Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer
- Conditions
- Interventions
- Registration Number
- NCT02947685
- Lead Sponsor
- Alliance Foundation Trials, LLC.
- Brief Summary
The primary objective of this study is to demonstrate that the combination of palbociclib with anti-HER2 therapy plus endocrine therapy is superior to anti-HER2-based therapy plus endocrine therapy alone in improving the outcomes of subjects with hormone receptor-positive, HER2+ metastatic breast cancer.
- Detailed Description
Subjects will be randomized into one of two treatment arms following minimum of 4 and maximum of 8 cycles of induction treatment with anti-HER2 therapy. Arm A subjects will receive the experimental therapy, palbociclib, in addition to their current anti-HER2 therapy and endocrine therapy. Arm B subjects will continue to receive the anti-HER2 therapy. It is e...
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 496
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A palbociclib Palbociclib 125 mg daily + AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestratnt) until confirmed disease progression Arm B Anastrozole AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestrant) until confirmed disease progression Arm B Fulvestrant AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestrant) until confirmed disease progression Arm A pertuzumab Palbociclib 125 mg daily + AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestratnt) until confirmed disease progression Arm A trastuzumab Palbociclib 125 mg daily + AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestratnt) until confirmed disease progression Arm A letrozole Palbociclib 125 mg daily + AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestratnt) until confirmed disease progression Arm B pertuzumab AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestrant) until confirmed disease progression Arm A Anastrozole Palbociclib 125 mg daily + AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestratnt) until confirmed disease progression Arm A Exemestane Palbociclib 125 mg daily + AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestratnt) until confirmed disease progression Arm B letrozole AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestrant) until confirmed disease progression Arm A Fulvestrant Palbociclib 125 mg daily + AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestratnt) until confirmed disease progression Arm B Exemestane AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestrant) until confirmed disease progression
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) as assessed by Investigator 24 months
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) 24 months Defined as time from date of randomization to date of death due to any cause
Objective Response Rate (OR: CR or PR) 24 months Defined as complete response (CR) or partial response (PR) according to RECIST v1.1
Duration of Response (DOR) 24 months Defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death from any cause, whichever occurs first
Safety: Type incidence and severity (as graded by NCI CTCAE v 4.0) 24 months Seriousness and attribution to the study medications of AEs and any laboratory abnormalities
3 and 5 year survival probabilities 24 months Survival probabilities will be estimated using the Kaplan-Meier method
Incidence of CNS Metastasis 24 months Compare the incidence of CNS metastasis between treatment arms
Clinical Benefit Rate (CBR: CR or PR or SD ≥ 24 weeks 24 months The Clinical Benefit Rate (CBR) on each treatment arm will be estimated by dividing the number of patients with CR, PR, or SD/Non-CR and Non-PD (for patients with measurable disease) ≥ 24 weeks by the number of patients randomized to the treatment arm.
Patient Reported Outcomes 24 months Time to symptom progression (FACT-B PFB-TOI), breast cancer specific health treatment related quality of life and general health status
Trial Locations
- Locations (118)
University of Maryland - Greenebaum Comprehensive Cancer Center
🇺🇸Baltimore, Maryland, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
The University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
MD Anderson
🇺🇸Houston, Texas, United States
Metro-Minnesota NCI Community Oncology Research Program
🇺🇸Minneapolis, Minnesota, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Huntsman Cancer Institute, University of Utah
🇺🇸Salt Lake City, Utah, United States
Centre Antoine Lacassagne
🇫🇷Nice, France
Centre Hospitalier Cholet
🇫🇷Cholet, France
Centre Eugene Marquis
🇫🇷Rennes, France
Institut de Cancérologie Lucien Neuwirth
🇫🇷Saint-Priest-en-Jarez, France
Intitut Claudius Regaud
🇫🇷Toulouse, France
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Anne Arundel Medical Center
🇺🇸Annapolis, Maryland, United States
Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
🇺🇸Baltimore, Maryland, United States
Baycare Healthcare (Morton Plant Mease)
🇺🇸Clearwater, Florida, United States
New England Cancer Specialists
🇺🇸Scarborough, Maine, United States
UCSF
🇺🇸San Francisco, California, United States
Ochsner Medical Center Jefferson
🇺🇸New Orleans, Louisiana, United States
Lowell General Hospital
🇺🇸Lowell, Massachusetts, United States
Breast Cancer Research Centre-WA
🇦🇺Nedlands, Australia
Institut Sainte Catherine
🇫🇷Avignon, France
Institut Bergonié
🇫🇷Bordeaux, France
Icon Cancer Care
🇦🇺South Brisbane, Australia
Mater Cancer Care Centre
🇦🇺South Brisbane, Australia
Institut de Cancérologie de l'Ouest, site Paul Papin
🇫🇷Angers, France
Institut Paoli Calmettes
🇫🇷Marseille, France
Centre Oscar Lambret
🇫🇷Lille, France
Institut de Cancerologie de Montpellier
🇫🇷Montpellier, France
Centre Azureen de Cancerologie
🇫🇷Mougins, France
Hospital Da Luz
🇵🇹Lisboa, Portugal
Hospital Clínic de Barcelona
🇪🇸Barcelona, Spain
ICO L'Hospitalet
🇪🇸Barcelona, Spain
Hospital Universitario de Fuenlabrada
🇪🇸Madrid, Spain
Hospital Regional Universitario de Málaga
🇪🇸Málaga, Spain
Complejo Hospitalario de Navarra
🇪🇸Navarro, Spain
Agaplesion Markus Krankenhaus
🇩🇪Frankfurt, Germany
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Universitario Fundación Jiménez Díaz
🇪🇸Madrid, Spain
Institut Curie Site Saint Cloud
🇫🇷Saint-Cloud, France
Centre Paul Strauss
🇫🇷Strasbourg, France
Marienhospital Bottrop
🇩🇪Bottrop, Germany
Hospital Beatriz Angelo
🇵🇹Loures, Portugal
Leopoldina-Krankenhaus Schweinfurt
🇩🇪Schweinfurt, Germany
Complejo Hospitalario Univ. De Santiago
🇪🇸Santiago, Spain
Hospital General de Catalunya
🇪🇸Barcelona, Spain
Hospital Quirón Sagrado Corazón
🇪🇸Seville, Spain
Calvary Mater Newcastle Hospital
🇦🇺Waratah, Australia
Westmead Hospital
🇦🇺Westmead, Australia
Legacy Good Samaritan Hospital
🇺🇸Portland, Oregon, United States
Duke Cancer Institute
🇺🇸Durham, North Carolina, United States
Institut Curie Site Paris
🇫🇷Paris, France
Hospital Clínico Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Emory University
🇺🇸Atlanta, Georgia, United States
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
Memorial Healthcare System
🇺🇸Hollywood, Florida, United States
Cancer Center of Kansas
🇺🇸Wichita, Kansas, United States
Ingalls Memorial Hospital
🇺🇸Harvey, Illinois, United States
Istituto Europeo di Oncologia
🇮🇹Milano, Italy
The Valley Hospital, Okonite Research Center
🇺🇸Paramus, New Jersey, United States
West Michigan Cancer Center
🇺🇸Grand Rapids, Michigan, United States
New Mexico Cancer Care Alliance
🇺🇸Albuquerque, New Mexico, United States
Hackensack Medical Center
🇺🇸Hackensack, New Jersey, United States
Mayo Clinic, Rochester, MN
🇺🇸Rochester, Minnesota, United States
Nebraska Methodist Hospital
🇺🇸Omaha, Nebraska, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
First Health of the Carolinas Cancer Center
🇺🇸Pinehurst, North Carolina, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
St. Vincent's Hospital, Sydney Kinghorn Cancer Centre
🇦🇺Darlinghurst, Australia
The Canberra Hospital
🇦🇺Garran, Australia
Lexington Medical Center
🇺🇸West Columbia, South Carolina, United States
Peter MacCallum Cancer Centre, Royal Melbourne Hospital
🇦🇺Melbourne, Australia
Centre Georges François Leclerc
🇫🇷Dijon, France
Centre Jean Perrin
🇫🇷Clermont-Ferrand, France
Centre Francois Baclesse
🇫🇷Caen, France
Centre Léon Bérard
🇫🇷Lyon, France
CHU de Limoges
🇫🇷Limoges, France
Centre CARIO-HPCA
🇫🇷Plerin Cedex, France
Hôpital Saint Louis
🇫🇷Paris, France
Tenon Oncologie Médicale - APHP
🇫🇷Paris, France
Institut Jean Godinot
🇫🇷Reims, France
Centre Henri Becquerel
🇫🇷Rouen, France
Praxisklinik Krebsheilkunde für Frauen
🇩🇪Berlin, Germany
Gustave Roussy
🇫🇷Villejuif, France
Studiengesellschaft Onkologie Bielefeld
🇩🇪Bielefeld, Germany
Kliniken Essen-Mitte, Evang. Huyssens-Stiftung/Knappschaft GmbH
🇩🇪Essen, Germany
Luisenkrankenhaus Düsseldorf
🇩🇪Düsseldorf, Germany
Universitätsklinikum Düsseldorf, Klinik für Frauenheilkunde & Geburtshilfe
🇩🇪Düsseldorf, Germany
Sana-Klinikum Hameln
🇩🇪Hameln, Germany
Universitätsklinikum Münster
🇩🇪Münster, Germany
Vidia Christliche Kliniken Karlsruhe Vincentius-Diakonissen-Kliniken gAG Frauenklinik
🇩🇪Karlsruhe, Germany
St. Elisabeth Krankenhaus
🇩🇪Köln, Germany
U.O. Oncologia AOU Arcispedale Sant'Anna
🇮🇹Cona, Italy
UKSH, Klinik für Gynäkologie und Geburtshilfe
🇩🇪Kiel, Germany
HELIOS Dr. Horst Schmidt Kliniken Wiesbaden; Klinik für Gynäkologie und gynäkologische Onkologie
🇩🇪Wiesbaden, Germany
Univ. Klinikum Oldenburg AÖR Hämatologie/Onkologie
🇩🇪Oldenburg, Germany
Diakovere Henriettenstift Frauenklinik
🇩🇪Hannover, Germany
Praxis Prof. Nitz im Brustzentrum Niederrhein
🇩🇪Munster, Germany
Auckland City Hospital Cancer and Blood Research
🇳🇿Auckland, New Zealand
Ospedale San Raffaele
🇮🇹Segrate, Italy
Policlinico Sant'Orsola-Malpighi
🇮🇹Bologna, Italy
Ospedale Santa Maria della Misericordia
🇮🇹Udine, Italy
Hospital Universitario Fundación Alcorcón
🇪🇸Madrid, Spain
Hospital Universitario de Salamanca
🇪🇸Salamanca, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
MD Anderson Cancer Center Spain
🇪🇸Madrid, Spain
Hospital Universitario Severo Ochoa
🇪🇸Madrid, Spain
Hospital Universitario Virgen de la Arrixaca
🇪🇸Murcia, Spain
Hospital Sant Joan de Reus
🇪🇸Tarragona, Spain
Florida Hospital
🇺🇸Orlando, Florida, United States
Michigan Cancer Research Consortium (St. Joseph Mercy Hospital
🇺🇸Ann Arbor, Michigan, United States
University of Miami
🇺🇸Miami, Florida, United States
Monash Health
🇦🇺Clayton, Australia
Hospital Champalimaud
🇵🇹Lisboa, Portugal
IPO Porto
🇵🇹Porto, Portugal
Related News
The Targeted Pulse: Explore Highlighted Updates From This Year's SABCS on Breast ...
SABCS: Pfizer's IBRANCE combo improves PFS in breast cancer study
Addition of Palbociclib to SOC Improves PFS in in HR+, HER2+ Breast Cancer
- Prev
- 1
- Next