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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00626106

  Hide Study Locations
Locations
United States, Arizona
Research Site
Chandler, Arizona, United States, 85224
United States, California
Research Site
Anaheim, California, United States, 92801
Research Site
Beverly Hills, California, United States, 90211
Research Site
Concord, California, United States, 94520
Research Site
Duarte, California, United States, 91010
Research Site
Montebello, California, United States, 90640
Research Site
San Francisco, California, United States, 94115
Research Site
Sylmar, California, United States, 91342
United States, Connecticut
Research Site
Stamford, Connecticut, United States, 06902
United States, Florida
Research Site
Boca Raton, Florida, United States, 33428
Research Site
Boynton Beach, Florida, United States, 33435
Research Site
Coral Springs, Florida, United States, 33065
Research Site
Gainesville, Florida, United States, 32605
Research Site
Lake Worth, Florida, United States, 33467
United States, Georgia
Research Site
Atlanta, Georgia, United States, 30309
Research Site
Marietta, Georgia, United States, 30060
United States, Illinois
Research Site
Chicago, Illinois, United States, 60637
United States, New Hampshire
Research Site
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Research Site
Denville, New Jersey, United States, 07834
United States, North Carolina
Research Site
High Point, North Carolina, United States, 27262
United States, Pennsylvania
Research Site
Hershey, Pennsylvania, United States, 17033
Research Site
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Research Site
Memphis, Tennessee, United States, 38120
United States, Utah
Research Site
American Fork, Utah, United States, 84003
United States, Washington
Research Site
Tacoma, Washington, United States, 98405
Australia, New South Wales
Research Site
Waratah, New South Wales, Australia, 2298
Australia, South Australia
Research Site
Woodville South, South Australia, Australia, 5011
Australia, Victoria
Research Site
Footscray, Victoria, Australia, 3011
Research Site
Geelong, Victoria, Australia, 3220
Research Site
Malvern, Victoria, Australia, 3144
Canada, British Columbia
Research Site
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Research Site
Ottawa, Ontario, Canada, K1H 8L6
Research Site
Sault Ste. Marie, Ontario, Canada, P6A 2C4
Research Site
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Research Site
Montreal, Quebec, Canada, H1T 2M4
France
Research Site
Dijon, France, 21079
Research Site
Le Mans, France, 72000
Research Site
Lyon, France, 69008
Research Site
Montpellier Cedex 5, France, 34298
Research Site
Nice Cedex 2, France, 06182
Research Site
Paris Cedex 5, France, 75248
Research Site
Reims Cedex, France, 51056
Research Site
Saint Herblain, France, 44800
Germany
Research Site
Frankfurt, Germany, 65929
Research Site
Frankfurt, Germany, 60590
Research Site
Hannover, Germany, 30177
Research Site
München, Germany, 80637
Ireland
Research Site
Dublin, Ireland, 4
Research Site
Dublin, Ireland, 8
Spain
Research Site
Barcelona, Cataluña, Spain, 08003
Research Site
L'Hospitalet de Llobregat, Cataluña, Spain, 08907
Research Site
Sabadell, Cataluña, Spain, 08208
Research Site
Madrid, Spain, 28040
Switzerland
Research Site
Chur, Switzerland, 7000
Research Site
Luzern 16, Switzerland, 6000
Research Site
Zurich, Switzerland, 8032
United Kingdom
Research Site
Derby, United Kingdom, DE22 3DT
Research Site
London, United Kingdom, W6 8RF
Research Site
Manchester, United Kingdom, M20 4BX
Research Site
Peterborough, United Kingdom, PE3 9GZ
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 July 28, 2014