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Trial registered on ANZCTR


Registration number
ACTRN12607000176460
Ethics application status
Approved
Date submitted
8/03/2007
Date registered
20/03/2007
Date last updated
14/11/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Phase III Open Label, Randomized Two-Parallel-Arm Multicenter Study of E7389 versus Capecitabine in Patients with Locally Advanced or Metastatic Breast Cancer Previously Treated with Anthracyclines and Taxanes
Scientific title
A Phase III Open Label, Randomized Two-Parallel-Arm Multicenter Study of E7389 versus Capecitabine in Patients with Locally Advanced or Metastatic Breast Cancer Previously Treated with Anthracyclines and Taxanes - to compare the efficacy in terms of Overall Survival and Progression-Free Survival.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer Locally Advanced or Metastatic 1694 0
Condition category
Condition code
Cancer 1786 1786 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
E7389 versus Capecitabine in Patients with Locally Advanced or Metastatic
Breast Cancer Previously Treated with Anthracyclines and Taxanes and
Refractory to the Most Recent Chemotherapy. The intervention group E7389. E7389 will be administered 1.4mg/m2 as an infusion or as an injection into the vein on days 1 and 8 of a 21 day cycle.

Patients will continue on the study until they meet one of the following:
- progressive disease
- loss of benefit due to side effects of treatment
- patient withdraws consent
-investigator decision in the best interests of the patient
Intervention code [1] 1643 0
Treatment: Drugs
Comparator / control treatment
The control group is capecitabine. Capecitabine will be administered orally at a dose of 2.5mg/n2/day in two equal doses on days 1 to 14 of each 21 cycle.
Control group
Active

Outcomes
Primary outcome [1] 2497 0
To compare the efficacy of E7389 versus capecitabine monotherapy, in terms of Overall Survival in patients with locally advanced or metastatic breast cancer.
Timepoint [1] 2497 0
Overall survival is measured every 3 months from the date of randomisation until the date of all-cause mortality.
Primary outcome [2] 2498 0
To compare the efficacy of E7389 versus capecitabine monotherapy, in terms of Progression-Free Survival in patients with locally advanced or metastatic breast cancer.
Timepoint [2] 2498 0
Progression-free survival is measured from the date of randomisation to the date of recorded progression of the disease or all-cause mortality. Tumor response data utilised in the main analysis of progression-free survival will be obtained from an independent review of the imaging scans.
Secondary outcome [1] 4305 0
Quality of Life measured using the EORTC (European Organisation for Research and Treatment of Cancer) questionnaire.
Timepoint [1] 4305 0
At baseline, at week 6, 3 months, 6 months, 12 months, 18 months and 24 months after starting treatment.
Secondary outcome [2] 4306 0
Objective Tumor Response Rate as measured using RECIST (Response Evaluation Criteria in Solid Tumours) criteria.
Timepoint [2] 4306 0
Assessed every 2nd cycle of treatment while patients are on study and every 3 months when they come off study without progressive disease - Duration of Response will be assessed at end of study.
Secondary outcome [3] 4307 0
One, Two and Three year Survival.
Timepoint [3] 4307 0
One, two and three years after - Tumor Related Symptom Assessments measured by pain intensity (VAS), and analgesic consumption throughout the study from day of treatment till 30 days end of treatment.
Secondary outcome [4] 4308 0
Safety Parameters (adverse events, laboratory parameters, concomitant medication, and study drug exposure).
Timepoint [4] 4308 0
From day of consent till 30 days post end of treatment.
Secondary outcome [5] 4309 0
Pharmacokinetic/pharmacodynamic relationships in a population pharmacokinetic investigation in a minimum of 200 patients in the E7389 arm.
Timepoint [5] 4309 0
This will be measured during the first cycles of treatment only. A total of four samples will be taken from each participating patient. The time points will be assigned through IVRS.

Eligibility
Key inclusion criteria
Patients with histologically or cytologically confirmed carcinoma of the breast. Patients with locally advanced or metastatic disease who have received either one anthracycline-taxane combination chemotherapy, or two prior therapies, including an anthracycline-based regimen without a taxane, and a taxane-based regimen. The order in which the regimens were received is unimportant. The treatments may have been administered as adjuvant or neoadjuvant chemotherapy and/or for the treatment of advanced or metastatic disease.If the treatment has been administered as adjuvant or neoadjuvant disease (no both), the patient must have progressed during the treatment or within one year of the last dose of the most recent chemotherapy treatment If the treatment has been administered for advanced or metastatic disease, the patient must have progressed during the last treatment or within six months of the last dose of the most recent chemotherapy treatment.
Minimum age
18 Years
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who have received more than two prior chemotherapy regimens for their disease, including adjuvant therapies (other therapies are allowed eg anti-estrogens, trastuzumab and radiotherapy).Patients who have received capecitabine as prior therapy for their disease.Patients with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment with E7389. Any signs (eg radiologic) and/or symptoms of brain metastases must be stable for at least 4 weeks.

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)
Central randomisation - patients will be randomised through phone and fax via IVRS (Interactive Voice Response System).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed via IVRS (Interactive Voice Response System) which provides randomisation from a central location. The method used for sequence generation is stratified allocation based on geographical region and Her-2/neu status.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/09/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1937 0
Commercial sector/Industry
Name [1] 1937 0
Eisai
Country [1] 1937 0
United Kingdom
Primary sponsor type
Commercial sector/Industry
Name
Eisai
Address
3 shortlands, London, W6 8EE
Country
United Kingdom
Secondary sponsor category [1] 1748 0
Commercial sector/Industry
Name [1] 1748 0
PRA International
Address [1] 1748 0
Level 17, 323 Castlereagh Street, Sydney, NSW 2000
Country [1] 1748 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3608 0
St Vincent's Hospital Melbourne
Ethics committee address [1] 3608 0
Ethics committee country [1] 3608 0
Australia
Date submitted for ethics approval [1] 3608 0
Approval date [1] 3608 0
05/09/2006
Ethics approval number [1] 3608 0
HREC-D 068/06
Ethics committee name [2] 3609 0
Ashford Cancer Centre
Ethics committee address [2] 3609 0
Ethics committee country [2] 3609 0
Australia
Date submitted for ethics approval [2] 3609 0
Approval date [2] 3609 0
18/10/2006
Ethics approval number [2] 3609 0
Ethics committee name [3] 3610 0
Sydney Haematology and Oncology Clinics
Ethics committee address [3] 3610 0
Ethics committee country [3] 3610 0
Australia
Date submitted for ethics approval [3] 3610 0
Approval date [3] 3610 0
10/01/2007
Ethics approval number [3] 3610 0
0609-157M
Ethics committee name [4] 3611 0
Bankstown Hospital
Ethics committee address [4] 3611 0
Ethics committee country [4] 3611 0
Australia
Date submitted for ethics approval [4] 3611 0
Approval date [4] 3611 0
08/01/2007
Ethics approval number [4] 3611 0
HREC 2006/115a
Ethics committee name [5] 3612 0
Liverpool Hospital
Ethics committee address [5] 3612 0
Ethics committee country [5] 3612 0
Australia
Date submitted for ethics approval [5] 3612 0
Approval date [5] 3612 0
08/01/2000
Ethics approval number [5] 3612 0
HREC 2006/115a
Ethics committee name [6] 3613 0
Royal Hobart Hospital
Ethics committee address [6] 3613 0
Ethics committee country [6] 3613 0
Australia
Date submitted for ethics approval [6] 3613 0
Approval date [6] 3613 0
08/01/2007
Ethics approval number [6] 3613 0
HREC/D 068/06
Ethics committee name [7] 3614 0
Royal Perth Hospital
Ethics committee address [7] 3614 0
Ethics committee country [7] 3614 0
Australia
Date submitted for ethics approval [7] 3614 0
Approval date [7] 3614 0
21/01/2007
Ethics approval number [7] 3614 0
2007/019
Ethics committee name [8] 6107 0
Epworth Healthcare HREC
Ethics committee address [8] 6107 0
Ethics committee country [8] 6107 0
Australia
Date submitted for ethics approval [8] 6107 0
13/06/2007
Approval date [8] 6107 0
17/10/2007
Ethics approval number [8] 6107 0
Epworth Study Number 37807
Ethics committee name [9] 6108 0
Mater Health Services HREC
Ethics committee address [9] 6108 0
Ethics committee country [9] 6108 0
Australia
Date submitted for ethics approval [9] 6108 0
17/09/2007
Approval date [9] 6108 0
08/02/2008
Ethics approval number [9] 6108 0
1154A

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

Contacts
Principal investigator
Name 27577 0
Address 27577 0
Country 27577 0
Phone 27577 0
Fax 27577 0
Email 27577 0
Contact person for public queries
Name 10832 0
A/Prof Anthony Dowling, Principal Investigator
Address 10832 0
Medical Oncology
Level 2 Healy Wing
St Vincent's Hospital
41 Victoria Parade
Fitzroy VIC 3065
Country 10832 0
Australia
Phone 10832 0
+61 3 92883177
Fax 10832 0
+61 3 92883185
Email 10832 0
[email protected]
Contact person for scientific queries
Name 1760 0
Maree Ward, Clinical Operations Manager
Address 1760 0
PRA International
Level 17
Suite 1701
323 Castlereagh Street
Sydney NSW 2000
Country 1760 0
Australia
Phone 1760 0
+61 2 92891910
Fax 1760 0
+61 2 92811982
Email 1760 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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