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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 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 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

  • UCLA Hematology Oncology - Alhambra
    Alhambra, California, 91801, USA
  • CBCC Global Research Inc. at Comprehensive Blood and Cancer Center
    Bakersfield, California, 93309, USA
  • Administrative Manaaement Only: Translational Research Management
    Culver City, California, 90232, USA
  • Administrative Management Only
    Culver City, California, 90232, USA
  • Translational Research Management
    Culver City, California, 90232, USA
  • City of Hope
    Duarte, California, 91010, USA
  • St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare
    Fullerton, California, 92835, USA
  • Global Research Management
    Glendale, California, 91204, USA
  • UCLA Hematology Oncology - Irvine
    Irvine, California, 92604, USA
  • UC San Diego Moores Cancer Center - Investigational Drug Services
    La Jolla, California, 92037, USA
  • UC San Diego Moores Cancer Center
    La Jolla, California, 92093, USA
  • UC San Diego Medical Center-La Jolla
    La Jolla, California, 92307, USA
  • Drug Management Only: TRIO-US Pharmacy UCLA Med Plaza - Level 1 Attn: Steven L. Wong, Pharm. D.
    Los Angelas, California, 90095, USA
  • Keck Hospital of USC
    Los Angeles, California, 90033, USA
  • LAC & USC Medical Center
    Los Angeles, California, 90033, USA
  • USC/Norris Comprehensive Cancer Center
    Los Angeles, California, 90033, USA
  • Drug Management Only: TRIO-US Pharmacy, UCLA West Medical Pharmacy
    Los Angeles, California, 90095, USA
  • Drug Management Only: UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm. D
    Los Angeles, California, 90095, USA
  • Drug Management only: UCLA West Medical Pharmacy
    Los Angeles, California, 90095, USA
  • CRU Administrative Office: UCLA Hematology Oncology
    Los Angeles, California, 90095, USA
  • Drug Management Only: UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm. D.
    Los Angeles, California, 90095, USA
  • Drug Management Only: UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm. D
    Los Angeles, California, 90095, USA
  • Drug Management only: UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm.D
    Los Angeles, California, 90095, USA
  • Drug Management Only: UCLA West Medical Pharmacy
    Los Angeles, California, 90095, USA
  • Drug shipment only: Ronald Reagan UCLA Medical Center
    Los Angeles, California, 90095, USA
  • Regulatory Management only-TRIO -US Central Administration
    Los Angeles, California, 90095, USA
  • Regulatory Management only: TRIO- US Central Administration
    Los Angeles, California, 90095, USA
  • Regulatory Management only: TRIO-US Central Administration
    Los Angeles, California, 90095, USA
  • Regulatory Management Only: TRIO-US Central Adminstration
    Los Angeles, California, 90095, USA
  • Ronald Reagan UCLA Medical Center
    Los Angeles, California, 90095, USA
  • TRIO- US Central Administration
    Los Angeles, California, 90095, USA
  • UCLA Hematology Oncology
    Los Angeles, California, 90095, USA
  • Westwood Bowyer Clinic
    Los Angeles, California, 90095, USA
  • Drug management only: UCLA West Medical Pharmacy, attn:
    Los Angles, California, 90095, USA
  • UCLA Hematology/Oncology - Pasadena
    Pasadena, California, 91105, USA
  • UCLA Hematology Oncology - Porter Ranch
    Porter Ranch, California, 91326, USA
  • Torrance Health Association, DBA Torrance Memorial Physician Network/Cancer Care Associates Medical
    Redondo Beach, California, 90277, USA
  • UC San Diego Medical Center-Hillcrest
    San Diego, California, 92103, USA
  • San Luis Obispo Oncology and Hematology Health Center/Pacific Central Coast Health Centers
    San Luis Obispo, California, 93401, USA
  • Central Coast Medical Oncology Corporation
    Santa Maria, California, 93454, USA
  • UCLA Hematology Oncology - Santa Monica
    Santa Monica, California, 90404, USA
  • UCLA Hematology/Oncology - Santa Monica
    Santa Monica, California, 90404, USA
  • UCLA Santa Monica Medical Center and Orthopaedic Hospital
    Santa Monica, California, 90404, USA
  • City of Hope
    South Pasadena, California, 91030, USA
  • UCLA Hematology/Oncology - Santa Clarita
    Valencia, California, 91355, USA
  • Wellness Oncology & Hematology
    West Hills, California, 91307, USA
  • UCLA Hematology Oncology - Westlake
    Westlake Village, California, 91361, USA

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
January 2017