Clinical trial NCT00626106: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Breast Tumors
Metastatic Cancer
Keywords: postmenopausal
hormone receptor positive
locally advanced
metastatic
Lead sponsor: NantCell, Inc.
Sponsor class: INDUSTRY
First posted: 2008-02-29
Enrollment: 156
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: 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:
measure: Number of Participants With Adverse Events
timeFrame: 30 days after the last dose of study treatment, up to 109 weeks
measure: Cmax of AMG 479
timeFrame: 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.
measure: Clinical Benefit and Objective Response Rate
timeFrame: 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.
measure: Duration of Response and Time-to-response
timeFrame: 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.
measure: Time To Progression, Time-to-treatment Failure, Overall Survival
timeFrame: 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.
measure: Global Health Status Time-Adjusted AUC
timeFrame: From start of study, on Day 1 of cycles 2, 3, and 4 and Day 1 every 3rd cycle thereafter, up to cycle 25 (Cycle = 28 days), approximately 700 days.
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Research Site
state: Arizona
city: Anaheim
country: United States
facility: Research Site
state: California
city: Beverly Hills
country: United States
facility: Research Site
state: California
city: Concord
country: United States
facility: Research Site
state: California
city: Duarte
country: United States
facility: Research Site
state: California
city: Montebello
country: United States
facility: Research Site
state: California
city: San Francisco
country: United States
facility: Research Site
state: California
city: Sylmar
country: United States
facility: Research Site
state: California
city: Stamford
country: United States
facility: Research Site
state: Connecticut
city: Boca Raton
country: United States
facility: Research Site
state: Florida
city: Boynton Beach
country: United States
facility: Research Site
state: Florida
city: Coral Springs
country: United States
facility: Research Site
state: Florida
city: Gainesville
country: United States
facility: Research Site
state: Florida
city: Lake Worth
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Marietta
country: United States
facility: Research Site
state: Georgia
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Lebanon
country: United States
facility: Research Site
state: New Hampshire
city: Denville
country: United States
facility: Research Site
state: New Jersey
city: High Point
country: United States
facility: Research Site
state: North Carolina
city: Hershey
country: United States
facility: Research Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Research Site
state: Pennsylvania
city: Memphis
country: United States
facility: Research Site
state: Tennessee
city: American Fork
country: United States
facility: Research Site
state: Utah
city: Tacoma
country: United States
facility: Research Site
state: Washington
city: Waratah
country: Australia
facility: Research Site
state: New South Wales
city: Woodville South
country: Australia
facility: Research Site
state: South Australia
city: Footscray
country: Australia
facility: Research Site
state: Victoria
city: Geelong
country: Australia
facility: Research Site
state: Victoria
city: Malvern
country: Australia
facility: Research Site
state: Victoria
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: Ottawa
country: Canada
facility: Research Site
state: Ontario
city: Sault Ste. Marie
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Dijon
country: France
facility: Research Site
city: Le Mans
country: France
facility: Research Site
city: Lyon
country: France
facility: Research Site
city: Montpellier Cedex 5
country: France
facility: Research Site
city: Nice Cedex 2
country: France
facility: Research Site
city: Paris Cedex 5
country: France
facility: Research Site
city: Reims Cedex
country: France
facility: Research Site
city: Saint Herblain
country: France
facility: Research Site
city: Frankfurt
country: Germany
facility: Research Site
city: Frankfurt
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Munich
country: Germany
facility: Research Site
city: Dublin
country: Ireland
facility: Research Site
city: Dublin
country: Ireland
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
state: CataluÃ±a
city: L'Hospitalet de Llobregat
country: Spain
facility: Research Site
state: CataluÃ±a
city: Sabadell
country: Spain
facility: Research Site
state: CataluÃ±a
city: Madrid
country: Spain
facility: Research Site
city: Chur
country: Switzerland
facility: Research Site
city: Luzern 16
country: Switzerland
facility: Research Site
city: Zurich
country: Switzerland
facility: Research Site
city: Derby
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Peterborough
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.