Palbociclib In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR+, HER2- Advanced Breast Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

252 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-09

Study Completion Date

2019-07-25

Brief Summary

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A study of palbociclib in combination with letrozole as treatment of post-menopausal women with hormone receptor-positive, her2-negative advanced breast cancer for whom letrozole therapy is deemed appropriate.

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Detailed Description

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To provide access to palbociclib to post-menopausal patients with hormone receptor-positive \[HR(+)\], HER2-negative \[HER2(-)\] ABC who are deemed appropriate for letrozole therapy.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental arm

Palbociclib plus Letrozole

Group Type EXPERIMENTAL

Palbociclib

Intervention Type DRUG

125 mg/d capsules orally for 3 out of 4 weeks in repeated cycles

Letrozole

Intervention Type DRUG

2.5 mg/d tablets orally on a continuous regimen

Interventions

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Palbociclib

125 mg/d capsules orally for 3 out of 4 weeks in repeated cycles

Intervention Type DRUG

Letrozole

2.5 mg/d tablets orally on a continuous regimen

Intervention Type DRUG

Other Intervention Names

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IBRANCE

Eligibility Criteria

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Inclusion Criteria

* Post-menopausal women (\>=18 years of age) with proven diagnosis of advanced carcinoma of the breast (ER(+) and/or PgR(+) and HER2(-)) who are appropriate for letrozole therapy (in the first-line advanced/metastatic disease setting).
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* Adequate bone marrow, liver, and renal function.

Exclusion Criteria

* Prior treatment with any CDK inhibitor .
* QTc \>480 msec; history of QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes.
* High cardiovascular risk, including, but not limited to myocardial infarction, severe/unstable angina, severe cardiac dysrhythmias, and symptomatic pulmonary embolism in the past 6 months of enrollment.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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