ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12605000478617

Ethics application status

Approved

Date submitted

12/09/2005

Date registered

23/09/2005

Date last updated

14/07/2016

Type of registration

Retrospectively registered

Titles & IDs

Public title

ANZ 9311. Phase III trial to compare the effect of a short high dose intensive course of chemotherapy with filgrastim support versus a conventional standard dose course of chemotherapy in patients with advanced breast cancer.

Scientific title

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

ANZ 9311

Linked study record

Health condition

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

Advanced Breast Cancer

Condition category

Condition code

Cancer

Breast

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The purpose of the study is to compare a high dose epirubicin/cyclophosphamide (EC) chemotherapy regimen, plus Filgrastim support, given over a 9 week period with a standard epirubicin/cyclophosphamide (EC) chemotherapy regimen given over 18 weeks. The total dose of EC is the same.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

High dose epirubicin/cyclophosphamide (EC) chemotherapy regimen over 9 weeks.

Control group

Active

Outcomes

Primary outcome [1]

Evaluate whether the same total dose of chemotherapy given in half the time (with Filgrastim support) will result in improved quality of life in patients with breast cancer, due to greater time without toxicity or symptoms of disease. Quality of Life is measured by standard tools developed by the ANZ BCTG including Quality adjusted time without symptoms or toxicity (TWiST and QTWiST).

The main analysis will be performed after recruitment of the planned 225 patients, with a further 2 years of follow up. It is estimated that 3 years of accrual and 2 years of follow up will be required. The primary analysis will compare all randomised eligible patients on the two treatment regimens with respect to quality of life, survival duration, time to disease progression and quality adjusted survival analysis.

Timepoint [1]

In the first year after the beginning of treatment and the complete period of follow up.

The main analysis will be performed after recruitment of the planned 225 patients, with a further 2 years of follow up.

Primary outcome [2]

Evaluate whether the same total dose of chemotherapy given in half the time (with Filgrastim support) will result in improved quality of life in patients with breast cancer, due to greater time without toxicity or symptoms of disease. Quality of Life is measured by standard tools developed by the ANZ BCTG including survival.

The main analysis will be performed after recruitment of the planned 225 patients, with a further 2 years of follow up. It is estimated that 3 years of accrual and 2 years of follow up will be required. The primary analysis will compare all randomised eligible patients on the two treatment regimens with respect to quality of life, survival duration, time to disease progression and quality adjusted survival analysis.

Timepoint [2]

The main analysis will be performed after recruitment of the planned 225 patients, with a further 2 years of follow up.

Primary outcome [3]

Evaluate whether the same total dose of chemotherapy given in half the time (with Filgrastim support) will result in improved quality of life in patients with breast cancer, due to greater time without toxicity or symptoms of disease. Quality of Life is measured by standard tools developed by the ANZ BCTG including complete and partial response.

The main analysis will be performed after recruitment of the planned 225 patients, with a further 2 years of follow up. It is estimated that 3 years of accrual and 2 years of follow up will be required. The primary analysis will compare all randomised eligible patients on the two treatment regimens with respect to quality of life, survival duration, time to disease progression and quality adjusted survival analysis.

Timepoint [3]

The main analysis will be performed after recruitment of the planned 225 patients, with a further 2 years of follow up.

Primary outcome [4]

valuate whether the same total dose of chemotherapy given in half the time (with Filgrastim support) will result in improved quality of life in patients with breast cancer, due to greater time without toxicity or symptoms of disease. Quality of Life is measured by standard tools developed by the ANZ BCTG including the economic cost of treatment and patient care.

The main analysis will be performed after recruitment of the planned 225 patients, with a further 2 years of follow up. It is estimated that 3 years of accrual and 2 years of follow up will be required. The primary analysis will compare all randomised eligible patients on the two treatment regimens with respect to quality of life, survival duration, time to disease progression and quality adjusted survival analysis.

Timepoint [4]

The main analysis will be performed after recruitment of the planned 225 patients, with a further 2 years of follow up.

Primary outcome [5]

valuate whether the same total dose of chemotherapy given in half the time (with Filgrastim support) will result in improved quality of life in patients with breast cancer, due to greater time without toxicity or symptoms of disease. Quality of Life is measured by standard tools developed by the ANZ BCTG including comparing the same parameters of efficacy and toxicity over the first 3 cycles of chemotherapy.

The main analysis will be performed after recruitment of the planned 225 patients, with a further 2 years of follow up. It is estimated that 3 years of accrual and 2 years of follow up will be required. The primary analysis will compare all randomised eligible patients on the two treatment regimens with respect to quality of life, survival duration, time to disease progression and quality adjusted survival analysis.

Timepoint [5]

The main analysis will be performed after recruitment of the planned 225 patients, with a further 2 years of follow up.

Secondary outcome [1]

-nil-

Timepoint [1]

-nil-

Eligibility

Key inclusion criteria

Histologically proven primary breast cancer with recurrent and/or metastatic disease; no more than one previous cytotoxic chemotherapy regimen for recurrent or metastatic disease; disease must be measurable or evaluable; patient must be geographically accessible for follow up; written informed consent provided.

Minimum age

Not stated

Maximum age

Not stated

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

Past or recurrent malignancies at other sites, except adequately treated squamous or basal cell carcinoma of the skin, or carcinoma in situ of the cervix; radiotherapy in excess of regional therapy to primary disease, cranial therapy or limited localized therapy; patients whose only demonstrable disease is intracranial.

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)

The ANZ BCTG Operations Office provided a central randomisation service by phone for all Australian and New Zealand institutions. At the time of study entry all participants were allocated to one of two treatment arms.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Stratified block assignment. Computer generated stratified blocks.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

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

1/04/1994

Actual

2/02/1994

Date of last participant enrolment

Anticipated

Actual

1/07/1998

Date of last data collection

Anticipated

Actual

Sample size

Target

225

Accrual to date

Final

235

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

ANZ Breast Cancer Trials Group

Address [1]

PO BOX 155
HRMC NSW2310

Country [1]

Australia

Primary sponsor type

Other Collaborative groups

Name

Australia and New Zealand Breast Cancer Trials Group Ltd

Address

PO BOX 155
HMRC NSW 2310

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Nil

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Auckland Hospital

Ethics committee address [1]

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

Ethics committee name [2]

Austin Health

Ethics committee address [2]

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

Ethics approval number [2]

Ethics committee name [3]

Bendigo Hospital

Ethics committee address [3]

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

Approval date [3]

Ethics approval number [3]

Ethics committee name [4]

Box Hill Hospital

Ethics committee address [4]

Ethics committee country [4]

Australia

Date submitted for ethics approval [4]

Approval date [4]

Ethics approval number [4]

Ethics committee name [5]

Canberra Hospital

Ethics committee address [5]

Ethics committee country [5]

Australia

Date submitted for ethics approval [5]

Approval date [5]

Ethics approval number [5]

Ethics committee name [6]

Geelong Hospital

Ethics committee address [6]

Ethics committee country [6]

Australia

Date submitted for ethics approval [6]

Approval date [6]

Ethics approval number [6]

Ethics committee name [7]

Liverpool Hospital

Ethics committee address [7]

Ethics committee country [7]

Australia

Date submitted for ethics approval [7]

Approval date [7]

Ethics approval number [7]

Ethics committee name [8]

Mount Hospital

Ethics committee address [8]

Ethics committee country [8]

Australia

Date submitted for ethics approval [8]

Approval date [8]

Ethics approval number [8]

Ethics committee name [9]

Newcastle Mater Hospital

Ethics committee address [9]

Ethics committee country [9]

Australia

Date submitted for ethics approval [9]

Approval date [9]

Ethics approval number [9]

Ethics committee name [10]

Royal Hobart Hospital

Ethics committee address [10]

Ethics committee country [10]

Australia

Date submitted for ethics approval [10]

Approval date [10]

Ethics approval number [10]

Ethics committee name [11]

Royal Melbourne Hospital

Ethics committee address [11]

Ethics committee country [11]

Australia

Date submitted for ethics approval [11]

Approval date [11]

Ethics approval number [11]

Ethics committee name [12]

Royal North Shore Hospital

Ethics committee address [12]

Ethics committee country [12]

Australia

Date submitted for ethics approval [12]

Approval date [12]

Ethics approval number [12]

Ethics committee name [13]

Royal Prince Alfred Hospital

Ethics committee address [13]

Ethics committee country [13]

Australia

Date submitted for ethics approval [13]

Approval date [13]

01/07/1993

Ethics approval number [13]

Ethics committee name [14]

Sir Charles Gairdner Hospital

Ethics committee address [14]

Ethics committee country [14]

Australia

Date submitted for ethics approval [14]

Approval date [14]

Ethics approval number [14]

Ethics committee name [15]

Waikato Hospital

Ethics committee address [15]

Ethics committee country [15]

New Zealand

Date submitted for ethics approval [15]

Approval date [15]

Ethics approval number [15]

Ethics committee name [16]

Western Hospital

Ethics committee address [16]

Ethics committee country [16]

Australia

Date submitted for ethics approval [16]

Approval date [16]

Ethics approval number [16]

Ethics committee name [17]

Westmead Hospital

Ethics committee address [17]

Ethics committee country [17]

Australia

Date submitted for ethics approval [17]

Approval date [17]

Ethics approval number [17]

Summary

Brief summary

Phase III trial to campare the effect of a short high-dose intensive course of chemotherapy with filgrastim support versus a conventional standard-dose course of chemotherapy in patients with advanced breast cancer.

Trial website

Trial related presentations / publications

N/A

Public notes

Contacts

Principal investigator

Name

Prof Michael Green

Address

Department Haematology and Oncology
Royal Melbourne Hospital
Grattan Street
PARKVILLE VIC 3050

Country

Australia

Phone

+61 (03) 9342-7560

Fax

[email protected]

Contact person for public queries

Name

Corinna Beckmore

Address

ANZBCTG
PO Box 283
The Junction NSW 2291

Country

Australia

Phone

+61 2 4925 3068

Fax

+61 2 49850141

enquiries at anzbctg.org

Contact person for scientific queries

Name

John F Forbes

Address

ANZBCTG
PO Box 283
The Junction NSW 2291

Country

Australia

Phone

+61 2 49850113

Fax

+61 2 49601539

[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

Source	Title	Year of Publication	DOI
Embase	Dose intensity in anthracycline-based chemotherapy for metastatic breast cancer: mature results of the randomised clinical trial ANZ 9311.	2019	https://dx.doi.org/10.1007/s10549-019-05187-y

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

Trial Review

Documents added manually

Documents added automatically