Trial Outcomes & Findings for A Real-life Study to Learn About the Use and Effects of the CDK4/6 Inhibitors in Canadian Patients With Breast Cancer. (NCT NCT05770713)

Last Updated: 2024-07-22

Results Overview

Number of participants according to the treatment patterns for first line, second line and third line were reported in this outcome measure. CDK4/6i included abemaciclib, palbociclib and ribociclib. Endocrine therapy (ET) included anastrozole, exemestane, fulvestrant, letrozole and tamoxifen. Chemotherapy included capecitabine, cisplatin, cyclophosphamide, docetaxel, doxorubicin, eribulin, gemcitabine and paclitaxel.

Recruitment status

COMPLETED

Target enrollment

48 participants

Primary outcome timeframe

From date of ABC/MBC diagnosis until date of death, date of last follow-up or the end of the study period, whichever came first (maximum follow-up of 67.6 months); available data evaluated over approximately 4.5 months of this retrospective study

Results posted on

2024-07-22

Participant Flow

Participants diagnosed with hormone receptor-positive (HR+) and human epidermal growth factor receptor 2 negative (HER2)- advanced/metastatic breast cancer (ABC/MBC) between 01-Jan-2016 to 01-Jul-2021 and received a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) at Sinai Health were included in this retrospective study. Data were extracted from electronic health records until 01-Oct-2021. Available data was evaluated from 12-Oct-2022 to 28-Feb-2023 (approximately 4.5 months).

A total of 48 female participants were included in this study.

Participant milestones

Participant milestones
Measure	HR+/HER2- ABC/MBC Participants Participants with HR+/HER2- advanced/metastatic breast cancer who received treatment with CDK4/6 inhibitors) at Sinai Health between 01-Jan-2016 to 01-Oct-2021 were observed in this retrospective study.
Overall Study STARTED	48
Overall Study COMPLETED	48
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	HR+/HER2- ABC/MBC Participants n=48 Participants Participants with HR+/HER2- advanced/metastatic breast cancer who received treatment with CDK4/6 inhibitors) at Sinai Health between 01-Jan-2016 to 01-Oct-2021 were observed in this retrospective study.
Age, Continuous	57.9 Years STANDARD_DEVIATION 14.0 • n=48 Participants
Sex: Female, Male Female	48 Participants n=48 Participants
Sex: Female, Male Male	0 Participants n=48 Participants

PRIMARY outcome

Timeframe: From date of ABC/MBC diagnosis until date of death, date of last follow-up or the end of the study period, whichever came first (maximum follow-up of 67.6 months); available data evaluated over approximately 4.5 months of this retrospective study

Population: Analysis population included all eligible participants whose data were retrieved and observed in the study. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows.

Outcome measures

Outcome measures
Measure	HR+/HER2- ABC/MBC Participants n=48 Participants Participants with HR+/HER2- advanced/metastatic breast cancer who received treatment with CDK4/6 inhibitors) at Sinai Health between 01-Jan-2016 to 01-Oct-2021 were observed in this retrospective study.
Number of Participants Classified According to Treatment Pattern 1st line: Palbociclib + ET	30 Participants
Number of Participants Classified According to Treatment Pattern 1st line: Palbociclib + ET + goserelin	NA Participants Data was not reported for observations including \<=5 participants in accordance with hospital data privacy regulations in place at Sinai Health.
Number of Participants Classified According to Treatment Pattern 1st line: Other CDK 4/6i + ET	NA Participants Data was not reported for observations including \<=5 participants in accordance with hospital data privacy regulations in place at Sinai Health.
Number of Participants Classified According to Treatment Pattern 2nd line: Other CDK 4/6i + ET	7 Participants
Number of Participants Classified According to Treatment Pattern 3rd line: Palbociclib + ET + goserelin	NA Participants Data was not reported for observations including \<=5 participants in accordance with hospital data privacy regulations in place at Sinai Health.
Number of Participants Classified According to Treatment Pattern 3rd line: Other CDK 4/6i	NA Participants Data was not reported for observations including \<=5 participants in accordance with hospital data privacy regulations in place at Sinai Health.
Number of Participants Classified According to Treatment Pattern 3rd line: Chemotherapy	10 Participants
Number of Participants Classified According to Treatment Pattern 1st line: Other CDK 4/6i + ET + goserelin	NA Participants Data was not reported for observations including \<=5 participants in accordance with hospital data privacy regulations in place at Sinai Health.
Number of Participants Classified According to Treatment Pattern 1st line: ET	NA Participants Data was not reported for observations including \<=5 participants in accordance with hospital data privacy regulations in place at Sinai Health.
Number of Participants Classified According to Treatment Pattern 1st line: Chemotherapy	7 Participants
Number of Participants Classified According to Treatment Pattern 2nd line: Palbociclib + ET	NA Participants Data was not reported for observations including \<=5 participants in accordance with hospital data privacy regulations in place at Sinai Health.
Number of Participants Classified According to Treatment Pattern 2nd line: Palbociclib + ET + goserelin	NA Participants Data was not reported for observations including \<=5 participants in accordance with hospital data privacy regulations in place at Sinai Health.
Number of Participants Classified According to Treatment Pattern 2nd line: Other CDK 4/6i + ET + goserelin	NA Participants Data was not reported for observations including \<=5 participants in accordance with hospital data privacy regulations in place at Sinai Health.
Number of Participants Classified According to Treatment Pattern 2nd line: Alpelisib + ET	NA Participants Data was not reported for observations including \<=5 participants in accordance with hospital data privacy regulations in place at Sinai Health.
Number of Participants Classified According to Treatment Pattern 2nd line: ET	NA Participants Data was not reported for observations including \<=5 participants in accordance with hospital data privacy regulations in place at Sinai Health.
Number of Participants Classified According to Treatment Pattern 2nd line: Chemotherapy	6 Participants

SECONDARY outcome

Timeframe: From date of ABC/MBC diagnosis until introduction of CDK 4/6 inhibitor(anytime between Jan 2016 to May 2016, approximately 4 months); available data evaluated over approximately 4.5 months of this retrospective study

Population: Analysis population included all eligible participants whose data were retrieved and observed in the study. Here "Overall Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	HR+/HER2- ABC/MBC Participants n=1 Participants Participants with HR+/HER2- advanced/metastatic breast cancer who received treatment with CDK4/6 inhibitors) at Sinai Health between 01-Jan-2016 to 01-Oct-2021 were observed in this retrospective study.
Number of Participants Classified According to Type of Treatment Before Introduction of CDK4/6 Inhibitor	NA Participants Data was not estimated to protect privacy in accordance with hospital data privacy regulations in place at Sinai Health.

SECONDARY outcome

Timeframe: From date of introduction of CDK4/6 inhibitor until date of death, date of last follow-up or the end of the study period, whichever came first (approximately 33 months); available data evaluated over approximately 4.5 months of this retrospective study

Outcome measures

Outcome measures
Measure	HR+/HER2- ABC/MBC Participants n=8 Participants Participants with HR+/HER2- advanced/metastatic breast cancer who received treatment with CDK4/6 inhibitors) at Sinai Health between 01-Jan-2016 to 01-Oct-2021 were observed in this retrospective study.
Number of Participants Classified According to Type of Treatment After Introduction of CDK4/6 Inhibitor	NA Participants Data was not reported for observations including \<=5 participants in accordance with hospital data privacy regulations in place at Sinai Health.

Adverse Events

HR+/HER2- ABC/MBC Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 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 publication 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