Breast Cancer
Conditions
Brief summary
This is a retrospective, observational study that will document the treatment patterns and clinical outcomes of patients diagnosed with HR+/HER2- A/MBC who received CDK4/6i combination therapy with aromatase inhibitors (AI) as the initial endocrine-based therapy in the A/MBC setting.
Interventions
None listed
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Female or male sex. 2. Diagnosis (confirmed by clinical review) of A/MBC, defined as breast cancer at stage IIIB, stage IIIC, stage IV or identified as having distant metastasis. 3. Age ≥18 years at A/MBC diagnosis. 4. Initiated a CDK4/6i in combination with an AI as initial endocrine-based therapy after A/MBC diagnosis on or after 2/3/2015 and before 4/1/2019. •Note that the date of the start of the inclusion period reflects the month that the first CDK4/6i (ie, Palbociclib) received U.S. FDA approval. 5. Evidence of ER or PR positive disease, or absence of any indication of ER and PR negative disease closest to A/MBC diagnosis (ie, patients are eligible without affirmative indication of ER/PR+ status as long as ER/PR- indication is not present). 6. Evidence of HER2 negative disease, or absence of any indication of HER2 positive disease closest to A/MBC diagnosis (ie, patients are eligible without affirmative indication of HER2- status as long as HER2+ indication is not present).
Exclusion criteria
1\. Enrollment in an interventional clinical trial for A/MBC during the study observation period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Different Type of Treatment Regimens | From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period) | Treatment regimen was defined as one or more anti-cancer agents given in combination, over a period of time. |
| Number of Participants Who Received Different Treatment Sequence Across Lines | From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period) | 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. |
| Number of Participants With Start and End Dose of CDK4/6 Inhibitors | From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period) | — |
| Duration of Treatment of CDK4/6 Inhibitors | From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period) | — |
| Number of Participants With Reason for Treatment Discontinuation of CDK4/6 Inhibitors | From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period) | — |
| Time to Dose Discontinuation of CDK4/6 Inhibitors | From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period) | — |
| Number of Participants With Type of Dose Adjustments of CDK4/6 Inhibitors | From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period) | — |
| Time to First Dose Adjustment of CDK4/6 Inhibitors | From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period) | — |
| Real Progression Free Survival (rwPFS) | From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period) | 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. |
| Overall Survival (OS) | From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period) | 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 |
| Real-World Tumor Response (rwTR) | From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period) | 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. |
| Percentage of Participants With Complete Response (CR) or Partial Response (PR) | From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period) | 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. |
| Time to First Positive Response | From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period) | — |
| Duration of Response (DOR) | From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period) | 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. |
| Duration of Initial Endocrine-based Treatment | 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) | — |
| Duration of Treatment | 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) | — |
| Duration of Follow-up | From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period) | — |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 as part of their routine clinical treatment, was to be accrued from the Concerto Health AI Definitive Oncology Dataset, during this retrospective observational study. | 975 |
| Total | 975 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Premature termination of study | 975 |
Baseline characteristics
| Characteristic | Cyclin-dependent Kinase 4/6 Inhibitor (CDK4/6i) + Aromatase Inhibitor (AI) | — |
|---|---|---|
| Age, Continuous | 63.78 Years STANDARD_DEVIATION 11.79 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 973 Participants | — |
| Sex: Female, Male Male | 2 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Duration of Follow-up
Time frame: 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.
Primary
Duration of Initial Endocrine-based Treatment
Time frame: 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.
Primary
Duration of Response (DOR)
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.
Time frame: 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.
Primary
Duration of Treatment
Time frame: 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.
Primary
Duration of Treatment of CDK4/6 Inhibitors
Time frame: 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.
Primary
Number of Participants Who Received Different Treatment Sequence Across Lines
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.
Time frame: 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.
Primary
Number of Participants With Different Type of Treatment Regimens
Treatment regimen was defined as one or more anti-cancer agents given in combination, over a period of time.
Time frame: 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.
Primary
Number of Participants With Reason for Treatment Discontinuation of CDK4/6 Inhibitors
Time frame: 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.
Primary
Number of Participants With Start and End Dose of CDK4/6 Inhibitors
Time frame: 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.
Primary
Number of Participants With Type of Dose Adjustments of CDK4/6 Inhibitors
Time frame: 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.
Primary
Overall Survival (OS)
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
Time frame: 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.
Primary
Percentage of Participants With Complete Response (CR) or Partial Response (PR)
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.
Time frame: 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.
Primary
Real Progression Free Survival (rwPFS)
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.
Time frame: 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.
Primary
Real-World Tumor Response (rwTR)
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.
Time frame: 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.
Primary
Time to Dose Discontinuation of CDK4/6 Inhibitors
Time frame: 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.
Primary
Time to First Dose Adjustment of CDK4/6 Inhibitors
Time frame: 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.
Primary
Time to First Positive Response
Time frame: 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.