518
Participants
Start Date
June 21, 2017
Primary Completion Date
October 15, 2024
Study Completion Date
July 31, 2026
palbociclib
o Starting dose: 125 mg capsule taken orally once per day for 21 days followed by 7 days off to complete 28 day cycle. Dose reductions: 100 mg, 75 mg. allowed. Number of Cycles: until progression or unacceptable toxicity develops
trastuzumab
Patients must have received a minimum of 4 and maximum of 8 cycles of induction therapy prior to randomization to Arm A or B, at which point they will continue on antiHER2 therapy and endocrine therapy, with or without palbociclib. Trastuzumab dosing will be determined based on a loading dose of 8mg trastuzumab/kg body weight for Q3WK dosing schedules or a maintenance dose of 6mg/kg trastuzumab/kg dosing weight for Q3WK dosing schedules. Loading dose will be administered on Cycle 1, Day 1.
pertuzumab
Patients must have received a minimum of 4 and maximum of 8 cycles of induction therapy prior to randomization to Arm A or B, at which point they will continue on antiHER2 therapy and endocrine therapy, with or without palbociclib.Pertuzumab will be administered at a loading dose of 840 mg infusion and then at a maintenance dose of 420 mg q3wks. If patient is within 5 weeks of receiving loading dose at Cycle 1, Day 1, patient may start with maintenance dose of 420 mg.
letrozole
There are several allowed endocrine treatment agents for Arm A and Arm B of this study. Administration is performed on an outpatient, self-administration basis according to local requirements and local standard practice. Endocrine treatment may have started before the patient enters the study. Agents will be administered at the discretion of principal investigator as well as according to standard institutional or regional practice. Recommended dosing regimen for letrozole oral therapy is 2.5 mg orally, once a day.
Anastrozole
There are several allowed endocrine treatment agents for Arm A and Arm B of this study. Administration is performed on an outpatient, self-administration basis according to local requirements and local standard practice. Endocrine treatment may have started before the patient enters the study. Agents will be administered at the discretion of principal investigator as well as according to standard institutional or regional practice. Recommended dosing regimen for anastrozole is 1 mg orally, once a day.
Exemestane
There are several allowed endocrine treatment agents for Arm A and Arm B of this study. Administration is performed on an outpatient, self-administration basis according to local requirements and local standard practice. Endocrine treatment may have started before the patient enters the study. Agents will be administered at the discretion of principal investigator as well as according to standard institutional or regional practice. Recommended dosing regimen for exemestane is 25 mg orally, once a day.
Fulvestrant
There are several allowed endocrine treatment agents for Arm A and Arm B of this study. Administration is performed on an outpatient, self-administration basis according to local requirements and local standard practice. Endocrine treatment may have started before the patient enters the study. Agents will be administered at the discretion of principal investigator as well as according to standard institutional or regional practice. Recommended dosing regimen for Fulvestrant is 250 mg injections on Day 1 and Day 15 of Cycle 1, and q4weeks thereafter.
University of Pennsylvania, Philadelphia
Georgetown University Medical Center, Washington D.C.
University of Maryland - Greenebaum Comprehensive Cancer Center, Baltimore
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore
Duke Cancer Institute, Durham
First Health of the Carolinas Cancer Center, Pinehurst
Lexington Medical Center, West Columbia
Emory University, Atlanta
Florida Hospital, Orlando
Memorial Healthcare System, Hollywood
University of Miami, Miami
Baycare Healthcare (Morton Plant Mease), Clearwater
Vanderbilt University Medical Center, Nashville
Ohio State University, Columbus
Michigan Cancer Research Consortium (St. Joseph Mercy Hospital, Ann Arbor
West Michigan Cancer Center, Grand Rapids
Metro-Minnesota NCI Community Oncology Research Program, Minneapolis
Mayo Clinic, Rochester, MN, Rochester
Ingalls Memorial Hospital, Harvey
University of Illinois at Chicago, Chicago
Washington University School of Medicine, St Louis
Cancer Center of Kansas, Wichita
Nebraska Methodist Hospital, Omaha
University of Nebraska Medical Center, Omaha
Ochsner Medical Center Jefferson, New Orleans
MD Anderson, Houston
Huntsman Cancer Institute, University of Utah, Salt Lake City
New Mexico Cancer Care Alliance, Albuquerque
UCSF, San Francisco
Legacy Good Samaritan Hospital, Portland
New England Cancer Specialists, Scarborough
Dana-Farber Cancer Institute, Boston
Lowell General Hospital, Lowell
Hackensack Medical Center, Hackensack
The Valley Hospital, Okonite Research Center, Paramus
Monash Health, Clayton
St. Vincent's Hospital, Sydney Kinghorn Cancer Centre, Darlinghurst
The Canberra Hospital, Garran
Peter MacCallum Cancer Centre, Royal Melbourne Hospital, Melbourne
Breast Cancer Research Centre-WA, Nedlands
Icon Cancer Care, South Brisbane
Mater Cancer Care Centre, South Brisbane
Calvary Mater Newcastle Hospital, Waratah
Westmead Hospital, Westmead
Institut de Cancérologie de l'Ouest, site Paul Papin, Angers
Institut Sainte Catherine, Avignon
Institut Bergonié, Bordeaux
Centre Francois Baclesse, Caen
Centre Hospitalier Cholet, Cholet
Centre Jean Perrin, Clermont-Ferrand
Centre Georges François Leclerc, Dijon
Centre Oscar Lambret, Lille
CHU de Limoges, Limoges
Centre Léon Bérard, Lyon
Institut Paoli Calmettes, Marseille
Institut de Cancerologie de Montpellier, Montpellier
Centre Azureen de Cancerologie, Mougins
Centre Antoine Lacassagne, Nice
Institut Curie Site Paris, Paris
Tenon Oncologie Médicale - APHP, Paris
Centre CARIO-HPCA, Plérin
Institut Jean Godinot, Reims
Centre Eugene Marquis, Rennes
Centre Henri Becquerel, Rouen
Institut Curie Site Saint Cloud, Saint-Cloud
Institut de Cancérologie Lucien Neuwirth, Saint-Priest-en-Jarez
Centre Paul Strauss, Strasbourg
Intitut Claudius Regaud, Toulouse
Gustave Roussy, Villejuif
Marienhospital Bottrop, Bottrop
St. Elisabeth Krankenhaus, Cologne
Kliniken Essen-Mitte, Evang. Huyssens-Stiftung/Knappschaft GmbH, Essen
Agaplesion Markus Krankenhaus, Frankfurt
Diakovere Henriettenstift Frauenklinik, Hanover
UKSH, Klinik für Gynäkologie und Geburtshilfe, Kiel
Praxis Prof. Nitz im Brustzentrum Niederrhein, Münster
Universitätsklinikum Münster, Münster
Leopoldina-Krankenhaus Schweinfurt, Schweinfurt
Policlinico Sant'Orsola-Malpighi, Bologna
U.O. Oncologia AOU Arcispedale Sant'Anna, Cona
Istituto Europeo di Oncologia, Milan
Ospedale San Raffaele, Segrate
Ospedale Santa Maria della Misericordia, Udine
Auckland City Hospital Cancer and Blood Research, Auckland
Hospital Champalimaud, Lisbon
Hospital Da Luz, Lisbon
Hospital Beatriz Angelo, Loures
IPO Porto, Porto
Hospital Clínic de Barcelona, Barcelona
Hospital General de Catalunya, Barcelona
Hospital Universitari Vall d'Hebron, Barcelona
ICO L'Hospitalet, Barcelona
Hospital Universitario 12 de Octubre, Madrid
Hospital Universitario de Fuenlabrada, Madrid
Hospital Universitario Fundación Alcorcón, Madrid
Hospital Universitario Fundación Jiménez Díaz, Madrid
Hospital Universitario La Paz, Madrid
MD Anderson Cancer Center Spain, Madrid
Hospital Regional Universitario de Málaga, Málaga
Hospital Universitario Virgen de la Arrixaca, Murcia
Complejo Hospitalario de Navarra, Navarro
Hospital Universitario de Salamanca, Salamanca
Complejo Hospitalario Univ. De Santiago, Santiago
Hospital Quirón Sagrado Corazón, Seville
Hospital Sant Joan de Reus, Tarragona
Hospital Clínico Universitario de Valencia, Valencia
Collaborators (2)
Pfizer
INDUSTRY
GBG Forschungs GmbH
OTHER
Fondazione Michelangelo
OTHER
PrECOG, LLC.
OTHER
Breast Cancer Trials, Australia and New Zealand
OTHER
Syneos Health
OTHER
SOLTI Breast Cancer Research Group
OTHER
UNICANCER
OTHER
Alliance Foundation Trials, LLC.
OTHER