Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000065493
Ethics application status
Approved
Date submitted
15/01/2007
Date registered
19/01/2007
Date last updated
11/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
IBCSG 21-99 - Menstrual Cycle and Surgical Treatment of Breast Cancer
Scientific title
Menstrual Cycle and Surgical Treatment of Breast Cancer
Secondary ID [1] 331 0
International Breast Cancer Study Group (IBCSG): IBCSG 21-99
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 1556 0
Condition category
Condition code
Cancer 1656 1656 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients will undergo either a one-stage surgical procedure (open biopsy followed by mastectomy or breastconserving
approach) or two-stage surgical procedure (open biopsy followed later by mastectomy or breast-conserving approach) and will be followed every year for 10 years.
Intervention code [1] 1556 0
None
Comparator / control treatment
No conrtol group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2291 0
Disease-free survival
Timepoint [1] 2291 0
Patients will be assessed for progression of disease every 6 months for the first year after study entry and annually thereafter until year 10.
Secondary outcome [1] 3997 0
Distant disease free-survival
Timepoint [1] 3997 0
Patients will be assessed for progression of disease and survival status every 6 months for the first year after study entry and annually thereafter until year 10.
Secondary outcome [2] 3998 0
Overall survival
Timepoint [2] 3998 0
Patients will be assessed for progression of disease and survival status every 6 months for the first year after study entry and annually thereafter until year 10.

Eligibility
Key inclusion criteria
One-stage surgical procedure (open biopsy followed by mastectomy or breast conserving approach):Required characteristics• Premenopausal women with regular menstrual periods (21–35 days) and pathologic stage I–II breast cancer.• One-stage surgical procedure plus serum drawn within one calendar day of procedure.• FNA, core needle, or stereotactic biopsy is allowed at any time prior to the one-stage procedure. Sentinel node dissection/axillary node dissection is also acceptable.• The use of chemotherapy and/or radiation therapy is allowable according to the usual internationally accepted criteria.• All gross disease removed including DCIS.• Contraindications• Pregnant women.• Previous breast cancer.• Any previous cancer.
Minimum age
18 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exceptions: 1) >10 years disease free or 2) squamous or basal cell skin carcinoma.• Neoadjuvant treatment.• Galactorrhea.• Lactating within the past 3 months.• Oral contraceptive use within the last 3 months.• Stage III or IV disease.Two-stage surgical procedure (open biopsy followed later by mastectomy or breast-conserving approach):Required characteristics:• Pathologic stage I-II breast cancer.• Premenopausal women with regular menstrual periods (21–35 days).• Undergoing a two-stage surgical procedure.• Serum drawn within one calendar day of open biopsy.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/1996
Actual
1/11/1999
Date of last participant enrolment
Anticipated
Actual
1/12/2001
Date of last data collection
Anticipated
Actual
Sample size
Target
884
Accrual to date
Final
1118
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1802 0
Self funded/Unfunded
Name [1] 1802 0
Australia and New Zealand Breast Cancer Trials Group
Country [1] 1802 0
Australia
Primary sponsor type
Other Collaborative groups
Name
North Central Cancer Treatment Group
Address
NCCTG
Operations Office
200 First Street SW
Rochester, MN 55905
Country
United States of America
Secondary sponsor category [1] 1621 0
Government body
Name [1] 1621 0
International Breast Cancer Study Group
Address [1] 1621 0
International Breast Cancer Study Group Effingerstrasse 40
CH-3008 Bern, Switzerland
Country [1] 1621 0
Switzerland
Secondary sponsor category [2] 1622 0
Other Collaborative groups
Name [2] 1622 0
National Surgical Adjuvant Breast and Bowel Project
Address [2] 1622 0
NSABP Foundation, Inc.
Four Allegheny Center, Fifth Floor
Pittsburgh, PA 15212-5234
Country [2] 1622 0
United States of America
Secondary sponsor category [3] 1623 0
Other Collaborative groups
Name [3] 1623 0
Australia and New Zealand Breast Cancer Trials Group
Address [3] 1623 0
PO BOX 155
HRMC NSW 2310
Country [3] 1623 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3363 0
Newcastle Mater Misericordiae Hospital
Ethics committee address [1] 3363 0
Ethics committee country [1] 3363 0
Australia
Date submitted for ethics approval [1] 3363 0
Approval date [1] 3363 0
01/11/1999
Ethics approval number [1] 3363 0
Ethics committee name [2] 3364 0
Austin Hospital
Ethics committee address [2] 3364 0
Ethics committee country [2] 3364 0
Australia
Date submitted for ethics approval [2] 3364 0
Approval date [2] 3364 0
Ethics approval number [2] 3364 0
Ethics committee name [3] 3365 0
Box Hill Hospital
Ethics committee address [3] 3365 0
Ethics committee country [3] 3365 0
Australia
Date submitted for ethics approval [3] 3365 0
Approval date [3] 3365 0
Ethics approval number [3] 3365 0
Ethics committee name [4] 3366 0
Maroondah Hospital
Ethics committee address [4] 3366 0
Ethics committee country [4] 3366 0
Australia
Date submitted for ethics approval [4] 3366 0
Approval date [4] 3366 0
Ethics approval number [4] 3366 0
Ethics committee name [5] 3367 0
Royal Melbourne Hospital
Ethics committee address [5] 3367 0
Ethics committee country [5] 3367 0
Australia
Date submitted for ethics approval [5] 3367 0
Approval date [5] 3367 0
Ethics approval number [5] 3367 0
Ethics committee name [6] 3368 0
The Mater Hospital
Ethics committee address [6] 3368 0
Ethics committee country [6] 3368 0
Australia
Date submitted for ethics approval [6] 3368 0
Approval date [6] 3368 0
Ethics approval number [6] 3368 0

Summary
Brief summary
The purpose of this study is to evaluate whether the timing of breast cancer surgery during a woman’s menstrual cycle affects her ultimate outcome- the likelihood of recurrence of breast cancer or death from breast cancer. This study involves taking a small sample of blood from the woman close to her surgery to evaluate her menstrual phase on the basis of hormones in her blood. The woman will then go on to have whichever treatments for her breast cancer that she decides with her doctor. The woman will be observed for at least 5 years and information regarding her treatment and disease progression will be submitted.
Trial website
http://www.anzbctg.org/
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 27490 0
Prof John F Forbes
Address 27490 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 27490 0
Australia
Phone 27490 0
+61 2 4985 0113
Fax 27490 0
Email 27490 0
enquiries@anzbctg.org
Contact person for public queries
Name 10745 0
Ms Corinna Beckmore
Address 10745 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 10745 0
Australia
Phone 10745 0
+61 2 4925 3068
Fax 10745 0
+ 61 2 4985 0141
Email 10745 0
enquiries@anzbctg.org
Contact person for scientific queries
Name 1673 0
Prof John F Forbes
Address 1673 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 1673 0
Australia
Phone 1673 0
+61 2 4925 3068
Fax 1673 0
+ 61 2 4985 0141
Email 1673 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

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