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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00626106




Registration number
NCT00626106
Ethics application status
Date submitted
21/02/2008
Date registered
29/02/2008
Date last updated
27/10/2016

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
QUILT-2.015
Secondary ID [2] 0 0
20060362
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Breast Tumors 0 0
Metastatic Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AMG 479 or placebo administered with either exemestane or fulvestrant
Treatment: Drugs - AMG 479 or placebo administered with either exemestane or fulvestrant
Treatment: Drugs - AMG 479 or placebo administered with either exemestane or fulvestrant

Placebo comparator: Placebo -

Active comparator: Investigational Product -

Other: Roll-over -


Treatment: Drugs: AMG 479 or placebo administered with either exemestane or fulvestrant
Arm 2 - placebo with exemestane or fulvestrant

Treatment: Drugs: AMG 479 or placebo administered with either exemestane or fulvestrant
Arm 3 - roll over to open-label AMG 479 with exemestane or fulvestrant

Treatment: Drugs: AMG 479 or placebo administered with either exemestane or fulvestrant
Arm 1 - AMG 479 administered with exemestane or fulvestrant
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression free survival (PFS), as measured by Response Evaluation Criteria in Solid Tumors criteria (modified RECIST) per local review
Timepoint [1] 0 0
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 [1] 0 0
Incidence of adverse events, abnormal laboratory values, and anti-AMG 479 antibody formation
Timepoint [1] 0 0
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 [2] 0 0
PK parameters of AMG 479
Timepoint [2] 0 0
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 [3] 0 0
Breast cancer related symptoms, health related quality of life, and skin toxicity burden
Timepoint [3] 0 0
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 [4] 0 0
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
Timepoint [4] 0 0
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
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* HR-unknown or HR-negative disease
* Not amenable to endocrine therapy
* Central nervous system metastasis

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2011
Sample size
Target
Accrual to date
Final
156
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Research Site - Waratah
Recruitment hospital [2] 0 0
Research Site - Woodville South
Recruitment hospital [3] 0 0
Research Site - Footscray
Recruitment hospital [4] 0 0
Research Site - Geelong
Recruitment hospital [5] 0 0
Research Site - Malvern
Recruitment postcode(s) [1] 0 0
2298 - Waratah
Recruitment postcode(s) [2] 0 0
5011 - Woodville South
Recruitment postcode(s) [3] 0 0
3011 - Footscray
Recruitment postcode(s) [4] 0 0
3220 - Geelong
Recruitment postcode(s) [5] 0 0
3144 - Malvern
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
New Hampshire
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
Tennessee
Country [12] 0 0
United States of America
State/province [12] 0 0
Utah
Country [13] 0 0
United States of America
State/province [13] 0 0
Washington
Country [14] 0 0
Canada
State/province [14] 0 0
British Columbia
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Canada
State/province [16] 0 0
Quebec
Country [17] 0 0
France
State/province [17] 0 0
Dijon
Country [18] 0 0
France
State/province [18] 0 0
Le Mans
Country [19] 0 0
France
State/province [19] 0 0
Lyon
Country [20] 0 0
France
State/province [20] 0 0
Montpellier Cedex 5
Country [21] 0 0
France
State/province [21] 0 0
Nice Cedex 2
Country [22] 0 0
France
State/province [22] 0 0
Paris Cedex 5
Country [23] 0 0
France
State/province [23] 0 0
Reims Cedex
Country [24] 0 0
France
State/province [24] 0 0
Saint Herblain
Country [25] 0 0
Germany
State/province [25] 0 0
Frankfurt
Country [26] 0 0
Germany
State/province [26] 0 0
Hannover
Country [27] 0 0
Germany
State/province [27] 0 0
München
Country [28] 0 0
Ireland
State/province [28] 0 0
Dublin
Country [29] 0 0
Spain
State/province [29] 0 0
Cataluña
Country [30] 0 0
Spain
State/province [30] 0 0
Madrid
Country [31] 0 0
Switzerland
State/province [31] 0 0
Chur
Country [32] 0 0
Switzerland
State/province [32] 0 0
Luzern 16
Country [33] 0 0
Switzerland
State/province [33] 0 0
Zurich
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Derby
Country [35] 0 0
United Kingdom
State/province [35] 0 0
London
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Manchester
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Peterborough

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
NantCell, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00626106