MedPath

PALbociclib CoLlaborative Adjuvant Study

Phase 3
Active, not recruiting
Conditions
Breast Cancer
Interventions
Drug: Standard Adjuvant Endocrine Therapy
Registration Number
NCT02513394
Lead Sponsor
Alliance Foundation Trials, LLC.
Brief Summary

This is a prospective, two arm, international, multicenter, randomized, open-label Phase III study evaluating the addition of 2 years of palbociclib to standard adjuvant endocrine therapy for patients with HR+ / HER2- early breast cancer (EBC).

The purpose of the PALLAS study is to determine whether the addition of palbociclib to adjuvant endocrine therapy will improve outcomes over endocrine therapy alone for HR+/HER2- early breast cancer. Assessment of a variety of correlative analysis, including evaluation of the effect of palbociclib in genomically defined tumor subgroups, is planned.

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
5796
Inclusion Criteria
  • Signed informed consent prior to study specific procedures.
  • Age ≥18 years (or per national guidelines).
  • Pre- and postmenopausal women or men with Stage II (Stage IIA limited to max. 1000 patients) or Stage III early invasive breast cancer
  • Patients with multicentric and/or multifocal and/or bilateral early invasive breast cancer are eligible if all histopathologically examined tumors meet pathologic criteria for ER+ and/or PR+ and HER2-.
  • Patients must have histologically confirmed ER+ and/or PR+, HER2-, early invasive breast cancer.
  • Patients must have undergone adequate (definitive) breast surgery for the current malignancy.

FFPE tumor tissue block must be confirmed to be received at the central sample repository prior to randomization.

  • ECOG performance status 0-1.
  • Patients must be able and willing to swallow and retain oral medication.
  • Serum or urine pregnancy test must be negative in premenopausal women within 14 days of randomization, or in women with amenorrhea of less than 12 months at time of randomization.
  • Patients who received neo/adjuvant therapy must be after last dose of chemotherapy and/or biologic therapy and must have sufficient resolution of side effects.
  • Patients who received breast/axilla/post-mastectomy chest wall radiotherapy must be after last dose of radiotherapy and must have sufficient resolution of side effects.
  • Patients must have sufficient resolution of any surgical side effects (no active wound healing complications).

-Patients must either be initiating or have already started adjuvant hormonal treatment. -

  • Patients who already received neo/adjuvant endocrine therapy are eligible as long as they are enrolled within 12 months of initial histological diagnosis and after completing no more than 6 months of adjuvant endocrine therapy.
  • Absolute neutrophil count ≥ 1,500/µL
  • Platelets ≥ 100,000/ mm3
  • Hemoglobin ≥ 10g/dL
  • Total serum bilirubin ≤ ULN; or total bilirubin ≤ 3.0 × ULN with direct bilirubin within normal range in patients with documented Gilbert's Syndrome.
  • Aspartate amino transferase (AST or SGOT) and alanine amino transferase (ALT or SGPT) ≤ 1.5 × institutional ULN.
  • Serum creatinine below the upper limit of the institutional normal range (ULN) or creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with serum creatinine levels above institutional ULN.
Exclusion Criteria
  • Concurrent therapy with other Investigational Products.
  • Prior therapy with any CDK inhibitor.
  • Patients with Stage I or IV breast cancer are not eligible.
  • History of allergic reactions attributed to compounds of chemical or biologic composition similar to palbociclib.
  • Patients receiving any medications or substances that are potent inhibitors or inducers of
  • CYP3A isoenzymes within 7 days of randomization.
  • Uncontrolled intercurrent illness that would limit compliance with study requirements.
  • Pregnant women, or women of childbearing potential without a negative pregnancy test within 14 days prior to randomization.
  • Patients with a history of any malignancy are ineligible
  • Patients who previously received endocrine therapy within 5 years prior to diagnosis of the current malignancy.
  • Patients on antiretroviral therapy.
  • Patients with clinically significant history of any chronic liver disease.
  • Patients receiving concurrent exogenous hormone therapy (topical vaginal estrogen therapy is allowable).

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Arm APalbociclibPalbociclib at a dose of 125 mg orally once daily, Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle for a total duration of 2 years, in addition to standard adjuvant endocrine therapy for a duration of at least 5 years.
Arm AStandard Adjuvant Endocrine TherapyPalbociclib at a dose of 125 mg orally once daily, Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle for a total duration of 2 years, in addition to standard adjuvant endocrine therapy for a duration of at least 5 years.
Arm BStandard Adjuvant Endocrine TherapyStandard adjuvant endocrine therapy for a duration of at least 5 years.
Primary Outcome Measures
NameTimeMethod
Invasive Disease Free Survival (iDFS)4 years

Invasive disease-free survival (iDFS) for the combination of at least 5 years endocrine therapy and 2-year palbociclib treatment versus at least 5 years endocrine therapy alone in patients with histologically confirmed HR+/HER2- invasive early breast cancer (EBC) at 4 years. iDFS is defined as the time from randomization to the date of the first event: local/regional invasive ipsilateral recurrence, contralateral invasive breast cancer, distant recurrence, second primary invasive cancer of non-breast origin or death from any cause. Direct comparison between arms used time to iDFS events and Kaplan-Meier Log-rank analysis. Due to the medians not yet achieved, the percentage of patients considered iDFS at 4 years is reported.

Secondary Outcome Measures
NameTimeMethod
Invasive Disease Free Survival (iDFS) Excluding Second Primary Invasive Cancers of Non-breast Origin.4 years

Invasive disease-free survival (iDFS, excluding second primary invasive cancers of non-breast origin) for the combination of at least 5 years endocrine therapy and 2-year palbociclib treatment versus at least 5 years endocrine therapy alone in patients with histologically confirmed HR+/HER2- invasive early breast cancer (EBC) at 4 years. iDFS excluding second primary invasive cancers of non-breast origin is defined as the time from randomization to the date of the first event: local/regional invasive ipsilateral recurrence, contralateral invasive breast cancer, distant recurrence, or death from any cause. Second primary invasive cancers of non-breast origin will not be considered as events for this endpoint. Direct comparison between arms used time to iDFS events and Kaplan-Meier Log-rank analysis. Due to the medians not yet achieved, the percentage of patients considered iDFS at 4 years is reported.

Distant Recurrence-free Survival (DRFS)4 years

Compare time to distant recurrence-free survival (DRFS). Distant recurrence is defined according to STEEP criteria as the time from randomization to the date of the first event: distant recurrence or death from any cause. Patients with a locoregional recurrence will continue to be followed for DRFS. Surviving patients who are event-free will be censored at: the date of last disease assessment, or withdrawal of consent to be followed, or death whichever came first. Direct comparison between arms used time to DRFS events and Kaplan-Meier Log-rank analysis. Due to the medians not yet achieved, the percentage of patients considered DRFS at 4 years is reported.

Overall Survival (OS)4 years

Compare overall survival (OS). Overall survival is defined as the time period between randomization and death. Surviving patients classified as lost-to-follow up or having withdrawn consent to be followed will be censored at their date of last contact or withdrawal of consent to be followed, whichever occurs first.

Locoregional Recurrences-free Survival (LRRFS)4 years

Compare locoregional recurrence-free survival (LRRFS). LRRFS is defined as the time from randomization to the date of the first event: local/regional invasive ipsilateral recurrence, contralateral invasive breast cancer, or death from any cause. Patients with second primary invasive cancers of non-breast origin or distant recurrence will be censored at the date of diagnosis. Surviving patients who are event-free will be censored at: the date of last disease assessment, or withdrawal of consent to be followed, whichever occurs first.

Trial Locations

Locations (434)

Hematology Oncology Associates of Central New York - East Syracuse

🇺🇸

East Syracuse, New York, United States

Kaiser Permanente Sunset Medical Center

🇺🇸

Los Angeles, California, United States

University of Pittsburgh Cancer Institute- Hillman Cancer Center

🇺🇸

Pittsburgh, Pennsylvania, United States

Onkologisches Forschungszentrum Klinik St. Anna, Hirslanden

🇨🇭

Luzern, Switzerland

Massachusetts General Hospital

🇺🇸

Boston, Massachusetts, United States

Dana Farber Cancer Institute

🇺🇸

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

🇺🇸

Boston, Massachusetts, United States

Mercy Medical Center

🇺🇸

Baltimore, Maryland, United States

University of Miami Miller School of Medicine Sylvester Cancer Center

🇺🇸

Miami, Florida, United States

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

🇺🇸

Houston, Texas, United States

Houston Methodist Hospital Cancer Center

🇺🇸

Houston, Texas, United States

University of California

🇺🇸

San Diego, California, United States

Kaiser Permanente San Diego Medical Center

🇺🇸

San Diego, California, United States

Sharp Memorial Hospital

🇺🇸

San Diego, California, United States

Kaiser Permanente San Francisco Medical Center

🇺🇸

San Francisco, California, United States

UCSF Helen Diller Comprehensive Cancer Center

🇺🇸

San Francisco, California, United States

Kaiser Permanente San Leandro Medical Center

🇺🇸

San Leandro, California, United States

Huntsman Cancer Institute - University of Utah

🇺🇸

Salt Lake City, Utah, United States

Mayo Clinic in Arizona

🇺🇸

Phoenix, Arizona, United States

Vanderbilt University/Ingram Cancer Center

🇺🇸

Nashville, Tennessee, United States

Nashville General Hospital at Meharry

🇺🇸

Nashville, Tennessee, United States

Kaiser Permanente Baldwin Park Medical Center

🇺🇸

Baldwin Park, California, United States

Katmai Oncology Group

🇺🇸

Anchorage, Alaska, United States

University of South Alabama Mitchell Cancer Institute

🇺🇸

Mobile, Alabama, United States

Marin Cancer Center

🇺🇸

Greenbrae, California, United States

Kaiser Permanente Irvine Medical Center

🇺🇸

Irvine, California, United States

Kaiser Permanente Anaheim Medical Center

🇺🇸

Anaheim, California, United States

Southern Cancer Center PC - Providence

🇺🇸

Mobile, Alabama, United States

Kaiser Permanente Harbor City Medical Center

🇺🇸

Harbor City, California, United States

Providence Alaska Cancer Center

🇺🇸

Anchorage, Alaska, United States

Kaiser Permanente Bellflower Medical Center

🇺🇸

Bellflower, California, United States

Marin Cancer Care

🇺🇸

Greenbrae, California, United States

Long Beach Memorial Medical Center - Todd Cancer Institute

🇺🇸

Long Beach, California, United States

UCSD Moores Cancer Center

🇺🇸

La Jolla, California, United States

Palo Alto Medical Foundation Health Care

🇺🇸

Palo Alto, California, United States

Kaiser Permanente Riverside Medical Center

🇺🇸

Riverside, California, United States

Kaiser Permanente Panorama City Medical Center

🇺🇸

Panorama City, California, United States

Stanford Women's Cancer Center

🇺🇸

Stanford, California, United States

Kaiser Permanente Walnut Creek Medical Center

🇺🇸

Walnut Creek, California, United States

Kaiser Permanente Vallejo Medical Center

🇺🇸

Vallejo, California, United States

Kaiser Permanente San Marcos Medical Center

🇺🇸

San Marcos, California, United States

Kaiser Permanente Santa Clara Medical Center

🇺🇸

Santa Clara, California, United States

Kaiser Permanente San Jose Medical Center

🇺🇸

San Jose, California, United States

Hartford Hospital

🇺🇸

Hartford, Connecticut, United States

Kaiser Permanente South San Francisco Medical Center

🇺🇸

South San Francisco, California, United States

Kaiser Permanente Cadillac Medical Center

🇺🇸

West Los Angeles, California, United States

Memorial Sloan Cancer Center - Hartford Healthcare Center Institute at HOCC

🇺🇸

New Britain, Connecticut, United States

Georgetown University Medical Center

🇺🇸

Washington, District of Columbia, United States

Christiana Health System - Christiana Hospital

🇺🇸

Newark, Delaware, United States

Morton Plant Hospital

🇺🇸

Clearwater, Florida, United States

Memorial Health University Medical Center

🇺🇸

Savannah, Georgia, United States

Mount Sinai Comprehensive Cancer Center

🇺🇸

Miami Beach, Florida, United States

Illinois CancerCare-Peoria

🇺🇸

Peoria, Illinois, United States

Decatur Memorial Hospital

🇺🇸

Decatur, Illinois, United States

University of Illinois

🇺🇸

Chicago, Illinois, United States

University of Kentucky-Markey Cancer Center

🇺🇸

Lexington, Kentucky, United States

OSF Saint Anthony Medical Center

🇺🇸

Rockford, Illinois, United States

McFarland Clinic PC-William R Bliss Cancer Center

🇺🇸

Ames, Iowa, United States

Cancer Care Specialist of Central Illinois

🇺🇸

Decatur, Illinois, United States

Greater Baltimore Medical Center

🇺🇸

Baltimore, Maryland, United States

MedStar Franklin Square Medical Center Winberg Cancer Institute

🇺🇸

Baltimore, Maryland, United States

Medical Oncology and Hematology Associates - Des Moines

🇺🇸

Des Moines, Iowa, United States

Covenant Medical Center

🇺🇸

Waterloo, Iowa, United States

Anne Arundel Medical Center

🇺🇸

Annapolis, Maryland, United States

Medstar Union Memorial Hospital

🇺🇸

Baltimore, Maryland, United States

JHU Sidney Kimmel Comprehensive Cancer Center LAPS

🇺🇸

Baltimore, Maryland, United States

NorthShore Hematology Oncology-Libertyville

🇺🇸

Skokie, Illinois, United States

Indiana University - Melvin and Bren Simon Cancer Center LAPS

🇺🇸

Indianapolis, Indiana, United States

Physicians' Clinic of Iowa PC

🇺🇸

Cedar Rapids, Iowa, United States

Frederick Regional Health System James M Stockman Cancer Institute

🇺🇸

Baltimore, Maryland, United States

Tidal Health Peninsula Regional

🇺🇸

Salisbury, Maryland, United States

MedStar Good Samaritan Hospital

🇺🇸

Baltimore, Maryland, United States

Trinity Health Michigan

🇺🇸

Livonia, Michigan, United States

Lowell General Hospital

🇺🇸

Lowell, Massachusetts, United States

Missouri Baptist Medical Center

🇺🇸

Saint Louis, Missouri, United States

Phelps Country Regional Medical Center

🇺🇸

Rolla, Missouri, United States

Spectrum Health Butterworth Research Pharmacy

🇺🇸

Grand Rapids, Michigan, United States

Metro Minnesota Oncology Research Consortium

🇺🇸

Saint Louis Park, Minnesota, United States

Cancer Research for the Ozarks NCORP

🇺🇸

Springfield, Missouri, United States

Nebraska Hematology and Oncology

🇺🇸

Lincoln, Nebraska, United States

Hackensack University Medical Center

🇺🇸

Hackensack, New Jersey, United States

Robert Wood Johnson University Hospital Somerset

🇺🇸

Somerville, New Jersey, United States

Rutgers Cancer Center Institute of New Jersey

🇺🇸

New Brunswick, New Jersey, United States

University of New Mexico Comprehensive Cancer Center

🇺🇸

Albuquerque, New Mexico, United States

Montefiore Medical Center - Einstein Campus

🇺🇸

Bronx, New York, United States

Carolinas Medical Center/Levine Cancer Institute

🇺🇸

Charlotte, North Carolina, United States

Cleveland Clinic

🇺🇸

Cleveland, Ohio, United States

Cancer Centers of Southwest Oklahoma Research

🇺🇸

Lawton, Oklahoma, United States

Cleveland Clinic Cancer Center/Fairview Hospital

🇺🇸

Cleveland, Ohio, United States

Penn State Milton S Hershey Medical Center

🇺🇸

Hershey, Pennsylvania, United States

University of Pennsylvania/Abramson Cancer Center

🇺🇸

Philadelphia, Pennsylvania, United States

Allegheny General Hospital

🇺🇸

Pittsburgh, Pennsylvania, United States

Avera Cancer Institute-Aberdeen

🇺🇸

Aberdeen, South Dakota, United States

University of Wisconsin Hospital and Clinics

🇺🇸

Madison, Wisconsin, United States

Gunderson Lutheran Medical Center

🇺🇸

La Crosse, Wisconsin, United States

Wheaton Franciscan Healthcare-All Saints

🇺🇸

Racine, Wisconsin, United States

UW Cancer Center at ProHealth Care

🇺🇸

Waukesha, Wisconsin, United States

Wheaton Franciscan Healthcare - Wauwatosa

🇺🇸

Wauwatosa, Wisconsin, United States

Coffs Harbour Health Campus - MNCCI

🇦🇺

Coffs Harbour, New South Wales, Australia

St Vincent's Hospital

🇦🇺

Fitzroy, Victoria, Australia

Peninsula Health - Frankston Hospital

🇦🇺

Melbourne, Victoria, Australia

Royal Brisbane & Women's Hospital

🇦🇺

Brisbane, Queensland, Australia

Gosford Hospital

🇦🇺

Gosford, New South Wales, Australia

Wollongong Hospital

🇦🇺

Wollongong, New South Wales, Australia

Western Health, Sunshine Hospital

🇦🇺

St. Albans, Victoria, Australia

St John of God Bunbury Hospital

🇦🇺

Bunbury, Western Australia, Australia

Medical University of Graz, Gyn. Dept.

🇦🇹

Graz, Austria

CHU Sart Tilman Liège (Medical Oncology)

🇧🇪

Liège, Belgium

LKH Salzburg, Univ. Klinik f. Innere Med. III

🇦🇹

Salzburg, Austria

Universitätsklinikum St. Pölten, Innere Medizin

🇦🇹

St. Pölten, Austria

Breast Centre Dr. Wette Viktor

🇦🇹

St. Veit an der Glan, Austria

Chiba Cancer Center

🇯🇵

Chiba, Japan

CHC - Saint-Joseph/Oncology-Hematology

🇧🇪

Liège, Belgium

Clinique et Maternite Sainte-Elisabeth - Oncology Department

🇧🇪

Namur, Belgium

UZ Leuven/ Gynaecologie-Oncologie

🇧🇪

Leuven, Belgium

CHU Saint Pierre/Medical Oncology

🇧🇪

Brussels, Belgium

Grand Hopital de Charleroi - Oncologie-hématologie

🇧🇪

Charleroi, Belgium

University Hospital Antwerp (UZA)

🇧🇪

Edegem, Belgium

CHR - Centre Hospitalier Peltzer La Tourelle/ Oncology Department

🇧🇪

Verviers, Belgium

GZA Ziekenhuizen (Campus Sint-Augustinus) / Oncologische Centrum

🇧🇪

Wilrijk, Belgium

BC Cancer Agency- Abbotsford Centre

🇨🇦

Abbotsford, British Columbia, Canada

BC Cancer Agency - Vancouver Cancer Centre

🇨🇦

Vancouver, British Columbia, Canada

CHU de Québec - Hôpital du St Sacrement

🇨🇦

Québec, Quebec, Canada

Allan Blair Cancer Centre

🇨🇦

Regina, Saskatchewan, Canada

University Hospital Aachen

🇩🇪

Aachen, Germany

Agaplesion Markus Krankenhaus

🇩🇪

Frankfurt, Germany

Praxisklinik Krebsheilkunde für Frauen

🇩🇪

Berlin, Germany

Onkol. GP Dres. med. Wilke/Wagner/Petzoldt

🇩🇪

Fürth, Germany

Universitätsmedizin Mainz

🇩🇪

Mainz, Germany

University Medical Center Hamburg-Eppendorf, Department of Gynecology

🇩🇪

Hamburg, Germany

Praxis Gynäkologie Arabella

🇩🇪

München, Germany

Országos Onkológiai Intézet - "B" Belgyógyászati Onkológiai és Klinikai Farmakológiai Osztály

🇭🇺

Budapest, Hungary

University Clinic Oldenburg

🇩🇪

Oldenburg, Germany

Oncologianova GmbH

🇩🇪

Recklinghausen, Germany

Uzsoki Utcai Kórház - Onkoradiológia, Sugárterápia, Fővárosi Onkoradiológiai Központ

🇭🇺

Budapest, Hungary

Petz Aladár Megyei Oktatókórház - Onkoradiológiai Osztály

🇭🇺

Győr, Hungary

St. Josefs-Hospital

🇩🇪

Wiesbaden, Germany

Bon Secours Hospital, Cork

🇮🇪

Cork, Ireland

Department of Internal Medicine (DIMI) - IRCCS San Martino University Hospital

🇮🇹

Genoa, Italy

Sheba Medical Center Tel Hashomer

🇮🇱

Ramat Gan, Tel Aviv, Israel

Azienda Ospedaliero-Universitaria Careggi/Florence University/Radiation Oncology Unit

🇮🇹

Florence, Italy

Hospital Vall d´Hebron

🇪🇸

Barcelona, Spain

Ospedale San Raffaele

🇮🇹

Milano, Italy

Nuovo Ospedale di Prato (NOP) - Azienda USL4 Prato

🇮🇹

Prato, Italy

S. Anna Hospital (Ospedale Sant'Anna)- Turin

🇮🇹

Turin, Italy

Nagoya City University Hospital/Dept. of Breast & Endocrine Surgery

🇯🇵

Nagoya, Aichi, Japan

Department of Breast Surgery National Hospital Organization Hokkaido Cancer Center

🇯🇵

Sapporo, Hokkaido, Japan

Seoul National University Hospital, Hematology-Medical Oncology

🇰🇷

Seoul, Korea, Republic of

Samsung Medical Centre, Breast Cancer Center, Department of Medicine, Division of Hematology/Oncology

🇰🇷

Seoul, Korea, Republic of

Máxima Medisch Centrum

🇳🇱

Eindhoven, Netherlands

Zaans Medical Center

🇳🇱

Zaandam, Netherlands

Zuyderland Ziekenhuis, Oncology

🇳🇱

Geleen, Netherlands

Opolskie Centrum Onkologii, Oddzial Onkologii Klinicznej

🇵🇱

Opole, Poland

Instytut MSF Spółka z ograniczoną odpowiedzialnością

🇵🇱

Łódź, Poland

Complejo Hospitalario Universitario A Coruña (CHUAC)

🇪🇸

A Coruña, Spain

Hospital Clinic Barcelona

🇪🇸

Barcelona, Spain

Hospital Reina Sofía

🇪🇸

Córdoba, Spain

ICO/ H. Josep Trueta

🇪🇸

Girona, Spain

Hospital Universitari Sant Joan de Reus

🇪🇸

Reus, Spain

Hospital Quirón Sagrado Corazón

🇪🇸

Sevilla, Spain

Hospital Son Llatzer

🇪🇸

Palma, Spain

Complejo Hospitalario de Navarra

🇪🇸

Pamplona, Spain

Gävle Hospital, Dept. of Oncology

🇸🇪

Gävle, Sweden

Sahlgrenska University Hospital, Dept. Oncology

🇸🇪

Göteborg, Sweden

Hospital Universitario Virgen del Rocio

🇪🇸

Sevilla, Spain

Hosital Arnau de Vilanova Valencia

🇪🇸

Valencia, Spain

Spital STS AG, Onkologiezentrum Thun-Berner Oberland

🇨🇭

Thun, Bern, Switzerland

IOSI-Breast Cancer Unit-Ospedale San Giovanni-Bellinzona

🇨🇭

Bellinzona, Tessin, Switzerland

Kaohsiung Medical University Hospital

🇨🇳

Kaohsiung, Taiwan

Universitetssjukhuset Örebro (University Hospital) Örebro, Onkologkliniken

🇸🇪

Örebro, Sweden

Dep. Oncology, University Hospital

🇨🇭

Basel, Switzerland

Hôpitaux Universitaires de Genève

🇨🇭

Genève, Geneva, Switzerland

Kantonspital Baden

🇨🇭

Baden, Aargau, Switzerland

Kantonsspital Graubünden

🇨🇭

Chur, Graubünden, Switzerland

Kantonsspital St.Gallen, Onkologie/Hämatologie

🇨🇭

St.Gallen, Switzerland

National Taiwan University Hospital/Department of Surgery

🇨🇳

Taipei, Taiwan

Taipei Veterans General Hospital/General Surgery

🇨🇳

Taipei, Taiwan

University Hospitals Bristol NHS Foundation Trust

🇬🇧

Bristol, United Kingdom

Velindre Cancer Centre

🇬🇧

Cardiff, United Kingdom

The Royal Marsden Sutton

🇬🇧

London, United Kingdom

Charing Cross Hospital

🇬🇧

London, United Kingdom

Royal Liverpool University Hospital

🇬🇧

Liverpool, United Kingdom

Maidstone Hospital, Kent Oncology Centre

🇬🇧

Maidstone, United Kingdom

Royal Cornwall Hospitals NHS Trust, Oncology Trials, Sunrise Centre

🇬🇧

Truro, United Kingdom

City Hospital Birmingham

🇬🇧

Birmingham, United Kingdom

Royal Marsden Hospital Chelsea

🇬🇧

Chelsea, United Kingdom

Sunnybrook

🇨🇦

Toronto, Ontario, Canada

The Jewish General Hospital

🇨🇦

Montréal, Quebec, Canada

MD Anderson Cancer Center

🇪🇸

Madrid, Spain

San Pedro de Alcántara

🇪🇸

Cáceres, Spain

Hospital Universitario de Burgos

🇪🇸

Burgos, Spain

Hospital General Universitario de Elche

🇪🇸

Elche, Spain

Hospital Universitario Ramon y Cajal

🇪🇸

Madrid, Spain

CIOCC - Centro Integral Oncológico Clara Campal / Hospital HM Universitario Sanchinarro

🇪🇸

Madrid, Spain

Hospital Puerta de Hierro Majadahonda, Oncologia Médica

🇪🇸

Madrid, Spain

Hospital Universitario Donostia

🇪🇸

San Sebastián, Spain

Hospital Clinico Universitario de Santiago

🇪🇸

Santiago, Spain

Hospital Unversitario Virgen Macarena

🇪🇸

Sevilla, Spain

Consorci Sanitari de Terrassa

🇪🇸

Terrassa, Spain

Hospital Virgen de la Salud

🇪🇸

Toledo, Spain

Hospital Clínico Universitario de Valencia

🇪🇸

Valencia, Spain

Hospital Universitario Miguel Servet

🇪🇸

Zaragoza, Spain

Helios Klinikum Berlin-Buch

🇩🇪

Berlin, Germany

Praxis und Tagesklinik für gynäkologische Onkologie,

🇩🇪

Ebersberg, Germany

Marienhospital Bottrop, Klinik für Gynäkologie und Geburtshilfe

🇩🇪

Bottrop, Germany

Albertinen Krankenhaus

🇩🇪

Hamburg, Germany

St. Vincenz KH Limburg Frauenklinik

🇩🇪

Limburg, Germany

Elisabeth Krankenhaus Kassel Brustzentrum

🇩🇪

Kassel, Germany

HELIOS Klinik Rottweil - Gynäkologie

🇩🇪

Rottweil, Germany

MVZ Eggenfelden

🇩🇪

Eggenfelden, Germany

UKSH Campus Lübeck, Klinik für Frauenheilkunde und Geburtshilfe

🇩🇪

Lübeck, Germany

Western States Cancer Research NCORP

🇺🇸

Denver, Colorado, United States

Missouri Valley Cancer Consortium

🇺🇸

Omaha, Nebraska, United States

Mayo Clinic-Rochester

🇺🇸

Rochester, Minnesota, United States

Mayo Clinic

🇺🇸

Rochester, Minnesota, United States

Cancer Alliance of Nebraska

🇺🇸

Omaha, Nebraska, United States

Providence Portland Medical Center

🇺🇸

Portland, Oregon, United States

Wheaton Franciscan Healthcare - St. Joseph

🇺🇸

Milwaukee, Wisconsin, United States

Columbia St. Mary's Water Tower Medical Commons

🇺🇸

Milwaukee, Wisconsin, United States

Coborn Cancer Center at Saint Cloud Hospital

🇺🇸

Saint Cloud, Minnesota, United States

Metro Minnesota Community Oncology Research Consortium

🇺🇸

Saint Louis Park, Minnesota, United States

Maryland Oncology Hematology PA

🇺🇸

Bethesda, Maryland, United States

University Hospital, Geelong

🇦🇺

Geelong, Victoria, Australia

Macquarie University Hospital

🇦🇺

Macquarie Park, New South Wales, Australia

Monument Health Rapid City Hospital

🇺🇸

Rapid City, South Dakota, United States

Joliet Oncology Hematology Associates Limited

🇺🇸

Joliet, Illinois, United States

NorthShore University Health System - Evanston Hospital

🇺🇸

Evanston, Illinois, United States

Ingalls Memorial Hospital

🇺🇸

Harvey, Illinois, United States

Juravinski Cancer Centre

🇨🇦

Hamilton, Ontario, Canada

Studien GbR Braunschweig, Lorenz&HeckerWesche

🇩🇪

Braunschweig, Germany

Essentia Health NCORP

🇺🇸

Duluth, Minnesota, United States

Rapid City Regional Hospital/Regional Cancer Care Institute

🇺🇸

Rapid City, South Dakota, United States

Städtisches Klinikum Karlsruhe

🇩🇪

Karlsruhe, Germany

Studienzentrum City

🇩🇪

Berlin, Germany

St. Elisabeth Krankenhaus Leipzig

🇩🇪

Leipzig, Germany

Englewood Hospital and Medical Center

🇺🇸

Englewood, New Jersey, United States

Kaiser Permanente Sacramento Medical Center

🇺🇸

Sacramento, California, United States

Saint Joseph Mercy Hospital

🇺🇸

Ann Arbor, Michigan, United States

Kaiser Permanente Roseville Medical Center

🇺🇸

Roseville, California, United States

Kaiser Permanente Woodland Hills Medical Center

🇺🇸

Woodland Hills, California, United States

George Washington University Medical Faculty Associates

🇺🇸

Washington, District of Columbia, United States

Mayo Clinic in Florida

🇺🇸

Jacksonville, Florida, United States

Emory University Hospital

🇺🇸

Atlanta, Georgia, United States

Phoebe Putney Memorial Hospital

🇺🇸

Albany, Georgia, United States

Rush University Medical Center

🇺🇸

Chicago, Illinois, United States

University of Chicago Cancer Center LAPS

🇺🇸

Chicago, Illinois, United States

Carle Cancer Center

🇺🇸

Urbana, Illinois, United States

Orchard Healthcare Research Inc.

🇺🇸

Waukesha, Wisconsin, United States

McFarland Clinic, P.C.

🇺🇸

Ames, Iowa, United States

IU Health Ball Memorial Hospital

🇺🇸

Muncie, Indiana, United States

Iowa Oncology Research Assoc

🇺🇸

Des Moines, Iowa, United States

New England Cancer Specialists - Scarborough

🇺🇸

Scarborough, Maine, United States

Eastern Maine Medical Center d/b/a Northern Light Cancer Institute

🇺🇸

Bangor, Maine, United States

Holy Cross Hospital

🇺🇸

Silver Spring, Maryland, United States

Tufts Medical Center

🇺🇸

Boston, Massachusetts, United States

Beth Israel Deaconess Hospital - Plymouth Jordan Club Cancer Center

🇺🇸

Plymouth, Massachusetts, United States

Cancer Research Consortium of West Michigan NCORP

🇺🇸

Grand Rapids, Michigan, United States

Washington University School of Medicine

🇺🇸

Saint Louis, Missouri, United States

Mercy Hospital Saint Louis

🇺🇸

Saint Louis, Missouri, United States

Southeast Nebraska Cancer Center

🇺🇸

Lincoln, Nebraska, United States

New Hampshire Oncology-Hematology PA, Concord

🇺🇸

Concord, New Hampshire, United States

New Hampshire Oncology-Hematology PA

🇺🇸

Hooksett, New Hampshire, United States

Solinsky Center for Cancer Care

🇺🇸

Hooksett, New Hampshire, United States

Dartmouth Hitchcock Medical Center

🇺🇸

Lebanon, New Hampshire, United States

Norris Cotton Cancer Center - Nashua

🇺🇸

Lebanon, New Hampshire, United States

Roswell Park Cancer Institute

🇺🇸

Buffalo, New York, United States

Beth Israel Medical Center - New York

🇺🇸

New York, New York, United States

Northwell Health NCORP

🇺🇸

New Hyde Park, New York, United States

Mary Imogene Bassett Hospital

🇺🇸

Cooperstown, New York, United States

Queens Hospital Center

🇺🇸

Jamaica, New York, United States

Oneonta FoxCare Center

🇺🇸

Oneonta, New York, United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone

🇺🇸

New York, New York, United States

Memorial Sloan Kettering Cancer Center - LAPS

🇺🇸

New York, New York, United States

SUNY Upstate Medical University

🇺🇸

Syracuse, New York, United States

The Charlotte-Mecklenburg Hospital Authority

🇺🇸

Charlotte, North Carolina, United States

Duke University Medical Center

🇺🇸

Durham, North Carolina, United States

Cone Health Cancer Center

🇺🇸

Greensboro, North Carolina, United States

Kinston Medical Specialists, PA

🇺🇸

Kinston, North Carolina, United States

First Health of the Carolinas - Moore Regional Hospital

🇺🇸

Pinehurst, North Carolina, United States

Ohio State University Comprehensive Cancer Center

🇺🇸

Columbus, Ohio, United States

Cleveland Clinic Cancer Center/Hillcrest Hospital

🇺🇸

Mayfield Heights, Ohio, United States

Stephenson Cancer Center

🇺🇸

Oklahoma City, Oklahoma, United States

University of Oklahoma Health Sciences Center

🇺🇸

Oklahoma City, Oklahoma, United States

Hematology & Oncology Associates of Northeastern PA

🇺🇸

Dunmore, Pennsylvania, United States

Lancaster General Hospital

🇺🇸

Lancaster, Pennsylvania, United States

Hospital of the University of Pennsylvania Perelman Center for Advanced Medicine

🇺🇸

Philadelphia, Pennsylvania, United States

Pennsylvania Hospital

🇺🇸

Philadelphia, Pennsylvania, United States

UPMC MaGee Women's Hospital

🇺🇸

Pittsburgh, Pennsylvania, United States

WellSpan Health York Cancer Center

🇺🇸

York, Pennsylvania, United States

Reading Hospital/McGlinn Cancer Institute

🇺🇸

Wyomissing, Pennsylvania, United States

Lexington Medical Center/Lexington Oncology Associates

🇺🇸

Columbia, South Carolina, United States

Avera Cancer Institute

🇺🇸

Sioux Falls, South Dakota, United States

Doctors Hospital of Laredo

🇺🇸

Laredo, Texas, United States

Inova Schar Cancer Institute

🇺🇸

Fairfax, Virginia, United States

CAMC Cancer Center

🇺🇸

Charleston, West Virginia, United States

HSHS Saint Vincent Hospital

🇺🇸

Green Bay, Wisconsin, United States

ThedaCare Regional Cancer Center

🇺🇸

Appleton, Wisconsin, United States

Southern Highlands Cancer Centre

🇦🇺

Bowral, New South Wales, Australia

Orange Health Service

🇦🇺

Orange, New South Wales, Australia

The Breast & Endocrine Centre

🇦🇺

Gateshead, New South Wales, Australia

Flinders Drive

🇦🇺

Bedford Park, South Australia, Australia

South West Healthcare, Warrnambool

🇦🇺

Warrnambool, Victoria, Australia

Royal Hobart Hospital

🇦🇺

Hobart, Tasmania, Australia

The Northern Hospital

🇦🇺

Epping, Victoria, Australia

Breast Cancer Research Centre - WA

🇦🇺

Nedlands, Western Australia, Australia

Peter MacCallum Cancer Centre

🇦🇺

Melbourne, Victoria, Australia

LKH Univ Klinikum Graz, Dept of Internal Med. and Oncology

🇦🇹

Graz, Austria

Fiona Stanley Hospital

🇦🇺

Murdoch, Western Australia, Australia

LKH Feldkirch, Department of Internal Medicine

🇦🇹

Feldkirch, Austria

St. Josef Krankenhaus, Department of Internal I

🇦🇹

Vienna, Austria

Klinik Ottakring

🇦🇹

Vienna, Austria

Salzkammergut-Klinikum Vöcklabruck

🇦🇹

Voecklabruck, Austria

OLV ziekenhuis Aalst/Radiotherapy-Oncology

🇧🇪

Aalst, Belgium

Landesklinikum Wr. Neustadt, Department of Surgery

🇦🇹

Wr. Neustadt, Austria

Institut Jules Bordet/Medical Oncology Department

🇧🇪

Brussels, Belgium

Cliniques Universitaires Saint-Luc, Oncologisch centrum

🇧🇪

Bruxelles, Belgium

CancerCare Manitoba - St. Boniface Hospital

🇨🇦

Winnipeg, Manitoba, Canada

Horizon Health Network - Saint John Regional Hospital

🇨🇦

Saint John, New Brunswick, Canada

The Vitalite Health Network - Dr. Leon Richard

🇨🇦

Moncton, New Brunswick, Canada

University Health Network Princess Margaret Cancer Centre

🇨🇦

Toronto, Ontario, Canada

Kingston General Hospital, Cancer Centre of Southeastern Ontario/Oncology

🇨🇦

Kingston, Ontario, Canada

Niagara Health System

🇨🇦

St. Catharines, Ontario, Canada

Grand River Regional Cancer Center

🇨🇦

Kitchener, Ontario, Canada

CHUM Hôtel Dieu

🇨🇦

Montréal, Quebec, Canada

Frauenklinik/University Hospital Erlangen

🇩🇪

Erlangen, Germany

Centrum für Hämatologie und Onkologie Bethanien

🇩🇪

Frankfurt, Germany

Klinikum Frankfurt Höchst

🇩🇪

Frankfurt, Germany

Universitätsfrauenklinik Halle (Saale)

🇩🇪

Halle (Saale), Germany

University of Debrecen Medical Center, Clinic of Oncology

🇭🇺

Debrecen, Hungary

St James's Hospital, Cancer Clinical Trials Office, Old Admin Building,

🇮🇪

Dublin, Ireland

Mater Misericordiae University Hospital

🇮🇪

Dublin, Ireland

St Vincent Hospital - Medical Oncology Research Department

🇮🇪

Dublin, Ireland

Sligo University Hospital

🇮🇪

Sligo, Ireland

Cork University Hospital, Oncology Clinical Trials Unit

🇮🇪

Cork, Ireland

Szegedi Tudomanyegyetem Általános Orvostudományi Kar Szent-Györgyi Albert Klinikai Központ, Onkoterápiás Klinika

🇭🇺

Szeged, Hungary

Rabin Medical Center (RMC)

🇮🇱

Petah Tikva, Central, Israel

P.O. Misericordia AUSL Toscana Sud Est

🇮🇹

Grosseto, Italy

Sourasky Medical Center

🇮🇱

Tel-Aviv, Israel

Azienda Ospedaliero-Universitaria di Ferrara

🇮🇹

Ferrara, Italy

Policlinico di Monza - Istituto di Oncologia del Policlinico di Monza

🇮🇹

Monza, Italy

Ospedale "Mater Salutis" di Legnago, Dept. of Medical Oncology

🇮🇹

Legnago, Italy

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) IRCCS

🇮🇹

Meldola, Italy

Istituto Europeo di Oncologia

🇮🇹

Milano, Italy

Medical Oncology Unit; University Hospital of Parma (Azienda Ospedaliero-Universitaria di Parma)

🇮🇹

Parma, Italy

ASST Bergamo Ovest

🇮🇹

Treviglio, Italy

Severance Hospital Medical Doctor at Department of Medical Oncology

🇰🇷

Seoul, Korea, Republic of

Kyoto University Hospital/Breast Surgery

🇯🇵

Kyoto, Japan

National Hospital Organization Osaka National Hospital

🇯🇵

Osaka, Japan

Osaka International Cancer Institute

🇯🇵

Osaka, Japan

Centro Médico Zambrano Hellion

🇲🇽

Monterrey, Nuevo León, Mexico

Hagaziekenhuis

🇳🇱

Den Haag, Netherlands

St Antonius Hospital

🇳🇱

Nieuwegein, Netherlands

Isala, Dept of Medical Oncology

🇳🇱

Zwolle, Netherlands

Klinika Nowotworów Piersi i Chirurgii Rekonstrukcyjnej, Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie

🇵🇱

Warsaw, Poland

Hospital da Luz

🇵🇹

Lisboa, Portugal

CUF Descobertas Hospital, Hemato-Oncologia

🇵🇹

Lisboa, Portugal

Centro Clinico Champalimaud

🇵🇹

Lisbon, Portugal

Instituto Português de Oncologia (IPO) Francisco Gentil do Porto

🇵🇹

Porto, Portugal

ICO Badalona

🇪🇸

Badalona, Spain

Centro Oncologico de Galicia

🇪🇸

A Coruña, Spain

Hospital General Universitario Alicante

🇪🇸

Alicante, Spain

Hospital Universitari Quirón Dexeus

🇪🇸

Barcelona, Spain

Hospital General de Granollers

🇪🇸

Barcelona, Spain

Hospital del Mar

🇪🇸

Barcelona, Spain

Consorcio Hospitalario Provincial de Castellon

🇪🇸

Castellón De La Plana, Spain

Complejo asistencial universitario de Leon

🇪🇸

León, Spain

Hospital Universitario Gregorio Marañón

🇪🇸

Madrid, Spain

Hospital La Paz, Servicio de Oncologia Médica

🇪🇸

Madrid, Spain

Hospital Universitario 12 de Octubre

🇪🇸

Madrid, Spain

Fundación Jiménez Díaz

🇪🇸

Madrid, Spain

Hospital General Universitario José Mª Morales Meseguer

🇪🇸

Murcia, Spain

Hospital Universitario Fundacion Alcorcón

🇪🇸

Madrid, Spain

Hospital Clínico Universitario Virgen de la Arrixaca

🇪🇸

Murcia, Spain

Hospital Universitario Central de Asturias

🇪🇸

Oviedo, Spain

Hospital Clínico Universitario Virgen de la Victoria

🇪🇸

Málaga, Spain

Hospitali Universitari son Espases

🇪🇸

Palma, Spain

Hospital de Sant Juan Despi Moisés Broggi

🇪🇸

Sant Joan Despì, Spain

Hospital Clinico Universitario Lozano Blesa

🇪🇸

Zaragoza, Spain

Karolinska Universitetssjukhuset, Bröstcentrum A2:00

🇸🇪

Stockholm, Sweden

Akademiska Sjukhuset Uppsala (University Hospital), Onkologkliniken

🇸🇪

Uppsala, Sweden

Fondazione Oncologia Lago Maggiore, Locarno

🇨🇭

Locarno, Tessin, Switzerland

Luzerner Kantonsspital, Dept. of Medical Oncology

🇨🇭

Luzern, Switzerland

The Beatson West of Scotland Cancer Centre

🇬🇧

Glasgow, United Kingdom

University Hospitals of Leicester

🇬🇧

Leicester, United Kingdom

Northern Centre for Cancer Care

🇬🇧

Newcastle upon Tyne, United Kingdom

The Christie NHS Foundation Trust

🇬🇧

Manchester, United Kingdom

Nottingham University Hospitals NHS TRUST UK

🇬🇧

Nottingham, United Kingdom

Weston Park Hospital, Sheffield Teaching Hospitals

🇬🇧

Sheffield, United Kingdom

Advent Health Orlando

🇺🇸

Orlando, Florida, United States

Orlando Health Cancer Institute

🇺🇸

Orlando, Florida, United States

Norton Cancer Institute - Brownsboro

🇺🇸

Louisville, Kentucky, United States

Women & Infants Hospital of Rhode Island

🇺🇸

Providence, Rhode Island, United States

Fox Chase Cancer Center

🇺🇸

Philadelphia, Pennsylvania, United States

University Hospital Innsbruck, Department of Obstetrics and Gynaecology

🇦🇹

Innsbruck, Austria

BHS Ried, Abt. f. Gynäkologie

🇦🇹

Ried, Austria

Phyrn-Eisenwurzen Klinikum Steyr

🇦🇹

Steyr, Austria

LKH Wolfsberg, Department of Surgery

🇦🇹

Wolfsberg, Austria

Centro Oncológico Estatal ISSEMYM

🇲🇽

Toluca de Lerdo, Toluca, Mexico

BC Cancer Agency - Sindi Ahluwalia Hawkins Centre for the Southern Interior

🇨🇦

Kelowna, British Columbia, Canada

Brustordination Dr. Thiel

🇦🇹

Weiz, Austria

Cedars Sinai Medical Center

🇺🇸

Los Angeles, California, United States

BKH Kufstein, Innere Medizin

🇦🇹

Kufstein, Austria

LKH Hochsteiermark Leoben

🇦🇹

Leoben, Austria

Kepler Universitätsklinikum Med. Campus III

🇦🇹

Linz, Austria

University Hospital Limerick, Midwestern Cancer Centre

🇮🇪

Limerick, Ireland

Advocate Lutheran General Hospital

🇺🇸

Park Ridge, Illinois, United States

Hospital of the Sisters of Charity Linz, Surg. Dept., Breast Health Center

🇦🇹

Linz, Austria

Medical University of Vienna Department of Obstetrics and Gynaecology

🇦🇹

Vienna, Austria

Medical University Vienna - Coop Group Surgery/Oncology

🇦🇹

Vienna, Austria

Hospital Hietzing, Gynecology

🇦🇹

Vienna, Austria

Instituto Português de Oncologia (IPO) de Lisboa Francisco Gentil

🇵🇹

Lisboa, Portugal

National Cheng Kung University Hospital, Division of Hemato-Oncology, Dept. Internal Medicine

🇨🇳

Tainan, Taiwan

Weinviertelklinikum Mistelbach, Department of Surgery

🇦🇹

Mistelbach, Austria

Klinikum Wels - Grieskirchen GmbH, Department of Internal Medicine IV

🇦🇹

Wels, Austria

Beaumont Hospital - Cancer Clinical Trials Unit

🇮🇪

Dublin, Ireland

University Hospital Waterford, Cancer Research Department

🇮🇪

Waterford, Ireland

National Cancer Institute Mexico, Breast Cancer Department

🇲🇽

Mexico City, Mexico

HFR Fribourg, Oncology Department

🇨🇭

Fribourg, Switzerland

Saskatoon Cancer Center, University of Saskatchewan

🇨🇦

Saskatoon, Saskatchewan, Canada

Changhua Christian Hospital/General Surgery

🇨🇳

Changhua, Changhua County, Taiwan

Brust-Zentrum Zürich

🇨🇭

Zurich, Switzerland

Universitätsspital Zürich, Klinik für Onkologie

🇨🇭

Zurich, Switzerland

Uniwersyteckie Centrum Kliniczne (UCK), Klinika Onkologii I Radioterapii

🇵🇱

Gdansk, Poland

St. Luke's Hospital

🇺🇸

Kansas City, Missouri, United States

Ochsner Medical Center

🇺🇸

New Orleans, Louisiana, United States

VCU Massey Cancer Center

🇺🇸

Richmond, Virginia, United States

Tom Baker Cancer Centre - Dept. of Oncology

🇨🇦

Calgary, Alberta, Canada

Kaiser Permanente Oakland Medical Center

🇺🇸

Oakland, California, United States

Kaiser Permanente Fontana Medical Center

🇺🇸

Fontana, California, United States

Instituto Catalán de Oncología (ICO) de L'Hospitalet de Llobregat

🇪🇸

Barcelona, Spain

Guy's and St Thomas' NHS Foundation Trust

🇬🇧

London, United Kingdom

Thomas Jefferson University

🇺🇸

Philadelphia, Pennsylvania, United States

Rhode Island Hospital

🇺🇸

Providence, Rhode Island, United States

Queen Elizabeth II Health Sciences Centre

🇨🇦

Halifax, Nova Scotia, Canada

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