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
NCT ID: NCT00626106
Last Updated: 2024-09-19
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
156 participants
INTERVENTIONAL
2008-03-27
2011-09-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Trial of Exemestane +/- MM-121 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive and/or Progesterone Receptor Positive Her2 Negative Breast Cancer
NCT01151046
Neoadjuvant and Adjuvant Exemestane in Treating Postmenopausal Women With Locally Advanced Hormone Receptor-Positive Breast Cancer
NCT00080613
Exemestane Compared With Tamoxifen in Treating Postmenopausal Women With Primary Breast Cancer
NCT00003418
Fulvestrant 500mg With Exemestane Endocrine Therapy for Postmenopausal Advanced Breast Cancer Patients
NCT02646735
Exemestane in Treating Postmenopausal Women With Resected Stage I, Stage II, or Stage IIIA Breast Cancer Who Have Completed 5 Years of Tamoxifen
NCT00016432
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm A: AMG 479 12 mg/kg IV Q2W + Endocrine Therapy
AMG 479
AMG 479 administered with exemestane or fulvestrant
Arm B: placebo IV Q2W + Endocrine Therapy
Placebo
Placebo administered with either exemestane or fulvestrant
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AMG 479
AMG 479 administered with exemestane or fulvestrant
Placebo
Placebo administered with either exemestane or fulvestrant
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Not amenable to endocrine therapy
* Central nervous system metastasis
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
NantCell, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
MD
Role: STUDY_DIRECTOR
Amgen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Chandler, Arizona, United States
Research Site
Anaheim, California, United States
Research Site
Beverly Hills, California, United States
Research Site
Concord, California, United States
Research Site
Duarte, California, United States
Research Site
Montebello, California, United States
Research Site
San Francisco, California, United States
Research Site
Sylmar, California, United States
Research Site
Stamford, Connecticut, United States
Research Site
Boca Raton, Florida, United States
Research Site
Boynton Beach, Florida, United States
Research Site
Coral Springs, Florida, United States
Research Site
Gainesville, Florida, United States
Research Site
Lake Worth, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Marietta, Georgia, United States
Research Site
Chicago, Illinois, United States
Research Site
Lebanon, New Hampshire, United States
Research Site
Denville, New Jersey, United States
Research Site
High Point, North Carolina, United States
Research Site
Hershey, Pennsylvania, United States
Research Site
Pittsburgh, Pennsylvania, United States
Research Site
Memphis, Tennessee, United States
Research Site
American Fork, Utah, United States
Research Site
Tacoma, Washington, United States
Research Site
Waratah, New South Wales, Australia
Research Site
Woodville South, South Australia, Australia
Research Site
Footscray, Victoria, Australia
Research Site
Geelong, Victoria, Australia
Research Site
Malvern, Victoria, Australia
Research Site
Vancouver, British Columbia, Canada
Research Site
Ottawa, Ontario, Canada
Research Site
Sault Ste. Marie, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Dijon, , France
Research Site
Le Mans, , France
Research Site
Lyon, , France
Research Site
Montpellier, , France
Research Site
Nice, , France
Research Site
Paris, , France
Research Site
Reims, , France
Research Site
Saint-Herblain, , France
Research Site
Frankfurt, , Germany
Research Site
Frankfurt, , Germany
Research Site
Hanover, , Germany
Research Site
Munich, , Germany
Research Site
Dublin, , Ireland
Research Site
Dublin, , Ireland
Research Site
Barcelona, Cataluña, Spain
Research Site
L'Hospitalet de Llobregat, Cataluña, Spain
Research Site
Sabadell, Cataluña, Spain
Research Site
Madrid, , Spain
Research Site
Chur, , Switzerland
Research Site
Lucerne, , Switzerland
Research Site
Zurich, , Switzerland
Research Site
Derby, , United Kingdom
Research Site
London, , United Kingdom
Research Site
Manchester, , United Kingdom
Research Site
Peterborough, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Robertson JF, Ferrero JM, Bourgeois H, Kennecke H, de Boer RH, Jacot W, McGreivy J, Suzuki S, Zhu M, McCaffery I, Loh E, Gansert JL, Kaufman PA. Ganitumab with either exemestane or fulvestrant for postmenopausal women with advanced, hormone-receptor-positive breast cancer: a randomised, controlled, double-blind, phase 2 trial. Lancet Oncol. 2013 Mar;14(3):228-35. doi: 10.1016/S1470-2045(13)70026-3. Epub 2013 Feb 13.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
AmgenTrials clinical trials website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
QUILT-2.015
Identifier Type: OTHER
Identifier Source: secondary_id
20060362
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.