Clinical trial NCT02679755: Palbociclib In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR+, HER2- Advanced Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Cancer
Keywords: Hormone receptor positive advanced breast cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2016-02-10
Enrollment: 252
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (All Causalities)
timeFrame: Baseline up to 28 days after last dose of study treatment, an average of 14 months
measure: Number of Participants With Treatment-Emergent Adverse Events by Severity (All Causalities)
timeFrame: Baseline up to 28 days after last dose of study treatment, an average of 14 months
measure: Number of Participants With Treatment-Emergent Adverse Events (Palbociclib-Related)
timeFrame: Baseline up to 28 days after last dose of study treatment, an average of 14 months
measure: Number of Participants With Treatment-Emergent Adverse Events by Severity (Palbociclib-Related)
timeFrame: Baseline up to 28 days after last dose of study treatment, an average of 14 months
measure: Number of Participants With Serious Adverse Events (All Causalities and Palbociclib-Related)
timeFrame: Baseline up to 28 days after last dose of study treatment, an average of 14 months
Secondary outcomes:
measure: Percentage of Participants With Complete Response and Partial Response
timeFrame: Baseline and per routine clinical practice to time of last dose of study treatment, an average of 1 year
measure: The Objective Response Rate (ORR)
timeFrame: Baseline and per routine clinical practice to time of last dose of study treatment, an average of 1 year
measure: EQ-5D Health Utility Index Score
timeFrame: 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.
measure: Change From Baseline in EQ-5D Health Utility Index Score
timeFrame: 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.
measure: EQ-VAS Score
timeFrame: 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.
measure: Change From Baseline in EQ-VAS Score
timeFrame: 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.
Other outcomes:
Locations:
city: North Sydney
country: Australia
facility: Benjamin Carl Forster
state: New South Wales
city: North Sydney
country: Australia
facility: Dr. Alexander Maxwell Menzies
state: New South Wales
city: North Sydney
country: Australia
facility: HPS Pharmacies - North Sydney
state: New South Wales
city: North Sydney
country: Australia
facility: Mater Hospital Sydney
state: New South Wales
city: North Sydney
country: Australia
facility: Professor Frances Mary Boyle
state: New South Wales
city: St Leonards
country: Australia
facility: Royal North Shore Hospital - Clinical Trials Pharmacy
state: New South Wales
city: St Leonards
country: Australia
facility: Royal North Shore Hospital, Dept. of Medical Oncology
state: New South Wales
city: Auchenflower
country: Australia
facility: Icon Cancer Care Wesley
state: Queensland
city: Auchenflower
country: Australia
facility: River City Pharmacy
state: Queensland
city: Chermside
country: Australia
facility: Icon Cancer Care Chermside
state: Queensland
city: South Brisbane
country: Australia
facility: Icon Cancer Care South Brisbane
state: Queensland
city: South Brisbane
country: Australia
facility: Icon Cancer Care, Corporate Office
state: Queensland
city: Southport
country: Australia
facility: Icon Cancer Care Southport
state: Queensland
city: Bedford Park
country: Australia
facility: Flinders Medical Centre-Pharmacy Department
state: South Australia
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Clayton
country: Australia
facility: Monash Health
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre Pharmacy
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: St Albans
country: Australia
facility: Sunshine Hospital
state: Victoria
city: St. Albans
country: Australia
facility: Sunshine Hospital Pharmacy
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Murdoch
country: Australia
facility: Pharmacy Department
state: Western Australia
city: New Delhi
country: India
facility: Rajiv Gandhi Cancer Institute And Research Centre
state: Delhi
city: New Delhi
country: India
facility: Dr. B.R.A Institute Rotary Cancer Hospital, All India Institue of Medical Sciences
state: Delhi
city: Ahmedabad
country: India
facility: The Gujarat Cancer & Research Institute, M.P Shah Cancer Hospital
state: Gujarat
city: Bangalore
country: India
facility: Manipal Hospital
state: Karnataka
city: Bangalore
country: India
facility: HealthCare Global Enterprises Ltd.
state: Karnataka
city: Manipal
country: India
facility: Kasturba Hospital
state: Karnataka
city: Mumbai
country: India
facility: Tata Memorial Centre, Tata Memorial Hospital
state: Maharashtra
city: Nagpur
country: India
facility: Meditrina Institute Of Medical Sciences
state: Maharashtra
city: Nashik
country: India
facility: Shatabdi Hospital
state: Maharashtra
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital and Research Center
state: Maharashtra
city: Pune
country: India
facility: Sahyadri Super Speciality Hospital
state: Maharashtra
city: Chennai
country: India
facility: Apollo Speciality Hospital
state: Tamilnadu
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: