Clinical trial NCT04396626: HR+/ HER2- Advanced/ Metastatic Breast Cancer Real World Treatment Patterns and Outcomes
Official title: Patient Characteristics, Treatment Patterns, and Clinical Outcomes in Patients Diagnosed With HR+/HER2- Advanced/Metastatic Breast Cancer Receiving CDK4/6i + Aromatase Inhibitor (AI) Combination Therapy as Initial Endocrine-based Treatment
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-05-20
Enrollment: 975
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include adult patients 18 years or older, diagnosed with HR+/HER2- A/MBC who initiated CDK4/6i combination therapy with AI as the initial endocrine-based therapy on or after 2/3/2015 and before 4/1/2019.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Different Type of Treatment Regimens
timeFrame: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
measure: Number of Participants Who Received Different Treatment Sequence Across Lines
timeFrame: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
measure: Number of Participants With Start and End Dose of CDK4/6 Inhibitors
timeFrame: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
measure: Duration of Treatment of CDK4/6 Inhibitors
timeFrame: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
measure: Number of Participants With Reason for Treatment Discontinuation of CDK4/6 Inhibitors
timeFrame: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
measure: Time to Dose Discontinuation of CDK4/6 Inhibitors
timeFrame: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
measure: Number of Participants With Type of Dose Adjustments of CDK4/6 Inhibitors
timeFrame: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
measure: Time to First Dose Adjustment of CDK4/6 Inhibitors
timeFrame: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
measure: Real Progression Free Survival (rwPFS)
timeFrame: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
measure: Overall Survival (OS)
timeFrame: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
measure: Real-World Tumor Response (rwTR)
timeFrame: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
measure: Percentage of Participants With Complete Response (CR) or Partial Response (PR)
timeFrame: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
measure: Time to First Positive Response
timeFrame: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
measure: Duration of Response (DOR)
timeFrame: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
measure: Duration of Initial Endocrine-based Treatment
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)
measure: Duration of Treatment
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)
measure: Duration of Follow-up
timeFrame: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Pfizer United States
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: