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Palbociclib In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR+, HER2- Advanced Breast Cancer

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ClinicalTrials.gov Identifier: NCT02679755
Recruitment Status : Active, not recruiting
First Posted : February 10, 2016
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Palbociclib Drug: Letrozole Phase 4

Detailed Description:
To provide access to palbociclib to post-menopausal patients with hormone receptor-positive [HR(+)], HER2-negative [HER2(-)] ABC who are deemed appropriate for letrozole therapy.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 252 participants
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : March 9, 2016
Estimated Primary Completion Date : July 25, 2019
Estimated Study Completion Date : July 25, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental arm
Palbociclib plus Letrozole
Drug: Palbociclib
125 mg/d capsules orally for 3 out of 4 weeks in repeated cycles
Other Name: IBRANCE

Drug: Letrozole
2.5 mg/d tablets orally on a continuous regimen




Primary Outcome Measures :
  1. Percentage of patients with treatment-emergent averse events (AEs) or serious adverse events (SAEs) [ Time Frame: Baseline up to 28 days after last dose of study treatment ]
    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.


Secondary Outcome Measures :
  1. Objective Response [ Time Frame: Baseline and per routine clinical practice to time of last dose of study treatment, up to 24 months ]
    Number of patients with objective response (complete response or partial response)

  2. Change from Baseline in Dimension Health State EuroQol (EQ-5D) Score [ Time Frame: Baseline, Day 1 of each cycle up to 3 years ]
    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]



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02679755


Locations
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Australia, New South Wales
Alexander David Guminski
North Sydney, New South Wales, Australia, 2060
Alexander Maxwell Menzies
North Sydney, New South Wales, Australia, 2060
Benjamin Carl Forster
North Sydney, New South Wales, Australia, 2060
Frances Mary Boyle
North Sydney, New South Wales, Australia, 2060
HPS Pharmacies - North Sydney
North Sydney, New South Wales, Australia, 2060
Mater Hospital Sydney
North Sydney, New South Wales, Australia, 2060
Royal North Shore Hospital - Clinical Trials Pharmacy
St Leonards, New South Wales, Australia, 2065
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065
Pathology North-RNS
Sydney, New South Wales, Australia, 2065
Australia, Queensland
Icon Cancer Care Wesley
Auchenflower, Queensland, Australia, 4066
River City Pharmacy
Auchenflower, Queensland, Australia, 4066
Icon Cancer Care Chermside
Chermside, Queensland, Australia, 4032
Haematology & Oncology Clinics of Australia Pty Ltd trading as Icon Cancer Care Corporate Office
South Brisbane, Queensland, Australia, 4101
Icon Cancer Care South Brisbane
South Brisbane, Queensland, Australia, 4101
Icon Cancer Foundation
South Brisbane, Queensland, Australia, 4101
Icon Cancer Care Southport
Southport, Queensland, Australia, 4215
Australia, South Australia
Flinders Medical Centre-Pharmacy Department
Bedford Park, South Australia, Australia, 5042
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5042
Australia, Victoria
Monash Health-Parmacy
Clayton, Victoria, Australia, 3168
Monash Health
Clayton, Victoria, Australia, 3168
Peter MacCallum Cancer Centre Pharmacy
Melbourne, Victoria, Australia, 3000
Sunshine Hospital Pharmacy - Clinical Trials
St Albans, Victoria, Australia, 3021
Sunshine Hospital
St Albans, Victoria, Australia, 3021
Australia, Western Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia, 6150
Pharmacy Department
Murdoch, Western Australia, Australia, 6150
India
Rajiv Gandhi Cancer Institute And Research Centre
New Delhi, Delhi, India, 110 085
Dr. B.R.A Institute Rotary Cancer Hospital, All India Institue of Medical Sciences
New Delhi, Delhi, India, 110029
The Gujarat Cancer & Research Institute
Ahmedabad, Gujarat, India, 380016
Manipal Hospital
Bangalore, Karnataka, India, 560017
HealthCare Global Enterprises Ltd.
Bangalore, Karnataka, India, 560027
Kasturba Hospital, Manipal Centre For Clinical Research
Manipal, Karnataka, India, 576104
Tata Memorial Centre, Tata Memorial Hospital
Mumbai, Maharashtra, India, 400 012
Meditrina Institute Of Medical Sciences
Nagpur, Maharashtra, India, 440012
Shatabdi Hospital
Nashik, Maharashtra, India, 422005
Deenanath Mangeshkar Hospital and Research Center
Pune, Maharashtra, India, 411 004
Sahyadri Speciality Hospital
Pune, Maharashtra, India, 411004
Apollo Speciality Hospital
Chennai, Tamilnadu, India, 600 035
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02679755     History of Changes
Other Study ID Numbers: A5481037
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

Keywords provided by Pfizer:
Hormone receptor positive advanced breast cancer

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
Palbociclib
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Protein Kinase Inhibitors