Trial Review

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
ACTRN12607000023459
Ethics application status
Approved
Date submitted
3/11/1994
Date registered
3/11/1994
Date last updated
11/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
IBCSG VII - Adjuvant chemotherapy in node positive postmenopausal breast cancer patients: endocrine vs. chemo-endocrine vs. chemo-endocrine with delayed chemotherapy.
Scientific title
Adjuvant chemotherapy in node positive postmenopausal breast cancer patients: endocrine vs. chemo-endocrine vs. chemo-endocrine with delayed chemotherapy.
Secondary ID [1] 4 0
National Clinical Trials Registry: NCTR91
Universal Trial Number (UTN)
Trial acronym
IBCSG VII
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 7 0
Condition category
Condition code
Cancer 7 7 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm B: Delayed CMF (cyclophosphamide 100mg/m^2 orally days 1-14, methotrexate 40mg/m^2 iv days 1 and 8, fluorouracil 600mg/m^2 iv days 1 and 8; cycle duration = 28 days) - administered at month 9, 12 and 15 + Tamoxifen (20mg orally daily for 5 years)

Arm C: Immediate CMF (cyclophosphamide 100mg/m^2 orally days 1-14, methotrexate 40mg/m^2 iv days 1 and 8, fluorouracil 600mg/m^2 iv days 1 and 8; cycle duration = 28 days) - administered at months 1,2,3 + Tamoxifen (20mg orally daily for 5 years)

Arm D: Immediate CMF (cyclophosphamide 100mg/m^2 orally days 1-14, methotrexate 40mg/m^2 iv days 1 and 8, fluorouracil 600mg/m^2 iv days 1 and 8; cycle duration = 28 days) - administered at month 1,2,3 + delayed CMF (cyclophosphamide 100mg/m^2 orally days 1-14, methotrexate 40mg/m^2 iv days 1 and 8, fluorouracil 600mg/m^2 iv days 1 and 8; cycle duration = 28 days) - administered at month 9, 12 and 15 + Tamoxifen (20mg orally daily for 5 years)
Intervention code [1] 1246 0
Treatment: Drugs
Comparator / control treatment
Arm A: Tamoxifen alone (20mg orally daily for 5 years)
Control group
Active

Outcomes
Primary outcome [1] 8 0
Disease-free survival
Timepoint [1] 8 0
All patients will be assessed by clinicians for recurrence of disease every third month during the first 2 years, every six months for years 3-5 and annually thereafter for life.
Secondary outcome [1] 11 0
Overall survival
Timepoint [1] 11 0
All patients will be assessed by clinicians for the secondary endpoints every third month during the first 2 years, every six months for years 3-5 and annually thereafter for life. Treatment related side effects will also be assessed after every CMF (cyclophosphamide, methotrexate, 5-fluorouracil) administration.
Secondary outcome [2] 12 0
Relapse site
Timepoint [2] 12 0
All patients will be assessed by clinicians for the secondary endpoints every third month during the first 2 years, every six months for years 3-5 and annually thereafter for life. Treatment related side effects will also be assessed after every CMF (cyclophosphamide, methotrexate, 5-fluorouracil) administration.
Secondary outcome [3] 13 0
Side-effects
Timepoint [3] 13 0
All patients will be assessed by clinicians for the secondary endpoints every third month during the first 2 years, every six months for years 3-5 and annually thereafter for life. Treatment related side effects will also be assessed after every CMF (cyclophosphamide, methotrexate, 5-fluorouracil) administration.

Eligibility
Key inclusion criteria
a) >52 years, with at least 1 year of amenorrhea OR b) <=52 years, with 3 years or more of amenorrhea OR c) >55 years, and who have had hysterectomy, without bilateral oopherectomy OR d) who have had Biochemical evidence of cessation of ovarian function (in questionable cases); All N+ patients with ER status determined for stratification; Tumour confined to breast with or without metastatic spread limited to ipsilateral axilla; Axillary nodes were not fixed and there was no arm oedema; WBC is >= 4,000/mm^3 and platelet count is >= 100,000/mm^3; Documented evidence of adequate renal ( creatinine < 120umol/L) and hepatic (bilirubin < 20umol/L, SGOT < 60 iu/L) function; Patients must give consent to be in study and be geographically accessible for follow-up; UICC performance status of 0 – 2; Either total mastectomy, quadrantectomy or lumpectomy with axillary clearance, performed no earlier than 6 weeks (addendum 2, previously 4 weeks) before randomization; A minimum of 8 lymph nodes has been histologically examined
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Malignant breast tumours other than carcinoma; Inflammatory carcinoma, with ulceration or infiltration of skin, or peau d'orange; T3b ot T4 breast carcinoma, or N2 or N3 nodal status; Bilateral malignancies, or mass in opposite breast; Less than total mastectomy procedures; Pregnant or lactating women; Previous or concomitant malignancy; Prior therapy for breast cancer; Clinically positive nodes in axilla opposite to affected breast; Other non-malignant systemic diseases preventing treatment options/follow-up; Psychiatric or addictive disorders preventing informed consent; Premenopausal patients with ER+ primary tumours; Bone scintigrams showing hot spots which cannot be confirmed as benign disease; N- patients (Addendum 1)

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
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
1/07/1986
Actual
29/08/1986
Date of last participant enrolment
Anticipated
Actual
1/04/1993
Date of last data collection
Anticipated
Actual
Sample size
Target
1200
Accrual to date
Final
1266
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 8 0
Self funded/Unfunded
Name [1] 8 0
Australia and New Zealand Breast Cancer Trials Group
Country [1] 8 0
Australia
Primary sponsor type
Other Collaborative groups
Name
International Breast Cancer Study Group
Address
Effingerstrasse 40, 3008 Bern
Country
Switzerland
Secondary sponsor category [1] 7 0
Other Collaborative groups
Name [1] 7 0
Australia and New Zealand Breast Cancer Trials Group
Address [1] 7 0
PO BOX 155
HRMC NSW 2310
Country [1] 7 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 30 0
Newcastle Mater Misericordiae Hospital
Ethics committee address [1] 30 0
Ethics committee country [1] 30 0
Australia
Date submitted for ethics approval [1] 30 0
Approval date [1] 30 0
Ethics approval number [1] 30 0
Ethics committee name [2] 31 0
Sydney
Ethics committee address [2] 31 0
Ethics committee country [2] 31 0
Australia
Date submitted for ethics approval [2] 31 0
Approval date [2] 31 0
Ethics approval number [2] 31 0
Ethics committee name [3] 32 0
Adelaide
Ethics committee address [3] 32 0
Ethics committee country [3] 32 0
Australia
Date submitted for ethics approval [3] 32 0
Approval date [3] 32 0
01/04/1993
Ethics approval number [3] 32 0
Ethics committee name [4] 33 0
Melbourne
Ethics committee address [4] 33 0
Ethics committee country [4] 33 0
Australia
Date submitted for ethics approval [4] 33 0
Approval date [4] 33 0
Ethics approval number [4] 33 0
Ethics committee name [5] 34 0
Perth
Ethics committee address [5] 34 0
Ethics committee country [5] 34 0
Australia
Date submitted for ethics approval [5] 34 0
Approval date [5] 34 0
Ethics approval number [5] 34 0
Ethics committee name [6] 35 0
Auckland Hospital
Ethics committee address [6] 35 0
Ethics committee country [6] 35 0
New Zealand
Date submitted for ethics approval [6] 35 0
Approval date [6] 35 0
Ethics approval number [6] 35 0

Summary
Brief summary
The use of tamoxifen has provided a reduction in deaths due to breast cancer in postmenopausal women with both node-positive and node-negative disease. However, the benefit of tamoxifen treatment may be confined to patients with oestrogen receptor positive disease and a standard adjuvant treatment for all postmenopausal patients with node-positive, oestrogen receptor negative disease has not yet been defined. Results from previous trials have indicated that the combination of CMF and tamoxifen (chemo-endocrine therapy) improved disease-free survival in all postmenopausal patients when compared with CMF or surgery alone. Patients with oestrogen receptor negative disease were found to benefit significantly from the combined treatments. Therefore, IBCSG VII will investigate the effectiveness of adding early combination chemotherapy and late additional chemotherapy to adjuvant tamoxifen compared to administering tamoxifen treatment alone in postmenopausal women.
Trial website
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 35985 0
Prof John F Forbes
Address 35985 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 35985 0
Australia
Phone 35985 0
+61 2 4985 0113
Fax 35985 0
Email 35985 0
[email protected]
Contact person for public queries
Name 10435 0
Ms Corinna Beckmore
Address 10435 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 10435 0
Australia
Phone 10435 0
+61 2 4925 3068
Fax 10435 0
+61 2 49850141
Email 10435 0
[email protected]
Contact person for scientific queries
Name 1363 0
Prof John F Forbes
Address 1363 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 1363 0
Australia
Phone 1363 0
+61 2 4985 0113
Fax 1363 0
+ 61 2 4960 1539
Email 1363 0
[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.