HR+/ HER2- Advanced/ Metastatic Breast Cancer Real World Treatment Patterns and Outcomes

• ClinicalTrials.gov Identifier: NCT04396626
• Recruitment Status: Active, not recruiting
• First Posted: May 20, 2020
• Last Update Posted: May 20, 2020
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: April 28, 2020
• First Posted Date: May 20, 2020
• Last Update Posted Date: May 20, 2020
• Actual Study Start Date: November 18, 2019
• Estimated Primary Completion Date: September 30, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 18, 2020)

• Proportion of patients receiving various cancer treatment regimens [ Time Frame: A/MBC diagnosis through end of study (assessed up to 36 months) ]
• Proportion of patients receiving each therapy sequence across lines [ Time Frame: A/MBC diagnosis through end of study (assessed up to 36 months) ]
• Proportion of patients receiving each starting dose and end dose for those on CDK4/6i combination therapy [ Time Frame: A/MBC diagnosis through end of study (assessed up to 36 months) ]
• Proportion of patients that experience dose adjustment [ Time Frame: A/MBC diagnosis through end of study (assessed up to 36 months) ]
• Proportion of patients that discontinue therapy [ Time Frame: A/MBC diagnosis through end of study (assessed up to 36 months) ]
• Real-world progression-free survival (rwPFS) [ Time Frame: A/MBC diagnosis through end of study (assessed up to 36 months) ]
  Defined as the time from the index date to disease progression, death, or end of record or end of data availability, whichever comes first.
• Overall survival (OS) [ Time Frame: A/MBC diagnosis through end of study (assessed up to 36 months) ]
  Overall survival is defined as the time between the index date to disease progression, death due to any cause or end of data availability, whichever comes first.
• Real-world tumor response (rwTR) [ Time Frame: A/MBC diagnosis through end of study (assessed up to 36 months) ]
  Best overall response for each regimen

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.
• Condition: Breast Cancer
• Intervention: Not Provided

Study Groups/Cohorts

Breast Cancer Patients

HR + /HER2- Advanced/Metastatic Breast Cancer patients in U.S.A

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: May 18, 2020): 1
• Original Actual Enrollment: Same as current
• Estimated Study Completion Date: September 30, 2020
• Estimated Primary Completion Date: September 30, 2020 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04396626
• Other Study ID Numbers: A5481144; Concerto ( Other Identifier: Alias Study Number )
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: May 2020