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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NantCell, Inc.
ClinicalTrials.gov Identifier:
NCT00626106
First received: February 21, 2008
Last updated: October 26, 2016
Last verified: October 2016
  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
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:


Further study details as provided by NantCell, Inc.:

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 ]

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 ]
  • 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 ]
  • 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 ]
  • 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 ]

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   (Adult, Senior)
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
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

  Show 60 Study Locations
Sponsors and Collaborators
NantCell, Inc.
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications:
Responsible Party: NantCell, Inc.
ClinicalTrials.gov Identifier: NCT00626106     History of Changes
Other Study ID Numbers: 20060362
QUILT-2.015 ( Other Identifier: NantCell, Inc. )
Study First Received: February 21, 2008
Last Updated: October 26, 2016

Keywords provided by NantCell, Inc.:
postmenopausal
hormone receptor positive
locally advanced
metastatic

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Hormones
Estradiol
Fulvestrant
Exemestane
Antibodies, Monoclonal
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Estrogens
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors

ClinicalTrials.gov processed this record on June 28, 2017