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Palbociclib in Real World Practice

Last updated on March 21, 2019

FOR MORE INFORMATION
Study Location
New England Hematology Oncology/Massachusetts General Cancer Center at Newton Wellesley Hospital
Newton, Massachusetts, 02462 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Advanced Breast Cancer, Metastatic Breast Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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1. Age ≥18 years or older.

2. Diagnosis of adenocarcinoma of the breast with evidence of metastatic disease or
advanced disease not amenable to treatment with curative intent.

3. Documented HR+ (ER+ and/or PR+) tumor based on local standards.

4. Documented HER2- tumor based on local standards.

5. Physician has determined that treatment with palbociclib is indicated.

6. Evidence of a personally signed and dated informed consent document indicating that
the patient has been informed of all pertinent aspects of the study.

7. 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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1. Patients with a life expectancy of less than 3 months at the time of ABC diagnosis,
per the investigator's judgment.

2. 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).

3. Patients on active treatment for malignancies other than ABC at the time of
enrollment.

4. Patients who are unable to understand the nature of the study and are unwilling to
sign an informed consent.

NCT03280303
Pfizer
Recruiting
Palbociclib in Real World Practice

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now