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:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01740427
First received: November 26, 2012
Last updated: October 6, 2014
Last verified: October 2014

November 26, 2012
October 6, 2014
February 2013
October 2015   (final data collection date for primary outcome measure)
Progression-Free Survival (PFS) [ Time Frame: Baseline up to 2.5 years ] [ Designated as safety issue: No ]
Median time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.
Progression-Free Survival (PFS) [ Time Frame: Baseline up to 2.5 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01740427 on ClinicalTrials.gov Archive Site
  • Probability of Participant Survival [ Time Frame: From start of study treatment up to 6 years ] [ Designated as safety issue: Yes ]
    Probability of survival 1-year, 2- and 3-years after the first dose of study treatment
  • Overall Survival (OS) [ Time Frame: Baseline to date of death from any cause (up to 6 years) ] [ Designated as safety issue: Yes ]
    Time from date of randomization to date of death due to any cause.
  • Objective Response (OR) [ Time Frame: Baseline up to 2.5 years ] [ Designated as safety issue: No ]
    OR is defined as a complete response (CR) or partial response (PR) according to RECIST v.1.1. recorded from randomization until disease progression or death due to any cause.
  • Duration of Response (DR) [ Time Frame: Baseline up to 2.5 years ] [ Designated as safety issue: No ]
    Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer.
  • Disease Control (DC) [ Time Frame: Baseline up to 2.5 years ] [ Designated as safety issue: No ]
    DC is defined as complete response (CR), partial response (PR), or stable disease (SD) ≥24 weeks according to the RECIST version 1.1 recorded in the time period between randomization and disease progression or death to any cause.
  • QTc interval [ Time Frame: Baseline and Day 14 of Cycle 1 ] [ Designated as safety issue: Yes ]
    Time between the start of the Q wave and the end of the T wave corrected for heart rate.
  • Minimum Observed Plasma Trough Concentration (Cmin) [ Time Frame: Day 14 of cycles 1 and 2 ] [ Designated as safety issue: No ]
    Minimum Observed Plasma Trough Concentration (Cmin)
  • Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility at Week X [ Time Frame: Baseline up to 2.5 years ] [ Designated as safety issue: No ]
    Instrument designed to assess health status in terms of a single index value or utility score.
  • Change From Baseline in Functional Assessment od Cancer therapy -Breast (FACT-B) at Week X [ Time Frame: Baseline up to 2.5 years ] [ Designated as safety issue: No ]
    Instrument designed to assess patient concerns relating to breast cancer
  • Tumor tissue biomarkers [ Time Frame: Baseline, 24 months ] [ Designated as safety issue: No ]
    Tumor tissue biomarkers will be analyzed to investigate possible associations with resistance/sensitivity to treatment with study drugs. Biomarkers that will be analyzed will be selected based on their known relevance to mechanisms involved in cell cycle regulation.
  • Probability of Participant Survival [ Time Frame: From start of study treatment up to 6 years ] [ Designated as safety issue: Yes ]
  • Overall Survival (OS) [ Time Frame: Baseline to date of death from any cause (up to 6 years) ] [ Designated as safety issue: Yes ]
  • Objective Response (OR) [ Time Frame: Baseline up to 2.5 years ] [ Designated as safety issue: No ]
  • Duration of Response (DR) [ Time Frame: Baseline up to 2.5 years ] [ Designated as safety issue: No ]
  • Disease Control (DC) [ Time Frame: Baseline up to 2.5 years ] [ Designated as safety issue: No ]
  • QTc interval [ Time Frame: Baseline and Day 14 of Cycle 1 ] [ Designated as safety issue: Yes ]
  • Minimum Observed Plasma Trough Concentration (Cmin) [ Time Frame: Day 14 of cycles 1 and 2 ] [ Designated as safety issue: No ]
  • Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility at Week X [ Time Frame: Baseline up to 2.5 years ] [ Designated as safety issue: No ]
  • Change From Baseline in Functional Assessment od Cancer therapy -Breast (FACT-B) at Week X [ Time Frame: Baseline up to 2.5 years ] [ Designated as safety issue: No ]
  • Tumor tissue biomarkers [ Time Frame: Baseline, 24 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)
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,

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Breast Neoplasms
  • 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
  • Drug: Letrozole
    Letrozole, 2.5mg, orally once daily (continuously)
  • Drug: Placebo
    Placebo, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
  • 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).
    Interventions:
    • Drug: PD-0332991
    • Drug: Letrozole
  • 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).
    Interventions:
    • Drug: Placebo
    • Drug: Letrozole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
650
October 2016
October 2015   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   Canada,   Czech Republic,   France,   Germany,   Hungary,   Ireland,   Italy,   Japan,   Korea, Republic of,   Poland,   Russian Federation,   Spain,   Taiwan,   Ukraine,   United Kingdom
 
NCT01740427
A5481008, 2012-004601-27
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP