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

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00626106
First received: February 21, 2008
Last updated: January 10, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Breast Tumors
Metastatic Cancer
Drug: AMG 479 or placebo administered with either exemestane or fulvestrant
Phase 2

Study Type: 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
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Progression free survival (PFS), as measured by Response Evaluation Criteria in Solid Tumors criteria (modified RECIST) per local review [ 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of adverse events, abnormal laboratory values, and anti-AMG 479 antibody formation [ 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 ] [ Designated as safety issue: No ]
  • PK parameters of AMG 479 [ 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 ] [ Designated as safety issue: No ]
  • Breast cancer related symptoms, health related quality of life, and skin toxicity burden [ 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 ] [ Designated as safety issue: No ]
  • Clin benefit(complete/partial response,or stable disease≥24 wks per modified RECIST/local review),objective response rate(complete/partial response per modified RECIST/local review),duration of response,TTP,time-to-response,time-to-tx failure,survival [ 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 ] [ Designated as safety issue: No ]

Enrollment: 156
Study Start Date: March 2008
Study Completion Date: August 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: AMG 479 or placebo administered with either exemestane or fulvestrant
Arm 2 - placebo with exemestane or fulvestrant
Active Comparator: Investigational Product Drug: AMG 479 or placebo administered with either exemestane or fulvestrant
Arm 1 - AMG 479 administered with exemestane or fulvestrant
Roll-over Drug: AMG 479 or placebo administered with either exemestane or fulvestrant
Arm 3 - roll over to open-label AMG 479 with exemestane or fulvestrant

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00626106

  Show 60 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00626106     History of Changes
Other Study ID Numbers: 20060362
Study First Received: February 21, 2008
Last Updated: January 10, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul_Ehrlich-Institut Bundesamt fur Sera und Impfstoffe
Australia: Therapeutic Goods Administration
Canada: Health Canada
Ireland: Irish Medicines Board
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Switzerland: Swissmedic (Swiss Agency for Therapeutic Products)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
United States: Western Institutional Review Board

Keywords provided by Amgen:
postmenopausal
hormone receptor positive
locally advanced
metastatic

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Hormones
Estradiol
Exemestane
Fulvestrant
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Antineoplastic Agents, Hormonal
Estrogens

ClinicalTrials.gov processed this record on April 22, 2014