Trial Outcomes & Findings for HR+/ HER2- Advanced/ Metastatic Breast Cancer Real World Treatment Patterns and Outcomes (NCT NCT04396626)
NCT ID: NCT04396626
Last Updated: 2023-04-27
Results Overview
Treatment regimen was defined as one or more anti-cancer agents given in combination, over a period of time.
TERMINATED
975 participants
From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
2023-04-27
Participant Flow
Data for this study was not collected as study was prematurely discontinued due to significant data quality issues. There were no safety concerns that led to the decision to terminate.
Participant milestones
| Measure |
Cyclin-dependent Kinase 4/6 Inhibitor (CDK4/6i) + Aromatase Inhibitor (AI)
Data for participants who received CDK4/6i along with AI as initial endocrine-based therapy for advanced and metastatic breast cancer (A/MBC) as part of their routine clinical treatment, was to be accrued from the Concerto Health AI Definitive Oncology Dataset, during this retrospective observational study.
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|---|---|
|
Overall Study
STARTED
|
975
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
975
|
Reasons for withdrawal
| Measure |
Cyclin-dependent Kinase 4/6 Inhibitor (CDK4/6i) + Aromatase Inhibitor (AI)
Data for participants who received CDK4/6i along with AI as initial endocrine-based therapy for advanced and metastatic breast cancer (A/MBC) as part of their routine clinical treatment, was to be accrued from the Concerto Health AI Definitive Oncology Dataset, during this retrospective observational study.
|
|---|---|
|
Overall Study
Premature termination of study
|
975
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Cyclin-dependent Kinase 4/6 Inhibitor (CDK4/6i) + Aromatase Inhibitor (AI)
n=975 Participants
Data for participants who received CDK4/6i along with AI as initial endocrine-based therapy for advanced and metastatic breast cancer as part of their routine clinical treatment, was to be accrued from the Concerto Health AI Definitive Oncology Dataset, during this retrospective observational study.
|
|---|---|
|
Age, Continuous
|
63.78 Years
STANDARD_DEVIATION 11.79 • n=975 Participants
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Sex: Female, Male
Female
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973 Participants
n=975 Participants
|
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Sex: Female, Male
Male
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2 Participants
n=975 Participants
|
PRIMARY outcome
Timeframe: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)Population: Data for this study was not collected as study was prematurely discontinued due to significant data quality issues. There were no safety concerns that led to the decision to terminate.
Treatment regimen was defined as one or more anti-cancer agents given in combination, over a period of time.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)Population: Data for this study was not collected as study was prematurely discontinued due to significant data quality issues. There were no safety concerns that led to the decision to terminate.
Lines of therapy was defined as the following progression-based lines, in which a disease progression must occur for a new regimen to be interpreted as a new line of therapy. Disease progression was taken to have occurred when a pathology report or radiological scan indicated disease progression and/or there was a physician progress note consistent with that determination.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)Population: Data for this study was not collected as study was prematurely discontinued due to significant data quality issues. There were no safety concerns that led to the decision to terminate.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)Population: Data for this study was not collected as study was prematurely discontinued due to significant data quality issues. There were no safety concerns that led to the decision to terminate.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)Population: Data for this study was not collected as study was prematurely discontinued due to significant data quality issues. There were no safety concerns that led to the decision to terminate.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)Population: Data for this study was not collected as study was prematurely discontinued due to significant data quality issues. There were no safety concerns that led to the decision to terminate.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)Population: Data for this study was not collected as study was prematurely discontinued due to significant data quality issues. There were no safety concerns that led to the decision to terminate.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)Population: Data for this study was not collected as study was prematurely discontinued due to significant data quality issues. There were no safety concerns that led to the decision to terminate.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)Population: Data for this study was not collected as study was prematurely discontinued due to significant data quality issues. There were no safety concerns that led to the decision to terminate.
rwPFS was defined as the time from the index date to disease progression, death, or end of record or end of data availability, whichever comes first. Index date was defined as the date of A/MBC diagnosis. Disease progression was taken to have occurred when a pathology report or radiological scan indicated disease progression and/or there was a physician progress note consistent with that determination.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)Population: Data for this study was not collected as study was prematurely discontinued due to significant data quality issues. There were no safety concerns that led to the decision to terminate.
OS was defined as the time between the index date to disease progression, death due to any cause or end of data availability, whichever comes first. Index date was defined as the date of A/MBC diagnosis. Disease progression was taken to have occurred when a pathology report or radiological scan indicated disease progression and/or there was a physician progress note consistent with that determination
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)Population: Data for this study was not collected as study was prematurely discontinued due to significant data quality issues. There were no safety concerns that led to the decision to terminate.
rwTR was defined as the best overall response for each regimen. Responses were classified as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), not evaluable (NE), or undocumented. The date of the first positive response (CR or PR) and of the best overall response for each regimen was collected. CR: Complete resolution of all visible disease. PR: Partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease. SD: no change in size of visible disease. PD: Disease progression was taken to have occurred when a pathology report or radiological scan indicated disease progression and/or there was a physician progress note consistent with that determination.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)Population: Data for this study was not collected as study was prematurely discontinued due to significant data quality issues. There were no safety concerns that led to the decision to terminate.
CR: Complete resolution of all visible disease. PR: Partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)Population: Data for this study was not collected as study was prematurely discontinued due to significant data quality issues. There were no safety concerns that led to the decision to terminate.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)Population: Data for this study was not collected as study was prematurely discontinued due to significant data quality issues. There were no safety concerns that led to the decision to terminate.
DOR: time from first documented occurrence of response (CR or PR) until date of first documented PD or death due to underlying cancer. Participants without a PD assessment or death were censored at the data cutoff date. CR: Complete resolution of all visible disease. PR: Partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease. PD: Disease progression was taken to have occurred when a pathology report or radiological scan indicated disease progression and/or there was a physician progress note consistent with that determination.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: From the start date of the initial endocrine-based therapy to the end date of the initial endocrine-based therapy (during 15 months of retrospective observation period)Population: Data for this study was not collected as study was prematurely discontinued due to significant data quality issues. There were no safety concerns that led to the decision to terminate.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: From the start date of the initial endocrine-based therapy to the end date of the initial endocrine-based therapy (during 15 months of retrospective observation period)Population: Data for this study was not collected as study was prematurely discontinued due to significant data quality issues. There were no safety concerns that led to the decision to terminate.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)Population: Data for this study was not collected as study was prematurely discontinued due to significant data quality issues. There were no safety concerns that led to the decision to terminate.
Outcome measures
Outcome data not reported
Adverse Events
Cyclin-dependent Kinase 4/6 Inhibitor (CDK4/6i) + Aromatase Inhibitor (AI)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
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