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| ID | Type | Description | Link |
|---|---|---|---|
| NCT04671615 | Registry Identifier | ClinicalTrials.gov |
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The purpose of this study is to understand the treatment patterns, patients and their clinical outcomes in a real life setting in Israel. This study was done in adult breast cancer patients who have started palbociclib combination treatment as per the national basket of health services in January 2018 until August 2020 for all lines of therapy.
This study had included adult patients who were prescribed with palbociclib for their breast cancer which had spread to other parts of the body.
Patients are followed for around 3.5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with metastatic, HR+/HER2- breast cancer. | Patients who initiated first or subsequent lines of treatment with palbociclib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| palbociclib | Drug | As provided in real world practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Categorized According to Type of Index Combination Treatment Regimen | Number of participants were classified on the basis of type of combination treatment along with palbociclib as first line therapy. Index treatment was palbociclib combination treatment. Index period was defined as duration in which participant initiated palbociclib combination treatment. | Day 1 of index treatment (any day from 01 January 2018 to 30 June 2020 [index period]), data observed and evaluated during 18 months of this retrospective study |
| Duration of Index Treatment Per Type of Combination Treatment | Duration in months between the start and stop of therapy was reported. Index treatment was palbociclib combination treatment. Kaplan-Meier method was used for the assessment of this outcome measure. | Day 1 of index treatment till discontinuation of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study |
| Number of Participants Categorized According to Number of Cycles of Index Treatment Per Type of Combination Treatment | Number of participants categorized according to number of cycles of treatment including less than or equal to (<=) 6, greater than (>) 6 to 11, >11 to 20 and >20 cycles were reported. Index treatment was palbociclib combination treatment. | Day 1 of index treatment till discontinuation of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study |
| Number of Participants Categorized According to Initial Palbociclib Dose Per Type of Combination Treatment | Number of participants were categorized according to initial palbociclib dose. Index treatment was palbociclib combination treatment. Index period was defined as duration in which participant initiated palbociclib combination treatment. | Day 1 of index treatment (any day from 01 January 2018 to 30 June 2020 [index period]), data observed and evaluated during 18 months of this retrospective study |
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Inclusion Criteria:
Exclusion Criteria:
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This is a population based retrospective database study that will include patients with metastatic, HR+/ HER2- breast cancer and who initiated first or subsequent lines of treatment with palbociclib. Data will be available from Maccabi Healthcare Services (MHS) database in Israel for patients who received approval for treatment with palbociclib since 01 January 2018 until 31 August 2020.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Pharmaceuticals Israel Ltd. | Herzliya Pituah | 4672509 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37529919 | Derived | Moser SS, Mazursky OF, Shalev H, Apter L, Chodick G, Siegelmann-Danieli N. Real-world outcomes of patients with metastatic endocrine-responsive breast cancer receiving palbociclib-based combinations. Future Oncol. 2023 Jul;19(21):1473-1483. doi: 10.2217/fon-2023-0176. Epub 2023 Aug 2. |
| 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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Data were identified and retrieved from Maccabi healthcare services (MHS) database for eligible participants who initiated palbociclib combination treatment from 01 January 2018 to 30 June 2020. The observation period was extended up to 30 June 2022 to include the follow up duration of minimum of 24 months post treatment initiation. Data was observed and evaluated during 18 months of this retrospective study (06 December 2020 to 30 June 2022) of this study.
Retrospective data from Israel participants with hormone receptor positive (HR+)/ human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer and who initiated first or subsequent lines of palbociclib along with combination treatment (aromatase inhibitor [AI] or fulvestrant) and had at least 24 months of follow up post treatment initiation were planned to be observed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Palbociclib | Participants with HR+/HER2- metastatic breast cancer, who had initiated palbociclib combination treatment in real world clinical practice as per the national basket of health services, were observed during this population based retrospective database study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Analysis population included all participants whose data were included and observed in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Palbociclib | Participants with HR+/HER2- metastatic breast cancer, who had initiated palbociclib combination treatment in real world clinical practice as per the national basket of health services, were observed during this population based retrospective database study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 Categorized According to Type of Index Combination Treatment Regimen | Number of participants were classified on the basis of type of combination treatment along with palbociclib as first line therapy. Index treatment was palbociclib combination treatment. Index period was defined as duration in which participant initiated palbociclib combination treatment. | Analysis population included all participants whose data were included and observed in the study. | Posted | Count of Participants | Participants | Day 1 of index treatment (any day from 01 January 2018 to 30 June 2020 [index period]), data observed and evaluated during 18 months of this retrospective study |
|
All-Cause Mortality: Any death due to any cause that happened was recorded during observation period from 01 January 2018 to 30 June 2022 (approximately 54 months); data observed and evaluated during 18 months of this retrospective study. Due to non-interventional nature of the study adverse events were not collected and recorded, hence time frame not applicable.
Due to non-interventional nature of the study, data for SAEs and non-SAEs were not collected.
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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 | Participants with HR+/HER2- metastatic breast cancer, who had initiated palbociclib combination treatment in real world clinical practice as per the national basket of health services, were observed during this population based retrospective database study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 30, 2022 | Dec 19, 2023 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C500026 | palbociclib |
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| Number of Participants With Modification (Reduction) in Initial Palbociclib Dose Per Type of Combination Treatment | Number of participants who had a reduction in initial palbociclib dose were reported. Index treatment was palbociclib combination treatment. | Day 1 of index treatment till discontinuation of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study |
| Time on Treatment for Subsequent Treatment After Palbociclib Therapy Per Type of Combination Treatment | Subsequent treatment after palbociclib therapy was the regimen received by participants following discontinuation from the palbociclib treatment and included chemotherapy, everolimus, fulvestrant and other. The duration between the start and stop of the post-palbociclib treatment was reported in this outcome measure. Index treatment was palbociclib combination treatment. Kaplan-Meier method was used for the assessment of this outcome measure. | Day 1 of subsequent treatment till last dose of subsequent treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study |
| Percentage of Participants With Ongoing Index Treatment at Month 6 Per Type of Combination Treatment | Percentage of participants with ongoing index treatment at Month 6 were reported. Index treatment was palbociclib combination treatment. | Day 1 of index treatment up to Month 6 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study |
| Percentage of Participants With Ongoing Index Treatment at Month 12 Per Type of Combination Treatment | Percentage of participants with ongoing index treatment at Month 12 were reported. Index treatment was palbociclib combination treatment. | Day 1 of index treatment up to Month 12 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study |
| Percentage of Participants With Ongoing Index Treatment at Month 24 Per Type of Combination Treatment | Percentage of participants with ongoing index treatment at Month 24 were reported. Index treatment was palbociclib combination treatment. | Day 1 of index treatment up to Month 24 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study |
| Number of Participants Who Died Following Initiation of Index Treatment up to Month 6 Per Type of Combination Treatment | Number of participants who died following index treatment up to Month 6 were reported. Index treatment was palbociclib combination treatment. | Day 1 of index treatment up to Month 6 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study |
| Number of Participants Who Died Following Initiation of Index Treatment up to Month 12 Per Type of Combination Treatment | Number of participants who died following index treatment up to Month 12 were reported. Index treatment was palbociclib combination treatment. | Day 1 of index treatment up to Month 12 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study |
| Number of Participants Who Died Following Initiation of Index Treatment up to Month 24 Per Type of Combination Treatment | Number of participants who died following index treatment up to Month 24 were reported. Index treatment is palbociclib combination treatment. | Day 1 of index treatment up to Month 24 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study |
| Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 6 Per Type of Combination Treatment | Subsequent treatment after palbociclib therapy was the regimen received by participants following discontinuation from the palbociclib treatment. Number of participants who advanced and did not advance to a subsequent treatment up to Month 6 were reported. Index treatment is palbociclib combination treatment. | Day 1 of index treatment up to Month 6 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study |
| Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 12 Per Type of Combination Treatment | Subsequent treatment after palbociclib therapy was the regimen received by participants following discontinuation from the palbociclib treatment. Number of participants who advanced and did not advance to a subsequent treatment up to Month 12 were reported. Index treatment is palbociclib combination treatment. | Day 1 of index treatment up to Month 12 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study |
| Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 24 Per Type of Combination Treatment | Subsequent treatment after palbociclib therapy was the regimen received by participants following discontinuation from the palbociclib treatment. Number of participants who advanced and did not advance to a subsequent treatment up to Month 24 were reported. Index treatment is palbociclib combination treatment. | Day 1 of index treatment up to Month 24 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study |
| Time to Initiation of Chemotherapy After Cessation of Initial Palbociclib Therapy Per Type of Combination Treatment | Time to initiation of chemotherapy was the duration from end of index treatment up to start of chemotherapy. Index treatment is palbociclib combination treatment. | From cessation of index treatment up to initiation of chemotherapy (during 01 January 2018 to 31 December 2020 [approximately 36 months]); data observed and evaluated during 18 months of this retrospective study |
| Time to Initiation of Next Treatment (TTNT) From Initiation of Palbociclib Treatment Per Type of Combination Treatment | TTNT was defined as the interval between the start of the index treatment date and the date of the next-line treatment. Participants who did not advance to the next treatment were censored on the study end date or death, whichever occurred first. Index treatment is palbociclib combination treatment. Kaplan-Meier method was used for the assessment of this outcome measure. | Day 1 of index treatment up to initiation of next treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study |
| Years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Median | Inter-Quartile Range | Kilogram per meter square |
|
| Number of Participants Categorized According to BMI | Number of participants were classified according to BMI as underweight (BMI less than [<]18.50 kilogram per meter square [kg/m^2]), normal (BMI 18.50-24.99 kg/m^2), overweight (BMI 25.00-29.99 kg/m^2), obese (BMI greater than or equal to [>=] 30 kg/m^2) and missing. | Count of Participants | Participants |
|
| Number of Participants According to Smoking History | Number of participants were classified according to smoking history as current or former and never | Count of Participants | Participants |
|
| Number of Participants According to Region of Residence | Number of participants according to region of residence included north, south and central region were reported. | Count of Participants | Participants |
|
| Number of Participants According to Socioeconomic Status | Number of participants were classified according to socioeconomic status as low, medium and high. | Count of Participants | Participants |
|
| Number of Participants With Co-morbidities Diagnosed in one Year Prior to Palbociclib Initiation | Participants with their co-morbidities diagnosed 1 year prior to palbociclib initiation were reported. One participant could have more than 1 co-morbidity so 1 participant could be included in more than 1 row reported below. | Count of Participants | Participants |
|
| Number of Participants With Chronic Disease - Depression | Number of participants with depression as defined by international classification of diseases, ninth revision (ICD-9) codes were reported below. | Count of Participants | Participants |
|
| Number of Participants According to Deyo-Charlson Comorbidity Index Categories | Deyo-Charlson co-morbidity index was used to determine presence/absence of disease using international classification of diseases, ninth revision, clinical modification (ICD-9-CM) codes and MHS registries. It was calculated based on the presence of 19 comorbidities which have been selected and weighted on the basis of the strength of their association with mortality. Total score ranged from 0 to 9. A score of zero indicated that no comorbidities were found. The higher the score, the more likely the cumulative severity of a participant's comorbidities. | Count of Participants | Participants |
|
| Number of Participants who Used Other Medications Prior to Palbociclib Initiation | Number of participants who used other medications i.e. other than palbociclib (at least 2 purchases) within 3 months prior to index date (palbociclib initiation) were included. | Count of Participants | Participants |
|
| Number of Participants who Visited Community/Hospital for Genetic Counselling | Number of participants who visited community/hospital for genetic counselling for germline breast cancer gene mutation (gBRCAm) before index date were reported. Index date is date for initiation of palbociclib. | Count of Participants | Participants |
|
| Number of Participants With Germline Breast Cancer Gene Mutation (gBRCAm) Test Performed | Number of participants whose gBRCAm test was performed were reported. | Count of Participants | Participants |
|
| Number of Participants According to Histology of Breast Cancer | Number of participants according to histology of breast cancer as invasive ductal, invasive lobular, lobular and ductal and other/missing/unknown were reported. | Count of Participants | Participants |
|
| Number of Participants According to Location of Metastases | Number of participants according to location of metastases included visceral (lung, liver, abdomen or skin), lymph, bone and brain were reported. One participant could have more than 1 location so 1 participant could be included in more than 1 row. | Count of Participants | Participants |
|
| Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status | ECOG performance status was used to assess the physical health of participants and ranged from 0 to 5. where Grade 0: fully active; Grade 1: restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; Grade 2: ambulatory and capable of all self-care but unable to carry out any work activities; Grade 3: capable of only limited self-care; Grade 4: completely disabled. cannot carry on any selfcare and Grade 5: dead. Number of participants according to ECOG status were reported. | Count of Participants | Participants |
|
| Number of Participants Categorized According to Hormone Receptor Sensitivity | Number of participants according to hormone receptor sensitivity status included estrogen receptor positive (ER+)/ progesterone receptor positive (PR+), ER+, PR+ and missing were reported. | Count of Participants | Participants |
|
|
|
| Primary | Duration of Index Treatment Per Type of Combination Treatment | Duration in months between the start and stop of therapy was reported. Index treatment was palbociclib combination treatment. Kaplan-Meier method was used for the assessment of this outcome measure. | Analysis population included all participants whose data were included and observed in the study. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows. | Posted | Median | 95% Confidence Interval | Months | Day 1 of index treatment till discontinuation of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study |
|
|
|
| Primary | Number of Participants Categorized According to Number of Cycles of Index Treatment Per Type of Combination Treatment | Number of participants categorized according to number of cycles of treatment including less than or equal to (<=) 6, greater than (>) 6 to 11, >11 to 20 and >20 cycles were reported. Index treatment was palbociclib combination treatment. | Analysis population included all participants whose data were included and observed in the study. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows. | Posted | Count of Participants | Participants | Day 1 of index treatment till discontinuation of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study |
|
|
|
| Primary | Number of Participants Categorized According to Initial Palbociclib Dose Per Type of Combination Treatment | Number of participants were categorized according to initial palbociclib dose. Index treatment was palbociclib combination treatment. Index period was defined as duration in which participant initiated palbociclib combination treatment. | Analysis population included all participants whose data were included and observed in the study. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows. | Posted | Count of Participants | Participants | Day 1 of index treatment (any day from 01 January 2018 to 30 June 2020 [index period]), data observed and evaluated during 18 months of this retrospective study |
|
|
|
| Primary | Number of Participants With Modification (Reduction) in Initial Palbociclib Dose Per Type of Combination Treatment | Number of participants who had a reduction in initial palbociclib dose were reported. Index treatment was palbociclib combination treatment. | Analysis population included all participants whose data were included and observed in the study. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows. | Posted | Count of Participants | Participants | Day 1 of index treatment till discontinuation of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study |
|
|
|
| Primary | Time on Treatment for Subsequent Treatment After Palbociclib Therapy Per Type of Combination Treatment | Subsequent treatment after palbociclib therapy was the regimen received by participants following discontinuation from the palbociclib treatment and included chemotherapy, everolimus, fulvestrant and other. The duration between the start and stop of the post-palbociclib treatment was reported in this outcome measure. Index treatment was palbociclib combination treatment. Kaplan-Meier method was used for the assessment of this outcome measure. | Analysis population included all participants whose data were included and observed in the study. Here "Overall Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure. All participants reported under "Overall Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. "Number Analyzed" refers to the number of participants evaluable for the specified rows. | Posted | Median | 95% Confidence Interval | Months | Day 1 of subsequent treatment till last dose of subsequent treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study |
|
|
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| Primary | Percentage of Participants With Ongoing Index Treatment at Month 6 Per Type of Combination Treatment | Percentage of participants with ongoing index treatment at Month 6 were reported. Index treatment was palbociclib combination treatment. | Analysis population included all participants whose data were included and observed in the study. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 1 of index treatment up to Month 6 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study |
|
|
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| Primary | Percentage of Participants With Ongoing Index Treatment at Month 12 Per Type of Combination Treatment | Percentage of participants with ongoing index treatment at Month 12 were reported. Index treatment was palbociclib combination treatment. | Analysis population included all participants whose data were included and observed in the study. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 1 of index treatment up to Month 12 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study |
|
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| Primary | Percentage of Participants With Ongoing Index Treatment at Month 24 Per Type of Combination Treatment | Percentage of participants with ongoing index treatment at Month 24 were reported. Index treatment was palbociclib combination treatment. | Analysis population included all participants whose data were included and observed in the study. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 of index treatment up to Month 24 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study |
|
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| Primary | Number of Participants Who Died Following Initiation of Index Treatment up to Month 6 Per Type of Combination Treatment | Number of participants who died following index treatment up to Month 6 were reported. Index treatment was palbociclib combination treatment. | Analysis population included all participants whose data were included and observed in the study. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows. | Posted | Count of Participants | Participants | Day 1 of index treatment up to Month 6 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study |
|
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| Primary | Number of Participants Who Died Following Initiation of Index Treatment up to Month 12 Per Type of Combination Treatment | Number of participants who died following index treatment up to Month 12 were reported. Index treatment was palbociclib combination treatment. | Analysis population included all participants whose data were included and observed in the study. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows. | Posted | Count of Participants | Participants | Day 1 of index treatment up to Month 12 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study |
|
|
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| Primary | Number of Participants Who Died Following Initiation of Index Treatment up to Month 24 Per Type of Combination Treatment | Number of participants who died following index treatment up to Month 24 were reported. Index treatment is palbociclib combination treatment. | Analysis population included all participants whose data were included and observed in the study. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows. | Posted | Count of Participants | Participants | Day 1 of index treatment up to Month 24 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study |
|
|
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| Primary | Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 6 Per Type of Combination Treatment | Subsequent treatment after palbociclib therapy was the regimen received by participants following discontinuation from the palbociclib treatment. Number of participants who advanced and did not advance to a subsequent treatment up to Month 6 were reported. Index treatment is palbociclib combination treatment. | Analysis population included all participants whose data were included and observed in the study. Here "Overall Number of Participants Analyzed" signifies participants evaluable for the outcome measure. All participants reported under "Overall Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. "Number Analyzed" refers to the number of participants evaluable for the specified rows. | Posted | Count of Participants | Participants | Day 1 of index treatment up to Month 6 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study |
|
|
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| Primary | Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 12 Per Type of Combination Treatment | Subsequent treatment after palbociclib therapy was the regimen received by participants following discontinuation from the palbociclib treatment. Number of participants who advanced and did not advance to a subsequent treatment up to Month 12 were reported. Index treatment is palbociclib combination treatment. | Analysis population included all participants whose data were included and observed in the study. Here "Overall Number of Participants Analyzed" signifies participants evaluable for the outcome measure. All participants reported under "Overall Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. "Number Analyzed" refers to the number of participants evaluable for the specified rows. | Posted | Count of Participants | Participants | Day 1 of index treatment up to Month 12 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study |
|
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| Primary | Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 24 Per Type of Combination Treatment | Subsequent treatment after palbociclib therapy was the regimen received by participants following discontinuation from the palbociclib treatment. Number of participants who advanced and did not advance to a subsequent treatment up to Month 24 were reported. Index treatment is palbociclib combination treatment. | Analysis population included all participants whose data were included and observed in the study. Here "Overall Number of Participants Analyzed" signifies participants evaluable for the outcome measure. All participants reported under "Overall Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. "Number Analyzed" refers to the number of participants evaluable for the specified rows. | Posted | Count of Participants | Participants | Day 1 of index treatment up to Month 24 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study |
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| Primary | Time to Initiation of Chemotherapy After Cessation of Initial Palbociclib Therapy Per Type of Combination Treatment | Time to initiation of chemotherapy was the duration from end of index treatment up to start of chemotherapy. Index treatment is palbociclib combination treatment. | Analysis population included all participants whose data were included and observed in the study. Here "Overall Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure. All participants reported under "Overall Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. "Number Analyzed" refers to the number of participants evaluable for the specified rows. | Posted | Median | 95% Confidence Interval | Months | From cessation of index treatment up to initiation of chemotherapy (during 01 January 2018 to 31 December 2020 [approximately 36 months]); data observed and evaluated during 18 months of this retrospective study |
|
|
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| Primary | Time to Initiation of Next Treatment (TTNT) From Initiation of Palbociclib Treatment Per Type of Combination Treatment | TTNT was defined as the interval between the start of the index treatment date and the date of the next-line treatment. Participants who did not advance to the next treatment were censored on the study end date or death, whichever occurred first. Index treatment is palbociclib combination treatment. Kaplan-Meier method was used for the assessment of this outcome measure. | Analysis population included all participants whose data were included and observed in the study. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows. | Posted | Median | 95% Confidence Interval | Months | Day 1 of index treatment up to initiation of next treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study |
|
|
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| 269 |
| 559 |
| 0 |
| 0 |
| 0 |
| 0 |
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.
| D017437 |
| Skin and Connective Tissue Diseases |
|
| >11 - 20 cycles |
|
| >20 cycles |
|
| Palbociclib + Fulvestrant |
|
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| 125 mg |
|
| Palbociclib + Fulvestrant |
|
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|
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| Palbociclib + AI: Fulvestrant |
|
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| Palbociclib + AI: Other |
|
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| Palbociclib + Fulvestrant: Chemotherapy |
|
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| Palbociclib + Fulvestrant: Everolimus |
|
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| Palbociclib + Fulvestrant: Fulvestrant |
|
|
| Palbociclib + Fulvestrant: other |
|
|
|
|
|
|
|
|
| Palbociclib + Fulvestrant |
|
|
| Palbociclib + Fulvestrant |
|
|
| Palbociclib + Fulvestrant |
|
|
|
|