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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
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
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
Secondary ID [1] 0 0
A5481037
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Treatment-Emergent Adverse Events (All Causalities)
Timepoint [1] 0 0
Baseline up to 28 days after last dose of study treatment, an average of 14 months
Primary outcome [2] 0 0
Number of Participants With Treatment-Emergent Adverse Events by Severity (All Causalities)
Timepoint [2] 0 0
Baseline up to 28 days after last dose of study treatment, an average of 14 months
Primary outcome [3] 0 0
Number of Participants With Treatment-Emergent Adverse Events (Palbociclib-Related)
Timepoint [3] 0 0
Baseline up to 28 days after last dose of study treatment, an average of 14 months
Primary outcome [4] 0 0
Number of Participants With Treatment-Emergent Adverse Events by Severity (Palbociclib-Related)
Timepoint [4] 0 0
Baseline up to 28 days after last dose of study treatment, an average of 14 months
Primary outcome [5] 0 0
Number of Participants With Serious Adverse Events (All Causalities and Palbociclib-Related)
Timepoint [5] 0 0
Baseline up to 28 days after last dose of study treatment, an average of 14 months
Secondary outcome [1] 0 0
Percentage of Participants With Complete Response and Partial Response
Timepoint [1] 0 0
Baseline and per routine clinical practice to time of last dose of study treatment, an average of 1 year
Secondary outcome [2] 0 0
The Objective Response Rate (ORR)
Timepoint [2] 0 0
Baseline and per routine clinical practice to time of last dose of study treatment, an average of 1 year
Secondary outcome [3] 0 0
EQ-5D Health Utility Index Score
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.
Secondary outcome [4] 0 0
Change From Baseline in EQ-5D Health Utility Index Score
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.
Secondary outcome [5] 0 0
EQ-VAS Score
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.
Secondary outcome [6] 0 0
Change From Baseline in EQ-VAS Score
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.

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
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
9/03/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/07/2019
Sample size
Target
Accrual to date
Final
252
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Benjamin Carl Forster - North Sydney
Recruitment hospital [2] 0 0
Dr. Alexander Maxwell Menzies - North Sydney
Recruitment hospital [3] 0 0
HPS Pharmacies - North Sydney - North Sydney
Recruitment hospital [4] 0 0
Mater Hospital Sydney - North Sydney
Recruitment hospital [5] 0 0
Professor Frances Mary Boyle - North Sydney
Recruitment hospital [6] 0 0
Royal North Shore Hospital - Clinical Trials Pharmacy - St Leonards
Recruitment hospital [7] 0 0
Royal North Shore Hospital, Dept. of Medical Oncology - St Leonards
Recruitment hospital [8] 0 0
Icon Cancer Care Wesley - Auchenflower
Recruitment hospital [9] 0 0
River City Pharmacy - Auchenflower
Recruitment hospital [10] 0 0
Icon Cancer Care Chermside - Chermside
Recruitment hospital [11] 0 0
Icon Cancer Care South Brisbane - South Brisbane
Recruitment hospital [12] 0 0
Icon Cancer Care, Corporate Office - South Brisbane
Recruitment hospital [13] 0 0
Icon Cancer Care Southport - Southport
Recruitment hospital [14] 0 0
Flinders Medical Centre-Pharmacy Department - Bedford Park
Recruitment hospital [15] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [16] 0 0
Monash Health - Clayton
Recruitment hospital [17] 0 0
Peter MacCallum Cancer Centre Pharmacy - Melbourne
Recruitment hospital [18] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [19] 0 0
Sunshine Hospital - St Albans
Recruitment hospital [20] 0 0
Sunshine Hospital Pharmacy - St. Albans
Recruitment hospital [21] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [22] 0 0
Pharmacy Department - Murdoch
Recruitment postcode(s) [1] 0 0
2060 - North Sydney
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
4066 - Auchenflower
Recruitment postcode(s) [4] 0 0
4032 - Chermside
Recruitment postcode(s) [5] 0 0
4101 - South Brisbane
Recruitment postcode(s) [6] 0 0
4215 - Southport
Recruitment postcode(s) [7] 0 0
5042 - Bedford Park
Recruitment postcode(s) [8] 0 0
3168 - Clayton
Recruitment postcode(s) [9] 0 0
3000 - Melbourne
Recruitment postcode(s) [10] 0 0
3021 - St Albans
Recruitment postcode(s) [11] 0 0
3021 - St. Albans
Recruitment postcode(s) [12] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
India
State/province [1] 0 0
Delhi
Country [2] 0 0
India
State/province [2] 0 0
Gujarat
Country [3] 0 0
India
State/province [3] 0 0
Karnataka
Country [4] 0 0
India
State/province [4] 0 0
Maharashtra
Country [5] 0 0
India
State/province [5] 0 0
Tamilnadu

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

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT02679755
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02679755