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

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

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.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer

• Study Type: Observational
• Enrollment (Actual): 975

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10017
      • Pfizer United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Breast Cancer Patients; HR + /HER2- Advanced/Metastatic Breast Cancer patients in U.S.A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
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.	From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
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)	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.	From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
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	From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
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.	From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
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.	From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
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)	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.	From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
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)

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2019
• Primary Completion (Actual): May 31, 2020
• Study Completion (Actual): May 31, 2020

Study Registration Dates

• First Submitted: April 28, 2020
• First Submitted That Met QC Criteria: May 18, 2020
• First Posted (Actual): May 20, 2020

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: March 31, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: A5481144; CONCERTO (Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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.