Clinical Trials Detail

JPBL: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Fulvestrant with or without LY2835219, a CDK4/6 Inhibitor, for Women with Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer

Objective

Diseases

Hormone Receptor positive, HER2 negative locally advanced or metastatic breast cancer.

Description

This study is designed to see if the drug LY2835219 may be effective in helping to control tumor growth in some women with breast cancer. A randomized, double-blind, placebo-controlled trial means that half of the patients will receive the drug LY2835219 (taken as a pill) and fulvestrant (given as shots) and half will receive fulvestrant and a placebo (a sugar pill). Neither the patient nor the doctor will know if the patient is receiving LY2835219 or placebo.

Objectives

  • Compare treatment with fulvestrant with and without the drug LY2835219
  • Evaluate response, survival, disease control, and clinical benefit

Participating Physician Clinics

  • Family Cancer Center Foundation – Walnut Grove, Bartlett, Southaven, Oxford
  • Boston Baskin Cancer Foundation – East Memphis, Bartlett, Southaven

Clinical Trial Categories

  • Breast Cancer
Sponsor(s)
Eli Lilly and Company
How to Participate

Partial Inclusion Criteria

  • Diagnosis of HR+, HER2- breast cancer
  • Inoperable locally advanced or metastatic disease and relapsed with radiologic evidence of progression after prior endocrine therapy or have not received prior endocrine therapy Postmenopausal status due to either surgical/natural menopause or ovarian suppression
  • Must not have a history of CNS metastasis
  • Must not have received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, everolimus, or any CDK4/6 inhibitor

For the current eligibility status of this clinical study, referring physicians may call the Baptist referral line at 901-227-DOCS (3627).