Palbociclib in Real World Practice

  • STATUS
    Recruiting
  • End date
    Jan 27, 2022
  • participants needed
    1500
  • sponsor
    Pfizer
Updated on 1 June 2021
Investigator
Pfizer CT.gov Call Center
Primary Contact
Contra Costa Oncology (2.2 mi away) Contact
+298 other location
breast cancer
metastasis
advanced breast cancer
adenocarcinoma
palbociclib
breast adenocarcinoma

Summary

This Non-Interventional Study will describe and analyze the clinical use of palbociclib in routine clinical practice in the treatment of advanced breast cancer.

Details
Condition Advanced Breast Cancer, Metastatic Breast Cancer, Stage IV Breast Cancer
Treatment Non-interventional
Clinical Study IdentifierNCT03280303
SponsorPfizer
Last Modified on1 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 years or older
Diagnosis of adenocarcinoma of the breast with evidence of metastatic disease or advanced disease not amenable to treatment with curative intent
Documented HR+ (ER+ and/or PR+) tumor based on local standards
Documented HER2- tumor based on local standards
Physician has determined that treatment with palbociclib is indicated
Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study
Patients who in the opinion of the investigator are willing and able to comply with regular clinic visits as per standard of care practice at the site

Exclusion Criteria

Patients with a life expectancy of less than 3 months at the time of ABC diagnosis, per the investigator's judgment
Patients participating in any interventional clinical trial that includes investigational or marketed products at the time of enrollment. (Patients participating in other investigator initiated research or NIS can be included as long as their standard of care is not altered by the study)
Patients on active treatment for malignancies other than ABC at the time of enrollment
Patients who are unable to understand the nature of the study and are unwilling to sign an informed consent
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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