Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000307909
Ethics application status
Approved
Date submitted
16/03/2011
Date registered
23/03/2011
Date last updated
23/03/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Paclitaxel and Epirubicin as neoadjuvant systemic treatment for locally advanced breast cancer
Scientific title
A phase II study of Paclitaxel and Epirubicin, as neoadjuvant systemic treatment, for women with locally advanced breast cancer to assess response rates
Secondary ID [1] 259795 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 261380 0
Condition category
Condition code
Cancer 259535 259535 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Neoadjuvant chemotherapy with Paclitaxel and Epirubicin.
Schedule: Paclitaxel 175mg per m2 intravenously, Epirubicin 90mg per m2, intravenously given once every 3 weeks for a total of 4 doses before surgery ( total of 12 weeks of treatment)
Intervention code [1] 264230 0
Treatment: Drugs
Comparator / control treatment
nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 262342 0
Response rates- to be assessed clinically and radiologically ( CT scan) before surgery. Also pathological response rates to be assessed after surgery.
Timepoint [1] 262342 0
16 weeks
Secondary outcome [1] 273583 0
Tolerance- to be assessed by blood tests ( Hemogram. biochemistry) and clinical examination ( Physical examination/ radiology)
Timepoint [1] 273583 0
3 weeks - tolerance will be assesed before start of each course of chemotherapy. If the patient presents with symptoms before this then they will be assessed on presentation.
Secondary outcome [2] 273590 0
Disease free survival. This will be assessed by 3 monthly for the for the first 2 years and 6 monthly for the next 3 years. Tests will involve CT scan and blood tests at every visit and mammogram of the contralateral breast every 12 months.
Timepoint [2] 273590 0
3 months
Secondary outcome [3] 273591 0
Overall Survival
Follow up visits will be 3 monthly for the for the first 2 years and 6 monthly for the next 3 years. Death due to nay cause will be recorded and analysed for survival.
Timepoint [3] 273591 0
3 months

Eligibility
Key inclusion criteria
Women aged 18 years or over with histological or cytologically confirmed locally advanced breast cancer. T3-4 Nx, Tx N2-3
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of metastatic disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Open label Phase II study
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Non randomised
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/08/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 264680 0
Hospital
Name [1] 264680 0
The Queen Elizabeth Hospital
Country [1] 264680 0
Australia
Primary sponsor type
Hospital
Name
The Queen Elizabeth Hospital
Address
Medical Oncology, The Queen Elizabeth Hospital, 28 Woodville Road, Woodville , SA 5011
Country
Australia
Secondary sponsor category [1] 263815 0
Commercial sector/Industry
Name [1] 263815 0
Bristol-Myers Squibb
Address [1] 263815 0
Bristol Myers Squibb Pharmaceuticals
Medical Department ,PO Box 39,Noble Park Vic 3174
Country [1] 263815 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266673 0
The Queen Elizabeth hospital ethics comittee
Ethics committee address [1] 266673 0
The Queen Elizabeth Hospital, 28 Woodville Road, Woodville , SA 5011
Ethics committee country [1] 266673 0
Australia
Date submitted for ethics approval [1] 266673 0
20/05/2004
Approval date [1] 266673 0
26/05/2004
Ethics approval number [1] 266673 0
2004059

Summary
Brief summary
This study is looking at the combination of the drugs Paclitaxel and Epirubicin used as neoadjuvant systemic treatment for women with locally advanced breast cancer in order to assess response rates

Who is it for?
You may take part in this study if you are a female aged 18 years or over and have a confirmed diagnosis of locally advanced breast cancer (cancer that is considered inoperable by your treating surgeon).

Trial Details

Participants in this study will receive Neoadjuvant (before surgery) chemotherapy with Paclitaxel and Epirubicin. The schedule of treatment will involve the drug Paclitaxel given at a dose of 175mg per m2 intravenously, and Epirubicin 90mg per m2 given intravenously given once every 3 weeks for a total of 4 doses before surgery (and an overall total of 12 weeks of treatment)

The aim of this study is to see how a combination of 2 chemotherapeutic drugs - Paclitaxel and Epirubicin, is tolerated in women with locally advanced breast cancer. We also expect to see how effective this combination is in the treatment of this condition.
Trial website
Nil
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 32350 0
Address 32350 0
Country 32350 0
Phone 32350 0
Fax 32350 0
Email 32350 0
Contact person for public queries
Name 15597 0
Dr Kenneth Pittman
Address 15597 0
Medical Oncology, The Queen Elizabeth hospital, 28 Woodville Road, Woodville, SA 5011
Country 15597 0
Australia
Phone 15597 0
+61 882226000
Fax 15597 0
Email 15597 0
[email protected]
Contact person for scientific queries
Name 6525 0
Dr Kenneth Pittman
Address 6525 0
Medical Oncology, The Queen Elizabeth hospital, 28 Woodville Road, Woodville, SA 5011
Country 6525 0
Australia
Phone 6525 0
+61 882226000
Fax 6525 0
Email 6525 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
No additional documents have been identified.