An observational study in Metastatic Breast Cancer, sponsored by Pfizer. Completed at 1 site in Israel. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-12-10.
Sponsored by Pfizer · Observational
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 559 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Patients who initiated first or subsequent lines of treatment with palbociclib
Drug: palbociclib
As provided in real world practice
Also known as: Ibrance
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
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.
| Milestone | Palbociclib |
|---|---|
| Started | 559 |
| Completed | 559 |
| Not completed | 0 |
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.
| Participants | Palbociclib |
|---|---|
| Palbociclib + Aromatase Inhibitor (AI) | 293 |
| Palbociclib + Fulvestrant | 266 |
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.
| Months | Palbociclib |
|---|---|
| Palbociclib + AI | 30.5 (23.7 to 37.2) |
| Palbociclib + Fulvestrant | 12.6 (10.6 to 15.6) |
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.
| Participants | Palbociclib |
|---|---|
| Palbociclib + AI — <= 6 cycles | 44 |
| Palbociclib + AI — >6 - 11 cycles | 37 |
| Palbociclib + AI — >11 - 20 cycles | 66 |
| Palbociclib + AI — >20 cycles | 146 |
| Palbociclib + Fulvestrant — <= 6 cycles | 99 |
| Palbociclib + Fulvestrant — >6 - 11 cycles | 47 |
| Palbociclib + Fulvestrant — >11 - 20 cycles | 52 |
| Palbociclib + Fulvestrant — >20 cycles | 68 |
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.
| Participants | Palbociclib |
|---|---|
| Palbociclib + AI — 75 milligrams (mg) | 8 |
| Palbociclib + AI — 100 mg | 23 |
| Palbociclib + AI — 125 mg | 262 |
| Palbociclib + Fulvestrant — 75 milligrams (mg) | 12 |
| Palbociclib + Fulvestrant — 100 mg | 26 |
| Palbociclib + Fulvestrant — 125 mg | 228 |
Number of participants who had a reduction in initial palbociclib dose were reported. Index treatment was palbociclib combination treatment.
| Participants | Palbociclib |
|---|---|
| Palbociclib + AI | 96 |
| Palbociclib+ Fulvestrant | 82 |
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.
| Months | Palbociclib |
|---|---|
| Palbociclib + AI: Chemotherapy | 5.19 (3.16 to 8.55) |
| Palbociclib + AI: Everolimus | 4.57 (2.6 to 7.07) |
| Palbociclib + AI: Fulvestrant | 4.41 (3.72 to 6.08) |
| Palbociclib + AI: Other | 12.89 (3.45 to NA) |
| Palbociclib + Fulvestrant: Chemotherapy | 6.08 (4.24 to 8.32) |
| Palbociclib + Fulvestrant: Everolimus | 4.44 (3.06 to 6.38) |
| Palbociclib + Fulvestrant: Fulvestrant | 7.76 (3.02 to NA) |
| Palbociclib + Fulvestrant: other | 4.37 (1.74 to NA) |
Percentage of participants with ongoing index treatment at Month 6 were reported. Index treatment was palbociclib combination treatment.
| Percentage of Participants | Palbociclib |
|---|---|
| Palbociclib + AI | 91.0 (87.7 to 94.3) |
| Palbociclib + Fulvestrant | 71.1 (65.7 to 76.9) |
Percentage of participants with ongoing index treatment at Month 12 were reported. Index treatment was palbociclib combination treatment.
| Percentage of Participants | Palbociclib |
|---|---|
| Palbociclib + AI | 76.3 (71.5 to 81.4) |
| Palbociclib + Fulvestrant | 51.2 (45.2 to 57.9) |
Percentage of participants with ongoing index treatment at Month 24 were reported. Index treatment was palbociclib combination treatment.
| Percentage of participants | Palbociclib |
|---|---|
| Palbociclib + AI | 54.7 (49.1 to 60.9) |
| Palbociclib + Fulvestrant | 26.0 (20.8 to 32.5) |
Number of participants who died following index treatment up to Month 6 were reported. Index treatment was palbociclib combination treatment.
| Participants | Palbociclib |
|---|---|
| Palbociclib + AI | 10 |
| Palbociclib + Fulvestrant | 31 |
Number of participants who died following index treatment up to Month 12 were reported. Index treatment was palbociclib combination treatment.
| Participants | Palbociclib |
|---|---|
| Palbociclib + AI | 21 |
| Palbociclib + Fulvestrant | 71 |
Number of participants who died following index treatment up to Month 24 were reported. Index treatment is palbociclib combination treatment.
| Participants | Palbociclib |
|---|---|
| Palbociclib + AI | 58 |
| Palbociclib + Fulvestrant | 119 |
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.
| Participants | Palbociclib |
|---|---|
| Palbociclib + AI — Advanced | 207 |
| Palbociclib + AI — Did not advance | 17 |
| Palbociclib + Fulvestrant — Advanced | 230 |
| Palbociclib + Fulvestrant — Did not advance | 12 |
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.
| Participants | Palbociclib |
|---|---|
| Palbociclib + AI — Advanced | 219 |
| Palbociclib + AI — Did not advance | 5 |
| Palbociclib + Fulvestrant — Advanced | 239 |
| Palbociclib + Fulvestrant — Did not advance | 3 |
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.
| Participants | Palbociclib |
|---|---|
| Palbociclib + AI — Advanced | 223 |
| Palbociclib + AI — Did not advance | 1 |
| Palbociclib + Fulvestrant — Advanced | 242 |
| Palbociclib + Fulvestrant — Did not advance | 0 |
Time to initiation of chemotherapy was the duration from end of index treatment up to start of chemotherapy. Index treatment is palbociclib combination treatment.
| Months | Palbociclib |
|---|---|
| Palbociclib + AI | 0.79 (0.59 to 1.51) |
| Palbociclib + Fulvestrant | 0.92 (0.79 to 1.118) |
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.
| Months | Palbociclib |
|---|---|
| Palbociclib + AI | 34.5 (27.2 to 51.6) |
| Palbociclib + Fulvestrant | 16.4 (13.3 to 18.1) |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Palbociclib | 269/559 (48.1%) | — | — |
Analysis population included all participants whose data were included and observed in the study.
| Age, Continuous(Years) | Palbociclib |
|---|---|
| Median | 65.00 (54.00 to 72.00) |
| Age, Customized(Participants) | Palbociclib |
|---|---|
| <=65 Years | 278 |
| >65 Years | 281 |
| Sex: Female, Male(Participants) | Palbociclib |
|---|---|
| Female | 554 |
| Male | 5 |
| Race and Ethnicity Not Collected(Participants) | Palbociclib |
|---|
| Body Mass Index (BMI)(Kilogram per meter square) | Palbociclib |
|---|---|
| Median | 27.85 (24.65 to 31.83) |
| Number of Participants Categorized According to BMI(Participants) | Palbociclib |
|---|---|
| Underweight | 9 |
| Normal | 138 |
| Overweight | 190 |
| Obese | 186 |
| Missing | 36 |
| Number of Participants According to Smoking History(Participants) | Palbociclib |
|---|---|
| Current or former | 210 |
| Never | 349 |
| Number of Participants According to Region of Residence(Participants) | Palbociclib |
|---|---|
| North | 99 |
| South | 81 |
| Central | 379 |
11 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — 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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