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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 (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00626106
First received: February 21, 2008
Last updated: September 19, 2014
Last verified: September 2014

February 21, 2008
September 19, 2014
March 2008
July 2010   (final data collection date for primary outcome measure)
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 ]
Progression free survival (PFS) [ Time Frame: Four to six months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00626106 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Pharmacokinetics of study treatment [ Time Frame: Before and/or after study treatment administration throughout study participants duration ] [ Designated as safety issue: No ]
  • safety and tolerability [ Time Frame: Throughout study participants duration ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of AMG 479 With Exemestane or Fulvestrant in Postmenopausal Women With Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Breast Cancer
  • Breast Tumors
  • Metastatic Cancer
  • Drug: AMG 479 or placebo administered with either exemestane or fulvestrant
    Arm 2 - placebo with exemestane or fulvestrant
  • Drug: AMG 479 or placebo administered with either exemestane or fulvestrant
    Arm 3 - roll over to open-label AMG 479 with exemestane or fulvestrant
  • Drug: AMG 479 or placebo administered with either exemestane or fulvestrant
    Arm 1 - AMG 479 administered with exemestane or fulvestrant
  • Placebo Comparator: Placebo
    Intervention: Drug: AMG 479 or placebo administered with either exemestane or fulvestrant
  • Active Comparator: Investigational Product
    Intervention: Drug: AMG 479 or placebo administered with either exemestane or fulvestrant
  • Roll-over
    Intervention: Drug: AMG 479 or placebo administered with either exemestane or fulvestrant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
156
August 2011
July 2010   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   France,   Germany,   Ireland,   Spain,   Switzerland,   United Kingdom
 
NCT00626106
20060362
Not Provided
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP