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Trial registered on ANZCTR


Registration number
ACTRN12606000075583
Ethics application status
Approved
Date submitted
6/02/2006
Date registered
22/02/2006
Date last updated
6/12/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
SWOG 0230 / IBCSG 34-05
Scientific title
SWOG 0230 / IBCSG 34-05 - Phase III Trial of LHRH Analogue Administration During Chemotherapy to reduce Ovarian Function Failure Following Chemotherapy in Early Stage, Hormone Receptor Negative Breast Cancer.
Secondary ID [1] 262912 0
NCT00068601
Universal Trial Number (UTN)
Trial acronym
POEMS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian function in premenopasual women with early stage, hormone-receptor negative breast cancer 1039 0
Condition category
Condition code
Cancer 1116 1116 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
SWOG 0230 / IBCSG 34-05 is being conducted internationally by the South West Oncology Group (SWOG). The study is coordinated in Australia and New Zealand by the Australia and New Zealand Breast Cancer Trials Group (ANZBCTG) who are participating in the study in conjunction with the International Breast Cancer Studies Group (IBCSG) collaboration. This study will evaluate the worth of ovarian function suppression (achieved by use of LHRH (lutenising hormone-releasing hormone) analogue (Goserelin)) in preventing premature ovarian failure in premenopausal patients receiving either standard chemotherapy or neo adjuvant chemotherapy as treatment for hormone receptor negative early breast cancer.

SWOG 0230 / IBCSG 34-05 is an international, multicentre, randomised phase III clinical trial of 416 premenopausal women who have had histologically or cytologically confirmed, receptor-negative primary breast cancer. Women will be randomised in a 2-arm design to receive either of the following: a. Standard cyclophosphamide containing adjuvant b. LHRH analogue (Goserelin) plus Standard cyclophosphamide containing adjuvant Patients are stratified according to:
* age (<40 verses 40-49)
* Chemotherapy regimen: 3 months / 4 cycles of anthracycline-based verses 6 months / 8 cycles of anthracycline-based verses 6 months / 8 cycles of non anthracycline-based. Goserelin (Zoladex) 3.6mg depot, administered subcutaneously by injection, commences one week prior to the first chemotherapy dose and is administered once every 4 weeks for the duration of chemotherapy (3-6 months depending on chemotherapy regimen).
Intervention code [1] 884 0
Treatment: Drugs
Comparator / control treatment
Neoadjuvant Chemotherapy
Control group
Active

Outcomes
Primary outcome [1] 1489 0
Rate of Ovarian Failure at two years from initiation of chemotherapy. Ovarian Failure is defined as amenorrhea (absence of menstrual bleeding) for the preceding six months and the presence of Follicle-stimulating hormone (FSH) in the post menopausal range.
Timepoint [1] 1489 0
At the one and two year timepoints following initiation of chemotherapy, patients will be evaluated for the presence or absence of menstrual bleeding in the preceding three and six months
Secondary outcome [1] 2677 0
Rate of Ovarian Dysfunction at 1 and 2 years from initiation of chemotherapy. Ovarian dysfunction is defined as amenorrhea for the preceding three months and the presence of FSH, estradiol and/or inhibin B levels in the post-menopausal range.
Timepoint [1] 2677 0
At the one and two year timepoints following initiation of chemotherapy, patients will be evaluated for the presence or absence of menstrual bleeding in the preceding three and six months
Secondary outcome [2] 2678 0
Ovarian Reserve. Measurements of ovarian reserve will consist of "Day 2 - 4" levels of
FSH, estradiol and inhibin B during Month 12/13 and Month 24/25 (or if amenorrheic,
anytime during Month 12/13 and Month 24/25).
Timepoint [2] 2678 0
At the one and two year timepoints following initiation of chemotherapy measurements of ovarian reserve will consist of 'Day 2-4' levles of FSH, estradiol and inhibin B during Month 12/13 and Month 24/25 (or if amenorrheic, anytime during Month 12/13 and Month 24/25). Fertility during the five year follow-up period will be described for the two groups.
Secondary outcome [3] 8906 0
Fertility information
Timepoint [3] 8906 0
Fertility information, including percent of successful pregnancies (number of pregnancies with no complications/number of pregnancies) and percent miscarriages (number of miscarriages/number of pregnancies), will be compared between the two arms at one, two and five years. Tests of binomial proportions will be used to assess differences in fertility measures between the two arms at both assessment times.

Eligibility
Key inclusion criteria
Participants must be premenopausal (defined as the presence of cyclic menstruation within 6 weeks prior to randomisation or FSH (follicle stimulating hormone) and Oestradiol levels in the premenopausal range), have histologically confirmed diagnosis of operable stage I, II or IIIa hormone receptor negative disease. The planned treatment must include 3-8 months/cycles (pre or post operatively) of an alkylating agent (cyclophosphamide) that can be anthracycline based or non-anthracycline based. Participants receiving pre-operative chemotherapy can not be planned to receive post-operative chemotherapy. Participants receiving post-operative chemotherapy must be randomised within 84 days of definitive surgery.
Minimum age
18 Years
Maximum age
50 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants can not have received prior cytotoxic chemotherapy (for this breast cancer or other condition), oestrogens, antiestrogens, selective oestrogen receptor modulators (SERMs), aromatase inhibitors or hormonal contraception in the 3 months prior to randomisation.Participants can not have had prior malignancies accept for adequately treated basal cell (or squamous cell) skin cancer, in situ cancer or other cancer for which the patient has been disease free for 5 years after treatment with curative intent.Women who are pregnant or lactating will be excluded from participation.

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 Statistical Centre at the NHMRC Clinical Trials Centre, University of Sydney will provide a central randomisation service by fax for all Australian and New Zealand institutions. At the time of study entry all participants will be allocated a treatment code via a web-based randomization system and study drug will be supplied in accordance with the treatment code.
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1220 0
Self funded/Unfunded
Name [1] 1220 0
Australia and New Zealand Breast Cancer Trials Group
Address [1] 1220 0
PO Box 155
Hunter Region Mail Centre NSW 2310
Country [1] 1220 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australia and New Zealand Breast Cancer Trials Group
Address
PO Box 155
Hunter Region Mail Centre NSW 2310
Country
Australia
Secondary sponsor category [1] 1078 0
Other Collaborative groups
Name [1] 1078 0
International Breast Cancer Study Group
Address [1] 1078 0
IBCSG Coordinating Center
Effingerstrasse 40
3008 Bern
SWITZERLAND
Country [1] 1078 0
Switzerland

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The trial is evaluating whether the LHRH analogue goserelin, which temporarily suppresses ovarian function, can prevent permanent ovarian failure after chemotherapy in premenopausal women with hormone receptor-negative breast cancer.
Trial website
www.anzbctg.org
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35216 0
Address 35216 0
Country 35216 0
Phone 35216 0
Fax 35216 0
Email 35216 0
Contact person for public queries
Name 10073 0
Australia and New Zealand Breast Cancer Trials Group
Address 10073 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 10073 0
Australia
Phone 10073 0
+61 2 4925 3068
Fax 10073 0
+612 49850141
Email 10073 0
enquiries@anzbctg.newcastle.edu.au
Contact person for scientific queries
Name 1001 0
Professor John F Forbes, Director of Research (ANZ BCTG)
Address 1001 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 1001 0
Australia
Phone 1001 0
+61 2 4925 3068
Fax 1001 0
+61 2 49850141
Email 1001 0
enquiries@anzbctg.newcastle.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary