Trial Outcomes & Findings for A Study to Understand the Treatment Patterns and Patients and Their Clinical Outcomes Who Are Taking Palbociclib in a Real Life Setting in Israel. (NCT NCT04671615)

Last Updated: 2025-12-10

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

559 participants

Primary outcome timeframe

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

Results posted on

2025-12-10

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	559
Overall Study COMPLETED	559
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Palbociclib n=559 Participants 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.
Age, Continuous	65.00 Years n=559 Participants
Age, Customized <=65 Years	278 Participants n=559 Participants
Age, Customized >65 Years	281 Participants n=559 Participants
Sex: Female, Male Female	554 Participants n=559 Participants
Sex: Female, Male Male	5 Participants n=559 Participants
Body Mass Index (BMI)	27.85 Kilogram per meter square n=559 Participants
Number of Participants Categorized According to BMI Underweight	9 Participants n=559 Participants
Number of Participants Categorized According to BMI Normal	138 Participants n=559 Participants
Number of Participants Categorized According to BMI Overweight	190 Participants n=559 Participants
Number of Participants Categorized According to BMI Obese	186 Participants n=559 Participants
Number of Participants Categorized According to BMI Missing	36 Participants n=559 Participants
Number of Participants According to Smoking History Current or former	210 Participants n=559 Participants
Number of Participants According to Smoking History Never	349 Participants n=559 Participants
Number of Participants According to Region of Residence North	99 Participants n=559 Participants
Number of Participants According to Region of Residence South	81 Participants n=559 Participants
Number of Participants According to Region of Residence Central	379 Participants n=559 Participants
Number of Participants According to Socioeconomic Status Low	212 Participants n=559 Participants
Number of Participants According to Socioeconomic Status Medium	108 Participants n=559 Participants
Number of Participants According to Socioeconomic Status High	239 Participants n=559 Participants
Number of Participants With Co-morbidities Diagnosed in one Year Prior to Palbociclib Initiation Diabetes mellitus	133 Participants n=559 Participants
Number of Participants With Co-morbidities Diagnosed in one Year Prior to Palbociclib Initiation Cardiovascular disease	76 Participants n=559 Participants
Number of Participants With Co-morbidities Diagnosed in one Year Prior to Palbociclib Initiation Ischemic heart disease	27 Participants n=559 Participants
Number of Participants With Co-morbidities Diagnosed in one Year Prior to Palbociclib Initiation Hypertension	279 Participants n=559 Participants
Number of Participants With Co-morbidities Diagnosed in one Year Prior to Palbociclib Initiation Chronic obstructive pulmonary disease (COPD)	33 Participants n=559 Participants
Number of Participants With Co-morbidities Diagnosed in one Year Prior to Palbociclib Initiation Osteoporosis	165 Participants n=559 Participants
Number of Participants With Co-morbidities Diagnosed in one Year Prior to Palbociclib Initiation Menopause	439 Participants n=559 Participants
Number of Participants With Chronic Disease - Depression	174 Participants n=559 Participants
Number of Participants According to Deyo-Charlson Comorbidity Index Categories 0	241 Participants n=559 Participants
Number of Participants According to Deyo-Charlson Comorbidity Index Categories 1-2	205 Participants n=559 Participants
Number of Participants According to Deyo-Charlson Comorbidity Index Categories >=3	113 Participants n=559 Participants
Number of Participants who Used Other Medications Prior to Palbociclib Initiation	0 Participants n=559 Participants
Number of Participants who Visited Community/Hospital for Genetic Counselling	170 Participants n=559 Participants
Number of Participants With Germline Breast Cancer Gene Mutation (gBRCAm) Test Performed	164 Participants n=559 Participants
Number of Participants According to Histology of Breast Cancer Invasive ductal	434 Participants n=559 Participants
Number of Participants According to Histology of Breast Cancer Invasive lobular	67 Participants n=559 Participants
Number of Participants According to Histology of Breast Cancer Lobular and ductal	19 Participants n=559 Participants
Number of Participants According to Histology of Breast Cancer Other/missing/unknown	39 Participants n=559 Participants
Number of Participants According to Location of Metastases Visceral	261 Participants n=559 Participants
Number of Participants According to Location of Metastases Lymph	251 Participants n=559 Participants
Number of Participants According to Location of Metastases Bone	394 Participants n=559 Participants
Number of Participants According to Location of Metastases Brain	15 Participants n=559 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG: 0-1	311 Participants n=559 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG: 2-4	70 Participants n=559 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG: Missing	178 Participants n=559 Participants
Number of Participants Categorized According to Hormone Receptor Sensitivity ER+/PR+	405 Participants n=559 Participants
Number of Participants Categorized According to Hormone Receptor Sensitivity ER+	139 Participants n=559 Participants
Number of Participants Categorized According to Hormone Receptor Sensitivity PR+	4 Participants n=559 Participants
Number of Participants Categorized According to Hormone Receptor Sensitivity Missing	11 Participants n=559 Participants

PRIMARY outcome

Timeframe: 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

Population: Analysis population included all participants whose data were included and observed in the study.

Outcome measures

Outcome measures
Measure	Palbociclib n=559 Participants 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.
Number of Participants Categorized According to Type of Index Combination Treatment Regimen Palbociclib + Aromatase Inhibitor (AI)	293 Participants
Number of Participants Categorized According to Type of Index Combination Treatment Regimen Palbociclib + Fulvestrant	266 Participants

PRIMARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Palbociclib n=559 Participants 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.
Duration of Index Treatment Per Type of Combination Treatment Palbociclib + AI	30.5 Months Interval 23.7 to 37.2
Duration of Index Treatment Per Type of Combination Treatment Palbociclib + Fulvestrant	12.6 Months Interval 10.6 to 15.6

PRIMARY outcome

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.

Outcome measures

Outcome measures
Measure	Palbociclib n=559 Participants 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.
Number of Participants Categorized According to Number of Cycles of Index Treatment Per Type of Combination Treatment Palbociclib + Fulvestrant · >11 - 20 cycles	52 Participants
Number of Participants Categorized According to Number of Cycles of Index Treatment Per Type of Combination Treatment Palbociclib + Fulvestrant · >20 cycles	68 Participants
Number of Participants Categorized According to Number of Cycles of Index Treatment Per Type of Combination Treatment Palbociclib + AI · <= 6 cycles	44 Participants
Number of Participants Categorized According to Number of Cycles of Index Treatment Per Type of Combination Treatment Palbociclib + AI · >6 - 11 cycles	37 Participants
Number of Participants Categorized According to Number of Cycles of Index Treatment Per Type of Combination Treatment Palbociclib + AI · >11 - 20 cycles	66 Participants
Number of Participants Categorized According to Number of Cycles of Index Treatment Per Type of Combination Treatment Palbociclib + AI · >20 cycles	146 Participants
Number of Participants Categorized According to Number of Cycles of Index Treatment Per Type of Combination Treatment Palbociclib + Fulvestrant · <= 6 cycles	99 Participants
Number of Participants Categorized According to Number of Cycles of Index Treatment Per Type of Combination Treatment Palbociclib + Fulvestrant · >6 - 11 cycles	47 Participants

PRIMARY outcome

Timeframe: 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 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.

Outcome measures

Outcome measures
Measure	Palbociclib n=559 Participants 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.
Number of Participants Categorized According to Initial Palbociclib Dose Per Type of Combination Treatment Palbociclib + AI · 125 mg	262 Participants
Number of Participants Categorized According to Initial Palbociclib Dose Per Type of Combination Treatment Palbociclib + Fulvestrant · 75 milligrams (mg)	12 Participants
Number of Participants Categorized According to Initial Palbociclib Dose Per Type of Combination Treatment Palbociclib + Fulvestrant · 100 mg	26 Participants
Number of Participants Categorized According to Initial Palbociclib Dose Per Type of Combination Treatment Palbociclib + Fulvestrant · 125 mg	228 Participants
Number of Participants Categorized According to Initial Palbociclib Dose Per Type of Combination Treatment Palbociclib + AI · 100 mg	23 Participants
Number of Participants Categorized According to Initial Palbociclib Dose Per Type of Combination Treatment Palbociclib + AI · 75 milligrams (mg)	8 Participants

PRIMARY outcome

Number of participants who had a reduction in initial palbociclib dose were reported. Index treatment was palbociclib combination treatment.

Outcome measures

Outcome measures
Measure	Palbociclib n=559 Participants 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.
Number of Participants With Modification (Reduction) in Initial Palbociclib Dose Per Type of Combination Treatment Palbociclib + AI	96 Participants
Number of Participants With Modification (Reduction) in Initial Palbociclib Dose Per Type of Combination Treatment Palbociclib+ Fulvestrant	82 Participants

PRIMARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Palbociclib n=324 Participants 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.
Time on Treatment for Subsequent Treatment After Palbociclib Therapy Per Type of Combination Treatment Palbociclib + AI: Chemotherapy	5.19 Months Interval 3.16 to 8.55
Time on Treatment for Subsequent Treatment After Palbociclib Therapy Per Type of Combination Treatment Palbociclib + AI: Everolimus	4.57 Months Interval 2.6 to 7.07
Time on Treatment for Subsequent Treatment After Palbociclib Therapy Per Type of Combination Treatment Palbociclib + AI: Fulvestrant	4.41 Months Interval 3.72 to 6.08
Time on Treatment for Subsequent Treatment After Palbociclib Therapy Per Type of Combination Treatment Palbociclib + AI: Other	12.89 Months Interval 3.45 to Upper limit of 95% CI has not been reached due to less number of participants with events.
Time on Treatment for Subsequent Treatment After Palbociclib Therapy Per Type of Combination Treatment Palbociclib + Fulvestrant: Chemotherapy	6.08 Months Interval 4.24 to 8.32
Time on Treatment for Subsequent Treatment After Palbociclib Therapy Per Type of Combination Treatment Palbociclib + Fulvestrant: Everolimus	4.44 Months Interval 3.06 to 6.38
Time on Treatment for Subsequent Treatment After Palbociclib Therapy Per Type of Combination Treatment Palbociclib + Fulvestrant: Fulvestrant	7.76 Months Interval 3.02 to Upper limit of 95% CI has not been reached due to less number of participants with events.
Time on Treatment for Subsequent Treatment After Palbociclib Therapy Per Type of Combination Treatment Palbociclib + Fulvestrant: other	4.37 Months Interval 1.74 to Upper limit of 95% CI has not been reached due to less number of participants with events.

PRIMARY outcome

Timeframe: 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 6 were reported. Index treatment was palbociclib combination treatment.

Outcome measures

Outcome measures
Measure	Palbociclib n=559 Participants 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.
Percentage of Participants With Ongoing Index Treatment at Month 6 Per Type of Combination Treatment Palbociclib + AI	91.0 Percentage of Participants Interval 87.7 to 94.3
Percentage of Participants With Ongoing Index Treatment at Month 6 Per Type of Combination Treatment Palbociclib + Fulvestrant	71.1 Percentage of Participants Interval 65.7 to 76.9

PRIMARY outcome

Timeframe: 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 12 were reported. Index treatment was palbociclib combination treatment.

Outcome measures

Outcome measures
Measure	Palbociclib n=559 Participants 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.
Percentage of Participants With Ongoing Index Treatment at Month 12 Per Type of Combination Treatment Palbociclib + AI	76.3 Percentage of Participants Interval 71.5 to 81.4
Percentage of Participants With Ongoing Index Treatment at Month 12 Per Type of Combination Treatment Palbociclib + Fulvestrant	51.2 Percentage of Participants Interval 45.2 to 57.9

PRIMARY outcome

Timeframe: 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

Percentage of participants with ongoing index treatment at Month 24 were reported. Index treatment was palbociclib combination treatment.

Outcome measures

Outcome measures
Measure	Palbociclib n=559 Participants 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.
Percentage of Participants With Ongoing Index Treatment at Month 24 Per Type of Combination Treatment Palbociclib + Fulvestrant	26.0 Percentage of participants Interval 20.8 to 32.5
Percentage of Participants With Ongoing Index Treatment at Month 24 Per Type of Combination Treatment Palbociclib + AI	54.7 Percentage of participants Interval 49.1 to 60.9

PRIMARY outcome

Number of participants who died following index treatment up to Month 6 were reported. Index treatment was palbociclib combination treatment.

Outcome measures

Outcome measures
Measure	Palbociclib n=559 Participants 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.
Number of Participants Who Died Following Initiation of Index Treatment up to Month 6 Per Type of Combination Treatment Palbociclib + AI	10 Participants
Number of Participants Who Died Following Initiation of Index Treatment up to Month 6 Per Type of Combination Treatment Palbociclib + Fulvestrant	31 Participants

PRIMARY outcome

Number of participants who died following index treatment up to Month 12 were reported. Index treatment was palbociclib combination treatment.

Outcome measures

Outcome measures
Measure	Palbociclib n=559 Participants 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.
Number of Participants Who Died Following Initiation of Index Treatment up to Month 12 Per Type of Combination Treatment Palbociclib + AI	21 Participants
Number of Participants Who Died Following Initiation of Index Treatment up to Month 12 Per Type of Combination Treatment Palbociclib + Fulvestrant	71 Participants

PRIMARY outcome

Number of participants who died following index treatment up to Month 24 were reported. Index treatment is palbociclib combination treatment.

Outcome measures

Outcome measures
Measure	Palbociclib n=559 Participants 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.
Number of Participants Who Died Following Initiation of Index Treatment up to Month 24 Per Type of Combination Treatment Palbociclib + AI	58 Participants
Number of Participants Who Died Following Initiation of Index Treatment up to Month 24 Per Type of Combination Treatment Palbociclib + Fulvestrant	119 Participants

PRIMARY outcome

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Palbociclib n=466 Participants 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.
Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 6 Per Type of Combination Treatment Palbociclib + AI · Advanced	207 Participants
Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 6 Per Type of Combination Treatment Palbociclib + AI · Did not advance	17 Participants
Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 6 Per Type of Combination Treatment Palbociclib + Fulvestrant · Advanced	230 Participants
Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 6 Per Type of Combination Treatment Palbociclib + Fulvestrant · Did not advance	12 Participants

PRIMARY outcome

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.

Outcome measures

Outcome measures
Measure	Palbociclib n=466 Participants 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.
Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 12 Per Type of Combination Treatment Palbociclib + AI · Advanced	219 Participants
Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 12 Per Type of Combination Treatment Palbociclib + AI · Did not advance	5 Participants
Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 12 Per Type of Combination Treatment Palbociclib + Fulvestrant · Advanced	239 Participants
Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 12 Per Type of Combination Treatment Palbociclib + Fulvestrant · Did not advance	3 Participants

PRIMARY outcome

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.

Outcome measures

Outcome measures
Measure	Palbociclib n=466 Participants 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.
Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 24 Per Type of Combination Treatment Palbociclib + AI · Advanced	223 Participants
Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 24 Per Type of Combination Treatment Palbociclib + AI · Did not advance	1 Participants
Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 24 Per Type of Combination Treatment Palbociclib + Fulvestrant · Advanced	242 Participants
Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 24 Per Type of Combination Treatment Palbociclib + Fulvestrant · Did not advance	0 Participants

PRIMARY outcome

Timeframe: 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 chemotherapy was the duration from end of index treatment up to start of chemotherapy. Index treatment is palbociclib combination treatment.

Outcome measures

Outcome measures
Measure	Palbociclib n=116 Participants 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.
Time to Initiation of Chemotherapy After Cessation of Initial Palbociclib Therapy Per Type of Combination Treatment Palbociclib + AI	0.79 Months Interval 0.59 to 1.51
Time to Initiation of Chemotherapy After Cessation of Initial Palbociclib Therapy Per Type of Combination Treatment Palbociclib + Fulvestrant	0.92 Months Interval 0.79 to 1.118

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Palbociclib n=559 Participants 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.
Time to Initiation of Next Treatment (TTNT) From Initiation of Palbociclib Treatment Per Type of Combination Treatment Palbociclib + AI	34.5 Months Interval 27.2 to 51.6
Time to Initiation of Next Treatment (TTNT) From Initiation of Palbociclib Treatment Per Type of Combination Treatment Palbociclib + Fulvestrant	16.4 Months Interval 13.3 to 18.1

Adverse Events

Palbociclib

Serious events: 0 serious events

Other events: 0 other events

Deaths: 269 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER