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Eligibility
for females ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

The study is designed to compare the clinical benefit following treatment with letrozole in combination with PD-0332991 versus letrozole in combination with placebo in postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti cancer therapies for their advanced/metastatic disease.

Official Title

A Randomized, Multicenter, Double-blind Phase 3 Study Of Pd-0332991 (Oral Cdk 4/6 Inhibitor) Plus Letrozole Versus Placebo Plus Letrozole For The Treatment Of Postmenopausal Women With Er (+), Her2 (-) Breast Cancer Who Have Not Received Any Prior Systemic Anti Cancer Treatment For Advanced Disease

Keywords

Breast Neoplasms breast cancer postmenopausal women estrogen-receptor positive HER2 negative locoregionally recurrent metastatic Palbociclib (PD-0332991) PALOMA-2 Palbociclib Letrozole

Eligibility

You can join if…

Open to females ages 18 years and up

  • Adult women with locoregionally recurrent or metastatic disease not amenable to curative therapy.
  • Confirmed diagnosis of ER positive breast cancer
  • No prior systemic anti-cancer therapy for advanced ER+ disease.
  • Postmenopausal women
  • Measurable disease as per Response Evaluation Criterion in Solid Tumors [RECIST] or bone-only disease
  • Eastern Cooperative Oncology Group [ECOG] 0-2
  • Adequate organ and marrow function
  • Patient must agree to provide tumor tissue

You CAN'T join if...

  • Confirmed diagnosis of HER2 positive disease
  • Patients with advanced, symptomatic, visceral spread that are at risk of life threatening complication in the short term
  • Known uncontrolled or symptomatic CNS metastases
  • Prior (neo)adjuvant treatment with letrozole or anastrozole with DFI ≤ 12-months from completion of treatment.
  • Prior treatment with any CDK 4/6 inhibitor.

Locations

  • Stanford Women's Cancer Center
    Stanford, California, 94304-5826, United States
  • Freidenrich Center for Translational Research
    Palo Alto, California, 94305, United States
  • San Luis Obispo Oncology and Hematology Health Center/ Pacific Central Coast Health Centers
    San Luis Obispo, California, 93401, United States
  • Central Coast Medical Oncology Corporation
    Santa Maria, California, 93454, United States
  • Granada Hills Cancer Center
    Granada Hills, California, 91344, United States
  • Wellness Oncology & Hematology
    West Hills, California, 91307, United States
  • UCLA Hematology/Oncology- Westlake
    Westlake Village, California, 91361, United States
  • Phillip L Chatham MD, Inc.
    Van Nuys, California, 91405, United States
  • Los Angeles Hematology/Oncology Medical Group
    Glendale, California, 91206, United States
  • Southern California Permanente Medical Group
    Los Angeles, California, 90027, United States
  • Beverly Hills Cancer Center
    Beverly Hills, California, 90211, United States
  • UCLA Hematology/ Oncology- Pasadena
    Pasadena, California, 91105, United States
  • UCLA Hematology Oncology Santa Monica
    Santa Monica, California, 90404, United States
  • UCLA Santa Monica Medical Center and Orthopaedic Hospital
    Santa Monica, California, 90404, United States
  • Los Angeles Hematology/Oncology Medical Group
    Los Angeles, California, 90017, United States
  • Translational Research Management
    Los Angeles, California, 90045, United States
  • Torrance Health Association, DBa Torrance Memorial Physician Network
    Redondo Beach, California, 90277, United States
  • Southern California Permanente Medical Group
    Bellflower, California, 90706, United States
  • Drug Management Only: UCLA West Medical Pharmacy, Attn: Steven L Wong, Pharm.D.
    Los Angeles, California, 90095-1772, United States
  • UCLA West Medical Pharmacy
    Los Angeles, California, 90095-1772, United States
  • UCLA West Medical Pharmacy, Attn: Steven L. Wong
    Los Angeles, California, 90095-7349, United States
  • UCLA West Medical Pharmacy: Drug Management Only
    Los Angeles, California, 90095-7349, United States
  • UCLA West Medical Pharmacy; Drug Management Only
    Los Angeles, California, 90095-7349, United States
  • UCLA West Medical Pharmacy
    Los Angeles, California, 90095-7349, United States
  • Administrative Address: UCLA School of Medicine
    Los Angeles, California, 90095, United States
  • Drug Management Only: UCLA West Medical Pharmacy, Attn: Steven L Wong, Pharm.D.
    Los Angeles, California, 90095, United States
  • Drug Shipping Address: Ronald Reagan UCLA Medical Center
    Los Angeles, California, 90095, United States
  • Regulatory Management Only: TRIO-US Central Administration
    Los Angeles, California, 90095, United States
  • Ronald Reagan UCLA Medical Center
    Los Angeles, California, 90095, United States
  • TRIO-US Central Administration: Regulatory Management Only
    Los Angeles, California, 90095, United States
  • TRIO-US Central Administration
    Los Angeles, California, 90095, United States
  • TRIO-US Pharmacy, UCLA Med Plaza- Level 1,
    Los Angeles, California, 90095, United States
  • UCLA Hematology Oncology
    Los Angeles, California, 90095, United States
  • Westwood Bowyer Clinic
    Los Angeles, California, 90095, United States
  • St. Joseph Heritage Healthcare
    Fullerton, California, 92835, United States
  • UCLA Hematology/ Oncology- Irvine
    Irvine, California, 92604, United States
  • UCLA Hematology Oncology- Laguna Hills
    Laguna Hills, California, 92653, United States
  • Comprehensive Cancer Centers of Nevada
    Las Vegas, Nevada, 89128, United States
  • Comprehensive Cancer Centers of Nevada
    Las Vegas, Nevada, 89148, United States
  • Comprehensive Cancer Centers of Nevada
    Las Vegas, Nevada, 89169, United States
  • Comprehensive Cancer Centers of Nevada
    Henderson, Nevada, 89052, United States
  • Comprehensive Cancer Centers of Nevada Research Department
    Henderson, Nevada, 89014, United States
  • Comprehensive Cancer Centers of Nevada
    Henderson, Nevada, 89074, United States

Details

Status
currently not accepting new patients, but might later
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
ID
NCT01740427
Phase
Phase 3
Lead Scientist
Hope Rugo
Study Type
Interventional
Last Updated
May 1, 2017
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