Clinical trial NCT04460898: RW Treatment Patterns and Outcomes in Postmenopausal HR+/HER2- mBC Patients Treated With Palbociclib Plus Letrozole as Initial Endocrine Therapy at Community Oncology Practices in the U.S.
Official title: Real-World Treatment Patterns and Outcomes in Postmenopausal, Hormone-Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative, Metastatic Breast Cancer Patients Treated With Palbociclib Plus an Letrozole as Initial Endocrine Therapy at Community Oncology Practices in the U.S.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-07-08
Enrollment: 195
Sex: FEMALE
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 aged 18 years and older, diagnosed with HR+/HER2- mBC and received treatment with Palbociclib in combination with letrozole as initial endocrine-therapy for advanced/metastatic breast cancer.

Brief summary: This is a retrospective, observational study that will document treatment patterns and clinical outcomes of postmenopausal patients diagnosed with HR+/HER2- mBC who received Palbociclib plus Letrozole as initial endocrine-based therapy in US community oncology network settings.


Eligibility criteria: Inclusion Criteria:

* Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

  1. Diagnosed with locoregional recurrent or metastatic female breast cancer.
  2. Pathologically confirmed HR-positive/HER2-negative diagnosis.
  3. Received treatment with palbociclib in combination with letrozole as initial endocrine-based therapy for advanced/metastatic breast cancer:

     1. Initiated treatment with palbociclib at least 3 months following the provider's first use of palbociclib following its FDA approval.
     2. At least 1 month of follow-up (at least one visit with the provider) after initiation of palbociclib.
  4. Postmenopausal (or receiving surgical or medical treatment to induce menopause) at the time of initiation of palbociclib.
  5. ≥18 year old at initiation of palbociclib.

     Exclusion Criteria:
* No exclusion criteria will be imposed for the selection of patients.

Primary outcomes:
measure: Number of Participants According to Year of Initial Diagnosis of Breast Cancer
timeFrame: Baseline during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
measure: Number of Participants With American Joint Committee on Cancer (AJCC) Stage Status
timeFrame: Baseline during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
measure: Number of Participants With Node Status
timeFrame: Baseline during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
measure: Number of Participants With Menopausal Status
timeFrame: Baseline during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
measure: Number of Participants With Type of Metastatic Disease
timeFrame: Baseline during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
measure: Number of Participants With Sites of Metastatic Disease
timeFrame: Baseline during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
measure: Number of Participants With Total Number of Metastatic Sites
timeFrame: Baseline during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
measure: Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG-PS) at the Time of Initiation of First-line Treatment
timeFrame: Pre-dose on Day 1 of treatment during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
measure: Number of Participants With Comorbidities at the Time of Initiation of First-line Treatment
timeFrame: Pre-dose on Day 1 of treatment during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
measure: Charlson Comorbidity Index (CCI) Score
timeFrame: Day 1 of treatment during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
measure: Number of Participants Who Received Chemotherapy (Neo/Adjuvant) and Hormonal Therapy
timeFrame: Baseline during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
measure: Duration of Adjuvant Therapy
timeFrame: Baseline during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
measure: Time From Discontinuation of Adjuvant Therapy to Initiation of First-line Treatment
timeFrame: Baseline during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
measure: Number of Participants With Different Initial Palbociclib Dose
timeFrame: Day 1 of treatment during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
measure: Total Number of Treatment Cycles Received
timeFrame: From first-line treatment up to the discontinuation of initial treatment of metastatic breast cancer during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
measure: Number of Participants With Dose Reductions
timeFrame: From start to end of treatment during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
measure: Number of Participants With Increased Dose Patterns
timeFrame: From start to end of treatment during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
measure: Number of Participants With Any Treatment Interruptions
timeFrame: From start to end of treatment during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
measure: Frequency of CBC Testing During First Cycle of Treatment
timeFrame: During first cycle of first line treatment during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
measure: Frequency of Electrolyte Testing During First Cycle of First Line Treatment
timeFrame: During first cycle of first line treatment during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
measure: Frequency of Liver Function Testing During First Cycle of First Line Treatment
timeFrame: During first cycle of first line treatment during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
measure: Percentage of Participants With Progression Free Survival (PFS) at Month 6
timeFrame: Month 6 during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
measure: Percentage of Participants With Progression Free Survival (PFS) at Month 12
timeFrame: Month 12 during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
measure: Percentage of Participants With Progression Free Survival (PFS) at Month 18
timeFrame: Month 18 during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
measure: Percentage of Participants With Progression Free Survival (PFS) at Month 24
timeFrame: Month 24 during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
measure: Overall Survival (OS)
timeFrame: From initiation of treatment up to death during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
measure: Percentage of Participants With Clinical Benefit Rate (CBR)
timeFrame: From initiation of treatment up to CR and PR and SD during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
measure: Objective Response Rate (ORR)
timeFrame: From initiation of treatment up to CR and PR and SD during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
measure: Number of Participants With Stable Disease Lasting Greater Than (>) 24 Weeks
timeFrame: From initiation of treatment up to end of treatment during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
measure: Number of Participants Who Received Drug Regimen Post Discontinuation of Initial Endocrine-Based Therapy
timeFrame: Post discontinuation of initial endocrine-based therapy during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
measure: Duration of Discontinued Therapy
timeFrame: Up to 24 months after palbociclib treatment initiation during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
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: