Trial Review

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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
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.
Secondary ID [1] 287866 0
Nil
Universal Trial Number (UTN)
Trial acronym
ANZ 9311
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Breast Cancer 599 0
Condition category
Condition code
Cancer 672 672 0 0
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] 504 0
Treatment: Drugs
Comparator / control treatment
High dose epirubicin/cyclophosphamide (EC) chemotherapy regimen over 9 weeks.
Control group
Active

Outcomes
Primary outcome [1] 799 0
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] 799 0
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] 800 0
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] 800 0
The main analysis will be performed after recruitment of the planned 225 patients, with a further 2 years of follow up.
Primary outcome [3] 801 0
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] 801 0
The main analysis will be performed after recruitment of the planned 225 patients, with a further 2 years of follow up.
Primary outcome [4] 802 0
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] 802 0
The main analysis will be performed after recruitment of the planned 225 patients, with a further 2 years of follow up.
Primary outcome [5] 803 0
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] 803 0
The main analysis will be performed after recruitment of the planned 225 patients, with a further 2 years of follow up.
Secondary outcome [1] 1623 0
-nil-
Timepoint [1] 1623 0
-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?
No
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] 741 0
Self funded/Unfunded
Name [1] 741 0
ANZ Breast Cancer Trials Group
Country [1] 741 0
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] 614 0
None
Name [1] 614 0
Nil
Address [1] 614 0
Country [1] 614 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1946 0
Auckland Hospital
Ethics committee address [1] 1946 0
Ethics committee country [1] 1946 0
New Zealand
Date submitted for ethics approval [1] 1946 0
Approval date [1] 1946 0
Ethics approval number [1] 1946 0
Ethics committee name [2] 1947 0
Austin Health
Ethics committee address [2] 1947 0
Ethics committee country [2] 1947 0
Australia
Date submitted for ethics approval [2] 1947 0
Approval date [2] 1947 0
Ethics approval number [2] 1947 0
Ethics committee name [3] 1948 0
Bendigo Hospital
Ethics committee address [3] 1948 0
Ethics committee country [3] 1948 0
Australia
Date submitted for ethics approval [3] 1948 0
Approval date [3] 1948 0
Ethics approval number [3] 1948 0
Ethics committee name [4] 1949 0
Box Hill Hospital
Ethics committee address [4] 1949 0
Ethics committee country [4] 1949 0
Australia
Date submitted for ethics approval [4] 1949 0
Approval date [4] 1949 0
Ethics approval number [4] 1949 0
Ethics committee name [5] 1950 0
Canberra Hospital
Ethics committee address [5] 1950 0
Ethics committee country [5] 1950 0
Australia
Date submitted for ethics approval [5] 1950 0
Approval date [5] 1950 0
Ethics approval number [5] 1950 0
Ethics committee name [6] 1951 0
Geelong Hospital
Ethics committee address [6] 1951 0
Ethics committee country [6] 1951 0
Australia
Date submitted for ethics approval [6] 1951 0
Approval date [6] 1951 0
Ethics approval number [6] 1951 0
Ethics committee name [7] 1952 0
Liverpool Hospital
Ethics committee address [7] 1952 0
Ethics committee country [7] 1952 0
Australia
Date submitted for ethics approval [7] 1952 0
Approval date [7] 1952 0
Ethics approval number [7] 1952 0
Ethics committee name [8] 1953 0
Mount Hospital
Ethics committee address [8] 1953 0
Ethics committee country [8] 1953 0
Australia
Date submitted for ethics approval [8] 1953 0
Approval date [8] 1953 0
Ethics approval number [8] 1953 0
Ethics committee name [9] 1954 0
Newcastle Mater Hospital
Ethics committee address [9] 1954 0
Ethics committee country [9] 1954 0
Australia
Date submitted for ethics approval [9] 1954 0
Approval date [9] 1954 0
Ethics approval number [9] 1954 0
Ethics committee name [10] 1955 0
Royal Hobart Hospital
Ethics committee address [10] 1955 0
Ethics committee country [10] 1955 0
Australia
Date submitted for ethics approval [10] 1955 0
Approval date [10] 1955 0
Ethics approval number [10] 1955 0
Ethics committee name [11] 1956 0
Royal Melbourne Hospital
Ethics committee address [11] 1956 0
Ethics committee country [11] 1956 0
Australia
Date submitted for ethics approval [11] 1956 0
Approval date [11] 1956 0
Ethics approval number [11] 1956 0
Ethics committee name [12] 1957 0
Royal North Shore Hospital
Ethics committee address [12] 1957 0
Ethics committee country [12] 1957 0
Australia
Date submitted for ethics approval [12] 1957 0
Approval date [12] 1957 0
Ethics approval number [12] 1957 0
Ethics committee name [13] 1958 0
Royal Prince Alfred Hospital
Ethics committee address [13] 1958 0
Ethics committee country [13] 1958 0
Australia
Date submitted for ethics approval [13] 1958 0
Approval date [13] 1958 0
01/07/1993
Ethics approval number [13] 1958 0
Ethics committee name [14] 1959 0
Sir Charles Gairdner Hospital
Ethics committee address [14] 1959 0
Ethics committee country [14] 1959 0
Australia
Date submitted for ethics approval [14] 1959 0
Approval date [14] 1959 0
Ethics approval number [14] 1959 0
Ethics committee name [15] 1960 0
Waikato Hospital
Ethics committee address [15] 1960 0
Ethics committee country [15] 1960 0
New Zealand
Date submitted for ethics approval [15] 1960 0
Approval date [15] 1960 0
Ethics approval number [15] 1960 0
Ethics committee name [16] 1961 0
Western Hospital
Ethics committee address [16] 1961 0
Ethics committee country [16] 1961 0
Australia
Date submitted for ethics approval [16] 1961 0
Approval date [16] 1961 0
Ethics approval number [16] 1961 0
Ethics committee name [17] 1962 0
Westmead Hospital
Ethics committee address [17] 1962 0
Ethics committee country [17] 1962 0
Australia
Date submitted for ethics approval [17] 1962 0
Approval date [17] 1962 0
Ethics approval number [17] 1962 0

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 35755 0
Prof Michael Green
Address 35755 0
Department Haematology and Oncology
Royal Melbourne Hospital
Grattan Street
PARKVILLE VIC 3050
Country 35755 0
Australia
Phone 35755 0
+61 (03) 9342-7560
Fax 35755 0
Email 35755 0
enquiries@anzbctg.org
Contact person for public queries
Name 9693 0
Ms Corinna Beckmore
Address 9693 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 9693 0
Australia
Phone 9693 0
+61 2 4925 3068
Fax 9693 0
+61 2 49850141
Email 9693 0
enquiries at anzbctg.org
Contact person for scientific queries
Name 621 0
Prof John F Forbes
Address 621 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 621 0
Australia
Phone 621 0
+61 2 49850113
Fax 621 0
+61 2 49601539
Email 621 0
enquiries@anzbctg.org

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
SourceTitleYear of PublicationDOI
EmbaseDose intensity in anthracycline-based chemotherapy for metastatic breast cancer: mature results of the randomised clinical trial ANZ 9311.2019https://dx.doi.org/10.1007/s10549-019-05187-y
N.B. These documents automatically identified may not have been verified by the study sponsor.