A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)

Breast Neoplasms Clinical Trial

Official title:

A RANDOMIZED, MULTICENTER, DOUBLE-BLIND PHASE 3 STUDY OF PD-0332991 (ORAL CDK 4/6 INHIBITOR) PLUS LETROZOLE VERSUS PLACEBO PLUS LETROZOLE FOR THE TREATMENT OF POSTMENOPAUSAL WOMEN WITH ER (+), HER2 (-) BREAST CANCER WHO HAVE NOT RECEIVED ANY PRIOR SYSTEMIC ANTI CANCER TREATMENT FOR ADVANCED DISEASE

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01740427
• Other study ID #: A5481008
• Secondary ID: 2012-004601-27PA
• Status: Completed
• Phase: Phase 3
• Start date: February 22, 2013
• Est. completion date: November 9, 2023

Study information

• Verified date: November 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is designed to compare the clinical benefit following treatment with letrozole in combination with PD-0332991 versus letrozole in combination with placebo in postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti cancer therapies for their advanced/metastatic disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 666
• Est. completion date: November 9, 2023
• Est. primary completion date: February 26, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult women with locoregionally recurrent or metastatic disease not amenable to curative therapy.

• Confirmed diagnosis of ER positive breast cancer

• No prior systemic anti-cancer therapy for advanced ER+ disease.

• Postmenopausal women

• Measurable disease as per Response Evaluation Criterion in Solid Tumors [RECIST] or bone-only disease

• Eastern Cooperative Oncology Group [ECOG] 0-2

• Adequate organ and marrow function

• Patient must agree to provide tumor tissue

Exclusion Criteria:

• Confirmed diagnosis of HER2 positive disease

• Patients with advanced, symptomatic, visceral spread that are at risk of life threatening complication in the short term

• Known uncontrolled or symptomatic CNS metastases

• Prior (neo)adjuvant treatment with letrozole or anastrozole with DFI = 12-months from completion of treatment.

• Prior treatment with any CDK 4/6 inhibitor.

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• PD-0332991
PD-0332991, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
• Letrozole
Letrozole, 2.5mg, orally once daily (continuously)
• Placebo
Placebo, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
• Letrozole
Letrozole, 2.5mg, orally once daily (continuously)

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Icon Cancer Care	Auchenflower	Queensland
Australia	Bendigo Health Care Group, The Bendigo Hospital Campus	Bendigo	Victoria
Australia	Sunshine Coast University Hospital	Birtinya	Queensland
Australia	St Vincent's Hospital Sydney	Darlinghurst	New South Wales
Australia	Northern Hospital	Epping	Victoria
Australia	Fiona Stanley Hospital	Murdoch	Western Australia
Australia	Royal Melbourne Hospital	Parkville	Victoria
Australia	Laverty Pathology	Port Macquarie	New South Wales
Australia	Mid North Coast Diagnostic Imaging	Port Macquarie	New South Wales
Australia	Epworth Healthcare	Richmond	Victoria
Australia	Maroondah Hospital	Ringwood East	Victoria
Australia	Goulburn Valley Health	Shepparton	Victoria
Australia	Icon Cancer Care Corporate Office	South Brisbane	Queensland
Australia	Calvary Mater Newcastle	Waratah	New South Wales
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
Belgium	UZ Brussel	Brussel
Belgium	Institut Jules Bordet	Brussels
Belgium	Oncologie	Brussels
Belgium	Grand Hopital de Charleroi / Service d'Hematologie et Oncologie	Charleroi
Belgium	Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg	Leuven
Belgium	CHU Start Tilman	Liege
Belgium	CHR East Belgium - Verviers	Verviers
Belgium	Gasthuis Zusters Antwerpen - Campus Sint- Augustinus	Wilrijk	Antwerpen
Canada	Tom Baker Cancer Centre	Calgary	Alberta
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	QEII Health Sciences Centre, Victoria General Site	Halifax	Nova Scotia
Canada	London Regional Cancer Program	London	Ontario
Canada	Hopital du Sacre-Coeur	Montreal	Quebec
Canada	McGill University Health Centre (MUHC), Glen Site, Cedars Cancer Centre	Montreal	Quebec
Canada	Southlake Regional Health Centre- Stronach Regional Cancer Centre	Newmarket	Ontario
Canada	Center Hospitalier Affilie Universitaire de Quebec, Universite Laval, Hopital du Saint Sacrement	Quebec City	Quebec
Canada	Allan Blair Cancer Centre	Regina	Saskatchewan
Canada	BC Cancer Agency-Fraser Valley Centre	Surrey	British Columbia
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
Canada	St. Michaels Hospital	Toronto	Ontario
Canada	Sunnybrook Research Institute	Toronto	Ontario
Canada	British Columbia Cancer Agency-Vancouver Centre	Vancouver	British Columbia
Czechia	Fakultni nemocnice Hradec Kralove, Klinika onkologie a radiologie	Hradec Kralove
France	Institut de Cancerologie de l'Ouest- Paul Papin	Anger Cedex 02
France	Centre François Baclesse	Caen Cedex 5
France	Centre Georges François Leclerc	Dijon
France	CHD Vendée	La Roche Sur Yon
France	Centre Val d'Aurelle,	Montpellier CEDEX 5
France	Centre Antoine Lacassagne	Nice cedex 2
France	Institut Curie, Departement d'Oncologie Medicale	Paris Cedex 05
France	Centre Eugene Marquis	Rennes
France	Hopital Rene Huguenin/Institut Curie	Saint-Cloud
France	Institut de Cancérologie de l'Ouest-Rene Gauducheau	St Herblain
France	Institut Claudius Regaud- Cancer Comprehensive Center- IUCT-O-Medical Oncology Department	Toulouse CEDEX-9
France	Institut Gustave Roussy	Villejuif
Germany	Klinikverbund Sudwest - Kliniken Sidelfingen-Boblingen	Boblingen
Germany	University Hospital Carl Gustav Carus - Department for Obstetrics and Gynecology.	Dresden
Germany	Universitatsklinikum Erlangen, Frauenklinik	Erlangen
Germany	Universitaetsklinikum Hamburg-Eppendorf	Hamburg
Germany	Universitatsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Gynakologie und Geburtshilfe	Kiel
Germany	Universitaetsklinikum Magdeburg AOR Universitaetsfrauenklinik	Magdeburg
Germany	Katholisches Klinikum Mainz	Mainz
Germany	Frauenklinik und Poliklinik Klinikum rechts der Isar, Technische Universitaet Muenchen	Muenchen
Germany	IOZ- Munchen, PGM- Studien GmbH	Muenchen	Bavaria
Germany	Breast Cancer, University of Munich, Grosshadern Hospital	Munich
Germany	Rotkreuzklinikum Munchen, Frauenklinik,	Munich
Germany	Klinikum Mutterhaus	Trier
Hungary	Affidea Diagnosztika Kft.	Budapest
Hungary	Országos Onkológiai Intézet "B" Belgyogyaszati osztaly	Budapest
Hungary	Orszagos Onkologiai Intezet ,	Budapest
Hungary	Országos Onkológiai Intézet, Nuklearis Medicina Osztaly	Budapest
Hungary	Országos Onkológiai Intézet, Radiologiai Diagnosztikai Osztily	Budapest
Hungary	Szent Margit Korhaz	Budapest
Hungary	Petz Aladar Megyei Oktato Korhaz, Onkoradiologiai Osztaly	Györ
Hungary	Josa Andras Teaching Hospital,	Nyiregyhaza
Hungary	Diagnoscan Magyarorszag Kft.	Szeged
Hungary	Szegedi Tudomanyegyetem Altalanos Orvosi Kar, Patologia Intezet	Szeged
Hungary	Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, Altalanos Orvostudomanyi Kar	Szeged
Ireland	Bon Secours Hospital	Cork
Ireland	Beaumont Hospital	Dublin
Ireland	Mater Misericordiae University Hospital	Dublin
Ireland	St. James Hospital	Dublin
Ireland	St Vincents University Hospital	Dublin 4
Ireland	Department of Medical Oncology	Galway
Ireland	Mid Western Regional Hospital	Limerick
Ireland	Waterford Regional Hospital	Waterford
Italy	Azienda Ospedaliera San Giuseppe Moscati	Avellino
Italy	Azienda Ospedaliero-Universitaria di Bologna, Policlinico Sant'Orsola-Malpighi	Bologna	BO
Italy	Irccs Irst	Meldola	FC
Italy	IRCCS - Istituto Europeo di Oncologia	Milano	Milan
Italy	Azienda Ospedaliero-Universitaria Pisana	Pisa
Italy	Istituti Fisioterapici Ospitalieri	Roma
Italy	Ospedale SS Trinita	Sora (FR)
Japan	Chiba Cancer Center	Chiba
Japan	National Cancer Center Hospital	Chuo-Ku	Tokyo
Japan	National Hospital Organization Kyushu Cancer Center	Fukuoka
Japan	Hiroshima City Hiroshima Citizens Hospital	Hiroshima
Japan	Iwate Medical University Hospital	Iwate
Japan	Hakuaikai Medical Corporation Sagara Hospital	Kagoshima
Japan	National Cancer Center Hospital East	Kashiwa	Chiba
Japan	Saitama Cancer Center	Kita-adachi-gun	Saitama
Japan	Kumamoto University Hospital	Kumamoto
Japan	Kumamoto City Hospital	Kumamoto-shi	Kumamoto
Japan	National Hospital Organization Shikoku Cancer Center	Matsuyama-city	Ehime
Japan	Aichi Cancer Center Hospital	Nagoya	Aichi
Japan	Niigata Cancer Center Hospital 2-15-3	Niigata
Japan	National Hospital Organization Osaka National Hospital	Osaka
Japan	National Hospital Organization Hokkaido Cancer Center	Sapporo	Hokkaido
Korea, Republic of	National Cancer Center, Center for Breast Cancer	Goyang-si	Gyeonggi-do
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seodaemun-gu	Seoul
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do
Korea, Republic of	Asan Medical Center, Division of Oncology, Department of Internal Medicine	Seoul
Korea, Republic of	Samsung Medical Center, Division of Hematology-Oncology, Department of Medicine	Seoul
Korea, Republic of	Seoul National University Hospital / Department of Internal Medicine	Seoul
Poland	Oncology and Radiotherapy Clinic	Gdansk
Poland	Europejskie Centrum Zdrowia Otwock	Otwock	Mazovia
Poland	Niepubliczny Zaklad Opieki Zdrowotnej "Onko-Dent" SP.P. G.L. Slomian	Zory
Russian Federation	GUZ Republic Clinical Oncology Dispensary of Ministry of Health of Republic of Tatarstan	Kazan
Russian Federation	Regional Budgetary Healthcare Institution Kursk Regional Clinical	Kursk	Kursk Region
Russian Federation	State Budget Healthcate Institution "Leningrad Region Oncology Dispensary"	Kuzmolovo	Leningrad Region
Russian Federation	Federal State Budget Institution	Moscow
Russian Federation	State Budget Healthcare Institution Moscow City Oncology Hospital	Moscow Area
Russian Federation	Budget Institution of Healthcare	Omsk
Russian Federation	Budget Institution of Healthcare	Omsk
Russian Federation	Ryazan Regional Clinical Oncology Dispensary	Ryazan
Russian Federation	Saint-Petersburg State Budget Healthcare Institution (SBHCI)	Saint-Petersburg
Russian Federation	Non-State Health Care agency "Road Clinical Hospital of PLC" Russian Railways	St Petersburg
Russian Federation	Republican Clinical Hospital n.a. G.G. Kuvatov	Ufa
Russian Federation	SBHI of Republic of Bashkortostan Emergency Hospital	Ufa
Russian Federation	State Budget Medical Institution Republican Clinical Oncology	Ufa
Spain	Hospital Universitario Fundacion de Alcorcon	Alcorcon	Madrid
Spain	Hospital Universitario Infanta Cristina	Badajoz
Spain	Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Clinic I Provincial	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital de Donostia	Donostia- San Sebastian
Spain	Complejo Hospitalario de Jaen	Jaen
Spain	Instituto Catalan de Oncologia L'Hospitalet	L'Hospitalet De Llobregat (Barcelona)
Spain	Centro Oncologico de Galicia	La Coruna
Spain	Hospital Universitario de Canarias	La Laguna	Santa CRUZ DE Tenerife
Spain	Hospital Universitario Arnau de Vilanova de Lleida	Lleida
Spain	Centro Oncologico MD Anderson Internacional España	Madrid
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital General Universitario Gregorio Marañon	Madrid
Spain	Hospital Madrid Universitario Sanchinarro	Madrid
Spain	HOSPITAL Universitario 12 DE OCTUBRE	Madrid
Spain	Hospital Universitari Son Espases	Palma de Mallorca	Islas Baleares
Spain	Hospital Universitario Virgen del Rocio	Sevilla
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Consorci Sanitari de Terrassa	Terrassa	Barcelona
Spain	Instituto Valenciano de Oncologia	Valencia
Taiwan	Mackay Memory Hospital	Taipei
Taiwan	National Taiwan University Hospital	Taipei City
Taiwan	Veterans General Hospital-Taipei	Taipei City
Ukraine	MI "Dnipropetrovsk City Multidisciplinary Clinical Hospital No.4" of the Dnipropetrovsk City Council	Dnipro
Ukraine	State Institution Dnipropetrovsk Medical Academy at the Ministry of Health of Ukraine	Dnipro
Ukraine	Municipal Non-profit Enterprise "Regional Centre of Oncology"	Kharkiv
Ukraine	Lviv State Oncologic Regional Treatment and Diagnostic Center, Chemotherapy Department	Lviv
Ukraine	Municipal Medical Institution "Makiivka City Hospital No.2 of Donetsk Region"	Makiivka
Ukraine	Regional Municipal Establishment "Sumy Regional Clinical Oncology Dispensary", Thoracic Department	Sumy
Ukraine	City Oncology Centre of Central Municipal Clinical Hospital	Uzhgorod
Ukraine	Institute of Postgraduate education and preuniversity preparing of Uzhgorod National Univ.	Uzhgorod
Ukraine	MI "Zaporizhzhia Regional Clinical Oncology Dispensary" Zaporizhzhia Regional Assembly,	Zaporizhzhia
Ukraine	State institution "Zaporizhzhia Medical Academy of Postgraduate Education MOH Ukraine",	Zaporizhzhya
United Kingdom	Edinburgh Cancer Centre, Western General Hospital	Edinburgh	Scotland
United Kingdom	Beatson Institute for Cancer Research	Glasgow	Scotland
United Kingdom	Charing Cross Hospital	London
United Kingdom	Guys Hospital	London
United Kingdom	The Royal Marsden NHS Foundation Trust	London
United Kingdom	Kent Oncology Center	Maidstone	Kent
United Kingdom	Christie Hospital NHS Foundation Trust	Manchester
United Kingdom	The Research And Development Office, The Christie NHS Foundation Trust	Manchester
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	Emory University Hospital	Atlanta	Georgia
United States	Emory University Hospital Midtown	Atlanta	Georgia
United States	Grady Health System	Atlanta	Georgia
United States	The Emory Clinic	Atlanta	Georgia
United States	Winship Cancer Institute	Atlanta	Georgia
United States	Mercy Clinic St. Louis Cancer and Breast Institute	Ballwin	Missouri
United States	University of Maryland, Greenebaum Cancer Center	Baltimore	Maryland
United States	Southern California Permanente Medical Group	Bellflower	California
United States	Walter Reed National Military Medical Center	Bethesda	Maryland
United States	Beverly Hills Cancer Center	Beverly Hills	California
United States	Oncology & Hematology Associates of Southwest Virginia, INC., D.B.A. Blue Rigde Cancer Care	Blacksburg	Virginia
United States	CareMount Medical	Brewster	New York
United States	The Mark M. Connolly Center for Cancer and Specialty Care	Chicago	Illinois
United States	Kootenai Clinic Cancer Services	Coeur d'Alene	Idaho
United States	The West Clinic, PC	Corinth	Mississippi
United States	Texas Oncology-Baylor Charles A. Sammons Cancer Center	Dallas	Texas
United States	Texas Oncology-Dallas Presbyterian Hospital	Dallas	Texas
United States	Carle Foundation Hospital DBA Carle Cancer Center	Danville	Illinois
United States	Sylvester at Deerfield Beach	Deerfield Beach	Florida
United States	Tennessee Oncology, PLLC	Dickson	Tennessee
United States	Carle Foundation Hospital DBA Carle Cancer Center	Effingham	Illinois
United States	Texas oncology-west Texas	El Paso	Texas
United States	Texas oncology-West Texas	El Paso	Texas
United States	Texas Oncology-west Texas	El Paso	Texas
United States	Presence Infusion Care- Evanston	Evanston	Illinois
United States	Investigational Products Center (IPC)	Fort Worth	Texas
United States	Tennessee Oncology PLLC	Franklin	Tennessee
United States	St. Joseph Heritage Healthcare	Fullerton	California
United States	Tennessee Oncology, PLLC	Gallatin	Tennessee
United States	The West Clinic, PC dba West Cancer Centre	Germantown	Tennessee
United States	Los Angeles Hematology/Oncology Medical Group	Glendale	California
United States	Saint Francis Medical Center	Grand Island	Nebraska
United States	Saint Francis Medical Center, Saint Francis Cancer Treatment Center	Grand Island	Nebraska
United States	St. Mary's Hospital Regional Cancer Center	Grand Junction	Colorado
United States	Saint Francis Medical Center	Hastings	Nebraska
United States	Comprehensive Cancer Centers of Nevada	Henderson	Nevada
United States	Comprehensive Cancer Centers of Nevada	Henderson	Nevada
United States	Tennessee Oncology PLLC	Hermitage	Tennessee
United States	Memorial Breast Cancer Center at Memorial Regional Hospital	Hollywood	Florida
United States	Memorial Cancer Institute at Memorial Regional Hospital	Hollywood	Florida
United States	Memorial Regional Hospital	Hollywood	Florida
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas
United States	The University of Texas MD Anderson Cancer Center, Department of Breast Medical Oncology	Houston	Texas
United States	The University of Texas MD Anderson Cancer Center.	Houston	Texas
United States	UCLA Hematology/ Oncology- Irvine	Irvine	California
United States	US Oncology Investigational Products Center	Irving	Texas
United States	Cancer Specialist of North Florida, Pharmacy	Jacksonville	Florida
United States	Cancer Specialists of North Florida-Southpoint	Jacksonville	Florida
United States	UCLA Hematology Oncology- Laguna Hills	Laguna Hills	California
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	Regulatory Office: Comprehensive Cancer Centers of Nevada Research Department	Las Vegas	Nevada
United States	Tennessee Oncology, PLLC	Lebanon	Tennessee
United States	Administrative Address: UCLA Hematology/Oncology	Los Angeles	California
United States	Drug Management Only: TRIO-US Pharmacy UCLA Medical Plaza, Attn: Steven L Wong, Pharm.D.	Los Angeles	California
United States	Drug Management Only: UCLA West Medical Pharmacy, Attn: Steven L Wong, Pharm.D.	Los Angeles	California
United States	Los Angeles Hematology/Oncology Medical Group	Los Angeles	California
United States	Regulatory Management Only: TRIO-US Central Administration	Los Angeles	California
United States	Ronald Reagan UCLA Medical Center	Los Angeles	California
United States	Southern California Permanente Medical Group	Los Angeles	California
United States	Translational Research Management	Los Angeles	California
United States	TRIO-US Central Administration	Los Angeles	California
United States	TRIO-US Central Administration: Regulatory Management Only	Los Angeles	California
United States	UCLA Hematology Oncology	Los Angeles	California
United States	UCLA Hematology/Oncology	Los Angeles	California
United States	UCLA West Medical Pharmacy	Los Angeles	California
United States	UCLA West Medical Pharmacy, Attn: Steven L. Wong	Los Angeles	California
United States	UCLA West Medical Pharmacy: Drug Management Only	Los Angeles	California
United States	UCLA West Medical Pharmacy; Drug Management Only	Los Angeles	California
United States	James Graham Brown Cancer Center	Louisville	Kentucky
United States	James Graham Brown Cancer Center and University Hospital	Louisville	Kentucky
United States	Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care	Low Moor	Virginia
United States	University of Wisconsin	Madison	Wisconsin
United States	Northwest Georgia Oncology Centers, PC	Marietta	Georgia
United States	Carle Foundation Hospital DBA Carle Cancer Center	Mattoon	Illinois
United States	The West Clinic, PC dba West Cancer Centre	Memphis	Tennessee
United States	WVU Medicine	Morgantown	West Virginia
United States	CareMount Medical	Mount Kisco	New York
United States	Northern Westchester Hospital	Mount Kisco	New York
United States	Tennessee Oncology PLLC	Murfreesboro	Tennessee
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Tennessee Oncology PLLC	Nashville	Tennessee
United States	Tennessee Oncology PLLC	Nashville	Tennessee
United States	Tennessee Oncology PLLC	Nashville	Tennessee
United States	Tennessee Oncology, PLLC	Nashville	Tennessee
United States	Smilow Cancer Hospital at Yale New Haven	New Haven	Connecticut
United States	Columbia University Medical Center	New York	New York
United States	Virginia Oncology Associates	Newport News	Virginia
United States	Virginia oncology Associates	Norfolk	Virginia
United States	Whittingham Cancer Center @ Norwalk Hospital	Norwalk	Connecticut
United States	Orlando Health, Inc.	Orlando	Florida
United States	UCLA Hematology/ Oncology- Pasadena	Pasadena	California
United States	Memorial Breast Cancer Center at Memorial Hospital West	Pembroke Pines	Florida
United States	Memorial Cancer Institute at Memorial Hospital West	Pembroke Pines	Florida
United States	Memorial Hospital West	Pembroke Pines	Florida
United States	Sylvester Comprehensive Cancer Center Plantation	Plantation	Florida
United States	Kaiser Permanente Northwest Region	Portland	Oregon
United States	Northwest Cancer Specialists, P.C.	Portland	Oregon
United States	Northwest Cancer Specialists, PC	Portland	Oregon
United States	OHSU Center for Health and Healing	Portland	Oregon
United States	OHSU Center for Health and Healing 2	Portland	Oregon
United States	OHSU Research Pharmacy Services	Portland	Oregon
United States	Oregon Health and Science University	Portland	Oregon
United States	Kootenai Clinic Cancer Services	Post Falls	Idaho
United States	Torrance Health Association, DBa Torrance Memorial Physician Network	Redondo Beach	California
United States	Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care	Roanoke	Virginia
United States	Cancer Specialists of North Florida - St. Augustine	Saint Augustine	Florida
United States	Mercy Clinic St. Louis Cancer and Breast Institute	Saint Louis	Missouri
United States	Mercy Hospital St. Louis	Saint Louis	Missouri
United States	Mercy Hospital St. Louis - David C. Pratt Cancer Center	Saint Louis	Missouri
United States	Park Nicollet Frauenshuh Cancer Center	Saint Louis Park	Minnesota
United States	Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care	Salem	Virginia
United States	Southern California Permanente Medical Group	San Diego	California
United States	University of California San Francisco - Helen Diller Family Comprehensive Cancer Center	San Francisco	California
United States	University of California, San Francisco	San Francisco	California
United States	San Luis Obispo Oncology and Hematology Health Center/ Pacific Central Coast Health Centers	San Luis Obispo	California
United States	Central Coast Medical Oncology Corporation	Santa Maria	California
United States	UCLA Santa Monica Medical Center and Orthopaedic Hospital	Santa Monica	California
United States	Seattle Cancer Care Alliance	Seattle	Washington
United States	Tennessee Oncology, PLLC	Shelbyville	Tennessee
United States	Presence Infusion Care- Skokie	Skokie	Illinois
United States	Tennessee Oncology PLLC	Smyrna	Tennessee
United States	The West Clinic, PC dba West Cancer Centre	Southaven	Mississippi
United States	Stanford Women's Cancer Center	Stanford	California
United States	Stony Brook University- Cancer Center	Stony Brook	New York
United States	Carle Foundation Hospital DBA Carle Cancer Center	Urbana	Illinois
United States	Northwest Cancer Specialists P.C.	Vancouver	Washington
United States	Northwest Cancer Specialists, P.C.	Vancouver	Washington
United States	Virginia Oncology Associates	Virginia Beach	Virginia
United States	MedStar Georgetown University Hospital	Washington	District of Columbia
United States	Wellness Oncology & Hematology	West Hills	California
United States	UCLA Hematology/Oncology- Westlake	Westlake Village	California
United States	Shenandoah Oncology PC	Winchester	Virginia
United States	Oncology & Hematology Associates of Southwest Virginia, INC., D.B.A. Blue Rigde Cancer Care	Wytheville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Czechia,  France,  Germany,  Hungary,  Ireland,  Italy,  Japan,  Korea, Republic of,  Poland,  Russian Federation,  Spain,  Taiwan,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival (PFS) as Assessed by the Investigator.	PFS is defined as the time from the date of randomization to the date of the first documentation of objective tumor progression as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) or death due to any cause in the absence of documented PD, whichever occurs first. If tumor progression data include more than 1 date, the first date will be used. PFS (in months) will be calculated as (first event date - randomization date +1)/30.4. Progression is defined using RECIST v1.1, as a 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions, or the appearance of new lesions.	From randomization date to date of first documentation of progression OR death (up to approximately 2.5 years)
Secondary	Objective Response as Assessed by the Investigator	Objective Response (OR) defined as the overall complete response (CR) or partial response (PR) according to the RECIST v1.1. Objective Response Rate (ORR) is defined as proportion of patients with CR or PR relative to all randomized patients with measurable disease at baseline. Patients who do not have on-study radiographic tumor re-evaluation, who received anti-tumor treatment, or who died, progressed/ dropped out for any reason prior to reaching a CR or PR were counted as non-responders in the assessment of ORR. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10mm). PR: =30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. Stable Disease: neither sufficient shrinkage nor increase to qualify for disease progression.	From randomization until end of treatment (up to approximately 2.5 years)
Secondary	Objective Response: Patients With Measurable Disease at Baseline as Assessed by the Investigator	The OR is defined as the overall CR or PR according to the RECIST v1.1. ORR is defined as proportion of patients with CR or PR relative to all randomized patients with measurable disease at baseline. Patients who do not have on-study radiographic tumor re-evaluation, who received anti-tumor treatment, or who died, progressed/ dropped out for any reason prior to reaching a CR or PR were counted as non-responders in the assessment of ORR. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10mm). PR: =30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. Stable Disease: neither sufficient shrinkage nor increase to qualify for disease progression.	From randomization until end of treatment (up to approximately 2.5 years)
Secondary	Duration of Response (DR)	DR is defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression or to death due to any cause, whichever occurs first. If tumor progression data included more than 1 date, the first date will be used. DR was calculated as [the date response ended (i.e. date of PD or death) - first CR or PR date + 1)]/30.4. DR would only be calculated for the subgroup of patients with an objective tumor response. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10mm). PR: =30% decrease under baseline of the sum of diameters of all target measurable lesions.The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. Stable Disease: neither sufficient shrinkage nor increase to qualify for disease progression.	From randomization until end of treatment (up to approximately 2.5 years)
Secondary	Disease Control (DC)/Clinical Benefit Response (CBR)	DC is defined as the overall CR, PR, or stable disease (SD) =24 weeks according to the RECIST version 1.1. Disease Control Rate (DCR) is defined as the patients with CR, PR, or SD =24 weeks relative to all randomized participants. Participants who do not have on-study radiographic tumor reevaluation, who received anti-tumor treatment, a best response of SD=24 weeks, or who died, progressed,or dropped out for any reason prior to achieving reaching a CR or PR and a best response of SD=24 weeks was counted as non-responders in DCR. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10mm). PR: =30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. SD: neither sufficient shrinkage nor increase to qualify for disease progression	From randomization until end of treatment (up to approximately 2.5 years)
Secondary	PFS by Tumor Tissue Biomarkers Status, Including Genes (eg, Copy Numbers of CCND1, CDKN2A), Proteins (eg, Ki67, pRb), and RNA Expression (eg, cdk4, cdk6)	PFS by biomarker status by Investigator assessment. Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.; Positive is defined as H-Score =1 and negative as H-Score <1. H-Score is calculated as the sum of the % of cells at each level of staining intensity (0, 1+, 2+, and 3+) multiplied by the staining intensity value: H-Score = (% at 0)*0 + (% at 1+)*1 + (% at 2+)*2 + (% at 3+)*3. H-Score values range from 0 to 300.; ER stands for estrogen receptor and Rb stands for retinoblastoma susceptibility gene product.	From randomization until end of treatment (up to approximately 24 Months)
Secondary	Corrected QT Interval (QTc) Time-matched Change From Baseline on Cycle 1 Day 14	Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and sent to a central laboratory for blinded manual adjudication. The average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR), by Bazette's formula (QTcB = QT divided by square root of RR) and corrected QT interval according to study-specific criteria (QTcS). Time-matched change from baseline values were reported for QTc analysis population.	Time-matched triplicate ECGs were collected at 0 (predose), 2, 4, 6 and 8 hours on Day 0 and on Cycle1 Day14
Secondary	Percentage of Participants With Corrected QT Interval (QTc)	Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and sent to a central laboratory for blinded manual adjudication. The average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR), by Bazette's formula (QTcB = QT divided by square root of RR) and corrected QT interval according to study-specific criteria (QTcS). Percentage of participants with post-baseline maximum absolute values and maximum increase from baseline were summarized for the safety analysis population.	For safety monitoring triplicate ECGs were obtained at 0 hour (pre-dose) on Day 1 of Cycle 1, Day 14 of Cycles 1 and Cycle 2, then on Day 1 of Cycles 4, 7, and 10. ECGs beyond Cycle 10 were performed as clinically indicated
Secondary	Observed Plasma Trough Concentration (Ctrough) at Steady-State	Summary of Plasma Palbociclib Within-Patient Mean Steady-State Trough Concentrations.	0 hour (predose) on Day 14 of cycles 1 and 2
Secondary	Change From Baseline Between Treatment Comparison in Euro Quality of Life (EQ-5D) Index	The EuroQol EQ-5D is a 6-item instrument designed to assess health status in terms of a single index value or utility score. It contains 5 descriptors of current health state (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) with each dimension having 3 levels of function (1=no problem, 2=some problem, and 3=extreme problem). The scores on the 5 descriptors are summarized to create a single summary score. An overall utility score is calculated based on these domains, with a range score from 0 (worse health scenario) to a maximum of 1.0 (best health scenario).	From Baseline up to 2.5 years
Secondary	Change From Baseline Between Treatment Comparison in Functional Assessment of Cancer Therapy -Breast (FACT-B)	FACT is a modular approach to assess participant health-related quality of life using a 'core' set of questions (FACT-G) as well as a cancer site-specific module. The FACT-G is a 27-item compilation of general questions divided into 4 domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. The FACT-B consisted of the FACT-G (27-item) and a breast-specific module: a 10-item instrument designed to assess participant concerns relating to breast cancer. For all questions, participants were asked to respond to a five-level scale where 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much. FACT-B total score = Physical Well-Being + Social/Family Well-Being + Emotional Well-Being + Functional Well-Being + Breast Cancer Subscale. As each of the items ranges from 0-4, the range of possible scores is 0-144, with 0 being the worst possible score and 144 the best.	From Baseline up to 2.5 years
Secondary	Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs; All Causalities)	An AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. SAE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required hospitalization; resulted in persistent or significant disability or in congenital anomaly/birth defect. TEAE were events that occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Severity was graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0 as Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening and Grade 5 = death related to AE.	From date of randomization up to 28 days after last dose of study drug, (assessed up to data cut-off date of 15-Nov-2021, approximately 8.7 years)
Secondary	Overall Survival (OS)	OS was defined as the time from date of randomization to date of death due to any cause. Participants without survival data beyond the date of their last follow-up were censored on the last date they were known to be alive.	From date of randomization until death due to any cause or censored, (assessed up to data cut-off date of 15-Nov-2021, approximately 8.7 years)
Secondary	Survival Probability at 1 Year, 2 Year and 3 Year	One, two or three-year survival probability was defined as the probability of survival 1 year, 2 or 3 years after the date of randomization. The survival probability was estimated using the Kaplan-Meier method and 2-sided 95% confidence interval (CI) was calculated using the product limit method.	1, 2 and 3 years after randomization
Secondary	Number of Participants With Laboratory Abnormalities by Maximum Common Terminology Criteria for Adverse Events (CTCAE) Grade	Laboratory abnormalities included anemia, hemoglobin increased, neutrophils (absolute), platelets, white blood cells, alanine aminotransferase (ALT), alkaline phosphatase, aspartate aminotransferase (AST), bilirubin (total), creatinine, hypercalcemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypokalemia, hypomagnesemia and hyponatremia. Laboratory abnormalities were graded by CTCAE version (v) 4.0 as Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = life-threatening. Categories with at least 1 non-zero data values are reported.	From randomization up to 28 days after last dose of study drug (assessed up to data cut-off date of 15-Nov-2021, approximately 8.7 years)

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