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QUILT-2.015: A Study of AMG 479 With Exemestane or Fulvestrant in Postmenopausal Women With Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT00626106
Recruitment Status : Completed
First Posted : February 29, 2008
Last Update Posted : October 27, 2016
Sponsor:
Information provided by (Responsible Party):
NantCell, Inc.

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Breast Tumors Metastatic Cancer Drug: AMG 479 or placebo administered with either exemestane or fulvestrant Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : March 2008
Actual Primary Completion Date : July 2010
Actual Study Completion Date : August 2011

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00626106


Locations
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Sponsors and Collaborators
NantCell, Inc.
Investigators
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Study Director: MD Amgen
More Information
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Additional Information:

Publications:

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Responsible Party: NantCell, Inc.
ClinicalTrials.gov Identifier: NCT00626106    
Other Study ID Numbers: 20060362
QUILT-2.015 ( Other Identifier: NantCell, Inc. )
First Posted: February 29, 2008    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016
Keywords provided by NantCell, Inc.:
postmenopausal
hormone receptor positive
locally advanced
metastatic
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Exemestane
Antibodies, Monoclonal
Antineoplastic Agents, Hormonal
Antineoplastic Agents
 Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors