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Brief Title: Study Of Letrozole With Or Without Palbociclib (PD-0332991) For The First-Line Treatment Of Hormone-Receptor Positive Advanced Breast Cancer
Official Title: PHASE 1/2, OPEN-LABEL, RANDOMIZED STUDY OF THE SAFETY, EFFICACY, AND PHARMACOKINETICS OF LETROZOLE PLUS PD 0332991 (ORAL CDK 4/6 INHIBITOR) AND LETROZOLE SINGLE AGENT FOR THE FIRST-LINE TREATMENT OF ER POSITIVE, HER2 NEGATIVE ADVANCED BREAST CANCER IN POSTMENOPAUSAL WOMEN
Study ID: NCT00721409
Brief Summary: The study is aimed to confirm that letrozole + PD 0332991 is safe and tolerable and to assess the effect of the combination on advanced breast cancer
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Central Hematology Oncology Medical group Inc., Alhambra, California, United States
UCLA Hematology/Oncology - Alhambra, Alhambra, California, United States
CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center, Bakersfield, California, United States
St. Joseph Heritage Healthcare, Fullerton, California, United States
UCLA West Medical Pharmacy (Drug Management Only), Los Angeles, California, United States
UCLA West Medical Pharmacy, Los Angeles, California, United States
Ronald Reagan UCLA Medical Center, Los Angeles, California, United States
UCLA West Medical Pharmacy, Los Angeles, California, United States
Drug Management Only: UCLA West Medical Pharmacy, Los Angeles, California, United States
Drug Management Only, Los Angeles, California, United States
Regulatory Managment, Los Angeles, California, United States
Ronald Reagan UCLA Medical Center, Los Angeles, California, United States
TORI -US Central Administration (Regulatory Management), Los Angeles, California, United States
TORI -US Central Administration, Los Angeles, California, United States
TORI Central Administration (Regulatory Management), Los Angeles, California, United States
TORI Central Administration (Regulatory Managment Only), Los Angeles, California, United States
TRIO-US Central Administration, Los Angeles, California, United States
UCLA Hematology/Oncology, Los Angeles, California, United States
UCLA, Hematology/Oncology, Los Angeles, California, United States
Westwood Bowyer Clinic, Peter Morton Medical Building, Los Angeles, California, United States
Central Hematology Oncology Medical Group, Inc, Pasadena, California, United States
Torrance Health Association, DBA Torrance Memorial Physician Network/Cancer Care Associates, Redondo Beach, California, United States
Sansum Santa Barbara Medical Foundation Clinic, Santa Barbara, California, United States
Central Coast Medical Oncology Corporation, Santa Maria, California, United States
Santa Monica-UCLA Medical Center and Orthopaedic Hospital, Santa Monica, California, United States
UCLA Hematology Oncology-Santa Monica, Santa Monica, California, United States
UCLA Hematology/Oncology - Santa Clarita, Valencia, California, United States
Gwinnett Hospital System Inc.-d/b/a-The Center for Cancer Care, Duluth, Georgia, United States
Gwinnett Hospital System Inc.-d/b/a-The Center for Cancer Care, Lawrenceville, Georgia, United States
Gwinnett Hospital System Inc.-d/b/a-The Center for Cancer Care, Snellville, Georgia, United States
Illinois Cancer Specialists, Chicago, Illinois, United States
Resurrection Medical Group, Chicago, Illinois, United States
North Shore Oncology-Hematology Associates, Crystal Lake, Illinois, United States
North Shore Hematology Oncology, Highland Park, Illinois, United States
North Shore Oncology-Hematology Associates, Libertyville, Illinois, United States
North Shore Hematology Oncology, Skokie, Illinois, United States
Regulatory Office: Comprehensive Cancer Centers of Nevada, Henderson, Nevada, United States
Comprehensive Cancer Centers of Nevada, Henderson, Nevada, United States
Comprehensive Cancer Centers of Nevada, Henderson, Nevada, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Texas Oncology-Dallas Presbyterian Hospital, Dallas, Texas, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
Investigational Products Center (IPC), Fort Worth, Texas, United States
US Oncology Research and Clinical Pharmacy, Fort Worth, Texas, United States
Virginia Cancer Specialists, PC, Arlington, Virginia, United States
Virginia Cancer Specialists, PC, Fairfax, Virginia, United States
Virginia Cancer Specialists, PC, Gainesville, Virginia, United States
Virginia Cancer Specialists, PC, Leesburg, Virginia, United States
Virginia Cancer Specialists, PC, Woodbridge, Virginia, United States
BC Cancer Agency - Vancouver Centre, Vancouver, British Columbia, Canada
CSSS Champlain-Charles-Le Moyne Local HS-0054, Greenfield Park, Quebec, Canada
Centre Paul Papin, CRLCC, ANGERS Cedex 9, , France
CHD Vendee, La Roche Sur Yon, , France
Gemeinschaftspraxis, Onkologischer Schwerpunkt am Oskar-Helene-Heim, Berlin, , Germany
Gemeinschaftspraxis Haematologie-Onkologie, Dresden, , Germany
Martin-Luther-Universitaet Halle-Wittenberg, Halle/Saale, , Germany
Universitaetsklinik und Poliklinik fuer Gynaekologie, Martin-Luther-Universitaet Halle-Wittenberg, Halle/Saale, , Germany
Nationales Centrum fuer Tumorerkrankungen, Heidelberg, , Germany
Frauenaerzte Pruener Gang Abts & Partner, Kiel, , Germany
Klinik und Poliklinik fuer Frauenheilkunde und Geburtshilfe Universitaetsklinik Mainz, Mainz, , Germany
Onkolog. Gemeinschaftspraxis, Muenchen, , Germany
Frauenklinik vom Roten Kreuz, Muenchen, , Germany
Frauenklinik und Poliklinik Klinikum rechts der Isar, Technische Universitaet Muenchen, Muenchen, , Germany
Mutterhaus der Borromaeerinnen, Innere Medizin I, Trier, , Germany
Szent Margit Korhaz, Onkologia, Budapest, , Hungary
Orszagos Onkologiai Intezet, Kemoterapia B, Budapest, , Hungary
Fovarosi Onkormanyzat Uzsoki Utcai Korhaz, Budapest, , Hungary
Petz Aladar Megyei Oktato Korhaz, Onkoradiologia, Gyor, , Hungary
Borsod-Abauj-Zemplen Megyei Korhaz és Egyetemi Oktato Korhaz, Onkologia, Miskolc, , Hungary
Szabolcs-Szatmar-Bereg Megyei Korhazak es, Nyiregyhaza, , Hungary
Markusovszky Egyetemi Oktatokorhaz, Onkoradiologiai Osztaly, Szombathely, , Hungary
Bon Secours Hospital, Cork, , Ireland
St. James's Hospital, Dublin 8, , Ireland
St. Vincent's University Hospital, Dublin, , Ireland
Mater Misericordiae University Hospital, Dublin, , Ireland
Mater Private Hospital, Dublin, , Ireland
Divisione Oncologia Medica Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, IRST, Meldola, FC, Italy
M.O. di Oncologia - Azienda USL di Rimini - Ospedale "Cervesi", Cattolica, , Italy
Ospedale Civile di Faenza Centro Oncologico, Faenza, RA, , Italy
Unita' Operativa di Oncologia, Ospedale Civile di Lugo, Lugo, RA, , Italy
Ospedale Civile di Ravenna, Ravenna, , Italy
Azienda Unita Sanitaria Locale di Rimini, U.O. di Oncologia ed Oncoematologia Ospedale degli Infermi, Rimini, , Italy
Ospedale Villa San Pietro, Roma, , Italy
National Cancer Center, Center for Breast Cancer, Goyang-si, Gyeonggi-do, Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Federal State Budgetary Scientific Institution, Moscow, , Russian Federation
Pyatigorsk Oncology Center, Pyatigorsk, , Russian Federation
State Budgetary Healthcare Institution "Samara Regional Clinical Oncology Dispensary", Samara, , Russian Federation
Republican Clinical Oncology Dispensary of the Ministry of Health of Bashkortostan Republic, Ufa, , Russian Federation
Department of Oncotherapy, National Hospital, Bloemfontein, , South Africa
Eastleigh Breast Care Centre, Pretoria, , South Africa
Ico-Hospitalet, Hospitalet de Llobregat, Barcelona, Spain
Hospital General Universitario Vall D'Hebron, Barcelona, , Spain
Centro Oncologico de Galicia, La Coruña, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario Virgen Del Rocio, Sevilla, , Spain
Department of Oncology and Medical Radiology, SI "DMA of MOH, Ukraine, "MI "Dnipropetrovsk City, Dnipropetrovsk, , Ukraine
Municipal Treatment-and-Prophylactic Institution 'Donetsk City Oncological Dispensary' Radiology dep, Donetsk, , Ukraine
Municipal clinical treatment-and-propyilactic institution "Donetsk regional oncology center',, Donetsk, , Ukraine
Kyiv City Clinical Oncologic Center, Kyiv, , Ukraine
Lviv State Oncologic Regional Treatment and Diagnostic Centre, Lviv, , Ukraine
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR