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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm | Experimental | Palbociclib plus Letrozole |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palbociclib | Drug | 125 mg/d capsules orally for 3 out of 4 weeks in repeated cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (All Causalities) | 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. | Baseline up to 28 days after last dose of study treatment, an average of 14 months |
| Number of Participants With Treatment-Emergent Adverse Events by Severity (All Causalities) | 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. | Baseline up to 28 days after last dose of study treatment, an average of 14 months |
| Number of Participants With Treatment-Emergent Adverse Events (Palbociclib-Related) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Complete Response and Partial Response | Tumor response assessments were evaluated as per local guidelines by investigators and were collected in the CRF. No response confirmation was applied. | Baseline and per routine clinical practice to time of last dose of study treatment, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Benjamin Carl Forster | North Sydney | New South Wales | 2060 | Australia | ||
| Dr. Alexander Maxwell Menzies |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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252 participants were assigned to treatment at 20 sites in India and Australia (100 in India, 152 in Australia)
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| ID | Title | Description |
|---|---|---|
| FG000 | Palbociclib+Letrozole India Cohort | Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 31, 2016 | Jul 31, 2020 |
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| Letrozole | Drug | 2.5 mg/d tablets orally on a continuous regimen |
|
| Baseline up to 28 days after last dose of study treatment, an average of 14 months |
| Number of Participants With Treatment-Emergent Adverse Events by Severity (Palbociclib-Related) | 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. | Baseline up to 28 days after last dose of study treatment, an average of 14 months |
| Number of Participants With Serious Adverse Events (All Causalities and Palbociclib-Related) | 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. | Baseline up to 28 days after last dose of study treatment, an average of 14 months |
| The Objective Response Rate (ORR) |
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. |
| Baseline and per routine clinical practice to time of last dose of study treatment, an average of 1 year |
| EQ-5D Health Utility Index Score | 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 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. |
| Change From Baseline in EQ-5D Health Utility Index Score | 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 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. |
| EQ-VAS Score | 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) | 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. |
| Change From Baseline in EQ-VAS Score | 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) | 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. |
| North Sydney |
| New South Wales |
| 2060 |
| Australia |
| HPS Pharmacies - North Sydney | North Sydney | New South Wales | 2060 | Australia |
| Mater Hospital Sydney | North Sydney | New South Wales | 2060 | Australia |
| Professor Frances Mary Boyle | North Sydney | New South Wales | 2060 | Australia |
| Royal North Shore Hospital - Clinical Trials Pharmacy | St Leonards | New South Wales | 2065 | Australia |
| Royal North Shore Hospital, Dept. of Medical Oncology | St Leonards | New South Wales | 2065 | Australia |
| Icon Cancer Care Wesley | Auchenflower | Queensland | 4066 | Australia |
| River City Pharmacy | Auchenflower | Queensland | 4066 | Australia |
| Icon Cancer Care Chermside | Chermside | Queensland | 4032 | Australia |
| Icon Cancer Care South Brisbane | South Brisbane | Queensland | 4101 | Australia |
| Icon Cancer Care, Corporate Office | South Brisbane | Queensland | 4101 | Australia |
| Icon Cancer Care Southport | Southport | Queensland | 4215 | Australia |
| Flinders Medical Centre-Pharmacy Department | Bedford Park | South Australia | 5042 | Australia |
| Flinders Medical Centre | Bedford Park | South Australia | 5042 | Australia |
| Monash Health | Clayton | Victoria | 3168 | Australia |
| Peter MacCallum Cancer Centre Pharmacy | Melbourne | Victoria | 3000 | Australia |
| Peter MacCallum Cancer Centre | Melbourne | Victoria | 3000 | Australia |
| Sunshine Hospital Pharmacy | St Albans | Victoria | 3021 | Australia |
| Sunshine Hospital | St Albans | Victoria | 3021 | Australia |
| Fiona Stanley Hospital | Murdoch | Western Australia | 6150 | Australia |
| Pharmacy Department | Murdoch | Western Australia | 6150 | Australia |
| The Gujarat Cancer & Research Institute, M.P Shah Cancer Hospital | Ahmedabad | Gujarat | 380016 | India |
| Manipal Hospital | Bangalore | Karnataka | 560017 | India |
| HealthCare Global Enterprises Ltd. | Bangalore | Karnataka | 560027 | India |
| Kasturba Hospital | Manipal | Karnataka | 576104 | India |
| Tata Memorial Centre, Tata Memorial Hospital | Mumbai | Maharashtra | 400 012 | India |
| Meditrina Institute Of Medical Sciences | Nagpur | Maharashtra | 440012 | India |
| Shatabdi Hospital | Nashik | Maharashtra | 422005 | India |
| Deenanath Mangeshkar Hospital and Research Center | Pune | Maharashtra | 411 004 | India |
| Sahyadri Super Speciality Hospital | Pune | Maharashtra | 411004 | India |
| Rajiv Gandhi Cancer Institute And Research Centre | New Delhi | National Capital Territory of Delhi | 110 085 | India |
| Dr. B.R.A Institute Rotary Cancer Hospital, All India Institue of Medical Sciences | New Delhi | National Capital Territory of Delhi | 110029 | India |
| Apollo Speciality Hospital | Chennai | Tamil Nadu | 600 035 | India |
| FG001 |
| Palbociclib+Letrozole Australia Cohort |
Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The analysis population included all participants who received at least 1 dose of palbociclib treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Palbociclib+Letrozole India Cohort | Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information |
| BG001 | Palbociclib+Letrozole Australia Cohort | Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (All Causalities) | 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. | The analysis population included all participants who received at least 1 dose of palbociclib treatment. | Posted | Count of Participants | Participants | Baseline up to 28 days after last dose of study treatment, an average of 14 months |
|
|
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| Primary | Number of Participants With Treatment-Emergent Adverse Events by Severity (All Causalities) | 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. | The analysis population included all participants who received at least 1 dose of palbociclib treatment. | Posted | Count of Participants | Participants | Baseline up to 28 days after last dose of study treatment, an average of 14 months |
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Treatment-Emergent Adverse Events (Palbociclib-Related) | 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. | The analysis population included all participants who received at least 1 dose of palbociclib treatment. | Posted | Count of Participants | Participants | Baseline up to 28 days after last dose of study treatment, an average of 14 months |
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Treatment-Emergent Adverse Events by Severity (Palbociclib-Related) | 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. | The analysis population included all participants who received at least 1 dose of palbociclib treatment. | Posted | Count of Participants | Participants | Baseline up to 28 days after last dose of study treatment, an average of 14 months |
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Serious Adverse Events (All Causalities and Palbociclib-Related) | 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. | The analysis population included all participants who received at least 1 dose of palbociclib treatment. | Posted | Count of Participants | Participants | Baseline up to 28 days after last dose of study treatment, an average of 14 months |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Complete Response and Partial Response | Tumor response assessments were evaluated as per local guidelines by investigators and were collected in the CRF. No response confirmation was applied. | The analysis population included participants with efficacy data contributing to the analysis | Posted | Number | Percentage of evaluable participants | Baseline and per routine clinical practice to time of last dose of study treatment, an average of 1 year |
| ||||||||||||||||||||||||||||||||||||
| Secondary | The Objective Response Rate (ORR) | 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. | The analysis population included participants with efficacy data contributing to the analysis | Posted | Number | 95% Confidence Interval | Percentage of evaluable participants | Baseline and per routine clinical practice to time of last dose of study treatment, an average of 1 year |
| |||||||||||||||||||||||||||||||||||
| Secondary | EQ-5D Health Utility Index Score | 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. | Patient reported outcome (PRO)-evaluable population was only consisted of the Australia cohort | Posted | Mean | Standard Deviation | Scores on a scale | 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. |
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| Secondary | Change From Baseline in EQ-5D Health Utility Index Score | 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. | PRO-evaluable population was only consisted of the Australia cohort | Posted | Mean | Standard Deviation | Scores on a scale | 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. |
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| Secondary | EQ-VAS Score | 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) | PRO-evaluable population was only consisted of the Australia cohort | Posted | Mean | Standard Deviation | Scores on a scale | 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 | Change From Baseline in EQ-VAS Score | 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) | PRO-evaluable population was only consisted of the Australia cohort | Posted | Mean | Standard Deviation | Scores on a scale | 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. |
|
AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Palbociclib+Letrozole India Cohort | Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information | 3 | 100 | 18 | 100 | 85 | 100 |
| EG001 | Palbociclib+Letrozole Australia Cohort | Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information | 7 | 152 | 45 | 152 | 151 | 152 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Stress cardiomyopathy | Cardiac disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA22.0 | Non-systematic Assessment |
| |
| Aspergillus infection | Infections and infestations | MedDRA22.0 | Non-systematic Assessment |
| |
| Campylobacter gastroenteritis | Infections and infestations | MedDRA22.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA22.0 | Non-systematic Assessment |
| |
| Enterocolitis bacterial | Infections and infestations | MedDRA22.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA22.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA22.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA22.0 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA22.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA22.0 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA22.0 | Non-systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | MedDRA22.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA22.0 | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA22.0 | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA22.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA22.0 | Non-systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA22.0 | Non-systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA22.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Transient global amnesia | Nervous system disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Venous stenosis | Vascular disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA22.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA22.0 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA22.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA22.0 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA22.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA22.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA22.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA22.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA22.0 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA22.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Insomina | Psychiatric disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Onychoclasis | Skin and subcutaneous tissue disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA22.0 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA22.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 29, 2016 | Jul 31, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C500026 | palbociclib |
| D000077289 | Letrozole |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Participants with grade 3 or 4 adverse events |
|
| Participants with grade 5 adverse events |
|
| Participants discontinued due to adverse events |
|
| OG002 | Palbociclib+Letrozole Total | Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment ofr each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information |
|
|
| OG001 | Palbociclib+Letrozole Australia Cohort | Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information |
| OG002 | Palbociclib+Letrozole Total | Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment ofr each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information |
|
|
| OG002 | Palbociclib+Letrozole Total | Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment ofr each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information |
|
|
| OG002 | Palbociclib+Letrozole Total | Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment ofr each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information |
|
|
Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment ofr each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information
|
|
| Palbociclib+Letrozole Total |
Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment ofr each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information |
|
|
| OG001 |
| Palbociclib+Letrozole Australia Cohort |
Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information |
|
|
| Palbociclib+Letrozole Australia Cohort |
Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|