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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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 website
https://clinicaltrials.gov/ct2/show/NCT00626106
Trial related presentations / publications
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.
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