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
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
2 other identifiers
interventional
156
9 countries
60
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Mar 2008
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2008
CompletedFirst Posted
Study publicly available on registry
February 29, 2008
CompletedStudy Start
First participant enrolled
March 27, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 5, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 23, 2011
CompletedResults Posted
Study results publicly available
September 19, 2024
CompletedSeptember 19, 2024
October 1, 2016
2.1 years
February 21, 2008
June 19, 2024
August 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS)
PFS was defined as the time from randomization to the first observation of disease progression (as classified by modified RECIST), symptomatic deterioration or death due to any cause, whichever occurs first. Disease progression per RECIST is defined as at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study and an absolute increase of at least 5 mm; the appearance of any new lesions is also considered progression.
Subject completing study will be contacted by the study staff by telephone or at routine clinic visits approximately every 3 months, up to approximately 3 years and 6 months.
Secondary Outcomes (6)
Number of Participants With Adverse Events
30 days after the last dose of study treatment, up to 109 weeks
Cmax of AMG 479
Subject completing study will be contacted by the study staff by telephone or at routine clinic visits approximately every 3 months, up to approximately 3 years and 6 months.
Clinical Benefit and Objective Response Rate
Subject completing study will be contacted by the study staff by telephone or at routine clinic visits approximately every 3 months, up to approximately 3 years and 6 months.
Duration of Response and Time-to-response
Subject completing study will be contacted by the study staff by telephone or at routine clinic visits approximately every 3 months, up to approximately 3 years and 6 months.
Time To Progression, Time-to-treatment Failure, Overall Survival
Subject completing study will be contacted by the study staff by telephone or at routine clinic visits approximately every 3 months, up to approximately 3 years and 6 months.
- +1 more secondary outcomes
Study Arms (2)
Arm A: AMG 479 12 mg/kg IV Q2W + Endocrine Therapy
ACTIVE COMPARATORArm B: placebo IV Q2W + Endocrine Therapy
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- HR-unknown or HR-negative disease
- Not amenable to endocrine therapy
- Central nervous system metastasis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NantCell, Inc.lead
Study Sites (60)
Research Site
Chandler, Arizona, 85224, United States
Research Site
Anaheim, California, 92801, United States
Research Site
Beverly Hills, California, 90211, United States
Research Site
Concord, California, 94520, United States
Research Site
Duarte, California, 91010, United States
Research Site
Montebello, California, 90640, United States
Research Site
San Francisco, California, 94115, United States
Research Site
Sylmar, California, 91342, United States
Research Site
Stamford, Connecticut, 06902, United States
Research Site
Boca Raton, Florida, 33428, United States
Research Site
Boynton Beach, Florida, 33435, United States
Research Site
Coral Springs, Florida, 33065, United States
Research Site
Gainesville, Florida, 32605, United States
Research Site
Lake Worth, Florida, 33467, United States
Research Site
Atlanta, Georgia, 30309, United States
Research Site
Marietta, Georgia, 30060, United States
Research Site
Chicago, Illinois, 60637, United States
Research Site
Lebanon, New Hampshire, 03756, United States
Research Site
Denville, New Jersey, 07834, United States
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High Point, North Carolina, 27262, United States
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Hershey, Pennsylvania, 17033, United States
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Pittsburgh, Pennsylvania, 15213, United States
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Memphis, Tennessee, 38120, United States
Research Site
American Fork, Utah, 84003, United States
Research Site
Tacoma, Washington, 98405, United States
Research Site
Waratah, New South Wales, 2298, Australia
Research Site
Woodville South, South Australia, 5011, Australia
Research Site
Footscray, Victoria, 3011, Australia
Research Site
Geelong, Victoria, 3220, Australia
Research Site
Malvern, Victoria, 3144, Australia
Research Site
Vancouver, British Columbia, V5Z 4E6, Canada
Research Site
Ottawa, Ontario, K1H 8L6, Canada
Research Site
Sault Ste. Marie, Ontario, P6B 0A8, Canada
Research Site
Toronto, Ontario, M5G 2M9, Canada
Research Site
Montreal, Quebec, H1T 2M4, Canada
Research Site
Dijon, 21079, France
Research Site
Le Mans, 72000, France
Research Site
Lyon, 69008, France
Research Site
Montpellier, 34298, France
Research Site
Nice, 06182, France
Research Site
Paris, 75248, France
Research Site
Reims, 51056, France
Research Site
Saint-Herblain, 44800, France
Research Site
Frankfurt, 60590, Germany
Research Site
Frankfurt, 65929, Germany
Research Site
Hanover, 30177, Germany
Research Site
Munich, 80637, Germany
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Dublin, 4, Ireland
Research Site
Dublin, 8, Ireland
Research Site
Barcelona, Cataluña, 08003, Spain
Research Site
L'Hospitalet de Llobregat, Cataluña, 08907, Spain
Research Site
Sabadell, Cataluña, 08208, Spain
Research Site
Madrid, 28040, Spain
Research Site
Chur, 7000, Switzerland
Research Site
Lucerne, 6000, Switzerland
Research Site
Zurich, 8032, Switzerland
Research Site
Derby, DE22 3DT, United Kingdom
Research Site
London, W6 8RF, United Kingdom
Research Site
Manchester, M20 4BX, United Kingdom
Research Site
Peterborough, PE3 9GZ, United Kingdom
Related Publications (1)
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.
PMID: 23414585BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sandeep Bobby Reddy, Chief Medical Officer
- Organization
- ImmunityBio
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2008
First Posted
February 29, 2008
Study Start
March 27, 2008
Primary Completion
May 5, 2010
Study Completion
September 23, 2011
Last Updated
September 19, 2024
Results First Posted
September 19, 2024
Record last verified: 2016-10