Palbociclib In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR+, HER2- Advanced Breast Cancer
- Registration Number
- NCT02679755
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 252
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Experimental arm Palbociclib Palbociclib plus Letrozole Experimental arm Letrozole Palbociclib plus Letrozole
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment-Emergent Adverse Events by Severity (All Causalities) Baseline up to 28 days after last dose of study treatment, an average of 14 months 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.
Number of Participants With Treatment-Emergent Adverse Events (All Causalities) Baseline up to 28 days after last dose of study treatment, an average of 14 months 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.
Number of Participants With Treatment-Emergent Adverse Events (Palbociclib-Related) Baseline up to 28 days after last dose of study treatment, an average of 14 months 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.
Number of Participants With Treatment-Emergent Adverse Events by Severity (Palbociclib-Related) Baseline up to 28 days after last dose of study treatment, an average of 14 months 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.
Number of Participants With Serious Adverse Events (All Causalities and Palbociclib-Related) Baseline up to 28 days after last dose of study treatment, an average of 14 months 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Complete Response and Partial Response Baseline and per routine clinical practice to time of last dose of study treatment, an average of 1 year Tumor response assessments were evaluated as per local guidelines by investigators and were collected in the CRF. No response confirmation was applied.
EQ-VAS Score 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. 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)
EQ-5D Health Utility Index Score 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. 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.
The Objective Response Rate (ORR) Baseline and per routine clinical practice to time of last dose of study treatment, an average of 1 year 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.
Change From Baseline in EQ-5D Health Utility Index Score 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. 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.
Change From Baseline in EQ-VAS Score 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. 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)
Trial Locations
- Locations (34)
HealthCare Global Enterprises Ltd.
🇮🇳Bangalore, Karnataka, India
Tata Memorial Centre, Tata Memorial Hospital
🇮🇳Mumbai, Maharashtra, India
Shatabdi Hospital
🇮🇳Nashik, Maharashtra, India
Deenanath Mangeshkar Hospital and Research Center
🇮🇳Pune, Maharashtra, India
Sahyadri Super Speciality Hospital
🇮🇳Pune, Maharashtra, India
Apollo Speciality Hospital
🇮🇳Chennai, Tamilnadu, India
River City Pharmacy
🇦🇺Auchenflower, Queensland, Australia
Monash Health
🇦🇺Clayton, Victoria, Australia
Icon Cancer Care Chermside
🇦🇺Chermside, Queensland, Australia
Manipal Hospital
🇮🇳Bangalore, Karnataka, India
Icon Cancer Care, Corporate Office
🇦🇺South Brisbane, Queensland, Australia
Icon Cancer Care South Brisbane
🇦🇺South Brisbane, Queensland, Australia
Peter MacCallum Cancer Centre
🇦🇺Melbourne, Victoria, Australia
Flinders Medical Centre-Pharmacy Department
🇦🇺Bedford Park, South Australia, Australia
Kasturba Hospital
🇮🇳Manipal, Karnataka, India
Meditrina Institute Of Medical Sciences
🇮🇳Nagpur, Maharashtra, India
Rajiv Gandhi Cancer Institute And Research Centre
🇮🇳New Delhi, Delhi, India
Dr. B.R.A Institute Rotary Cancer Hospital, All India Institue of Medical Sciences
🇮🇳New Delhi, Delhi, India
Professor Frances Mary Boyle
🇦🇺North Sydney, New South Wales, Australia
Dr. Alexander Maxwell Menzies
🇦🇺North Sydney, New South Wales, Australia
Royal North Shore Hospital, Dept. of Medical Oncology
🇦🇺St Leonards, New South Wales, Australia
Icon Cancer Care Southport
🇦🇺Southport, Queensland, Australia
Sunshine Hospital Pharmacy
🇦🇺St. Albans, Victoria, Australia
Pharmacy Department
🇦🇺Murdoch, Western Australia, Australia
Sunshine Hospital
🇦🇺St Albans, Victoria, Australia
Peter MacCallum Cancer Centre Pharmacy
🇦🇺Melbourne, Victoria, Australia
Fiona Stanley Hospital
🇦🇺Murdoch, Western Australia, Australia
The Gujarat Cancer & Research Institute, M.P Shah Cancer Hospital
🇮🇳Ahmedabad, Gujarat, India
Mater Hospital Sydney
🇦🇺North Sydney, New South Wales, Australia
Benjamin Carl Forster
🇦🇺North Sydney, New South Wales, Australia
HPS Pharmacies - North Sydney
🇦🇺North Sydney, New South Wales, Australia
Royal North Shore Hospital - Clinical Trials Pharmacy
🇦🇺St Leonards, New South Wales, Australia
Icon Cancer Care Wesley
🇦🇺Auchenflower, Queensland, Australia
Flinders Medical Centre
🇦🇺Bedford Park, South Australia, Australia