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Study Of Letrozole With Or Wi...

Study Of Letrozole With Or Without Palbociclib (PD-0332991) For The First-Line Treatment Of Hormone-Receptor Positive Advanced Breast Cancer

Last Updated: 2019-11-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

177 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-15

Study Completion Date

2017-12-20

Brief Summary

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The study is aimed to confirm that letrozole + PD 0332991 is safe and tolerable and to assess the effect of the combination on advanced breast cancer

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

letrozole + PD 0332991

Group Type EXPERIMENTAL

PD 0332991

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

Arm B

letrozole

Group Type ACTIVE_COMPARATOR

letrozole

Intervention Type DRUG

2.5 mg/d tablets orally on a continuous regimen

Interventions

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PD 0332991

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

letrozole

2.5 mg/d tablets orally on a continuous regimen

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Inoperable estrogen receptor positive and HER2 negative breast cancer.
* Postmenopausal status.
* Tumor tissue (archived acceptable) available for biomarker studies. For Phase 2 Part 2 - CCND1 amplification and/or loss of p16 as determined by the central laboratory.
* Acceptable bone marrow, liver and kidney function.

Exclusion Criteria

* Prior or concomitant treatment for advanced breast cancer.
* Other major cancer in the past 3 years.
* Important cardiovascular events in the past 6 months.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

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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Central Hematology Oncology Medical group Inc.

Alhambra, California, United States

Site Status

UCLA Hematology/Oncology - Alhambra

Alhambra, California, United States

Site Status

CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center

Bakersfield, California, United States

Site Status