SANDPIPER Study: A Study Of Taselisib + Fulvestrant Versus Placebo + Fulvestrant In Patients With Advanced or Metastatic Breast

Clinical Trial Details

SANDPIPER

SANDPIPER Study: A Study Of Taselisib + Fulvestrant Versus Placebo + Fulvestrant In Patients With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy

Purpose/Objective

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Full Trial Details: ClinicalTrials.gov

Condition: Breast Cancer
Study Type: Interventional
Phase: Phase III
Study Start Date: 01/13/2015
Study Completion Date: 07/31/2018

This international, multicenter, randomized, double-blinded, placebo-controlled study is designed to compare the efficacy and safety of taselisib + fulvestrant with that of placebo + fulvestrant in postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative, PIK3CA-mutant, unresectable, locally advanced or metastatic breast cancer after recurrence or progression during or after an aromatase inhibitor (AI) therapy. There will be a 2:1 randomization to the taselisib arm versus the placebo arm. Enrollment will be enriched for patients with PIK3CA mutant tumors via central testing. The anticipated duration of the study is approximately 3.5 years.

NCT Number
NCT02340221
Principal Investigator(s)
John Wallmark, MD
Sponsor(s)
Hoffmann-La Roche
Participant Eligibility
  • Age: 18 - No Maximum
  • Gender: Female

Location

  • Shady Grove Adventist Aquilino Cancer Center
    9905 Medical Center Drive
    Rockville, MD 20850
    Main: 240-826-6297

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