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Summary

for females ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

The study is a randomized, double blind, placebo controlled, Phase 3 clinical trial with the primary objective of demonstrating the superiority of palbociclib in combination with fulvestrant (Faslodex®) over fulvestrant alone in prolonging PFS in women with HR+, HER2 negative metastatic breast cancer whose disease has progressed after prior endocrine therapy. The safety between the two treatment arms will also be compared. During study treatment, pre- and perimenopausal women must be receiving therapy with the LHRH agonist goserelin (Zoladex® or generic).

Official Title

Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Trial Of Fulvestrant (Faslodex (Registered)). With Or Without Pd-0332991 (Palbociclib) +/- Goserelin In Women With Hormone Receptor-positive, Her2-negative Metastatic Breast Cancer Whose Disease Progressed After Prior Endocrine Therapy

Keywords

Metastatic Breast Cancer Palbociclib (PD-0332991) Fulvestrant Goserelin Hormone receptor-+ HER2-negative Prior Endocrine treatment any menopausal status PALOMA-3 Breast Neoplasms Hormones Estradiol Palbociclib

Eligibility

You can join if…

Open to females ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • UCSF Medical Center-Mt. Zion/Pharmaceutical Services
    San Francisco, California, 94115, United States
  • University of California, San Francisco: Helen Diller Comprehensive Cancer Center
    San Francisco, California, 94115, United States
  • CBCC Global Research Inc. at Comprehensive Blood and Cancer Center
    Bakersfield, California, 93309, 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
  • Wellness Oncology & Hematology
    West Hills, California, 91307, United States
  • UCLA Hematology Oncology - Westlake
    Westlake Village, California, 91361, United States
  • Global Research Management
    Glendale, California, 91204, United States
  • UCLA Hematology/Oncology - Pasadena
    Pasadena, California, 91105, United States
  • Santa Monica - UCLA Medical Center and Orthopaedic Hospital
    Santa Monica, California, 90404, United States
  • UCLA Hematology/Oncology - Santa Monica
    Santa Monica, California, 90404, United States
  • Administrative Management Only
    Culver City, California, 90232, United States
  • City of Hope
    South Pasadena, California, 91030, United States
  • Keck Hospital of USC
    Los Angeles, California, 90033, United States
  • LAC & USC Medical Center
    Los Angeles, California, 90033, United States
  • USC/Norris Comprehensive Cancer Center
    Los Angeles, California, 90033, United States
  • City of Hope
    Duarte, California, 91010, United States
  • UC San Diego Medical Center-La Jolla
    La Jolla, California, 92307, United States
  • Torrance Health Association, DBA Torrance Memorial Physician Network/Cancer Care Associates
    Redondo Beach, California, 90277, United States
  • TRIO-US Pharmacy, UCLA West Medical Pharmacy
    Los Angeles, California, 90095-1772, United States
  • Drug Management only: UCLA West Medical Pharmacy
    Los Angeles, California, 90095-7349, United States
  • TRIO-US Pharmacy UCLA Med Plaza - Level 1 Attn: Steven L. Wong, Pharm. D.
    Los Angeles, California, 90095-7349, United States
  • UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm. D.
    Los Angeles, California, 90095-7349, United States
  • UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm. D
    Los Angeles, California, 90095-7349, United States
  • UCLA West Medical Pharmacy, attn:
    Los Angeles, California, 90095-7349, United States
  • UCLA West Medical Pharmacy
    Los Angeles, California, 90095-7349, United States
  • Ronald Reagan UCLA Medical Center, Drug Information Center
    Los Angeles, California, 90095, United States
  • Ronald Reagan UCLA Medical Center
    Los Angeles, California, 90095, United States
  • TRIO -US Central Administration
    Los Angeles, California, 90095, United States
  • TRIO- US Central Administration
    Los Angeles, California, 90095, United States
  • TRIO-US Central Administration
    Los Angeles, California, 90095, United States
  • TRIO-US Central Adminstration
    Los Angeles, California, 90095, United States
  • UCLA Hematology Oncology
    Los Angeles, California, 90095, United States
  • UCLA Hematology/Oncology
    Los Angeles, California, 90095, United States
  • UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm. D.
    Los Angeles, California, 90095, United States
  • UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm. D
    Los Angeles, California, 90095, United States
  • UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm.D
    Los Angeles, California, 90095, United States
  • Westwood Bowyer Clinic
    Los Angeles, California, 90095, United States
  • St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare
    Fullerton, California, 92835, 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 Research Department
    Las Vegas, Nevada, 89119, United States
  • Comprehensive Cancer Centers of Nevada
    Henderson, Nevada, 89052, United States
  • Comprehensive Cancer Centers of Nevada
    Henderson, Nevada, 89074, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
ID
NCT01942135
Phase
Phase 3
Lead Scientist
Hope Rugo
Study Type
Interventional
Last Updated
September 8, 2017