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
Date results information 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
This will be a single arm, multicentre study involving women diagnosed with non-metastatic locally advanced breast cancer. The study will assess the feasibility of developing a uniform approach with chemotherapy, surgery and radiation therapy in the treatment of locally advanced breast cancer. It will also define the rates of objective clinical response and complete pathological response following 6 cycles TAC. Further, the accuracy of breast MRI and PET in predicting extent of breast cancer in the pathological examination of the surgical specimen will be assessed.
Trial website
Trial related presentations / publications
Chan A, Willsher P, Hastrich D et al Pre-operative Taxane-Based Chemotherapy in a Standardized Protocol for the Management of Locally Advanced Breast Cancer Apj Clin Oncol. 2012:8:62-70
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
[email protected]
Contact person for public queries
Name 9255 0
Mrs 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
[email protected]
Contact person for scientific queries
Name 183 0
Prof 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
[email protected]

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.