Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000099628
Ethics application status
Approved
Date submitted
25/07/2005
Date registered
9/08/2005
Date last updated
8/04/2021
Date data sharing statement initially provided
8/04/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
FEASIBILITY STUDY OF PREOPERATIVE TAC IN CONJUNCTION WITH THE DEVELOPMENT OF A STANDARD PROTOCOL FOR THE MANAGEMENT OF LOCALLY ADVANCED BREAST CANCER
Scientific title
FEASIBILITY STUDY OF PREOPERATIVE TAC (DOCETAXEL, DOXORUBICIN, CYCLOPHOSPHAMIDE) IN CONJUNCTION WITH THE DEVELOPMENT OF A STANDARD PROTOCOL FOR THE MANAGEMENT OF LOCALLY ADVANCED BREAST CANCER (XRP6976D/6164)
Secondary ID [1] 287835 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer Locally advanced 180 0
Condition category
Condition code
Cancer 204 204 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
6 cycles of TAC chemotherapy given pre-operatively and in responding patients, followed by surgery then radiation therapy.
Intervention code [1] 66 0
Treatment: Drugs
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 243 0
Rate of complete pathological response following surgery
Timepoint [1] 243 0
surgery
Primary outcome [2] 244 0
Feasibility of delivering 6 cycles of TAC followed by surgery within 21 days and subsequently radiation therapy
Timepoint [2] 244 0
30 days after last dose of chemo
Secondary outcome [1] 551 0
Assessment of response by 1) Breast MRI and 2) PET scan.
Timepoint [1] 551 0
post treatment but prior to surgery

Eligibility
Key inclusion criteria
Breast cancer T3Nany, T4Nany, N2 or N3 M0, ECOG performance status 0-2, Normal cardiac function.
Minimum age
Not stated
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
No metastases, Peripheral neuropathy > grade 2.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2005
Actual
1/03/2005
Date of last participant enrolment
Anticipated
Actual
1/11/2006
Date of last data collection
Anticipated
Actual
6/10/2010
Sample size
Target
34
Accrual to date
Final
34
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 258 0
Commercial sector/Industry
Name [1] 258 0
Investigator initiated pharmaceutical grant
Country [1] 258 0
Australia
Primary sponsor type
Individual
Name
Dr Arlene Chan
Address
Suite 41/ 146 Mounts Bay Road Perth WA 6000
Country
Australia
Secondary sponsor category [1] 197 0
Commercial sector/Industry
Name [1] 197 0
Sanofi-Aventis
Address [1] 197 0
unknown / trial documents archived
Country [1] 197 0
France

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1086 0
Mount Hospital, Perth
Ethics committee address [1] 1086 0
Ethics committee country [1] 1086 0
Australia
Date submitted for ethics approval [1] 1086 0
Approval date [1] 1086 0
07/02/2005
Ethics approval number [1] 1086 0
Ethics committee name [2] 1087 0
Sir Charles Gairdner Hospital, Perth
Ethics committee address [2] 1087 0
Ethics committee country [2] 1087 0
Australia
Date submitted for ethics approval [2] 1087 0
Approval date [2] 1087 0
Ethics approval number [2] 1087 0

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

Contacts
Principal investigator
Name 35597 0
Prof Arlene Chan
Address 35597 0
Hollywood Consulting Centre
Suite 407, 4th Floor
91 Monash Avenue
Nedlands WA 6009
Country 35597 0
Australia
Phone 35597 0
+61 8 9481 4522
Fax 35597 0
Email 35597 0
admin.profachan@me.com
Contact person for public queries
Name 9255 0
Jeannette Devoto
Address 9255 0
Hollywood Consulting Centre
Suite 407, 4th Floor
91 Monash Avenue
Nedlands WA 6009
Country 9255 0
Australia
Phone 9255 0
+61 8 9483 46643
Fax 9255 0
Email 9255 0
BCTU@bcrc-wa.com.au
Contact person for scientific queries
Name 183 0
Dr Arlene Chan
Address 183 0
Hollywood Consulting Centre
Suite 407, 4th Floor
91 Monash Avenue
Nedlands WA 6009
Country 183 0
Australia
Phone 183 0
+61 8 9481 4522
Fax 183 0
Email 183 0
admin.profachan@me.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.