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Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)

Last updated on March 14, 2019

FOR MORE INFORMATION
Study Location
University of Alabama at Birmingham, The Kirklin Clinic
Birmingham, Alabama, 35233 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Metastatic Breast Cancer
Sex
Female
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.
Show details

- Women 18 years or older with metastatic or locally advanced disease, not amenable to
curative therapy

- Confirmed diagnosis of HR+/HER2- breast cancer

- Any menopausal status

- Progressed within 12 months from prior adjuvant or progressed within 1 month from
prior advanced/metastatic endocrine breast cancer therapy

- On an LHRH agonist for at least 28 days, if pre-/peri-menopausal, and willing to
switch to goserelin (Zoladex ®) at time of randomization.

- Measurable disease defined by RECIST version 1.1, or bone-only disease

- Eastern Cooperative Oncology Group (ECOG) PS 0-1

- Adequate organ and marrow function, resolution of all toxic effects of prior therapy
or surgical procedures

- Patient must agree to provide tumor tissue from metastatic tissue at baseline

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Prior treatment with any CDK inhibitor, fulvestrant, everolimus, or agent that
inhibits the PI3K-mTOR pathway

- Patients with extensive advanced/metastatic, symptomatic visceral disease, or known
uncontrolled or symptomatic CNS metastases

- Major surgery or any anti-cancer therapy within 2 weeks of randomization

- Prior stem cell or bone marrow transplantation

- Use of potent CYP3A4 inhibitors or inducers

NCT01942135
Pfizer
Active, not recruiting
Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)

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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