Skip to main content
OpenTrials
Completed

NCT Number: NCT04498481

TREATMENT AND MONITORING PATTERNS AND CLINICAL OUTCOMES IN PATIENTS RECEIVING PALBOCICLIB COMBINATION TREATMENT (WITH AI OR FULVESTRANT) FOR HR+/HER2- A/MBC IN A COMMUNITY ONCOLOGY SETTING.

This is a retrospective, observational study that will document the treatment and monitoring patterns and clinical outcomes of patients diagnosed with HR+/HER2- a/mBC who received Palbociclib combination therapy with aromatase inhibitors or fulvestrant in the a/mBC community oncology setting.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Pfizer United States

New York, 10017, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients who are represented in the Vector Oncology Data Warehouse who meet all of the following criteria will be eligible for inclusion in the study.

  • Female.
  • Diagnosis of female breast cancer with evidence of metastatic disease or advanced disease.
  • Diagnosis (confirmed by clinical review) of advanced or metastatic breast cancer at any time, defined as breast cancer at stage IIIb, stage IIIc, or stage IV or identified as having distant metastasis.
  • Indication in the record of ER or PR positive disease, or absence of any indication of ER and PR negative disease (ie, patients are eligible without affirmative indication of ER/PR+ status as long as ER/PR- indication is not present).
  • Receipt of a palbociclib plus aromatase inhibitor (AI) or palbociclib plus fulvestrant regimen on 2/3/2015 or later in the advanced and metastatic setting. Data collection will prioritize accrual of patients with 1L use of palbociclib plus AI and with 2L use of palbociclib plus fulvestrant before collecting other use of palbociclib users.
  • Age greater than or equal to 18 years at A/MBC diagnosis.

Exclusion criteria

-There are no exclusion criteria for this study.

Treatment and study plan

Primary outcomes

  1. Proportion of patients receiving various cancer treatment regimens

    Time frame: A/MBC diagnosis through end of study (assessed up to 24 months)

  2. Proportion of patients receiving each therapy sequence across lines

    Time frame: A/MBC diagnosis through end of study (assessed up to 24 months)

  3. Treatment persistence

    Time frame: A/MBC diagnosis through end of study (assessed up to 24 months)

  4. Progression Free Survival (PFS)

    Time frame: A/MBC diagnosis through end of study (assessed up to 24 months)

  5. Overall Survival (OS)

    Time frame: A/MBC diagnosis through end of study (assessed up to 24 months)

  6. Tumor response rate

    Time frame: A/MBC diagnosis through end of study (assessed up to 24 months)

  7. Proportion of patients that experience dose adjustment

    Time frame: A/MBC diagnosis through end of study (assessed up to 24 months)

  8. Proportion of patients who discontinue therapy

    Time frame: A/MBC diagnosis through end of study (assessed up to 24 months)

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

TREATMENT AND MONITORING PATTERNS AND CLINICAL OUTCOMES IN PATIENTS RECEIVING PALBOCICLIB PLUS AROMATASE INHIBITOR OR PALBOCICLIB PLUS FULVESTRANT AS TREATMENT OF HORMONE RECEPTOR POSITIVE (HR+)/HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 NEGATIVE (HER2-) ADVANCED OR METASTATIC BREAST CANCER IN A REAL WORLD COMMUNITY ONCOLOGY SETTING

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 4, 2020
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.