NCT00626106

QUILT-2.015: A Study of AMG 479 With Exemestane or Fulvestrant in Postmenopausal Women With Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer

An International, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of AMG 479 With Exemestane or Fulvestrant in Postmenopausal Women With Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: NantCell, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, placebo-controlled, phase 2 study. Subjects will include postmenopausal women with confirmed HR-positive, locally advanced or metastatic breast cancer, who have disease progression during or within 12 months after completing prior adjuvant endocrine therapy or during the first prior endocrine therapy for metastatic disease.

Conditions

• Breast Cancer
• Breast Tumors
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	AMG 479	AMG 479 administered with exemestane or fulvestrant
DRUG	Placebo	Placebo administered with either exemestane or fulvestrant

Timeline

• Start date: 2008-03-27
• Primary completion: 2010-05-05
• Completion: 2011-09-23
• First posted: 2008-02-29
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

60 sites across 9 countries: United States, Australia, Canada, France, Germany, Ireland, Spain, Switzerland, United Kingdom