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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02679755




Registration number
NCT02679755
Ethics application status
Date submitted
22/01/2016
Date registered
10/02/2016
Date last updated
16/07/2019

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
Percentage of patients with treatment-emergent averse events (AEs) or serious adverse events (SAEs) - An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Timepoint [1] 0 0
Baseline up to 28 days after last dose of study treatment
Secondary outcome [1] 0 0
Objective Response - Number of patients with objective response (complete response or partial response)
Timepoint [1] 0 0
Baseline and per routine clinical practice to time of last dose of study treatment, up to 24 months
Secondary outcome [2] 0 0
Change from Baseline in Dimension Health State EuroQol (EQ-5D) Score - EQ-5D is a standard, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care,, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index is obtained with a formula that weighs each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health). [Australia only]
Timepoint [2] 0 0
Baseline, Day 1 of each cycle up to 3 years

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
Gender
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Alexander David Guminski - North Sydney
Recruitment hospital [2] 0 0
Alexander Maxwell Menzies - North Sydney
Recruitment hospital [3] 0 0
Benjamin Carl Forster - North Sydney
Recruitment hospital [4] 0 0
Frances Mary Boyle - North Sydney
Recruitment hospital [5] 0 0
HPS Pharmacies - North Sydney - North Sydney
Recruitment hospital [6] 0 0
Mater Hospital Sydney - North Sydney
Recruitment hospital [7] 0 0
Royal North Shore Hospital - Clinical Trials Pharmacy - St Leonards
Recruitment hospital [8] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [9] 0 0
Pathology North-RNS - Sydney
Recruitment hospital [10] 0 0
Icon Cancer Care Wesley - Auchenflower
Recruitment hospital [11] 0 0
River City Pharmacy - Auchenflower
Recruitment hospital [12] 0 0
Icon Cancer Care Chermside - Chermside
Recruitment hospital [13] 0 0
Haematology & Oncology Clinics of Australia Pty Ltd trading as Icon Cancer Care Corporate Office - South Brisbane
Recruitment hospital [14] 0 0
Icon Cancer Care South Brisbane - South Brisbane
Recruitment hospital [15] 0 0
Icon Cancer Foundation - South Brisbane
Recruitment hospital [16] 0 0
Icon Cancer Care Southport - Southport
Recruitment hospital [17] 0 0
Flinders Medical Centre-Pharmacy Department - Bedford Park
Recruitment hospital [18] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [19] 0 0
Monash Health-Parmacy - Clayton
Recruitment hospital [20] 0 0
Monash Health - Clayton
Recruitment hospital [21] 0 0
Peter MacCallum Cancer Centre Pharmacy - Melbourne
Recruitment hospital [22] 0 0
Sunshine Hospital Pharmacy - Clinical Trials - St Albans
Recruitment hospital [23] 0 0
Sunshine Hospital - St Albans
Recruitment hospital [24] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [25] 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
2065 - Sydney
Recruitment postcode(s) [4] 0 0
4066 - Auchenflower
Recruitment postcode(s) [5] 0 0
4032 - Chermside
Recruitment postcode(s) [6] 0 0
4101 - South Brisbane
Recruitment postcode(s) [7] 0 0
4215 - Southport
Recruitment postcode(s) [8] 0 0
5042 - Bedford Park
Recruitment postcode(s) [9] 0 0
3168 - Clayton
Recruitment postcode(s) [10] 0 0
3000 - Melbourne
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/show/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
Other publications