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



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


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


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


  • 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

Lead Scientist

  • Hope Rugo
    Dr. Hope Rugo is a medical oncologist and hematologist specializing in breast cancer research and treatment. A Clinical Professor of Medicine, Dr. Rugo joined the Breast Care Center in 1999 after a decade of experience at UCSF in malignant hematology and bone marrow transplantation for a variety of diseases, including breast cancer.


in progress, not accepting new patients
Start Date
Completion Date
To obtain contact information for a study center near you, click here.
Phase 3
Study Type
Last Updated