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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00229697




Registration number
NCT00229697
Ethics application status
Date submitted
28/09/2005
Date registered
30/09/2005
Date last updated
5/10/2015

Titles & IDs
Public title
Phase II Metastatic ER+/PgR+ Nolvadex +/- Iressa Study
Scientific title
A Phase II Randomised, Double-Blind, Stratified, Multi-Centre Trial Comparing the Nolvadex 20 Mg And Placebo Combination To The Nolvadex 20 Mg and ZD1839 (IRESSA™) 250 MG Combination In Patients With Metastatic Breast Cancer And Estrogen Receptor (ER) and/or Progesterone (PR) Positive Tumours
Secondary ID [1] 0 0
D7917C00225
Secondary ID [2] 0 0
1839IL/0225
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: 1 - ZD1839 + Nolvadex

Other: 2 - Nolvadex + placebo
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Strata 1: To compare the time to progression between 2 treatment arms (ZD1839/Nolvadex vs placebo/Nolvadex)
Timepoint [1] 0 0
Time to progression (progressive disease or death; equivalent to progression-free survival)
Primary outcome [2] 0 0
Strata 2: To compare the clinical benefit rate between 2 treatment arms (ZD1839/Nolvadex vs placebo/Nolvadex)
Timepoint [2] 0 0
Overall clinical benefit rate: Complete Response, Partial Response or Stable Disease > 24weeks after each combination
Secondary outcome [1] 0 0
To compare the clinical benefit rate between 2 treatment arms (ZD1839/Nolvadex vs placebo/Nolvadex) in Strata 1 and overall
Timepoint [1] 0 0
Overall clinical benefit rate: Complete Response, Partial Response or Stable Disease >24 weeks after each combination. Objective tumour resp defined according to RECIST criteria
Secondary outcome [2] 0 0
To compare time to progression between 2 treatment arms (ZD1839/Nolvadex vs placebo/Nolvadex) in Strata 2 and overall
Timepoint [2] 0 0
Time to progression (progressive disease or death)
Secondary outcome [3] 0 0
To compare the objective response rate between ZD1839/Nolvadex and placebo/Nolvadex in each strata and overall
Timepoint [3] 0 0
Objective tumour response (OR) defined according to RECIST criteria
Secondary outcome [4] 0 0
To estimate duration of response for the ZD1839/Nolvadex and placebo/Nolvadex treatments in each strata and overall
Timepoint [4] 0 0
Duration of response (CR and PR)
Secondary outcome [5] 0 0
To compare overall survival between the ZD1839/Nolvadex and placebo/Nolvadex in each strata
Timepoint [5] 0 0
Overall survival
Secondary outcome [6] 0 0
To assess whether patients with high tumour levels of HER-2 and/or AIB1 demonstrate de novo resistance to Nolvadex therapy or have shorter TTP or response duration when compared with Nolvadex/ZD1839 treatment
Timepoint [6] 0 0
Time to progression (progressive disease or death), duration of response (CR and PR)
Secondary outcome [7] 0 0
To compare the objective response rate between the ZD1839/Nolvadex and placebo/Nolvadex treatment arms in the subset of all patients with ER+ tumours staining 2+/3+ for Her2neu by IHC
Timepoint [7] 0 0
Objective tumour response (OR) defined according to RECIST criteria
Secondary outcome [8] 0 0
To compare the safety and tolerability of ZD1839/Nolvadex to placebo/Nolvadex
Timepoint [8] 0 0
Safety (frequency and severity of adverse events)
Secondary outcome [9] 0 0
To determine steady-state plasma trough concentrations of tamoxifen in all patients and to compare between the ZD1839/Nolvadex and placebo/Nolvadex treatment arms
Timepoint [9] 0 0
Tamoxifen (Cmin) steady-state plasma concentration
Secondary outcome [10] 0 0
To determine steady-state plasma trough concentrations of ZD1839 and relate values to historical data
Timepoint [10] 0 0
ZD1839 (Cmin) steady-state plasma concentration
Secondary outcome [11] 0 0
To relate steady-state plasma trough concentrations of ZD1839 to demographic, response, and safety variables
Timepoint [11] 0 0
ZD1839 (Cmin) steady-state plasma concentration
Secondary outcome [12] 0 0
To assess the quality of life (QOL) and symptom relief based on the Functional Assessment of Cancer Therapy - Breast (FACT-B) on both treatment arms
Timepoint [12] 0 0
FACT-B questionnaire, FBSI (FACT-B Symptom Index)
Secondary outcome [13] 0 0
To investigate subject hospital resource use and health status
Timepoint [13] 0 0
Hospitalisations and EQ-5D
Secondary outcome [14] 0 0
Characterization of specific adverse events
Timepoint [14] 0 0
Characterization of adverse events such as alopecia, rash and diarrhea
Secondary outcome [15] 0 0
To obtain tumour tissue for biologic studies in this patient population
Timepoint [15] 0 0
ER receptor, ErbB-1 &2 (immunohistochemistry) and other biological markers including Her2/neu, AIB1

Eligibility
Key inclusion criteria
* Histologically confirmed metastatic adenocarcinoma of the breast (seeTNM staging Appendix I) that is ER and/or PR positive as determined in local laboratories at each investigator site (central verification of ER status will be performed after the patient starts treatment
* A tissue block from either the metastatic or primary tumor site is required.
* WHO performance status (PS) 0-2
* Patients must not be pregnant or breast-feeding. A negative pregnancy test is required within 7 days prior to randomization if pre- or peri-menopausal. Postmenopausal patients are defined as:
* natural menopause with last menses > 1 year ago,
* radiation induced oophorectomy with last menses > 1 year ago,
* chemotherapy induced menopause with 1 year interval since last menses, or
* serum FSH and LH and plasma estradiol levels in the postmenopausal range for the institution.
* bilateral oophorectomy
Minimum age
18 Years
Maximum age
130 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients cannot be on hormone replacement therapy or received prior chemotherapy for metastatic disease.
* Patients previously treated with a Tyrosine Kinase inhibitor or have evidence of an active interstitial lung disease are not eligible.
* Treatment with LH-RH analog.
* Laboratory values as follow Bilirubin >1.5 times upper limit of normal ULN, alanine amino transferase (ALT) or aspartate amino transferase (AST) >2.5 times the ULN if no demonstrable liver metastases, or >5 times the ULN in the presence of liver metastases
* Bone marrow function: WBC <1500 mm3

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 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
1/10/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2015
Sample size
Target
Accrual to date
Final
317
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Bentleigh East
Recruitment hospital [2] 0 0
Research Site - Newcastle
Recruitment hospital [3] 0 0
Research Site - Randwick
Recruitment hospital [4] 0 0
Research Site - Westmead
Recruitment hospital [5] 0 0
Research Site - Wodonga
Recruitment postcode(s) [1] 0 0
- Bentleigh East
Recruitment postcode(s) [2] 0 0
- Newcastle
Recruitment postcode(s) [3] 0 0
- Randwick
Recruitment postcode(s) [4] 0 0
- Westmead
Recruitment postcode(s) [5] 0 0
- Wodonga
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Missouri
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
Argentina
State/province [4] 0 0
Bahía Blanca
Country [5] 0 0
Argentina
State/province [5] 0 0
Ciudad de Buenos Aires
Country [6] 0 0
Argentina
State/province [6] 0 0
Córdoba
Country [7] 0 0
Argentina
State/province [7] 0 0
El Palomar
Country [8] 0 0
Argentina
State/province [8] 0 0
Resistencia
Country [9] 0 0
Argentina
State/province [9] 0 0
Rosario
Country [10] 0 0
Argentina
State/province [10] 0 0
San Miguel de Tucuman
Country [11] 0 0
Argentina
State/province [11] 0 0
Santa Fe
Country [12] 0 0
Argentina
State/province [12] 0 0
Vicente Lopez
Country [13] 0 0
Belgium
State/province [13] 0 0
Brussels
Country [14] 0 0
Belgium
State/province [14] 0 0
Leuven
Country [15] 0 0
Belgium
State/province [15] 0 0
Wilrijk
Country [16] 0 0
Brazil
State/province [16] 0 0
Belo Horizonte
Country [17] 0 0
Brazil
State/province [17] 0 0
Curitiba
Country [18] 0 0
Brazil
State/province [18] 0 0
Porto Alegre
Country [19] 0 0
Brazil
State/province [19] 0 0
Sao Paulo
Country [20] 0 0
Brazil
State/province [20] 0 0
São Paulo
Country [21] 0 0
Canada
State/province [21] 0 0
Alberta
Country [22] 0 0
Canada
State/province [22] 0 0
New Brunswick
Country [23] 0 0
Canada
State/province [23] 0 0
Ontario
Country [24] 0 0
Canada
State/province [24] 0 0
Quebec
Country [25] 0 0
Denmark
State/province [25] 0 0
Herlev
Country [26] 0 0
France
State/province [26] 0 0
Lyon Cedex 08
Country [27] 0 0
France
State/province [27] 0 0
Mougins
Country [28] 0 0
France
State/province [28] 0 0
Poitiers
Country [29] 0 0
France
State/province [29] 0 0
Rouen
Country [30] 0 0
Germany
State/province [30] 0 0
Frankfurt
Country [31] 0 0
Germany
State/province [31] 0 0
Jena
Country [32] 0 0
Germany
State/province [32] 0 0
Kiel
Country [33] 0 0
Germany
State/province [33] 0 0
München
Country [34] 0 0
Germany
State/province [34] 0 0
Trier
Country [35] 0 0
South Africa
State/province [35] 0 0
Durban
Country [36] 0 0
South Africa
State/province [36] 0 0
Johannesburg
Country [37] 0 0
South Africa
State/province [37] 0 0
Klerksdorp
Country [38] 0 0
South Africa
State/province [38] 0 0
Observatory
Country [39] 0 0
Spain
State/province [39] 0 0
Barcelona
Country [40] 0 0
Spain
State/province [40] 0 0
Córdoba
Country [41] 0 0
Spain
State/province [41] 0 0
Madrid
Country [42] 0 0
Spain
State/province [42] 0 0
Majadahonda
Country [43] 0 0
Spain
State/province [43] 0 0
Zaragoza
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Colchester
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Dundee
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Manchester
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
AstraZeneca Iressa Medical Science Director, MD
Address 0 0
AstraZeneca
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/NCT00229697