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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01740427




Registration number
NCT01740427
Ethics application status
Date submitted
26/11/2012
Date registered
4/12/2012

Titles & IDs
Public title
A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)
Scientific 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
Secondary ID [1] 0 0
2012-004601-27
Secondary ID [2] 0 0
A5481008
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PD-0332991
Treatment: Drugs - Letrozole
Treatment: Drugs - Placebo
Treatment: Drugs - Letrozole

Experimental: PD-0332991 + Letrozole - PD-0332991, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment in combination with Letrozole, 2.5mg, orally once daily (continuously).

Active comparator: Placebo + Letrozole - Placebo, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment in combination with Letrozole, 2.5mg, orally once daily (continuously).


Treatment: Drugs: 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

Treatment: Drugs: Letrozole
Letrozole, 2.5mg, orally once daily (continuously)

Treatment: Drugs: Placebo
Placebo, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment

Treatment: Drugs: Letrozole
Letrozole, 2.5mg, orally once daily (continuously)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS) as Assessed by the Investigator.
Timepoint [1] 0 0
From randomization date to date of first documentation of progression OR death (up to approximately 2.5 years)
Secondary outcome [1] 0 0
Objective Response as Assessed by the Investigator
Timepoint [1] 0 0
From randomization until end of treatment (up to approximately 2.5 years)
Secondary outcome [2] 0 0
Objective Response: Patients With Measurable Disease at Baseline as Assessed by the Investigator
Timepoint [2] 0 0
From randomization until end of treatment (up to approximately 2.5 years)
Secondary outcome [3] 0 0
Duration of Response (DR)
Timepoint [3] 0 0
From randomization until end of treatment (up to approximately 2.5 years)
Secondary outcome [4] 0 0
Disease Control (DC)/Clinical Benefit Response (CBR)
Timepoint [4] 0 0
From randomization until end of treatment (up to approximately 2.5 years)
Secondary outcome [5] 0 0
PFS by Tumor Tissue Biomarkers Status, Including Genes (eg, Copy Numbers of CCND1, CDKN2A), Proteins (eg, Ki67, pRb), and RNA Expression (eg, cdk4, cdk6)
Timepoint [5] 0 0
From randomization until end of treatment (up to approximately 24 Months)
Secondary outcome [6] 0 0
Corrected QT Interval (QTc) Time-matched Change From Baseline on Cycle 1 Day 14
Timepoint [6] 0 0
Time-matched triplicate ECGs were collected at 0 (predose), 2, 4, 6 and 8 hours on Day 0 and on Cycle1 Day14
Secondary outcome [7] 0 0
Percentage of Participants With Corrected QT Interval (QTc)
Timepoint [7] 0 0
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 outcome [8] 0 0
Observed Plasma Trough Concentration (Ctrough) at Steady-State
Timepoint [8] 0 0
0 hour (predose) on Day 14 of cycles 1 and 2
Secondary outcome [9] 0 0
Change From Baseline Between Treatment Comparison in Euro Quality of Life (EQ-5D) Index
Timepoint [9] 0 0
From Baseline up to 2.5 years
Secondary outcome [10] 0 0
Change From Baseline Between Treatment Comparison in Functional Assessment of Cancer Therapy -Breast (FACT-B)
Timepoint [10] 0 0
From Baseline up to 2.5 years
Secondary outcome [11] 0 0
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs; All Causalities)
Timepoint [11] 0 0
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 outcome [12] 0 0
Overall Survival (OS)
Timepoint [12] 0 0
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 outcome [13] 0 0
Survival Probability at 1 Year, 2 Year and 3 Year
Timepoint [13] 0 0
1, 2 and 3 years after randomization
Secondary outcome [14] 0 0
Number of Participants With Laboratory Abnormalities by Maximum Common Terminology Criteria for Adverse Events (CTCAE) Grade
Timepoint [14] 0 0
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)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/02/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/11/2023
Sample size
Target
Accrual to date
Final
666
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
St Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [2] 0 0
Laverty Pathology - Port Macquarie
Recruitment hospital [3] 0 0
Mid North Coast Diagnostic Imaging - Port Macquarie
Recruitment hospital [4] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [5] 0 0
Icon Cancer Care - Auchenflower
Recruitment hospital [6] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [7] 0 0
Icon Cancer Care Corporate Office - South Brisbane
Recruitment hospital [8] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [9] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [10] 0 0
Bendigo Health Care Group, The Bendigo Hospital Campus - Bendigo
Recruitment hospital [11] 0 0
Northern Hospital - Epping
Recruitment hospital [12] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [13] 0 0
Epworth Healthcare - Richmond
Recruitment hospital [14] 0 0
Maroondah Hospital - Ringwood East
Recruitment hospital [15] 0 0
Goulburn Valley Health - Shepparton
Recruitment hospital [16] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [3] 0 0
2298 - Waratah
Recruitment postcode(s) [4] 0 0
4066 - Auchenflower
Recruitment postcode(s) [5] 0 0
4575 - Birtinya
Recruitment postcode(s) [6] 0 0
4101 - South Brisbane
Recruitment postcode(s) [7] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [8] 0 0
5000 - Adelaide
Recruitment postcode(s) [9] 0 0
3550 - Bendigo
Recruitment postcode(s) [10] 0 0
3076 - Epping
Recruitment postcode(s) [11] 0 0
3050 - Parkville
Recruitment postcode(s) [12] 0 0
3121 - Richmond
Recruitment postcode(s) [13] 0 0
3135 - Ringwood East
Recruitment postcode(s) [14] 0 0
3630 - Shepparton
Recruitment postcode(s) [15] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Idaho
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
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Minnesota
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United States of America
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Mississippi
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United States of America
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Missouri
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United States of America
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Nebraska
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United States of America
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Nevada
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United States of America
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New York
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Oregon
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Virginia
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United States of America
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Washington
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United States of America
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West Virginia
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United States of America
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Wisconsin
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Belgium
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Antwerpen
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Belgium
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Brussels
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Belgium
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Brussel
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Belgium
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Charleroi
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Belgium
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Leuven
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Belgium
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Liege
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Belgium
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Verviers
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Canada
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British Columbia
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Canada
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Nova Scotia
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Ontario
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Quebec
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Canada
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Saskatchewan
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Czechia
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Hradec Kralove
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Anger Cedex 02
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France
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Caen Cedex 5
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France
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Dijon
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France
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La Roche Sur Yon
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France
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Montpellier CEDEX 5
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France
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Nice cedex 2
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France
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Paris Cedex 05
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France
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Rennes
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Saint-Cloud
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St Herblain
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France
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Toulouse CEDEX-9
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Villejuif
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Germany
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Bavaria
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Boblingen
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Germany
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Dresden
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Erlangen
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Kiel
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Magdeburg
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Germany
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Mainz
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Germany
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Muenchen
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Munich
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Trier
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Budapest
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Györ
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Hungary
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Nyiregyhaza
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Szeged
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Dublin 4
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Limerick
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Waterford
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Italy
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BO
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FC
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Milan
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Pisa
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Roma
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Aichi
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Chiba
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Ehime
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Hokkaido
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Kumamoto
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Saitama
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Tokyo
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Japan
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Fukuoka
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Hiroshima
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Iwate
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Kagoshima
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Japan
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Niigata
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Japan
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Osaka
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Seoul
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Poland
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Mazovia
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Poland
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Gdansk
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Poland
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Zory
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Russian Federation
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Kursk Region
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Russian Federation
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Leningrad Region
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Russian Federation
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Kazan
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Ryazan
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Ufa
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Barcelona
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Islas Baleares
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Spain
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Madrid
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Spain
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Santa CRUZ DE Tenerife
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Spain
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Badajoz
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Spain
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Donostia- San Sebastian
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Spain
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Jaen
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Spain
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L'Hospitalet De Llobregat (Barcelona)
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Spain
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La Coruna
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Spain
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Lleida
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Spain
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Sevilla
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Spain
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Valencia
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Taiwan
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Taipei City
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Taiwan
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Taipei
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Ukraine
State/province [121] 0 0
Dnipro
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Ukraine
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Kharkiv
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Ukraine
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Lviv
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Ukraine
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Makiivka
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Ukraine
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Sumy
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Ukraine
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Uzhgorod
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Ukraine
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Zaporizhzhia
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Ukraine
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Zaporizhzhya
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United Kingdom
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Kent
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Scotland
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United Kingdom
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London
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United Kingdom
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Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01740427