ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12605000588695

Ethics application status

Approved

Date submitted

21/09/2005

Date registered

4/10/2005

Date last updated

9/06/2021

Date data sharing statement initially provided

9/06/2021

Type of registration

Retrospectively registered

Titles & IDs

Public title

Neoadjuvant chemotherapy with docetaxel and anthracycline based chemotherapy in patients with advanced breast cancer: Evaluation of biological, clinical and imaging markers of tumour response.

Scientific title

Neoadjuvant chemotherapy with docetaxel and anthracycline based chemotherapy in patients with advanced breast cancer: Evaluation of biological, clinical and imaging markers of tumour response

Secondary ID [1]

nil known

Universal Trial Number (UTN)

Trial acronym

SETUP

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Breast Cancer

Condition category

Condition code

Cancer

Breast

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Treatment A=
FEC100

Epirubicin iv over 15-30 minutes 100 mg/m2 once every 21 days, 4 cyles
plus
Fluorouracil iv bolus 500mg/m2 once every 21 days for 4 cycles
plus
Cyclophosphamide iv over 60 minutes 500mg/m2 once every 21 days for 4 cycles
Treatment B
Docetaxel
iv over 60 minutes 100 mg/m2 once every 21 days for 4 cycles
Trastuzumab Iv over 15-30 min 8 mg/m2 as loading dose, subsequent dose 6mg/m2 once evewry 21 days (after completion of anthracycline)
(after completion of anthracycline)
Subjects will receive treatment A followed by Treatment B with no wash out period
Subjects will only recieve the Trastuzumab if they are HER2 positive

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

both arms are considered standard of care

Control group

Active

Outcomes

Primary outcome [1]

Identification of markers that correlate with tumour response to chemotherapy

Timepoint [1]

Measured after surgical removal of tumour

Secondary outcome [1]

Disease free and overall survival.

Timepoint [1]

as event occurs

Eligibility

Key inclusion criteria

locally advanced breast cancer

Minimum age

18 Years

Maximum age

80 Years

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

metastatic disease (Stage 4)

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)

coin toss with no restriction

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Crossover

Other design features

Phase

Phase 3

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

8/04/2005

Actual

1/06/2004

Date of last participant enrolment

Anticipated

Actual

1/11/2017

Date of last data collection

Anticipated

Actual

29/12/2017

Sample size

Target

180

Accrual to date

Final

180

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Monash Health

Address [1]

Monash Cancer Centre
865 Centre rd
East Bentleigh VIC 3165

Country [1]

Australia

Primary sponsor type

Government body

Name

Monash Health

Address

246 Clayton rd, Clayton VIC 3168

Country

Australia

Secondary sponsor category [1]

Commercial sector/Industry

Name [1]

Sanofi-Aventis

Address [1]

12-24 Talavera Road
Macquarie Park NSW 2113

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash Medical Centre, Moorabbin Mornington peninsula Hospital

Ethics committee address [1]

246 Clayton rd, Clayton VIC 3168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

20/04/2004

Ethics approval number [1]

20/04/20004

Summary

Brief summary

This study is evaluating the effect of neoadjuvant chemotherapy with docetaxel and anthracycline in patients with advanced breast cancer. Who is it for? You may be eligible to join this study if you are a female aged 18 years or above who has a diagnosis of locally advanced breast cancer. Study details Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will undergo 4 cycles of chemotherapy with docetaxel followed by 4 cycles of chemotherapy with anthracycline. Participants in the other group will receive the same treatments in reverse order. The overall duration of treatment in each group is 24 weeks. All participants will be monitored for up to 5 years in order to evaluate clinical response and to identify markers that correlate with tumour response to chemotherapy. Assessments required include clinical examinations, mammogram, PET scan, MRI scan, blood tests and biopsy. We believe this study may help us in individualising cancer treatment.

Trial website

Trial related presentations / publications

https://pubmed.ncbi.nlm.nih.gov/20565953/

Public notes

Contacts

Principal investigator

Name

A/Prof Vinod Ganju

Address

Monash Cancer Centre
865 Centre rd East Bentleigh VIC 3165

Country

Australia

Phone

610399288120

Fax

[email protected]

Contact person for public queries

Name

Vinod Ganju

Address

Medical Oncology
Monash Medical Centre
Southern Health
Moorabbin Centre Road
East Bentleigh VIC 3165

Country

Australia

Phone

+61 3 99288120

Fax

+61 3 99288341

[email protected]

Contact person for scientific queries

Name

Peter Midolo

Address

Medical Oncology
Monash Medical Centre
Southern Health
Moorabbin Centre Road
East Bentleigh VIC 3165

Country

Australia

Phone

+61 3 99288195

Fax

+61 3 99288341

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

subjects did not consent to this

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
11994	Study protocol	https://pubmed.ncbi.nlm.nih.gov/20565953/
11995	Informed consent form	https://pubmed.ncbi.nlm.nih.gov/20565953/

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Changes in aldehyde dehydrogenase-1 expression during neoadjuvant chemotherapy predict outcome in locally advanced breast cancer.	2014	https://dx.doi.org/10.1186/bcr3648
Embase	Identification of DNA methylation biomarkers with potential to predict response to neoadjuvant chemotherapy in triple-negative breast cancer.	2021	https://dx.doi.org/10.1186/s13148-021-01210-6

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically