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Completed Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT00721409

Public ClinicalTrials.gov record NCT00721409. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 10:23 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

PHASE 1/2, OPEN-LABEL, RANDOMIZED STUDY OF THE SAFETY, EFFICACY, AND PHARMACOKINETICS OF LETROZOLE PLUS PD 0332991 (ORAL CDK 4/6 INHIBITOR) AND LETROZOLE SINGLE AGENT FOR THE FIRST-LINE TREATMENT OF ER POSITIVE, HER2 NEGATIVE ADVANCED BREAST CANCER IN POSTMENOPAUSAL WOMEN

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT00721409
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Pfizer
Industry
Enrollment
177 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 15, 2008 (Actual)
Primary completion
Nov 29, 2013 (Actual)
Completion
Dec 20, 2017 (Actual)
Last update posted
Nov 4, 2019

2008 – 2017

United States locations

U.S. sites
51
U.S. states
6
U.S. cities
27
Facility City State ZIP Site status
Central Hematology Oncology Medical group Inc. Alhambra California 91801 —
UCLA Hematology/Oncology - Alhambra Alhambra California 91801 —
CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center Bakersfield California 93309 —
St. Joseph Heritage Healthcare Fullerton California 92835 —
UCLA West Medical Pharmacy (Drug Management Only) Los Angeles California 90095-1772 —
UCLA West Medical Pharmacy Los Angeles California 90095-1772 —
Ronald Reagan UCLA Medical Center Los Angeles California 90095-6984 —
UCLA West Medical Pharmacy Los Angeles California 90095-7349 —
Drug Management Only: UCLA West Medical Pharmacy Los Angeles California 90095 —
Drug Management Only Los Angeles California 90095 —
Regulatory Managment Los Angeles California 90095 —
Ronald Reagan UCLA Medical Center Los Angeles California 90095 —
TORI -US Central Administration (Regulatory Management) Los Angeles California 90095 —
TORI -US Central Administration Los Angeles California 90095 —
TORI Central Administration (Regulatory Management) Los Angeles California 90095 —
TORI Central Administration (Regulatory Managment Only) Los Angeles California 90095 —
TRIO-US Central Administration Los Angeles California 90095 —
UCLA Hematology/Oncology Los Angeles California 90095 —
UCLA, Hematology/Oncology Los Angeles California 90095 —
Westwood Bowyer Clinic, Peter Morton Medical Building Los Angeles California 90095 —
Central Hematology Oncology Medical Group, Inc Pasadena California 91107 —
Torrance Health Association, DBA Torrance Memorial Physician Network/Cancer Care Associates Redondo Beach California 90277 —
Sansum Santa Barbara Medical Foundation Clinic Santa Barbara California 93105 —
Central Coast Medical Oncology Corporation Santa Maria California 93454 —
Santa Monica-UCLA Medical Center and Orthopaedic Hospital Santa Monica California 90404 —
UCLA Hematology Oncology-Santa Monica Santa Monica California 90404 —
UCLA Hematology/Oncology - Santa Clarita Valencia California 91355 —
Gwinnett Hospital System Inc.-d/b/a-The Center for Cancer Care Duluth Georgia 30096 —
Gwinnett Hospital System Inc.-d/b/a-The Center for Cancer Care Lawrenceville Georgia 30046 —
Gwinnett Hospital System Inc.-d/b/a-The Center for Cancer Care Snellville Georgia 30078 —
Illinois Cancer Specialists Chicago Illinois 60611 —
Resurrection Medical Group Chicago Illinois 60657 —
North Shore Oncology-Hematology Associates Crystal Lake Illinois 60014 —
North Shore Hematology Oncology Highland Park Illinois 60035 —
North Shore Oncology-Hematology Associates Libertyville Illinois 60048 —
North Shore Hematology Oncology Skokie Illinois 60077 —
Regulatory Office: Comprehensive Cancer Centers of Nevada Henderson Nevada 89014 —
Comprehensive Cancer Centers of Nevada Henderson Nevada 89052 —
Comprehensive Cancer Centers of Nevada Henderson Nevada 89074 —
Comprehensive Cancer Centers of Nevada Las Vegas Nevada 89128 —
Comprehensive Cancer Centers of Nevada Las Vegas Nevada 89148 —
Comprehensive Cancer Centers of Nevada Las Vegas Nevada 89169 —
Texas Oncology-Dallas Presbyterian Hospital Dallas Texas 75231 —
Texas Oncology-Baylor Charles A. Sammons Cancer Center Dallas Texas 75246 —
Investigational Products Center (IPC) Fort Worth Texas 76177 —
US Oncology Research and Clinical Pharmacy Fort Worth Texas 76177 —
Virginia Cancer Specialists, PC Arlington Virginia 22205 —
Virginia Cancer Specialists, PC Fairfax Virginia 22031 —
Virginia Cancer Specialists, PC Gainesville Virginia 20155 —
Virginia Cancer Specialists, PC Leesburg Virginia 20176 —
Virginia Cancer Specialists, PC Woodbridge Virginia 22191 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 53 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00721409, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 4, 2019 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00721409 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →