Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02679755
Registration number
NCT02679755
Ethics application status
Date submitted
22/01/2016
Date registered
10/02/2016
Titles & IDs
Public title
Palbociclib In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR+, HER2- Advanced Breast Cancer
Query!
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
Query!
Secondary ID [1]
0
0
A5481037
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Breast
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Number of Participants With Treatment-Emergent Adverse Events (All Causalities)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Baseline up to 28 days after last dose of study treatment, an average of 14 months
Query!
Primary outcome [2]
0
0
Number of Participants With Treatment-Emergent Adverse Events by Severity (All Causalities)
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Baseline up to 28 days after last dose of study treatment, an average of 14 months
Query!
Primary outcome [3]
0
0
Number of Participants With Treatment-Emergent Adverse Events (Palbociclib-Related)
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Baseline up to 28 days after last dose of study treatment, an average of 14 months
Query!
Primary outcome [4]
0
0
Number of Participants With Treatment-Emergent Adverse Events by Severity (Palbociclib-Related)
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
Baseline up to 28 days after last dose of study treatment, an average of 14 months
Query!
Primary outcome [5]
0
0
Number of Participants With Serious Adverse Events (All Causalities and Palbociclib-Related)
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
Baseline up to 28 days after last dose of study treatment, an average of 14 months
Query!
Secondary outcome [1]
0
0
Percentage of Participants With Complete Response and Partial Response
Query!
Assessment method [1]
0
0
Tumor response assessments were evaluated as per local guidelines by investigators and were collected in the CRF. No response confirmation was applied.
Query!
Timepoint [1]
0
0
Baseline and per routine clinical practice to time of last dose of study treatment, an average of 1 year
Query!
Secondary outcome [2]
0
0
The Objective Response Rate (ORR)
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Baseline and per routine clinical practice to time of last dose of study treatment, an average of 1 year
Query!
Secondary outcome [3]
0
0
EQ-5D Health Utility Index Score
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
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.
Query!
Secondary outcome [4]
0
0
Change From Baseline in EQ-5D Health Utility Index Score
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
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.
Query!
Secondary outcome [5]
0
0
EQ-VAS Score
Query!
Assessment method [5]
0
0
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)
Query!
Timepoint [5]
0
0
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.
Query!
Secondary outcome [6]
0
0
Change From Baseline in EQ-VAS Score
Query!
Assessment method [6]
0
0
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)
Query!
Timepoint [6]
0
0
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.
Query!
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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Query!
Other design features
Query!
Phase
Phase 4
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
9/03/2016
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
25/07/2019
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
252
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Query!
Recruitment hospital [1]
0
0
Benjamin Carl Forster - North Sydney
Query!
Recruitment hospital [2]
0
0
Dr. Alexander Maxwell Menzies - North Sydney
Query!
Recruitment hospital [3]
0
0
HPS Pharmacies - North Sydney - North Sydney
Query!
Recruitment hospital [4]
0
0
Mater Hospital Sydney - North Sydney
Query!
Recruitment hospital [5]
0
0
Professor Frances Mary Boyle - North Sydney
Query!
Recruitment hospital [6]
0
0
Royal North Shore Hospital - Clinical Trials Pharmacy - St Leonards
Query!
Recruitment hospital [7]
0
0
Royal North Shore Hospital, Dept. of Medical Oncology - St Leonards
Query!
Recruitment hospital [8]
0
0
Icon Cancer Care Wesley - Auchenflower
Query!
Recruitment hospital [9]
0
0
River City Pharmacy - Auchenflower
Query!
Recruitment hospital [10]
0
0
Icon Cancer Care Chermside - Chermside
Query!
Recruitment hospital [11]
0
0
Icon Cancer Care South Brisbane - South Brisbane
Query!
Recruitment hospital [12]
0
0
Icon Cancer Care, Corporate Office - South Brisbane
Query!
Recruitment hospital [13]
0
0
Icon Cancer Care Southport - Southport
Query!
Recruitment hospital [14]
0
0
Flinders Medical Centre-Pharmacy Department - Bedford Park
Query!
Recruitment hospital [15]
0
0
Flinders Medical Centre - Bedford Park
Query!
Recruitment hospital [16]
0
0
Monash Health - Clayton
Query!
Recruitment hospital [17]
0
0
Peter MacCallum Cancer Centre Pharmacy - Melbourne
Query!
Recruitment hospital [18]
0
0
Peter MacCallum Cancer Centre - Melbourne
Query!
Recruitment hospital [19]
0
0
Sunshine Hospital - St Albans
Query!
Recruitment hospital [20]
0
0
Sunshine Hospital Pharmacy - St. Albans
Query!
Recruitment hospital [21]
0
0
Fiona Stanley Hospital - Murdoch
Query!
Recruitment hospital [22]
0
0
Pharmacy Department - Murdoch
Query!
Recruitment postcode(s) [1]
0
0
2060 - North Sydney
Query!
Recruitment postcode(s) [2]
0
0
2065 - St Leonards
Query!
Recruitment postcode(s) [3]
0
0
4066 - Auchenflower
Query!
Recruitment postcode(s) [4]
0
0
4032 - Chermside
Query!
Recruitment postcode(s) [5]
0
0
4101 - South Brisbane
Query!
Recruitment postcode(s) [6]
0
0
4215 - Southport
Query!
Recruitment postcode(s) [7]
0
0
5042 - Bedford Park
Query!
Recruitment postcode(s) [8]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [9]
0
0
3000 - Melbourne
Query!
Recruitment postcode(s) [10]
0
0
3021 - St Albans
Query!
Recruitment postcode(s) [11]
0
0
3021 - St. Albans
Query!
Recruitment postcode(s) [12]
0
0
6150 - Murdoch
Query!
Recruitment outside Australia
Country [1]
0
0
India
Query!
State/province [1]
0
0
Delhi
Query!
Country [2]
0
0
India
Query!
State/province [2]
0
0
Gujarat
Query!
Country [3]
0
0
India
Query!
State/province [3]
0
0
Karnataka
Query!
Country [4]
0
0
India
Query!
State/province [4]
0
0
Maharashtra
Query!
Country [5]
0
0
India
Query!
State/province [5]
0
0
Tamilnadu
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Pfizer
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT02679755
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Pfizer CT.gov Call Center
Query!
Address
0
0
Pfizer
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
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.
Query!
When will data be available (start and end dates)?
Query!
Available to whom?
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/55/NCT02679755/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/55/NCT02679755/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02679755