ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12606000529549

Ethics application status

Approved

Date submitted

12/05/1999

Date registered

12/05/1999

Date last updated

24/05/2011

Type of registration

Retrospectively registered

Titles & IDs

Public title

Adjuvant Treatment for patients with node-positive Breast Cancer Docetaxel sequentially or in combination with Doxorubicin, followed by CMF (cyclophosphamide, methotrexate, fluorouracil) vs. Doxorubicin alone or in combination with Cyclophosphamide, followed by CMF (cyclophosphamide, methotrexate, fluorouracil).

Scientific title

An Intergroup phase III trial to evaluate the activity of docetaxel, given either sequentially or in combination with doxorubicin, followed by CMF, in comparison to doxorubicin alone or in combination with cyclophosphamide, followed by CMF, in the adjuvant treatment of node-positive breast cancer patients

Secondary ID [1]

National Clinical Trials Registry: NCTR292

Universal Trial Number (UTN)

Trial acronym

BIG-2-98, EU-20002, RP-56976-V-315

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

Arm A1:doxorubicin 75 mg/m² i.v. once every 21 days for 4 cycles, followed by CMF (C = Cyclophosphamide - 100 mg/m² orally for days 1-14, M = Methotrexate - 40 mg/m² i.v. on days 1 and 8, FU = Flourouracil - 600 mg/m² i.v. days 1 and 8, every 28 days) for 3 cycles. (total treatment duration is 24 weeks)
Arm A2:doxorubicin 60 mg/m² i.v. and cyclophosphamide 600 mg/m² i.v., once every 21 days for 4 cycles, followed by CMF (C = Cyclophosphamide - 100 mg/m² orally for days 1-14, M = Methotrexate - 40 mg/m² i.v. on days 1 and 8, FU = Flourouracil - 600 mg/m² i.v. days 1 and 8, every 28 days) for 3 cycles. (total treatment duration is 24 weeks)
Arm B: doxorubicin 75 mg/m² i.v. day once every 21 days for 3 cycles, followed by Docetaxel 100 mg/m² i.v., once every 21 days for 3 cycles, followed by CMF (C = Cyclophosphamide - 100 mg/m² orally for days 1-14, M = Methotrexate - 40 mg/m² i.v. on days 1 and 8, FU = Flourouracil - 600 mg/m² i.v. days 1 and 8, every 28 days) for 3 cycles. (total treatment duration is 30 weeks)
Arm C: doxorubicin 50 mg/m² i.v. and docetaxel 75 mg/m² i.v. once every 21 days for 4 cycles, followed by CMF (C = Cyclophosphamide - 100 mg/m² orally for days 1-14, M = Methotrexate - 40 mg/m² i.v. on days 1 and 8, FU = Flourouracil - 600 mg/m² i.v. days 1 and 8, every 28 days) for 3 cycles. (total treatment duration is 24 weeks)

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

to be confirmed

Control group

Active

Outcomes

Primary outcome [1]

To compare disease free survival of adjuvant treatment containing docetaxel, either sequentially or in combination with doxorubicin followed by CMF (Cyclophosphamide, Methotrexate, Fluoruracil) to doxorubicin alone or in combination with cyclophosphamide followed by CMF.

Timepoint [1]

The primary outocome was assessed at a median follow up of 5 years. The primary analysis was performed in March 2006.

Secondary outcome [1]

To compare disease free survival of all treatment arms.

Timepoint [1]

The secondary outocomes were assessed at a median follow up of 5 years. The primary analysis was performed in March 2006.

Secondary outcome [2]

Toxicity and overall survival of treatment arms.

Timepoint [2]

The secondary outocomes were assessed at a median follow up of 5 years. The primary analysis was performed in March 2006.

Eligibility

Key inclusion criteria

Written or witnessed informed consent. Histologically proven breast cancer. Definitive surgical treatment must be either mastectomy, or breast conserving surgery with axillary lymph node dissection. Margins of resected specimen from definitive surgery must be histologically free of invasive adenocarcinoma and ductal carcinoma in situ (DCIS). Lobular carcinoma in-situ does not count as a positive margin. Histologic examination of the tumor: invasive adenocarcinoma with at least one axillary lymph node (pN1) showing evidence of tumor among a minimum of eight resected lymph nodes. The determination of ER (estrogen receptor) and PgR (progesterone receptor) is mandatory. Karnofsky Performance status index > or equal to 70 %. Normal cardiac function must be confirmed by assessment of LVEF (MUGA scan or echocardiography). Laboratory requirements: (within 14 days prior to registration) a) Hematology: i) Neutrophils > or equal to 2.0 x 109/Lii) Platelets > or equal to 100 x 109/Liii) Hemoglobin > or equal to 10 g/dLb) Hepatic functioni) Total bilirubin < or equal to 1 x Upper Normal Limitii) ASAT (SGOT) and ALAT (SGPT) < or equal to 1.5 x Upper Normal Limitiii) Alkaline phosphatase < or equal to 2.5 x Upper Normal Limitc) Renal function:i) Creatinine < or equal to 150 µmol/L (1.5 mg/dL); Complete staging work-up within 3 months prior to registration, including bilateral mammography, chest Xray (PA and lateral) and/or CT-scan, abdominal ultrasound and/or CT scan, bone scan. Patients must be accessible for treatment and follow-up. Negative pregnancy test (urine or serum) within 7 days prior to registration for all women of childbearing potential.

Minimum age

18 Years

Maximum age

70 Years

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

Prior systemic anticancer therapy for breast cancer (chemo-hormono-immuno-therapy). Prior radiation therapy for breast cancer. Pregnant, or lactating patients. Any locally advanced (clinical or pathological T4 and/or N2-known N3) or metastatic (M1) breast carcinoma. Patients with inoperable residual axillary nodal disease or with supraclavicular nodes.Pre-existing motor or sensory neurotoxicity of a severity > or equal to grade 2 by NCI criteria. Other serious illness or medical condition:o Congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or high-risk uncontrolled arrhythmias.o History of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent.o Active uncontrolled infection.o Active peptic ulcer, unstable diabetes mellitus. Past or current history of other neoplasm except for:o Curatively treated basal cell skin cancer.o Adequately treated in situ carcinoma of the cervix. In regard to past or current history of other breast carcinoma, criteria of exclusion are:o Past history of ipsilateral or past/current history of contralateral invasive breast carcinoma.o Past or current history of contralateral ductal in situ breast carcinoma. A past or current history of ipsilateral ductal in situ or lobular in situ (ipsilateral or contralateral) breast carcinoma is not a criteria of exclusion. Chronic treatment with corticosteroids unless initiated > 6 months prior to study entry and at low dose (< or equal to 20 mg methylprednisolone or equivalent). Concurrent treatment with hormonal replacement therapy: this treatment should be stopped before study entry. Definite contraindications for the use of corticosteroids. Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry. Concurrent treatment with any other anti-cancer therapy.

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)

Central randomisation by telephone/fax

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

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

1/06/1998

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

2730

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

BIG (Breast International Group)

Address [1]

Breast International Group (BIG)-aisbl
Institut Jules Bordet
Blvd de Waterloo 121, 7th fl
B-1000 Brussels
Belgium

Country [1]

Australia

Funding source category [2]

Self funded/Unfunded

Name [2]

IBCSG (International Breast Cancer Study Group)

Address [2]

International Breast Cancer Study Group IBCSG
Effingerstrasse 40
3008 Bern
Switzerland

Country [2]

Australia

Funding source category [3]

Commercial sector/Industry

Name [3]

Sanofi-Aventis

Address [3]

sanofi-aventis
Talavera Corporate Centre
Building D
12-24 Talavera Road
Macquarie Park, NSW 2113

Country [3]

Australia

Primary sponsor type

Commercial sector/Industry

Name

sanofi-aventis
Talavera Corporate Centre
Building D
12-24 Talavera Road
Macquarie Park, NSW 2113

Address

to be confirmed

Country

France

Secondary sponsor category [1]

Other Collaborative groups

Name [1]

BIG (Breast International Group)

Address [1]

Breast International Group (BIG)-aisbl
Institut Jules Bordet
Blvd de Waterloo 121, 7th fl
B-1000 Brussels
Belgium

Country [1]

Australia

Secondary sponsor category [2]

Other Collaborative groups

Name [2]

IBCSG (International Breast Cancer Study Group)

Address [2]

International Breast Cancer Study Group IBCSG
Effingerstrasse 40
3008 Bern
Switzerland

Country [2]

Australia

Secondary sponsor category [3]

Other Collaborative groups

Name [3]

locked bag 7, HRMC, NSW 2310

Address [3]

trial now complete. No further information will be added due to time constraints.

Country [3]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ashford Cancer Centre

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

Ethics committee name [2]

Auckland Hospital

Ethics committee address [2]

Ethics committee country [2]

New Zealand

Date submitted for ethics approval [2]

Approval date [2]

Ethics approval number [2]

Ethics committee name [3]

Austin & Repatriation Medical Centre

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]

Bendigo 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]

Border Medical Centre

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]

Box Hill 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]

Canberra 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]

Christchurch Hospital

Ethics committee address [8]

Ethics committee country [8]

New Zealand

Date submitted for ethics approval [8]

Approval date [8]

Ethics approval number [8]

Ethics committee name [9]

Concord 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]

Dunedin Hospital

Ethics committee address [10]

Ethics committee country [10]

New Zealand

Date submitted for ethics approval [10]

Approval date [10]

Ethics approval number [10]

Ethics committee name [11]

Flinders Medical Centre

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]

Frankston 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]

Geelong Hospital

Ethics committee address [13]

Ethics committee country [13]

Australia

Date submitted for ethics approval [13]

Approval date [13]

Ethics approval number [13]

Ethics committee name [14]

Lingard 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]

Liverpool Hospital

Ethics committee address [15]

Ethics committee country [15]

Australia

Date submitted for ethics approval [15]

Approval date [15]

Ethics approval number [15]

Ethics committee name [16]

Maroondah 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]

Monash Medical Centre

Ethics committee address [17]

Ethics committee country [17]

Australia

Date submitted for ethics approval [17]

Approval date [17]

Ethics approval number [17]

Ethics committee name [18]

Mount Hospital

Ethics committee address [18]

Ethics committee country [18]

Australia

Date submitted for ethics approval [18]

Approval date [18]

Ethics approval number [18]

Ethics committee name [19]

Newcastle Mater Hospital

Ethics committee address [19]

Ethics committee country [19]

Australia

Date submitted for ethics approval [19]

Approval date [19]

Ethics approval number [19]

Ethics committee name [20]

Palmerston North Hospital

Ethics committee address [20]

Ethics committee country [20]

New Zealand

Date submitted for ethics approval [20]

Approval date [20]

Ethics approval number [20]

Ethics committee name [21]

Peter MacCallum Cancer Institute

Ethics committee address [21]

Ethics committee country [21]

Australia

Date submitted for ethics approval [21]

Approval date [21]

Ethics approval number [21]

Ethics committee name [22]

Port Macquarie Hospital

Ethics committee address [22]

Ethics committee country [22]

Australia

Date submitted for ethics approval [22]

Approval date [22]

Ethics approval number [22]

Ethics committee name [23]

Prince of Wales Hospital

Ethics committee address [23]

Ethics committee country [23]

Australia

Date submitted for ethics approval [23]

Approval date [23]

Ethics approval number [23]

Ethics committee name [24]

Princess Alexandria Hospital

Ethics committee address [24]

Ethics committee country [24]

Australia

Date submitted for ethics approval [24]

Approval date [24]

Ethics approval number [24]

Ethics committee name [25]

Queen Elizabeth Hospital

Ethics committee address [25]

Ethics committee country [25]

Australia

Date submitted for ethics approval [25]

Approval date [25]

Ethics approval number [25]

Ethics committee name [26]

Royal Adelaide Hospital

Ethics committee address [26]

Ethics committee country [26]

Australia

Date submitted for ethics approval [26]

Approval date [26]

Ethics approval number [26]

Ethics committee name [27]

Royal Brisbane Hospital

Ethics committee address [27]

Ethics committee country [27]

Australia

Date submitted for ethics approval [27]

Approval date [27]

Ethics approval number [27]

Ethics committee name [28]

Royal Hobart Hospital

Ethics committee address [28]

Ethics committee country [28]

Australia

Date submitted for ethics approval [28]

Approval date [28]

Ethics approval number [28]

Ethics committee name [29]

Royal Melbourne Hospital

Ethics committee address [29]

Ethics committee country [29]

Australia

Date submitted for ethics approval [29]

Approval date [29]

Ethics approval number [29]

Ethics committee name [30]

Royal North Shore Hospital

Ethics committee address [30]

Ethics committee country [30]

Australia

Date submitted for ethics approval [30]

Approval date [30]

Ethics approval number [30]

Ethics committee name [31]

Royal Perth Hospital

Ethics committee address [31]

Ethics committee country [31]

Australia

Date submitted for ethics approval [31]

Approval date [31]

Ethics approval number [31]

Ethics committee name [32]

Royal Prince Alfred Hospital

Ethics committee address [32]

Ethics committee country [32]

Australia

Date submitted for ethics approval [32]

Approval date [32]

Ethics approval number [32]

Ethics committee name [33]

Sir Charles Gardiner Hospital

Ethics committee address [33]

Ethics committee country [33]

Australia

Date submitted for ethics approval [33]

Approval date [33]

Ethics approval number [33]

Ethics committee name [34]

St Andrew's Hospital

Ethics committee address [34]

Ethics committee country [34]

Australia

Date submitted for ethics approval [34]

Approval date [34]

Ethics approval number [34]

Ethics committee name [35]

St George Hospital

Ethics committee address [35]

Ethics committee country [35]

Australia

Date submitted for ethics approval [35]

Approval date [35]

Ethics approval number [35]

Ethics committee name [36]

St John of God Hospital (Subiaco)

Ethics committee address [36]

Ethics committee country [36]

Australia

Date submitted for ethics approval [36]

Approval date [36]

Ethics approval number [36]

Ethics committee name [37]

St Vincent's Hospital (Melbourne)

Ethics committee address [37]

Ethics committee country [37]

Australia

Date submitted for ethics approval [37]

Approval date [37]

Ethics approval number [37]

Ethics committee name [38]

The Alfred Hospital

Ethics committee address [38]

Ethics committee country [38]

Australia

Date submitted for ethics approval [38]

Approval date [38]

Ethics approval number [38]

Ethics committee name [39]

Western Hospital

Ethics committee address [39]

Ethics committee country [39]

Australia

Date submitted for ethics approval [39]

Approval date [39]

Ethics approval number [39]

Ethics committee name [40]

Westmead Hospital

Ethics committee address [40]

Ethics committee country [40]

Australia

Date submitted for ethics approval [40]

Approval date [40]

Ethics approval number [40]

Summary

Brief summary

This project is investigating the optimal use of docetaxel and doxorubicin in the treatment of women with breast cancer and involved lymph nodes (N+).

The efficacy of adjuvant chemotherapy in early breast cancer is well established by the international overview conducted by the Early Breast Cancer Trialist's Collaborative Group (EBCTCG).  They have demonstrated the efficacy of adjuvant chemotherapy on reducing mortality and recurrence rates, but current regimens are far from optimal.  Docetaxel (Taxotere), a new agent, has effectiveness and manageable side effects in the treatment of advanced breast cancer patients, and can plausibly improve outcomes for patients with early N+ breast cancer by optimal integration into current adjuvant chemotherapy regimens.

This clinical trial is designed to compare whether it is advantageous to use docetaxel and/or doxorubicin in combination or sequentially with other currently available chemotherapy drugs

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Administrative Officer, Data Management, Australia and New Zealand Breast Cancer Trial Group (ANZ BCTG) Operations Office

Address

Australia and New Zealand Breast Cancer Trial Group (ANZ BCTG) Operations Office
Department of Surgical Oncology
Locked Bag 7
Hunter Region Mail Centre NSW 2310

Country

Australia

Phone

+61 2 4925 3068

Fax

+61 2 49850141

[email protected]

Contact person for scientific queries

Name

Professor John F Forbes

Address

Australia and New Zealand Breast Cancer Trial Group (ANZ BCTG) Operations Office
Department of Surgical Oncology
Locked Bag 7
Hunter Region Mail Centre NSW 2310

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

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically