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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02679755
Registration number
NCT02679755
Ethics application status
Date submitted
22/01/2016
Date registered
10/02/2016
Date last updated
27/07/2022
Titles & IDs
Public title
Palbociclib In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR+, HER2- Advanced Breast Cancer
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Scientific title
A STUDY OF PALBOCICLIB IN COMBINATION WITH LETROZOLE AS TREATMENT OF POST-MENOPAUSAL WOMEN WITH HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED BREAST CANCER FOR WHOM LETROZOLE THERAPY IS DEEMED APPROPRIATE
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Secondary ID [1]
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A5481037
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Palbociclib
Treatment: Drugs - Letrozole
Experimental: Experimental arm - Palbociclib plus Letrozole
Treatment: Drugs: Palbociclib
125 mg/d capsules orally for 3 out of 4 weeks in repeated cycles
Treatment: Drugs: Letrozole
2.5 mg/d tablets orally on a continuous regimen
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Treatment-Emergent Adverse Events (All Causalities)
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Assessment method [1]
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An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. All AEs reported after initiation of study drug treatment were considered as treatment emergent adverse events (TEAEs). AE severity was graded according to Common Terminology Criteria for AEs (CTCAE) version 4.03. Grade 1 AEs are mild AEs; Grade 2 AEs are moderate AEs; Grade 3 AEs are severe AEs, Grade 4 AEs are life-threatening consequences and Grade 5 AEs are deaths related to AEs. Each AE was counted once for the participant in the most severe severity. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
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Timepoint [1]
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Baseline up to 28 days after last dose of study treatment, an average of 14 months
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Primary outcome [2]
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Number of Participants With Treatment-Emergent Adverse Events by Severity (All Causalities)
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Assessment method [2]
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An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. All AEs reported after initiation of study drug treatment were considered as TEAE. AE severity was graded according to Common Terminology Criteria for AEs (CTCAE) version 4.03. Grade 1 AEs are mild AEs; Grade 2 AEs are moderate AEs; Grade 3 AEs are severe AEs, Grade 4 AEs are life-threatening consequences and Grade 5 AEs are deaths related to AEs. Each AE was counted once for the participant in the most severe severity.
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Timepoint [2]
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Baseline up to 28 days after last dose of study treatment, an average of 14 months
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Primary outcome [3]
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Number of Participants With Treatment-Emergent Adverse Events (Palbociclib-Related)
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Assessment method [3]
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An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. All AEs reported after initiation of study drug treatment were considered as TEAE. AE severity was graded according to Common Terminology Criteria for AEs (CTCAE) version 4.03. Grade 1 AEs are mild AEs; Grade 2 AEs are moderate AEs; Grade 3 AEs are severe AEs, Grade 4 AEs are life-threatening consequences and Grade 5 AEs are deaths related to AEs. Each AE was counted once for the participant in the most severe severity. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Palbociclib-related TEAEs were determined by the investigator.
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Timepoint [3]
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Baseline up to 28 days after last dose of study treatment, an average of 14 months
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Primary outcome [4]
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Number of Participants With Treatment-Emergent Adverse Events by Severity (Palbociclib-Related)
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Assessment method [4]
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An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. All AEs reported after initiation of study drug treatment were considered as TEAE. AE severity was graded according to Common Terminology Criteria for AEs (CTCAE) version 4.03. Grade 1 AEs are mild AEs; Grade 2 AEs are moderate AEs; Grade 3 AEs are severe AEs, Grade 4 AEs are life-threatening consequences and Grade 5 AEs are deaths related to AEs. Each AE was counted once for the participant in the most severe severity. Palbociclib-related TEAEs were determined by the investigator.
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Timepoint [4]
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Baseline up to 28 days after last dose of study treatment, an average of 14 months
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Primary outcome [5]
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Number of Participants With Serious Adverse Events (All Causalities and Palbociclib-Related)
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Assessment method [5]
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An SAE was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. Palbociclib-related SAEs were determined by the investigator.
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Timepoint [5]
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Baseline up to 28 days after last dose of study treatment, an average of 14 months
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Secondary outcome [1]
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Percentage of Participants With Complete Response and Partial Response
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Assessment method [1]
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Tumor response assessments were evaluated as per local guidelines by investigators and were collected in the CRF. No response confirmation was applied.
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Timepoint [1]
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Baseline and per routine clinical practice to time of last dose of study treatment, an average of 1 year
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Secondary outcome [2]
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The Objective Response Rate (ORR)
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Assessment method [2]
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The tumor response was based on the response reported by investigator per local practice. No response confirmation was applied. ORR was defined as the percentage of participants with complete response or partial response relative to all as-treated population.
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Timepoint [2]
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Baseline and per routine clinical practice to time of last dose of study treatment, an average of 1 year
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Secondary outcome [3]
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EQ-5D Health Utility Index Score
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Assessment method [3]
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The EuroQol-5D (EQ-5D) (version 3L) consisted of 2 parts. The first part was a 5 item questionnaire designed to assess health status in terms of a single index value or utility score. It consisted of 5 descriptors of current health state (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). A respondent was asked to rate each state on a three level scale (1=no problem, 2=some problem, and 3=extreme problem) with higher levels indicating greater severity/impairment. The answers given to the 5 descriptors permit to find 243 unique health states which can be converted into a single EQ-5D index value by published algorithms. For the EQ-5D index, published weights are available that allow for the creation of a summary score ranging from -0.594 to 1, with low scores representing a higher level of dysfunction and 1 as perfect health.
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Timepoint [3]
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The descriptive analysis was carried out on Day 1 of each cycle (cycle 1 to cycle 38), at end of treatment (EOT) and end of study (EOS), up to 3 years. Cycle 1 Day 1 is taken to be baseline.
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Secondary outcome [4]
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Change From Baseline in EQ-5D Health Utility Index Score
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Assessment method [4]
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The EuroQol-5D (EQ-5D) (version 3L) consisted of 2 parts. The first part was a 5 item questionnaire designed to assess health status in terms of a single index value or utility score. It consisted of 5 descriptors of current health state (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). A respondent was asked to rate each state on a three level scale (1=no problem, 2=some problem, and 3=extreme problem) with higher levels indicating greater severity/impairment. The answers given to the 5 descriptors permit to find 243 unique health states which can be converted into a single EQ-5D index value by published algorithms. For the EQ-5D index, published weights are available that allow for the creation of a summary score ranging from -0.594 to 1, with low scores representing a higher level of dysfunction and 1 as perfect health.
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Timepoint [4]
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The descriptive analysis was carried out on Day 1 of each cycle (cycle 1 to cycle 38), at end of treatment (EOT) and end of study (EOS), up to 3 years. Cycle 1 Day 1 is taken to be baseline.
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Secondary outcome [5]
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EQ-VAS Score
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Assessment method [5]
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The EuroQol-5D (EQ-5D) (version 3L) consisted of 2 parts. The second part consisted of a visual analogue scale (the EuroQol-visual analogue scale [EQ-VAS]). The respondent's self-rated health was assessed on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state)
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Timepoint [5]
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The descriptive analysis was carried out on Day 1 of each cycle (cycle 1 to cycle 38), at end of treatment (EOT) and end of study (EOS), up to 3 years. Cycle 1 Day 1 is taken to be baseline.
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Secondary outcome [6]
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Change From Baseline in EQ-VAS Score
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Assessment method [6]
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The EuroQol-5D (EQ-5D) (version 3L) consisted of 2 parts. The second part consisted of a visual analogue scale (the EuroQol-visual analogue scale [EQ-VAS]). The respondent's self-rated health was assessed on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state)
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Timepoint [6]
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The descriptive analysis was carried out on Day 1 of each cycle (cycle 1 to cycle 38), at end of treatment (EOT) and end of study (EOS), up to 3 years. Cycle 1 Day 1 is taken to be baseline.
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Eligibility
Key inclusion criteria
- Post-menopausal women (>=18 years of age) with proven diagnosis of advanced carcinoma
of the breast (ER(+) and/or PgR(+) and HER2(-)) who are appropriate for letrozole
therapy (in the first-line advanced/metastatic disease setting).
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Adequate bone marrow, liver, and renal function.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Prior treatment with any CDK inhibitor .
- QTc >480 msec; history of QT syndrome, Brugada syndrome or known history of QTc
prolongation, or Torsade de Pointes.
- High cardiovascular risk, including, but not limited to myocardial infarction,
severe/unstable angina, severe cardiac dysrhythmias, and symptomatic pulmonary
embolism in the past 6 months of enrollment.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/03/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
25/07/2019
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Sample size
Target
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Accrual to date
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Final
252
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Benjamin Carl Forster - North Sydney
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Recruitment hospital [2]
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Dr. Alexander Maxwell Menzies - North Sydney
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Recruitment hospital [3]
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HPS Pharmacies - North Sydney - North Sydney
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Recruitment hospital [4]
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Mater Hospital Sydney - North Sydney
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Recruitment hospital [5]
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Professor Frances Mary Boyle - North Sydney
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Recruitment hospital [6]
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Royal North Shore Hospital - Clinical Trials Pharmacy - St Leonards
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Recruitment hospital [7]
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Royal North Shore Hospital, Dept. of Medical Oncology - St Leonards
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Recruitment hospital [8]
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Icon Cancer Care Wesley - Auchenflower
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Recruitment hospital [9]
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River City Pharmacy - Auchenflower
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Recruitment hospital [10]
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Icon Cancer Care Chermside - Chermside
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Recruitment hospital [11]
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Icon Cancer Care South Brisbane - South Brisbane
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Recruitment hospital [12]
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Icon Cancer Care, Corporate Office - South Brisbane
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Recruitment hospital [13]
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Icon Cancer Care Southport - Southport
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Recruitment hospital [14]
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Flinders Medical Centre-Pharmacy Department - Bedford Park
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Recruitment hospital [15]
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Flinders Medical Centre - Bedford Park
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Recruitment hospital [16]
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Monash Health - Clayton
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Recruitment hospital [17]
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Peter MacCallum Cancer Centre Pharmacy - Melbourne
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Recruitment hospital [18]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [19]
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Sunshine Hospital - St Albans
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Recruitment hospital [20]
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Sunshine Hospital Pharmacy - St. Albans
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Recruitment hospital [21]
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Fiona Stanley Hospital - Murdoch
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Recruitment hospital [22]
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Pharmacy Department - Murdoch
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Recruitment postcode(s) [1]
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2060 - North Sydney
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Recruitment postcode(s) [2]
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2065 - St Leonards
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Recruitment postcode(s) [3]
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4066 - Auchenflower
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Recruitment postcode(s) [4]
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4032 - Chermside
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Recruitment postcode(s) [5]
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4101 - South Brisbane
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Recruitment postcode(s) [6]
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4215 - Southport
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Recruitment postcode(s) [7]
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5042 - Bedford Park
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Recruitment postcode(s) [8]
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3168 - Clayton
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Recruitment postcode(s) [9]
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3000 - Melbourne
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Recruitment postcode(s) [10]
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3021 - St Albans
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Recruitment postcode(s) [11]
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3021 - St. Albans
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Recruitment postcode(s) [12]
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6150 - Murdoch
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Recruitment outside Australia
Country [1]
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India
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State/province [1]
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Delhi
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Country [2]
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India
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State/province [2]
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Gujarat
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Country [3]
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India
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State/province [3]
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Karnataka
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Country [4]
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India
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State/province [4]
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Maharashtra
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Country [5]
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India
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State/province [5]
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Tamilnadu
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
A study of palbociclib in combination with letrozole as treatment of post-menopausal women
with hormone receptor-positive, her2-negative advanced breast cancer for whom letrozole
therapy is deemed appropriate.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02679755
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Pfizer CT.gov Call Center
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Address
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Pfizer
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02679755
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