/kg every 21 days plus Capecitabine 1000 mg/m2 BID for 14 days in a 21-day cycle or Eribulin 1.4 mg/m2 Day 1 and 8 of a 21-day cycle or Gemcitabine 1000 mg/m2 Day 1 and 8 of a 21-day cycle or Vinorelbine 25-30 mg/m2 Day 1 and 8 of a 21-day cycle
Biological: Trastuzumab
8 mg/kg via IV (intravenous) infusion for the first dose and 6 mg/kg for all subsequent doses via IV infusion over 30-90 minutes on day 1 of each 21 day cycle, until progression or unacceptable toxicity develops.
Other Name: Herceptin®

Drug: Capecitabine
1000 mg/m2 BID for 14 days in a 21-day cycle
Other Name: Xeloda®

Drug: Eribulin
1.4 mg/m2 on days 1 and 8 of a 21-day cycle
Other Name: Halaven®

Drug: Gemcitabine
1000 mg/m2 on days 1 and 8 of a 21-day cycle
Other Name: Gemzar ®

Drug: Vinorelbine
25-30 mg/m2 on days 1 and 8 of a 21-day cycle
Other Name: Navelbine®




Primary Outcome Measures :
  1. Progression-free survival (PFS) as determined by independent radiological review. [ Time Frame: Approximately 41 months after the first subject is randomized; anticipated evaluation Dec 2018 ]
  2. Overall survival (OS) defined as the number of days from randomization to the date of death (from any cause). [ Time Frame: Approximately 15 months after the last subject is randomized; anticipated evaluation Mar 2020 ]
    Overall survival of margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy in patients with advanced HER2+ breast cancer.

  3. Infusion rate sub-study Grade 3 plus safety [ Time Frame: Cycle 2 (21 days) ]
    Incidence of Grade 3 or higher infusion-related reactions


Secondary Outcome Measures :
  1. To evaluate progression-free survival (PFS), as assessed by study investigators. [ Time Frame: PFS will be evaluated approximately 41 months after the first subject is randomized. ]
  2. To evaluate the objective response rate (ORR) as determined by independent radiological review. [ Time Frame: ORR will be evaluated approximately 41 months after the first subject is randomized. ]
  3. Infusion rate sub-study all safety [ Time Frame: Cycle 2 (21 days) ]
    Incidence of all grades of infusion-related reactions



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:

  • Histologically-proven metastatic or locally-advanced relapsed/refractory HER2+ breast cancer based on the most recently available tumor biopsy collected from the patient. Tumors may be estrogen receptor (ER)/progesterone receptor (PgR) positive or negative.
  • Have received at least 2 prior lines of anti-HER2 directed therapy in the metastatic setting, or in case of having received (neo)adjuvant pertuzumab, at least 1 prior line of anti-HER2 directed therapy in the metastatic setting. In either case, patients must have received prior treatment with pertuzumab, in the (neo)adjuvant or metastatic setting. Prior radiotherapy, hormonal therapies, and other anti-HER2 therapies are allowed.
  • Prior treatment with at least one, and no more than three, lines of therapy overall in the metastatic setting. Patients must have progressed on or following, the most recent line of therapy.
  • Resolution of all chemotherapy or radiation-related toxicities to ≤ Grade 1
  • Life expectancy ≥ 12 weeks
  • Acceptable laboratory parameters
  • Women of childbearing potential must have negative pregnancy test performed within 14 days of randomization and on the first day of treatment. All subjects must agree to use an effective form of contraception for the duration of study treatment and for 7 months after the last dose of study drug.

Infusion sub-study prior therapy requirements: Same as above, except:

  • Must have received 4 or more prior lines or therapy in the metastatic setting
  • Must have received prior trastuzumab, pertuzumab, and T-DM1

Exclusion Criteria:

  • Known, untreated brain metastasis. Patients with signs or symptoms of brain metastasis must have a CT or MRI performed within 4 weeks prior to randomization to specifically exclude the presence of radiographically-detected brain metastases
  • History of uncontrolled seizures within 6 months of randomization
  • History of prior allogeneic bone marrow, stem-cell, or solid organ transplantation
  • History of clinically significant cardiovascular disease
  • Clinically-significant pulmonary compromise, including a requirement for supplemental oxygen use to maintain adequate oxygenation
  • Any condition that would be a contraindication to receiving trastuzumab as described in the approved local label or a condition that would prevent treatment with the physician's choice of chemotherapy

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): NCT02492711


Contacts
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Contact: Sutton Edlich (240) 552-8082

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Locations
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United States, Alabama
Southern Cancer Center Withdrawn
Mobile, Alabama, United States, 36608
United States, Arizona
Ironwood Cancer & Research Center Recruiting
Chandler, Arizona, United States, 85224
Contact: Mindy Raisor    480-324-5230    mraisor@ironwoodcrc.com   
Principal Investigator: Sujith Kalmadi, MD         
Banner MD Anderson Cancer Center Recruiting
Gilbert, Arizona, United States, 85234
Contact: Wendy Schwoegler    480-256-5077    wendy.schwoegler@bannerhealth.com   
Principal Investigator: Shakeela Bahadur, MD         
Western Regional Medical Center, Inc. Recruiting
Goodyear, Arizona, United States, 85338
Contact: Brandy Harmon    623-207-3148    brandy.harmon@ctca-hope.com   
Principal Investigator: Cynthia Lynch, MD         
United States, California
Pacific Cancer Medical Center, Inc. Recruiting
Anaheim, California, United States, 92801
Contact: Elizabeth Brown    714-999-1465    elizabethg@pacificcancer.com   
Principal Investigator: Ajit Maniam, MD         
East Valley Hematology And Oncology Recruiting
Burbank, California, United States, 91505
Contact: Erikan Enyoung    818-748-4723    erikan.enyong@providence.org   
Principal Investigator: Raul Mena, MD         
Long Beach Memorial Medical Center Withdrawn
Long Beach, California, United States, 90806
Comprehensive Hematology Oncology Center Withdrawn
Los Angeles, California, United States, 90033
UCLA Hematology Oncology Santa Monica Recruiting
Los Angeles, California, United States, 90095
Contact: Katie Orefice    661-255-5350    korefice@mednet.ucla.edu   
Principal Investigator: Sara Hurvitz, MD         
UC Davis Comprehensive Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Jennifer Biddlecome    916-703-5559    jjbiddlecome@ucdavis.edu   
Principal Investigator: Helen Chew, MD         
Sharp Memorial Hospital Recruiting
San Diego, California, United States, 92123
Contact: Stephanie Manoff    858-939-5063    stephanie.manoff@sharp.com   
Principal Investigator: Reema Batra, MD         
University of California, San Francisco Helen Diller Family Comprehensive Cancer Center Recruiting
San Francisco, California, United States, 94115
Contact: Ivy Wong    415-353-7873    ivy.wong@ucsf.edu   
Principal Investigator: Hope Rugo, MD         
Central Coast Medical Oncology Withdrawn
Santa Maria, California, United States, 93454
Stanford University Medical Center Withdrawn
Stanford, California, United States, 94305
Kaiser Permenente Medical Center Recruiting
Vallejo, California, United States, 94589
Contact: Tiffany Traverso    707-651-2800    tiffany.e.traverso@kp.org   
Principal Investigator: Jennifer Suga, MD         
United States, Colorado
Poudre Valley Health Care, Inc. Recruiting
Fort Collins, Colorado, United States, 80528
Contact: Maureen Ralph    970-977-2979    maureen.ralph@uchealth.org   
Principal Investigator: Diana Medgyesy, MD         
United States, District of Columbia
MedStar Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Ronla Prince    202-877-4775    Ronla.N.Prince@medstar.net   
Principal Investigator: Christopher Gallagher, MD         
United States, Florida
Florida Cancer Specialists Recruiting
Fort Myers, Florida, United States, 33916
Contact: Lynn Bentz    941-363-5713    lbentz@flcancer.com   
Principal Investigator: Hart Lowell, MD         
Memorial Cancer Institute at Memorial Regional Hospital Recruiting
Hollywood, Florida, United States, 33021
Contact: Deborah Conte    954-210-1171    dmc238@med.miami.edu   
Principal Investigator: Alejandra Perez, MD         
Mount Sinai Comprehensive Cancer Center Recruiting
Miami Beach, Florida, United States, 33140
Contact: Christina Estevez    305-674-2121 ext 53760    Christina.Estevez@msmc.com   
Principal Investigator: Elisa Krill-Jackson, MD         
Florida Cancer Specialists Recruiting
New Port Richey, Florida, United States, 34655
Contact: Darby Suess    727-216-1143    dsuess@flcancer.com   
Principal Investigator: Gail Wright, MD         
Orlndo Health Cancer Center Recruiting
Orlando, Florida, United States, 32806
Contact: Leticia Morales    321-843-8370    Leticia.Morales@orlandohealth.com   
Principal Investigator: Nikita Shah, MD         
Florida Cancer Research Institute Withdrawn
Plantation, Florida, United States, 33324
Hem-Onc Associates Completed
Port Saint Lucie, Florida, United States, 34952
Palm Beach Cancer Center Recruiting
West Palm Beach, Florida, United States, 33401
Contact: Jennifer Bar-Nur    561-472-1696    jbar-nur@flcancer.com   
Principal Investigator: Sumithra Vattigunta, MD         
United States, Georgia
Piedmont Cancer Institute, P.C. Recruiting
Atlanta, Georgia, United States, 30318
Contact: Crystal Stargell    404-350-9853    CStargell@piedmontcancerinstitute.com   
Principal Investigator: Trevor Feinstein, MD         
Gwinnett Medical Center - Center for Cancer Care Withdrawn
Lawrenceville, Georgia, United States, 30046-3370
Northwest Georgia Oncology Centers, PC Recruiting
Marietta, Georgia, United States, 30060
Contact: Cheryl Verdi    770-281-5162    cverdi@ngoc.com   
Principal Investigator: Raul Oyola, MD         
CTCA - Southeastern Regional Medical Center Recruiting
Newnan, Georgia, United States, 30265
Contact: Kristen Nigro    770-440-7191    Kristen.Nigro@ctca-hope.com   
Principal Investigator: Mary Ninan, MD         
United States, Hawaii
Kaiser Permanente Hawaii Moanalua Medical Center Recruiting
Honolulu, Hawaii, United States, 96819
Contact: Shelley Clark    808-432-4689    shelley.a.clark@kp.org   
Principal Investigator: Jennifer Carney, MD         
United States, Illinois
Northwestern University Feinberg School of Medicine Recruiting
Chicago, Illinois, United States, 60611
Contact: Carmen Diaz    312-695-1387    carmen.diaz@northwestern.edu   
Principal Investigator: William Gradishar, MD         
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Olivia Pahl    312-942-5083    olivia_pahl@rush.edu   
Principal Investigator: Melody Cobleigh, MD         
Hematology Oncology North Shore Recruiting
Skokie, Illinois, United States, 60076
Contact: Marsha Weller    847-675-3900    mregwell@yahoo.com   
Principal Investigator: Edward Kaplan, MD         
Presence Medical Group Hematology Oncology Recruiting
Skokie, Illinois, United States, 60077
Contact: Jason Tangman    224-534-7580    jtangman@orchardhr.com   
Principal Investigator: Ira Oliff, MD         
Carle Cancer Center Recruiting
Urbana, Illinois, United States, 61801
Contact: Christine Canfield    217-383-6828    christine.canfield@carle.com   
Principal Investigator: Maria Grosse-Perdekamp, MD         
CTCA - Midwestern Regional Medical Center Recruiting
Zion, Illinois, United States, 60099
Contact: Elizabeth Londono    847-731-4143    Elizabeth.londono@ctca-hope.com   
Principal Investigator: Dennis Citrin, MD         
United States, Indiana
Indiana University Health Goshen Center for Cancer Care Recruiting
Goshen, Indiana, United States, 46526
Contact: Ann Flagg    574-364-2263    aflagg@goshenhealth.com   
Principal Investigator: Daniel Bruetman, MD         
United States, Iowa
Physicians Clinic of Iowa Recruiting
Cedar Rapids, Iowa, United States, 52403
Contact: Kristin Sperfslage    319-368-5514    kristin.sperfslage@unitypoint.org   
Principal Investigator: William Fusselman, MD         
United States, Kentucky
Flaget Cancer Center Withdrawn
Bardstown, Kentucky, United States, 40004
ARH Cancer Clinic Recruiting
Hazard, Kentucky, United States, 41701
Contact: Tracie McDaniel    606-439-2239    tmcdaniel@arh.org   
Principal Investigator: Samuel Bailey, MD         
St. Joseph's Hospital Recruiting
Lexington, Kentucky, United States, 40504
Contact: Celia Love    859-313-2650    CeliaLove@sjhlex.org   
Principal Investigator: Jessica Croley, MD         
Jewish Medical Center Northeast Withdrawn
Louisville, Kentucky, United States, 40245
United States, Louisiana
Touro Infirmary Hospital Recruiting
New Orleans, Louisiana, United States, 70115
Contact: Mary Ellen Burns    504-897-7419    mary.burns@touro.com   
Principal Investigator: Scott Sonnier, MD         
United States, Maine
New England Cancer Specialists Recruiting
Scarborough, Maine, United States, 04074
Contact: Lindsay St. Louis    207-396-8587    louisl@newecs.org   
Principal Investigator: Chiara Battelli, MD         
United States, Maryland
AAMC Oncology and Hematology Withdrawn
Annapolis, Maryland, United States, 21401
Mercy Medical Center Recruiting
Baltimore, Maryland, United States, 21202
Contact: Alexandra Cline    410-951-7956    acline@mdmercy.com   
Principal Investigator: David Riseberg, MD         
FRHS - James M. Stockman Cancer Institute Recruiting
Frederick, Maryland, United States, 21701
Contact: Hema Dimaggio    301-668-7043    hdimaggio@fmh.org   
Principal Investigator: Brian O'Connor, MD         
United States, Massachusetts
Tufts-NEMC Cancer Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Madeleine Arthur    617-636-7651    marthur@tuftsmedicalcenter.org   
Principal Investigator: John Erban, MD         
United States, Minnesota
Virginia Piper Cancer Institute Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Laura Rockwell    612-863-9466    Laura.Rockwell@allina.com   
Principal Investigator: Michaela Tsai, MD         
United States, Mississippi
Forrest General Hospital Recruiting
Hattiesburg, Mississippi, United States, 39401
Contact: Tammy McBeth    601-288-2495    tmcbeth@forrestgeneral.com   
Principal Investigator: John Hrom, MD         
United States, Missouri
Saint Luke's Cancer Specialists Recruiting
Kansas City, Missouri, United States, 64111
Contact: Jennifer Hutton    816-932-1601    jhutton@saint-lukes.org   
Principal Investigator: Timothy Pluard, MD         
Mercy Hospital Saint Louis Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Crystal Tindall    609-275-7257    crystal.tindall@mercy.net   
Principal Investigator: Bethany Sleckman, MD         
United States, New Hampshire
Dartmouth-Hitchcock - Norris C Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Tanya Perry    603-650-6056    tanya.m.perry@hitchcock.org   
Principal Investigator: Peter Kaufman, MD         
United States, New Jersey
New Jersey Hematology Oncology Associates Recruiting
Brick, New Jersey, United States, 08724
Contact: Justine Schwinge    732-840-8880 ext 16    njhoa.crc@gmail.com   
Principal Investigator: Apurv Agrawal, MD         
Cooper University Hospital Withdrawn
Camden, New Jersey, United States, 08103
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Aretha DiSalvo    551-996-8258    Aretha.Disalvo@hackensackmeridian.org   
Principal Investigator: Deena Graham, MD         
Saint Barnabas Medical Center - The Cancer Center Recruiting
Livingston, New Jersey, United States, 07039
Contact: Joanne Loeb    973-322-2934    joanne.loeb@rwjbh.org   
Principal Investigator: Anna Litvak, MD         
United States, New Mexico
New Mexico Cancer Care Alliance (NMCCA) Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Kaylee Deutsch    505-925-0354    kdeutsch@nmcca.org   
Principal Investigator: Ursa Brown-Glaberman, MD         
United States, New York
Queens Hospital Center Recruiting
Jamaica, New York, United States, 11432
Contact: Linda Bulone    718-883-3751    bulonel@nychhc.org   
Principal Investigator: Mary Kemeny, MD         
ProHEALTH CARE Associates, LLP Recruiting
Lake Success, New York, United States, 11042
Contact: Desiree Grogan         
Principal Investigator: Marc Citron, MD         
New York University Clinical Cancer Center Recruiting
New York, New York, United States, 10016
Contact: Laurelis Lantigua    212-404-3918    laurelis.lantigua@nyumc.org   
Principal Investigator: Yelena Novik, MD         
Weill Cornell Breast Center Recruiting
New York, New York, United States, 10065
Contact: David Ko    646-962-8342    dak2044@med.cornell.edu   
Principal Investigator: Eleni Andreopoulou, MD         
United States, North Carolina
ECU - Leo W. Jenkins Cancer Center Recruiting
Greenville, North Carolina, United States, 27834
Contact: Sue Ann Joyner    252-744-9010    joynersu@ecu.edu   
Principal Investigator: Mahvish Muzaffar, MD         
Wake Forest University Baptist Medical Center (WFUBMC) Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Diann Mendenhall    336-716-4512    dimenden@wakehealth.edu   
Principal Investigator: Susan Melin, MD         
United States, Ohio
Gabrail Cancer Center Research Withdrawn
Canton, Ohio, United States, 44718
United States, Oklahoma
Mercy Physicians Of Oklahoma Recruiting
Oklahoma City, Oklahoma, United States, 73120
Contact: Francis Frost    405-752-3392    mitzi.sutton@mercy.net   
Principal Investigator: Sonia Varghese, MD         
CTCA - Southwestern Regional Medical Center, Inc. Recruiting
Tulsa, Oklahoma, United States, 74133
Contact: Kristin Marshall    918-286-5206    Kristi.marshall@ctca-hope.com   
Principal Investigator: Sagun Shrestha, MD         
United States, Pennsylvania
Pinnacle Health Cancer Institute Recruiting
Harrisburg, Pennsylvania, United States, 17109
Contact: Kathy Litchfield    717-724-6765    klitchfield@pinnaclehealth.org   
Principal Investigator: Kit Lu, MD         
Monongahela Valley Hospital Recruiting
Monongahela, Pennsylvania, United States, 15063
Contact: Felicia Brown    888-370-9892    felicia@bioclin-research.com   
Principal Investigator: Andrew Zahalsky, MD         
CTCA - Eastern Regional Medical Center, Inc. Recruiting
Philadelphia, Pennsylvania, United States, 19124
Contact: Marianne Bonner    215-537-4881    Marianne.Bonner@ctca-hope.com   
Principal Investigator: Sramila Aithal, MD         
University of Pittsburgh Medical Center Withdrawn
Pittsburgh, Pennsylvania, United States, 15213
Guthrie Medical Group, PC Recruiting
Sayre, Pennsylvania, United States, 18840
Contact: Susan Hadlock    570-887-2141    hadlock_susan@guthrie.org   
Principal Investigator: Philip Lowry, MD         
United States, Tennessee
Tennessee Oncology, PLLC Recruiting
Chattanooga, Tennessee, United States, 37404
Contact: Tiffany Cason    423-698-1844    tiffany.cason@scresearch.net   
Principal Investigator: Brooke Daniel, MD         
Thompson Cancer Survival Center Withdrawn
Knoxville, Tennessee, United States, 37916
Tennessee Cancer Specialists, PLLC - Dowell Springs Recruiting
Knoxville, Tennessee, United States, 37920
Contact: Chris Hale    865-934-2676    chris.hale@biomed-research.com   
Principal Investigator: Tracy Dobbs, MD         
The Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Scott Miller    615-524-4447    scott.miller3@scresearch.net   
Principal Investigator: Denise Yardley, MD         
United States, Texas
Arlington Cancer Center Recruiting
Arlington, Texas, United States, 76012
Contact: Lisa Carson    817-261-4906 ext 1371    lisacarson@texashealth.org   
Principal Investigator: Alfred DiStefano, MD         
Austin Cancer Center Recruiting
Austin, Texas, United States, 78758
Contact: Luisa Sansalone    512-505-5500    lsansalone@austincancercenters.com   
Principal Investigator: Angel Rodriguez, MD         
St. Joseph Health Cancer Center Recruiting
Bryan, Texas, United States, 77802
Contact: Kristen Pearson    979-776-3984    kpearson@st-joseph.org   
Principal Investigator: Erin Fleener, MD         
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Sarah Weyandt    214-648-7020    sarah.weyandt@utsouthwestern.edu   
Principal Investigator: Barbara Haley, MD         
The Center for Cancer and Blood Disorders Recruiting
Fort Worth, Texas, United States, 76104
Contact: Brian Franklin    817-759-7021    bfranklin@txcc.com   
Principal Investigator: Robyn Young, MD         
East Texas Medical Center Cancer Institute Recruiting
Tyler, Texas, United States, 75701
Contact: Connie Gordon    903-596-3188    CLGordon@etmc.org   
Principal Investigator: Arielle Lee, MD         
United States, Utah
Utah Cancer Specialists Recruiting
Salt Lake City, Utah, United States, 84106
Contact: LeAnna Pace    801-270-2250    lpace@utahcancer.com   
Principal Investigator: Stephen Kendall, MD         
United States, Virginia
University of Virginia Cancer Center Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Natalie Salsini    434-297-7782    ns9sr@virginia.edu   
Principal Investigator: Christiana Brenin, MD         
Inova Schar Cancer Institute Recruiting
Fairfax, Virginia, United States, 22031
Contact: Elizabeth Gebregeorgis    571-472-0239    elizabeth.gebregeorgis@inova.org   
Principal Investigator: Mary Wilkinson, MD         
Fort Belvoir Community Hospital Recruiting
Fort Belvoir, Virginia, United States, 22060
Contact: Greneisha Jackson    571-231-3491    greneisha.t.jackson.ctr@mail.mil   
Principal Investigator: Pramvir Verma, MD         
United States, Washington
Swedish Cancer Institute/ Swedish Health Services Recruiting
Seattle, Washington, United States, 98104
Contact: Alana Brooks    206-386-2098    Alana.Brooks@swedish.org   
Principal Investigator: Erin Ellis, MD         
University of Washington/ Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109
Contact: Jenna Olyanich    206-288-7427    bolyanic@seattlecca.org   
Principal Investigator: Lupe Salazar, MD         
Cancer Care Northwest, PS Recruiting
Spokane, Washington, United States, 99202
Contact: Rose Miller    509-228-1687    rose.miller@ccnw.net   
Principal Investigator: Saritha Thumma, MD         
Austria
Medizinische Universität Innsbruck Recruiting
Innsbruck, Tirol, Austria, 6020
Contact: Carmen Albertini    43512 504 82477    carmen.albertini@tirol-kliniken.at   
Principal Investigator: Daniel Egle, MD         
Landeskrankenhaus Rankweil Withdrawn
Rankweil, Vorarlberg, Austria, 6830
Belgium
UZ Antwerpen Recruiting
Edegem, Antwerpen, Belgium, 2650
Contact: Valérie Du Caju    32 3 821 5306    valerie.ducaju@uza.be   
Principal Investigator: Sevilay Altintas, MD         
GZA Ziekenhuizen - Campus Sint-Augustinus Recruiting
Wilrijk, Antwerpen, Belgium, 2610
Contact: Jan Van der Eycken    32 3 443 37 59    jan.vandereycken@gza.be   
Principal Investigator: Luc Dirix, MD         
Clinique Saint-Pierre Ottignies Recruiting
Ottignies, Brabant Wallon, Belgium, 1340
Contact: Martine Gerard    3210437194    martine.gerard@cspo.be   
Principal Investigator: Renaud Poncin, MD         
UZ Brussel - Campus Jette Recruiting
Brussels, Brussels Capital Region, Belgium, 1090
Contact: Gerda Lauwers    3224775448    gerda.lauwers@uzbrussel.be   
Principal Investigator: Christel Fontaine, MD         
Cliniques universitaires Saint-Luc Recruiting
Brussels, Brussels Capital Region, Belgium, 1200
Contact: Nathalie Blondeel    32 2 764 42 14    nathalie.blondeel@uclouvain.be   
Principal Investigator: Jean-Francois Baurain, MD         
INDC Entité Jolimontoise - CH de Jolimont-Lobbes Withdrawn
Haine-Saint-Paul, Hainaut, Belgium, 7100
Jessa Ziekenhuis - Campus Virga Jesse Recruiting
Hasselt, Limburg, Belgium, 3500
Contact: Patrick Stijven    3211309451    patrick.stijven@jessazh.be   
Principal Investigator: Jeroen Mebis, MD         
CHR Verviers East Belgium Withdrawn
Verviers, Liège, Belgium, 4800
AZ Nikolaas - Campus Sint-Niklaas Moerland Recruiting
Sint-Niklaas, Oost-Vlaanderen, Belgium, 9100
Contact: Emily Van Gucht    3237602975    emily.vangucht@aznikolaas.be   
Principal Investigator: Ines Deleu, MD         
AZ Sint-Jan Brugge - Oostende - Campus Sint-Jan Recruiting
Brugge, West-Vlaanderen, Belgium, 8000
Contact: Deborah Van Massenhove    32 50 45 25 54    deborah.vanmassenhove@azsintjan.be   
Principal Investigator: Nele Claes, MD         
AZ Groeninge - Campus Loofstraat Recruiting
Kortrijk, West-Vlaanderen, Belgium, 8500
Contact: Delphine Mullebrouck    32 56 63 39 41    delphine.mullebrouck@azgroeninge.be   
Principal Investigator: Marleen Borms, MD         
AZ Damiaan Recruiting
Oostende, West-Vlaanderen, Belgium, 8400
Contact: Barbara Claerbout    32 5 941 63 34    bclaerbout@azdamiaan.be   
Principal Investigator: Isabelle Spoormans, MD         
Chc - Clinique Saint-Joseph Recruiting
Liège, Belgium, 4000
Contact: Ludivine Collard    32 4 224 89 92    ludivine.collard@chc.be   
Principal Investigator: Marie-Pascale Graas, MD         
Clinique Sainte Elisabeth Recruiting
Namur, Belgium, 5000
Contact: Caroline Yague    32 81 702 843    caroline.yague@cmsenamur.be   
Principal Investigator: Peter Vuylsteke, MD         
Canada, New Brunswick
Dr. Leon Richard Oncology Centre Recruiting
Moncton, New Brunswick, Canada, E1C 8X3
Contact: Cécile St-Coeur    506-862-4145    cecile.st-coeur@vitalitenb.ca   
Principal Investigator: Skander Ghedira, MD         
Canada, Nova Scotia
The Atlantic Clinical Cancer Research Unit (ACCRU) Withdrawn
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Lakeridge Health Oshawa Recruiting
Oshawa, Ontario, Canada, L1G 2B9
Contact: Ann Mueller    905-576-8711 ext 4517    amueller@lakeridgehealth.on.ca   
Principal Investigator: Orit Freedman, MD         
Czechia
Fakultni nemocnice Brno Withdrawn
Brno, Brno-město, Czechia, 625 00
Masarykuv onkologicky ustav Recruiting
Brno, Brno-město, Czechia, 656 53
Contact: Alena Holesovska    420 543 136 223    holesovska@mou.cz   
Principal Investigator: Katarina Petrakova, MD         
Fakultni nemocnice Olomouc Recruiting
Olomouc, Czechia, 779 00
Contact: Daniela Simkova    420 588 443 897    daniela.simkova@fnol.cz   
Principal Investigator: Bohuslav Melichar, MD         
Fakultni nemocnice v Motole Recruiting
Praha 5, Czechia, 150 06
Contact: Lucie Prausova    420 732 534 917    lucie.prausova@fnmotol.cz   
Principal Investigator: Jana Prausova, MD         
Denmark
Aarhus Universitetshospital Recruiting
Aarhus C, Central Jutland, Denmark, 8000
Contact: Mette Giørtz    45 7845 0000    mettgioe@rm.dk   
Principal Investigator: Sven Langkjer, MD         
Regionshospitalet Herning (Herning Centralsygehus) Recruiting
Herning, Central Jutland, Denmark, 7400
Contact: Grete Christensen    45 7843 7477    grete.christensen@vest.rm.dk   
Principal Investigator: Julia Kenholm, MD         
Vejle Sygehus Recruiting
Vejle, South Denmark, Denmark, 7100
Contact: Annette Rehmeier    4579406042    annette.rehmeier@rsyd.dk   
Principal Investigator: Erik Jakobsen, MD         
Næstved Sygehus Recruiting
Aarhus N, Zeeland, Denmark, 4700
Contact: Lene Voxen    45 56 51 32 21    ltv@regionsjaelland.dk   
Principal Investigator: Vesna Glavicic, MD         
Finland
Tampere University Hospital Recruiting
Tampere, Etelä-Suomen Lääni, Finland, 33521
Contact: Maarit Reiss    3583311611    maarit.reiss@pshp.fi   
Principal Investigator: Minna Tanner, MD         
Helsinki University Central Hospital (HUCH) - Meilahden Sair Recruiting
Helsinki, Länsi-Suomen Lääni, Finland, 00029
Contact: Kirsi Suvila    050 427 2880    kirsi.suvila@hus.fi   
Principal Investigator: Johanna Mattson, MD         
France
Center de Lutte Contre le Cancer (CLCC) Recruiting
Nice, Alpes-Martitimes, France, 06189
Contact: Kevin Zorzi    33 4 92 03 17 49    kevin.zorzi@nice.unicancer.fr   
Principal Investigator: Jean-Marc Ferrero, MD         
Hôpital Privé Clairval Recruiting
Marseille, Bouches-du-Rhône, France, 13009
Contact: Carine Tesic    33 4 91 17 14 21    c.tesic@gsante.fr   
Principal Investigator: Robert Herve, MD         
Center de Lutte Contre le Cancer (CLCC) Recruiting
Caen cedex 05, Calvados, France, 14076
Contact: Sara Grossi    33 2 31 45 50 99    s.grossi@baclesse.unicancer.fr   
Principal Investigator: Christelle Levy, MD         
Centre Georges-François Lecler Recruiting
Dijon, Côte-d'Or, France, 21079
Contact: Sandra Turlot    33 3 80 73 77 52    sturlot@cgfl.fr   
Principal Investigator: Bruno Coudert, MD         
Centre de Lutte Contre le Cancer (CLCC) - Institut de Cancer Recruiting
St Herblain, Loire-Atlantique, France, 44805
Contact: Thierry Palardy    33 2 40 67 91 71    thierry.palardy@ico.unicancer.fr   
Principal Investigator: Mario Campone, MD         
Centre Jean Perrin Recruiting
Clermont-Ferrand, Puy-de-Dôme, France, 63011
Contact: Margaux Marcoux    33 4 73 27 84 54    Margaux.MARCOUX@clermont.unicancer.fr   
Principal Investigator: Marie-Ange Mouret-Reynier, MD         
Centre Léon Bérard Recruiting
Lyon Cedex 08, Rhône-Alpes, France, 69373
Contact: Mathilde Peyron    33 (0)4 26 55 68 34    mathilde.peyron@lyon.unicancer.fr   
Principal Investigator: Thomas Bachelot, MD         
Institut Curie Recruiting
Paris, Île-de-France, France, 75005
Contact: Cécile Courty    33 (0)1 44 32 43 39    cecile.courty@curie.fr   
Principal Investigator: Francesco Ricci, MD         
Institut Curie - Hôpital René Huguenin Recruiting
Saint-Cloud, Île-de-France, France, 92210
Contact: Patrick Vavasseur    33 (0)1 47 11 23 83    patrick.vavasseur@curie.fr   
Principal Investigator: Etienne Brain, MD         
Germany
Universitaetsklinikum Tuebingen Recruiting
Tuebingen, Baden-Württemberg, Germany, 72076
Contact: Eva Kerschbaum    49 7071 29 8 5087    eva.kerschbaum@med.uni-tuebingen.de   
Principal Investigator: Eva-Maria Grischke, MD         
Universitätsklinikum Erlangen Recruiting
Erlangen, Bayern, Germany, 91054
Contact: Julia Franz    49 91318536167    julia.franz@uk-erlangen.de   
Principal Investigator: Peter Fasching, MD         
Interdisziplinäres Onkologisches Zentrum München Recruiting
München, Bayern, Germany, 80336
Contact: Simone Schiersner    4989599888844    s.schiersner@ioz-muenchen.de   
Principal Investigator: Wolfgang Eiermann, MD         
Städtisches Krankenhaus München - Neuperlach Recruiting
München, Bayern, Germany, 81737
Contact: Regine Biedenkopf    49 89 6794 2737    regine.biedenkopf@klinikum-muenchen.de   
Principal Investigator: Meinolf Karthaus, MD         
Praxis für Frauenheilkunde Anita Recruiting
München, Bayern, Germany, 81925
Contact: Ludwig Attenberger    49 8992791973    praxis@gynaekologie-arabella.de   
Principal Investigator: Anita Prechtl, MD         
Marien Hospital Düsseldorf Recruiting
Düsseldorf, Nordhein-Westfalen, Germany, 40479
Contact: Olga Kravchenko    49 211 4400 2079    olga.kravchenko@vkkd-kliniken.de   
Principal Investigator: Aristoteles Giagounidis, MD         
Universitaetsklinikum Essen - Klinik fuer Frauenheilkunde Recruiting
Essen, Nordrhein-Westfalen, Germany, 45122
Contact: Melanie Zeuner    0049 201 723 2575    melanie.zeuner@uk-essen.de   
Principal Investigator: Bahriye Aktas, MD         
Marien Hospital Recruiting
Witten, Nordrhein-Westfalen, Germany, 58452
Contact: Katja Fritz    49 2302 173 1327    katja.fritz@elisabethgruppe.de   
Principal Investigator: John Hackmann, MD         
Medizinische Fakultät Carl Gustav Carus Recruiting
Dresden, Sachsen, Germany, 01307
Contact: Olga Schubert    49 351 79 65 620    olga.schubert@uniklinikum-dresden.de   
Principal Investigator: Pauline Wimberger, MD         
Campus Charité Mitte (CCM) Withdrawn
Berlin, Germany, 10117
Katholisches Marienkrankenhaus gGmbH - Frauenklinik Recruiting
Hamburg, Germany, 22087
Contact: Brigitta Bergel    49 40 25462 114    bergel.innere@marienkrankenhaus.org   
Principal Investigator: Gerhard Gebauer, MD         
Universtatsklinikum Heidelberg Nationales Recruiting
Heidelberg, Germany
Contact: Christiane Dobeleit    49(0)6221 5638108    c.dobeleit@dkfz-heidelberg.de   
Principal Investigator: Andreas Schneeweiss, MD         
Israel
Soroka Medical Center [Oncology] Recruiting
Beersheba, HaDarom, Israel, 84802
Contact: Nataly Israeli    97286244127    natalyis@clalit.org.il   
Principal Investigator: David Geffen, MD         
The Edith Wolfson Medical Center Recruiting
Holon, HaMerkaz, Israel, 58100
Contact: Esty Frank    972526290473    esterf@wmc.gov.il   
Principal Investigator: Natalya Karminsky, MD         
Meir Medical Center Recruiting
Kfar Saba, HaMerkaz, Israel, 44281
Contact: Sharon Ben Rubi    972-9-747-2101    sharon.benrubi@clalit.org.il   
Principal Investigator: Iryna Kuchuk, MD         
Rabin Medical Center - Beilinson Hospital Recruiting
Petaẖ Tiqwa, HaMerkaz, Israel, 49100
Contact: Audrey Lewkowicz    03-9378076    audreyle@clalit.org.il   
Principal Investigator: Rinat Yerushalmi, MD         
The Chaim Sheba Medical Center - Insititute of Oncology Recruiting
Ramat Gan, HaMerkaz, Israel, 52621
Contact: Ivanov Miroslava    972-50-8662945    ivanov.miroslava@sheba.health.gov.il   
Principal Investigator: Bella Kaufman, MD         
Kaplan Medical Center Recruiting
Rehovot, HaMerkaz, Israel, 761001
Contact: Tali Mayafit    972-8-9441729    revitalma1@clalit.org.il   
Principal Investigator: Noa Efrat, MD         
Galilee Medical Center Recruiting
Nahariya, HaZafon, Israel, 20100
Contact: Christine Loubaton    97249107284    christine.loubaton@naharia.health.gov.il   
Principal Investigator: Goldberg Hadassah, MD         
Hadassah Medical Organisation, Hadassah Medical Center, Ein-Karem Recruiting
Jerusalem, Yerushalayim, Israel, 91120
Contact: Gladis Glinksi    97226777111    gladis@hadassah.org.il   
Principal Investigator: Beatrice Uziely, MD         
Clalit Health Services - Lin Medical Center Recruiting
Haifa, Israel, 35152
Contact: Mali Eisenkot         
Principal Investigator: Michelle Leviov, MD         
Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel, 64239
Contact: Limor Ben-Zvi    97236973193    limorb@tlvmc.gov.il   
Principal Investigator: Larisa Ryvo, MD         
Italy
PO Garibaldi-Nesima, ARNAS Garibaldi Recruiting
Catania, Cantania, Italy, 95122
Contact: Laura Longhitano    390957595823    laulonghitano@gmail.com   
Principal Investigator: Roberto Bordonaro, MD         
Irccs Irst Recruiting
Meldola, Forli, Italy, 47014
Contact: Daniele Andreis    39 0543 739264    daniele.andreis@irst.emr.it   
Principal Investigator: Andrea Rocco, MD         
Istituto di Candiolo, IRCCS Recruiting
Candiolo, Torino, Italy, 10060
Contact: Annamaria Nuzzo    390119933398    annamaria.nuzzo@ircc.it   
Principal Investigator: Filippo Montemurro, MD         
Azienda Ospedaliero Universitaria Senese Universita degli St Recruiting
Siena, Toscana, Italy, 53100
Contact: Giulia Rossi    39 577585406    giulia.rossi.84@alice.it   
Principal Investigator: Guido Francini, MD         
Ospedale Umberto I, AOU Ospedali Riuniti Umberto I - GM.Lanc Recruiting
Ancona, Italy, 60126
Contact: Michela Burattini    390715965093    burattini.michela@libero.it   
Principal Investigator: Rossana Berardi, MD         
AO G.Rummo Recruiting
Benevento, Italy, 82100
Contact: Stefania Competiello    39 0824-57724    stefania.competiello@libero.it   
Principal Investigator: Bruno Daniele, MD         
ASST Papa Giovanni XXIII - Oncologia-Bergamo Recruiting
Bergamo, Italy, 24127
Contact: Sara D'Alessandro    00390352673687    saradatamanager@gmail.com   
Principal Investigator: Elena Rota Caremoli, MD         
PO di Cremona, ASST di Cremona - Patologia Mammaria e Breast Unit - Cremona Recruiting
Cremona, Italy, 26100
Contact: Martina Dester    390372408374    destermartina@gmail.com   
Principal Investigator: Daniele Generali, MD         
Arcispedale S.Anna, AOU di Ferrara Recruiting
Ferrara, Italy, 44124
Contact: Emanuela Carantoni    39 0532237430    oncomanager@ospfe.it   
Principal Investigator: Antonio Frassoldati, MD         
E.O. Ospedali Galliera Recruiting
Genova, Italy, 16128
Contact: Davide Corradengo    39 01015634504    davide.corradengo@galliera.it   
Principal Investigator: Mauro D'Amico, MD         
PO A.Manzoni di Lecco, ASST Lecco - Oncologia Medica - Lecco Recruiting
Lecco, Italy, 23900
Contact: Giuseppe DeNittis    390341489155    g.denittis@asst-lecco.it   
Principal Investigator: Antonio Ardizzoia, MD         
Azienda Ospedaliera Fatebenefratelli e Oftalmico Recruiting
Milano, Italy, 20121
Contact: Serena Girelli    390263632223    serena.girelli@asst-fbf-sacco.it   
Principal Investigator: Nicla La Verde, MD         
Istituto Europeo di Oncologia Via Ripamonti Recruiting
Milano, Italy, 20141
Contact: Mara Negri    39 0257489536    mara.negri@ieo.it   
Principal Investigator: Marco Colleoni, MD         
AOU Policlinico di Modena Recruiting
Modena, Italy, 41122
Contact: Federica Caggia    390594223134    federica.caggia@unimore.it   
Principal Investigator: Gabriele Luppi, MD         
Fondazione Pascale, IRCCS Istituto Nazionale dei Tumori Recruiting
Napoli, Italy, 80131
Contact: Marina Licenziato    393389940491    marinalicenziato@libero.it   
Principal Investigator: Michelino De Laurentiis, MD         
AOU di Parma Recruiting
Parma, Italy, 43126
Contact: Roberta Camisa    39-0521-702682    rcamisa@ao.pr.it   
Principal Investigator: Antonio Musolino, MD         
IRCCS Policlinico San Matteo Recruiting
Pavia, Italy, 27100
Contact: Sara Mariucci    0039 0382 502511    s.mariucci@smatteo.pv.it   
Principal Investigator: Paolo Pedrazolli, MD         
IRCSS Fodazione Salvatore Maugeri Recruiting
Pavia, Italy, 27100
Contact: Annalisa Lanza    3903825921    annalisa.lanza@icsmaugeri.it   
Principal Investigator: Antonio Bernardo, MD         
SO S.Chiara, AOU Pisana Recruiting
Pisa, Italy, 56126
Contact: Maria Bianco    0039 050993173    mg.bianco@ao-pisa.toscana.it   
Principal Investigator: Alfredo Falcone, MD         
Nuovo ospedale di Prato Recruiting
Prato, Italy, 59100
Contact: Donata Cavaciocchi    0039 0574802531    donata.cavaciocchi@uslcentro.toscana.it   
Principal Investigator: Laura Biganzoli, MD         
PU Campus Bio-medico di Roma Recruiting
Roma, Italy, 00128
Contact: Teresa Grassani    39 06225411160    t.grassani@unicampus.it   
Principal Investigator: Giuseppe Tonini, MD         
AO S.Andrea, Università degli Studi di Roma La Sapienza Recruiting
Roma, Italy, 00189
Contact: Paola Caporello    393397814141    clinicaltrials.osa@gmail.com   
Principal Investigator: Paolo Marchetti, MD         
Ospedale Belcolle Viterbo Recruiting
Viterbo, Italy, 01100
Contact: Calogero Blandino    390761339043    calogeroblandino@hotmail.com   
Principal Investigator: Enzo Ruggeri, MD         
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03080
Contact: Min-Kyoung Kim    82-2-2072-7439    mkkim@snuh.org   
Principal Investigator: Seock-Ah Im, MD         
Severance Hospital, Yonsei University Health System Recruiting
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722
Contact: Bada Kim    82-2-2228-8176    dmonco7@yuhs.ac   
Principal Investigator: Joo Hyuk Sohn, MD         
Asan Medical Center Recruiting
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 05505
Contact: Sun Young Kim    82-2-3010-7179    cjw0908@amc.seoul.kr   
Principal Investigator: Sung-Bae Kim, MD         
Samsung Medical Center Recruiting
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
Contact: Ji Hyun Jeong    82-2-3410-6851    jh10.jeong@samsung.com   
Principal Investigator: Young-Hyuck Im, MD         
Netherlands
Maastricht University Medical Centre Recruiting
Maastricht, Limburg, Netherlands, 6229 HX
Contact: Maud Widdershoven    31433872001    maud.widdershoven@mumc.nl   
Principal Investigator: Maaike de Boer, MD         
Stichting Zuyderland Medisch Centrum Recruiting
Sittard, Limburg, Netherlands, 6162 BG
Contact: Mireille Diependaal-Hoekstra    0031-88-4597800    m.hoekstra@zuyderland.nl   
Principal Investigator: Franciscus Erdkamp, MD         
Elizabeth Tweesteden Ziekenhuis Recruiting
Tilburg, Noord-Brabant, Netherlands, 5042AD
Contact: Emile Maassen    0031-13-4655234    onco-research@tsz.nl   
Principal Investigator: Robbert van Alphen, MD         
Haga Ziekenhuis, loc. Leyenburg Recruiting
Haag, Zuid-Holland, Netherlands, 2545 CH
Contact: Yorik Visser    0031 70 210 2143    y.visser@hagaziekenhuis.nl   
Principal Investigator: Johanna Portielje, MD         
Poland
MAGODENT Sp. z o.o. Recruiting
Warszawa, Mazowieckie, Poland, 04-125
Contact: Maciej Cendrowski    48 22 430 87 04    ma89ciek@gmail.com   
Principal Investigator: Itrych Bartosz, MD         
Mazowiecki Szpital Onkologiczny Recruiting
Wieliszew, Mazowieckie, Poland, 05-135
Contact: Marzena Zmorzynska    48 22 766 15 00    M.Zmorzynska@szpitalonkologiczny.pl   
Principal Investigator: Barbara Bauer-Kosinska, MD         
Portugal
Centro Clínico Champalimaud/Fundação Champalimaud Recruiting
Lisbon, Lisboa, Portugal, 1400-038
Contact: Manuela Seixas    351 965289072    manuela.seixas@fundacaochampalimaud.pt   
Principal Investigator: Fatima Cardoso, MD         
H. Santa Maria - Centro Hospitalar Lisboa Norte Recruiting
Lisboa, Portugal, 1649-035
Contact: Mariana Laranjeiro    351 913331696    marianalaranjeirosc@gmail.com   
Principal Investigator: Maria Dionisio, MD         
Instituto Português Oncologia Francisco Gentil do Porto Recruiting
Porto, Portugal, 4200-072
Contact: Helena Rocha    00351 961 760 985    helena.rocha@ipoporto.min-saude.pt   
Principal Investigator: Miguel Abreu, MD         
Puerto Rico
Fundacion de Investigacion de Diego Recruiting
San Juan, Puerto Rico, 927
Contact: Jessica Mercado    17877221248    jmercado@fdipr.com   
Principal Investigator: Mirelis Acosta Rivera, MD         
Spain
H.U.V. del Rocío Recruiting
Sevilla, Andalucía, Spain, 41013
Contact: José Manuel Cuevas Milla    34 955 013 068    cuevasmilla@gmail.com   
Principal Investigator: Manuel Ruiz Borrego, MD         
Institut Català d'Oncologia-Hospital Germans Trias i Pujol Recruiting
Badalona, Barcelona, Spain, 08916
Contact: Silvia López Bernal    0034934978729    slopez@igtp.cat   
Principal Investigator: Beatriz Cirauqui, MD         
Hospital Universitari Parc Taulí Recruiting
Sabadell, Barcelona, Spain, 08208
Contact: Jose García Ruiz    34 937240084    jgarciar@tauli.cat   
Principal Investigator: Miguel Angel Segui Palmer, MD         
Hospital del Mar Recruiting
Barcelona, Catalunya, Spain, 08003
Contact: Clara Carreras Villa    34 93 248 36 09    ccarreras@parcdesalutmar.cat   
Principal Investigator: Sonia Servitja Tormo, MD         
H.C.U. Valencia Recruiting
Valencia, Comunidad, Spain, 46010
Contact: Silvia Coret    0034 96 197 35 83    silviacoret@hotmail.com   
Principal Investigator: Begoña Bermejo de las Heras, MD         
H. Madrid Norte Sanchinarro Recruiting
PAU de Sanchinarro, Madrid, Spain, 28050
Contact: Miriam Delgado    34917567984    mdelgado@fundacionhm.com   
Principal Investigator: Laura García Estévez, MD         
Hospital de Navarra Recruiting
Pamplona, Navarra, Spain, 31008
Contact: Teresa Prieto Leache    848.42.15.54    teresa.prieto.leache@navarra.es   
Principal Investigator: José Illarramendi, MD         
H.U. Sant Joan de Reus Recruiting
Reus, Tarragona, Spain, 43204
Contact: Dolors Salsench Boronat    34 977 31 03 00 ext 55740    mdsalsench@grupsagessa.cat   
Principal Investigator: Mireia Melé Olivé, MD         
H.G.U. Alicante Recruiting
Alicante, Spain, 03010
Contact: Cristina Velasco    0034965938300    cristinavelasco.onco@gmail.com   
Principal Investigator: José Ponce, MD         
H. Quirón Barcelona Recruiting
Barcelona, Spain, 08023
Contact: Veronica Raquel De Michele    34 93 238 16 61    vrdemichele@i-crom.net   
Principal Investigator: José Pérez García, MD         
Hospital Universitario Vall d'Hebron Recruiting
Barcelona, Spain, 08023
Contact: Gina Mares    34932746000 ext 4707    gmares@vhebron.net   
Principal Investigator: Cristina Saura Manich, MD         
H. San Pedro de Alcántara Recruiting
Cáceres, Spain, 10003
Contact: Maria Aguilella    34927621612    mj.aguilella.ensayosclinicos@gmail.com   
Principal Investigator: Santiago González Santiago, MD         
ICO-Hospital Universitari de Girona Dr. Josep Trueta Recruiting
Girona, Spain, 17007
Contact: Nuria Martin    34 972 22 58 27    nmartin@iconcologia.net   
Principal Investigator: Joan Dorca Ribugent, MD         
H.U. Arnau de Vilanova Recruiting
Lleida, Spain, 25198
Contact: Rubén Tejero    34973248100    eoncolleida@gmail.com   
Principal Investigator: Serafín Morales Murillo, MD         
M.D. Anderson Cancer Center Madrid Recruiting
Madrid, Spain, 28033
Contact: Marta Gutierrez García    34 917 878 600 ext 2883    mgutierrez@mdanderson.es   
Principal Investigator: Antonio Gonzalez Martin, MD         
Hospital Universitario Ramón y Cajal Recruiting
Madrid, Spain, 28034
Contact: Natalia Polo    34 91 336 8263    natalia.polo@salud.madrid.org   
Principal Investigator: Maria Fernández Abad, MD         
Hospital Universitario Clínico San Carlos Recruiting
Madrid, Spain, 28040
Contact: Sandra Merino    0034913303000 ext 7133    sandra.merino@salud.madrid.org   
Principal Investigator: José García Sáenz, MD         
Fundación Instituto Valenciano de Oncología Recruiting
Valencia, Spain, 46009
Contact: Lidia Riquelme Garcia    34961114000    datamanager3@fincivo.org   
Principal Investigator: Joaquin Gavilá Gregori, MD         
Hospital Universitari I Politecnic La Fe Recruiting
Valencia, Spain, 46026
Contact: Marian Lavin    34618730097    lavin_man@gva.es   
Principal Investigator: Laura Palomar Abad, MD         
Hospital Ntra. Sra. de Sonsoles Recruiting
Ávila, Spain, 5004
Contact: Lorena De Francisco    34 92 035 8516    oncoavilacec@yahoo.es   
Principal Investigator: José Alés Martínez, MD         
United Kingdom
Guys and St Thomas Hospital Recruiting
London, City Of London, United Kingdom, SE1 9RT
Contact: Chris Bayliss    0044 (0)20 7188 7188 ext 51694    chris.bayliss@gstt.nhs.uk   
Principal Investigator: Janine Mansi, MD         
Castle Hill Hospital (Hull) Recruiting
Hull, East Riding Of Yorkshire, United Kingdom, HU16 5JQ
Contact: Lyn Harrison    441482461234    lyn.harrison@hey.nhs.uk   
Principal Investigator: Amandeep Dhadda, MD         
Kent Oncology Centre, Maidstone Hospital Recruiting
Maidstone, Kent, United Kingdom, ME16 9QQ
Contact: Karen McDonald    01622 227078    karenmcdonald@nhs.net   
Principal Investigator: Catherine Harper-Wynne, MD         
Royal Preston Hospital Recruiting
Fulwood, Lancashire, United Kingdom, PR2 9HT
Contact: Alison Swan    0044 (0) 1772 524656    Alison.Swan@LTHTR.nhs.uk   
Principal Investigator: Martin Hogg, MD         
Nottingham University Hospitals NHS Trust - City Hospital Recruiting
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
Contact: Laura Redford    0115 969 1169 ext 57593    Laura.redford@nuh.nhs.uk   
Principal Investigator: Stephen Chan, MD         
Blackpool Victoria Hospital Recruiting
Blackpool, United Kingdom, FY3 8NR
Contact: Leeanne Davies    01253657107    leeanne.davies@bfwhospitals.nhs.uk   
Principal Investigator: Pavel Bezecny, MD         
University Hospital Coventry Recruiting
Coventry, United Kingdom, CV2 2DX
Contact: Pauline Kelly    2479 967476 ext 25781    pauline.kelly@uhcw.nhs.uk   
Principal Investigator: Christopher Poole, MD         
South Tees Hospitals NHS Foundation Trust Recruiting
Middlesbrough, United Kingdom, TS4 3BW
Contact: Andrea Watson    44 1642 837193    andrea.watson@stees.nhs.uk   
Principal Investigator: Janine Graham, MD         
Sponsors and Collaborators
MacroGenics
Investigators
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Study Director: Edwin Rock, MD PhD MacroGenics

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Responsible Party: MacroGenics
ClinicalTrials.gov Identifier: NCT02492711     History of Changes
Other Study ID Numbers: CP-MGAH22-04
First Posted: July 9, 2015    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Gemcitabine
Capecitabine
Trastuzumab
Vinorelbine
Antibodies, Monoclonal
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators