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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer, Breast Tumors, Metastatic Cancer

Thank you

Trial Information

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


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

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

Name

Location

Research SiteMesa, Arizona  
Research SiteAnaheim, California  
Research SiteDanbury, Connecticut  
Research SiteBoca Raton, Florida  
Research SiteAlbany, Georgia  
Research SiteArlington Heights, Illinois  
Research SiteHooksett, New Hampshire  
Research SiteBelleville, New Jersey  
Research SiteAsheville, North Carolina  
Research SiteAllentown, Pennsylvania  
Research SiteChattanooga, Tennessee  
Research SiteIvins, Utah  
Research SiteAuburn, Washington