Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective is to retrospectively describe and assess clinical and demographical characteristics, treatment patterns in a real-world (RW) setting of patients with HR+/HER2- (hormone receptor positive/human epidermal growth factor receptor 2 negative) locally advanced or metastatic breast cancer receiving palbociclib in combination treatment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) for Participants Who Received Palbociclib in Combination With Aromatase Inhibitor (AI) | PFS was defined as the time from the index date to progression or death, whichever occurred first. Progression of disease was based on scans and blood testing results. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). Index date was date of relapse or stage IV disease. Stage IV disease means that the cancer has spread to distant parts of the body. Kaplan-Meier method was used for analysis. | From index date until the first documentation of disease progression or death or censoring date of 07-Mar-2022 (maximum up to 5.2 years) |
| Time on Treatment (ToT) for Participants Who Received Palbociclib in Combination With Aromatase Inhibitor (AI) | ToT was defined as date of palbociclib treatment start to date of treatment stop with palbociclib. | From start date of palbociclib treatment until stop date of palbociclib treatment (maximum up to 5.2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) in Participants Who Received Palbociclib in Combination With AI | OS was defined as the date of metastatic breast cancer diagnosis until death of any cause. Participants were censored for OS by 01-May-2022. Stage IV disease means that the cancer has spread to distant parts of the body. | From date of metastatic breast cancer diagnosis until death due to any cause or censoring date of 01-May-2022 (approximately 6 years) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with HR+/HER2- locally advanced or metastatic breast cancer treated with palbociclib (1st or 2nd line between 01 Jan 2017- 31 Dec 2020).
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Danish Breast Cancer Group | Copenhagen | Denmark |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Participants diagnosed with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) locally advanced or metastatic breast cancer (BC) who initiated treatment with palbociclib in Denmark as either first or second line treatment between 01 January 2017 and 31 December 2020 were observed. Data was collected retrospectively from Danish Breast Cancer Group (DBCG) registry. Data analysis was performed over approximately 5 months in this study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Palbociclib | Participants with HR+/HER2- locally advanced or metastatic BC who initiated treatment with palbociclib as first or second line treatment between 01 January 2017 and 31 December 2020 were observed in this retrospective study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 9, 2021 | Jul 13, 2023 |
Not provided
Not provided
Not provided
Not provided
| Progression-Free Survival (PFS) for Participants Who Received Palbociclib in Combination With Fulvestrant | PFS was defined as the time from the index date to progression or death, whichever occurred first. Progression of disease was based on scans and blood testing results. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Index date was date of relapse or stage IV disease. Stage IV disease means that the cancer has spread to distant parts of the body. | From index date until the first documentation of disease progression or death or censoring date of 07-Mar-2022 (maximum up to 5.2 years) |
| Time on Treatment (ToT) for Participants Who Received Palbociclib in Combination With Fulvestrant | ToT is defined as date of palbociclib treatment start to date of treatment stop with palbociclib. | From start date of study treatment until stop date of treatment (maximum up to 5.2 years) |
| OS in Participants Who Received Palbociclib in Combination With Fulvestrant | OS was defined as the date of metastatic breast cancer diagnosis until death of any cause. Participants were censored for OS by 01-May-2022. Stage IV disease means that the cancer has spread to distant parts of the body. | From date of metastatic breast cancer diagnosis until death due to any cause or censoring date of 01-May-2022 (approximately 6 years) |
| Number of Participants According to First Subsequent Post-Palbociclib Treatment Upon Progression | Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Number of participants as per first subsequent post-palbociclib therapy upon disease progression was described in this outcome measure. | At progression (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years]) |
| Number of Participants According to Type of Metastases | Number of participants according to type of metastases (visceral, non-visceral, both visceral and non-visceral and inoperable locally-advanced breast cancer [ILABC]) is presented in this outcome measure. | At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years]) |
| Number of Participants According to Number of Metastases | Number of participants according to number of metastases (0,1,2,greater than [>] 2) is presented in this outcome measure. | At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years]) |
| Number of Participants According to Location of Metastases | Number of participants according to location of metastases (skin, bone, lung, liver, central nervous system [CNS], other) is presented in this outcome measure. One participant may have more than one location of metastases. | At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years]) |
| Number of Participants Who Underwent Surgery | Number of participants who underwent surgery were described. | At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years]) |
| Number of Participants According to Type of Adjuvant Treatment | Participants who received adjuvant treatment (endocrine therapy, taxane, cyclophosphamide and epirubicin, unknown and other) were described in this outcome measure. One participant may have received more than one type of adjuvant treatment. | At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years]) |
| Number of Participants With De Novo and Recurrent Metastatic Breast Cancer | Participants who had de novo and recurrent metastatic breast cancer were reported in this outcome measure. | At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years]) |
| Median Time From Initial Breast Cancer Diagnosis to Relapse | Median time from initial breast cancer diagnosis (incidence date) to relapse is reported in this outcome measure. | At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years]) |
| COMPLETED |
|
| NOT COMPLETED |
|
Analysis was performed on all eligible participants with HR+/HER2- locally advanced or metastatic BC who initiated treatment with palbociclib as first or second line treatment between 01 January 2017 and 31 December 2020.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Palbociclib | Participants with HR+/HER2- locally advanced or metastatic BC who initiated treatment with palbociclib as first or second line treatment between 01 January 2017 and 31 December 2020 were observed in this retrospective study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| 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 |
|
| 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 | Progression-Free Survival (PFS) for Participants Who Received Palbociclib in Combination With Aromatase Inhibitor (AI) | PFS was defined as the time from the index date to progression or death, whichever occurred first. Progression of disease was based on scans and blood testing results. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). Index date was date of relapse or stage IV disease. Stage IV disease means that the cancer has spread to distant parts of the body. Kaplan-Meier method was used for analysis. | Analysis was performed on participants with HR+/HER2- locally advanced or metastatic BC who initiated treatment with palbociclib in combination with AI between 01 January 2017 and 31 December 2020. | Posted | Median | Inter-Quartile Range | Months | From index date until the first documentation of disease progression or death or censoring date of 07-Mar-2022 (maximum up to 5.2 years) |
|
|
| |||||||||||||||||||||||||
| Secondary | Overall Survival (OS) in Participants Who Received Palbociclib in Combination With AI | OS was defined as the date of metastatic breast cancer diagnosis until death of any cause. Participants were censored for OS by 01-May-2022. Stage IV disease means that the cancer has spread to distant parts of the body. | Analysis was performed on participants with HR+/HER2- locally advanced or metastatic BC who initiated treatment with palbociclib in combination with AI between 01 January 2017 and 31 December 2020. | Posted | Median | Inter-Quartile Range | Months | From date of metastatic breast cancer diagnosis until death due to any cause or censoring date of 01-May-2022 (approximately 6 years) |
|
| ||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) for Participants Who Received Palbociclib in Combination With Fulvestrant | PFS was defined as the time from the index date to progression or death, whichever occurred first. Progression of disease was based on scans and blood testing results. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Index date was date of relapse or stage IV disease. Stage IV disease means that the cancer has spread to distant parts of the body. | Analysis was performed on participants with HR+/HER2- locally advanced or metastatic BC who initiated treatment with palbociclib in combination with fulvestrant between 01 January 2017 and 31 December 2020. | Posted | Median | Inter-Quartile Range | Months | From index date until the first documentation of disease progression or death or censoring date of 07-Mar-2022 (maximum up to 5.2 years) |
|
| ||||||||||||||||||||||||||
| Secondary | Time on Treatment (ToT) for Participants Who Received Palbociclib in Combination With Fulvestrant | ToT is defined as date of palbociclib treatment start to date of treatment stop with palbociclib. | Analysis was performed on participants with HR+/HER2- locally advanced or metastatic BC who initiated treatment with palbociclib in combination with fulvestrant between 01 January 2017 and 31 December 2020. | Posted | Median | Inter-Quartile Range | Months | From start date of study treatment until stop date of treatment (maximum up to 5.2 years) |
|
| ||||||||||||||||||||||||||
| Primary | Time on Treatment (ToT) for Participants Who Received Palbociclib in Combination With Aromatase Inhibitor (AI) | ToT was defined as date of palbociclib treatment start to date of treatment stop with palbociclib. | Analysis was performed on participants with HR+/HER2- locally advanced or metastatic BC who initiated treatment with palbociclib in combination with AI between 01 January 2017 and 31 December 2020. | Posted | Median | Inter-Quartile Range | Months | From start date of palbociclib treatment until stop date of palbociclib treatment (maximum up to 5.2 years) |
|
| ||||||||||||||||||||||||||
| Secondary | OS in Participants Who Received Palbociclib in Combination With Fulvestrant | OS was defined as the date of metastatic breast cancer diagnosis until death of any cause. Participants were censored for OS by 01-May-2022. Stage IV disease means that the cancer has spread to distant parts of the body. | Analysis was performed on participants with HR+/HER2- locally advanced or metastatic BC who initiated treatment with palbociclib in combination with fulvestrant between 01 January 2017 and 31 December 2020. | Posted | Median | Inter-Quartile Range | Months | From date of metastatic breast cancer diagnosis until death due to any cause or censoring date of 01-May-2022 (approximately 6 years) |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants According to First Subsequent Post-Palbociclib Treatment Upon Progression | Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Number of participants as per first subsequent post-palbociclib therapy upon disease progression was described in this outcome measure. | Analysis was performed on participants with HR+/HER2- locally advanced or metastatic BC who initiated treatment with palbociclib in combination with AI or fulvestrant between 01 January 2017 and 31 December 2020. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | At progression (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years]) |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants According to Type of Metastases | Number of participants according to type of metastases (visceral, non-visceral, both visceral and non-visceral and inoperable locally-advanced breast cancer [ILABC]) is presented in this outcome measure. | Analysis was performed on participants with HR+/HER2- locally advanced or metastatic BC who initiated treatment with palbociclib as first or second line treatment between 01 January 2017 and 31 December 2020. | Posted | Count of Participants | Participants | At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years]) |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants According to Number of Metastases | Number of participants according to number of metastases (0,1,2,greater than [>] 2) is presented in this outcome measure. | Analysis was performed on participants with HR+/HER2- locally advanced or metastatic BC who initiated treatment with palbociclib as first or second line treatment between 01 January 2017 and 31 December 2020. | Posted | Count of Participants | Participants | At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years]) |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants According to Location of Metastases | Number of participants according to location of metastases (skin, bone, lung, liver, central nervous system [CNS], other) is presented in this outcome measure. One participant may have more than one location of metastases. | Analysis was performed on participants with HR+/HER2- locally advanced or metastatic BC who initiated treatment with palbociclib as first or second line treatment between 01 January 2017 and 31 December 2020. | Posted | Count of Participants | Participants | At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years]) |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants Who Underwent Surgery | Number of participants who underwent surgery were described. | Analysis was performed on participants with HR+/HER2- locally advanced or metastatic BC who initiated treatment with palbociclib as first or second line treatment between 01 January 2017 and 31 December 2020. | Posted | Count of Participants | Participants | At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years]) |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants According to Type of Adjuvant Treatment | Participants who received adjuvant treatment (endocrine therapy, taxane, cyclophosphamide and epirubicin, unknown and other) were described in this outcome measure. One participant may have received more than one type of adjuvant treatment. | Analysis was performed on participants with HR+/HER2- locally advanced or metastatic BC who initiated treatment with palbociclib as first or second line treatment between 01 January 2017 and 31 December 2020. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years]) |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With De Novo and Recurrent Metastatic Breast Cancer | Participants who had de novo and recurrent metastatic breast cancer were reported in this outcome measure. | Analysis was performed on participants with HR+/HER2- locally advanced or metastatic BC who initiated treatment with palbociclib as first or second line treatment between 01 January 2017 and 31 December 2020. | Posted | Count of Participants | Participants | At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years]) |
|
| |||||||||||||||||||||||||||
| Secondary | Median Time From Initial Breast Cancer Diagnosis to Relapse | Median time from initial breast cancer diagnosis (incidence date) to relapse is reported in this outcome measure. | Analysis was performed on participants with HR+/HER2- locally advanced or metastatic BC who initiated treatment with palbociclib as first or second line treatment between 01 January 2017 and 31 December 2020. | Posted | Median | Full Range | years | At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years]) |
|
|
All-cause mortality: From date of metastatic breast cancer diagnosis until the end of follow-up (approximately 6 years). Data for non-serious adverse events and serious adverse events (SAEs) were not collected and evaluated during the study; hence timeframe is not applicable for non-SAEs and SAEs.
This observational retrospective study retrieved data from DBCG registry. In these data sources, individual participant data were not retrieved or validated, and it was not possible to link a particular product and medical event for any individual. Thus, the minimum criteria for reporting an adverse event could not be met, hence adverse events data were not collected and reported.
Not provided
| 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- locally advanced or metastatic BC who initiated treatment with palbociclib as first or second line treatment between 01 January 2017 and 31 December 2020 were observed in this retrospective study. | 525 | 1,054 | 0 | 0 | 0 | 0 |
Not provided
Not provided
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_Inquires@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 26, 2022 | Jul 13, 2023 | 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
|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|