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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression free survival (PFS), as measured by Response Evaluation Criteria in Solid Tumors criteria (modified RECIST) per local review

Outcome Time Frame:

Subject completing study will be contacted by the study staff by telephone or at routine clinic visits approximately every 3 months for up to 4 years after the last patient starts the study treatment for a max of 5 years and 3 months for any patient

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

20060362

NCT ID:

NCT00626106

Start Date:

March 2008

Completion Date:

August 2011

Related Keywords:

• Breast Cancer
• Breast Tumors
• Metastatic Cancer
• postmenopausal
• hormone receptor positive
• locally advanced
• metastatic
• Breast Neoplasms
• Neoplasm Metastasis
• Neoplasms
• Neoplasms, Second Primary