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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01740427
First Posted: December 4, 2012
Last Update Posted: November 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
Results First Submitted: October 21, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Breast Neoplasms
Interventions: Drug: PD-0332991
Drug: Letrozole
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between 28 February 2013 and 29 July 2014, 666 women were randomized at 186 sites in 17 countries.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study consisted of a screening visit within 28 days before randomization, an active treatment phase, divided in cycles of 28 days each, and a post-treatment follow-up period during which survival and new anti-cancer therapy information was collected every 6 months (±7 days) from the last dose of study treatment.

Reporting Groups
  Description
Palbociclib Plus Letrozole Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
Placebo Plus Letrozole Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.

Participant Flow:   Overall Study
    Palbociclib Plus Letrozole   Placebo Plus Letrozole
STARTED   444   222 
COMPLETED   0   0 
NOT COMPLETED   444   222 
Ongoing at date of cutoff (26 Feb 2016)                205                61 
Objective progression or relapse                172                125 
Adverse Event                20                9 
Global deterioration of health status                16                9 
Subject refused continued treatment                12                9 
Unspecified reasons                6                4 
Death                6                2 
Protocol Violation                5                3 
Lost to Follow-up                1                0 
Study terminated by Sponsor                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The intent-to-treat (ITT) population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.

Reporting Groups
  Description
Palbociclib Plus Letrozole Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
Placebo Plus Letrozole Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
Total Total of all reporting groups

Baseline Measures
   Palbociclib Plus Letrozole   Placebo Plus Letrozole   Total 
Overall Participants Analyzed 
[Units: Participants]
 444   222   666 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.7  (10.6)   60.6  (11.2)   61.3  (10.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      444 100.0%      222 100.0%      666 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-Free Survival (PFS) as Assessed by the Investigator.   [ Time Frame: From randomization date to date of first documentation of progression OR death (up to approximately 2.5 years) ]

2.  Secondary:   Objective Response as Assessed by the Investigator   [ Time Frame: From randomization until end of treatment (up to approximately 2.5 years) ]

3.  Secondary:   Objective Response: Patients With Measurable Disease at Baseline as Assessed by the Investigator   [ Time Frame: From randomization until end of treatment (up to approximately 2.5 years) ]

4.  Secondary:   Duration of Response (DR)   [ Time Frame: From randomization until end of treatment (up to approximately 2.5 years) ]

5.  Secondary:   Disease Control (DC)/Clinical Benefit Response (CBR)   [ Time Frame: From randomization until end of treatment (up to approximately 2.5 years) ]

6.  Secondary:   Tumor Tissue Biomarkers, Including Genes (eg, Copy Numbers of CCND1, CDKN2A), Proteins (eg, Ki67, pRb), and RNA Expression (eg, cdk4, cdk6): Protein Biomarker Analyses by Using Immunohistochemistry Are Presented   [ Time Frame: From randomization until end of treatment (up to approximately 24 Months) ]

7.  Secondary:   Corrected QT Interval (QTc) Time-matched Change From Baseline on Cycle 1 Day 14   [ Time Frame: Time-matched triplicate ECGs were collected at 0 (predose), 2, 4, 6 and 8 hours on Day 0 and on Cycle1 Day14 ]

8.  Secondary:   Corrected QT Interval (QTc)   [ Time Frame: 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 ]

9.  Secondary:   Observed Plasma Trough Concentration (Ctrough) at Steady-State   [ Time Frame: 0 hour (predose) on Day 14 of cycles 1 and 2 ]

10.  Secondary:   Change From Baseline Between Treatment Comparison in Euro Quality of Life (EQ-5D) Index   [ Time Frame: From Baseline up to 2.5 years ]

11.  Secondary:   Change From Baseline Between Treatment Comparison in Functional Assessment of Cancer Therapy -Breast (FACT-B)   [ Time Frame: From Baseline up to 2.5 years ]

12.  Secondary:   Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs; All Causalities)   [ Time Frame: From the participant randomization up to 28 days after last dose of study drug, up to 2.5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
For Overall Survival: The patients continue to be followed for survival and the final OS analysis will be performed when 390 deaths have been reported. OS should not be reported at this time because the OS data is still being followed.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01740427     History of Changes
Other Study ID Numbers: A5481008
2012-004601-27 ( EudraCT Number )
First Submitted: November 26, 2012
First Posted: December 4, 2012
Results First Submitted: October 21, 2016
Results First Posted: April 26, 2017
Last Update Posted: November 1, 2017