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

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NantCell, Inc.
• Treatments: Antibodies, Monoclonal; Estradiol; Exemestane; Fulvestrant; Hormones

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed carcinoma of the breast with locally advanced or metastatic disease

• Confirmation of hormone receptor (HR) positive disease status

• Amenable to receive endocrine therapy

• Disease progression while receiving prior endocrine therapy for locally advanced or metastatic breast cancer

• Postmenopausal woman ≥ 18 years old

Exclusion Criteria:

• HR-unknown or HR-negative disease

• Not amenable to endocrine therapy

• Central nervous system metastasis