Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000237280
Ethics application status
Approved
Date submitted
3/02/2009
Date registered
11/05/2009
Date last updated
16/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluative Study of Quality of Life in pre-menopausal women with low-risk early breast cancer (Goserelin Study)
Scientific title
Evaluative Study of Quality of Life in pre-menopausal women with low-risk early breast cancer (Goserelin Study)
Secondary ID [1] 283222 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 4264 0
Condition category
Condition code
Cancer 4489 4489 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study involves the collection of detailed information over a two year period about treatment choices and preferences of pre-menopausal low risk young (47 years or younger) women with breast cancer who will be receiving Goserelin/ Zoladex as part of their breast cancer treatment. This is a prospective study looking at treatment preferences, decision making, decision regret, patient preferences, side effects and disease outcome in pre-menopausal women under 47 years with low-risk early breast cancer. Patients will be entered into the study after they have chosen their treatment. Treatment arms will include patients with "low risk" breast cancer choosing endocrine therapy alone with goserelin (monthly injection for 2 years) and Tamoxifen (Group 1) and "low risk" patients choosing chemotherapy (approximately 6 months) with or without endocrine therapy (Group 2).
Intervention code [1] 4522 0
Not applicable
Comparator / control treatment
Not applicable as this is an observational study
Control group
Active

Outcomes
Primary outcome [1] 5370 0
To establish whether young women with ER positive early breast cancer who choose Goserelin will have a better quality of life, fewer side effects and less decisional regret than those choosing chemotherapy. Quality of life will be measured at four time points (study entry, 6, 12 and 24 months) using validated instruments: FACT ES (Functional Assessment of Cancer Therapy for patients with Endocrine Symptoms), FACT B (Functional Assessment of Cancer Therapy for patients with Breast Cancer), Sexual Activity Questionnaire and the Greene Menopause Scale.
Timepoint [1] 5370 0
Surveys implemented at study entry (baseline), 6 12 and 24 months.
Secondary outcome [1] 9027 0
To collect detailed information on treatment choices and preferences of pre-menopausal women under 47 years with low-risk early breast cancer who have had over 2 years of endocrine treatment. Patient preference interviews will be conducted with group 1 participants and a designated number of group 2 participants. All participants will be invited to complete a Decisional Conflict Questionnaire at study entry. Decision Regret Questionnaires will be completed by participants at 24 months. Information about treatment received, side effects and tolerability will be taken from patient notes and pharmacy data. Data will also be collected on patient status (disease free and overall survival).
Timepoint [1] 9027 0
Surveys implemented at study entry (baseline), 6, 12 and 24 months. Treatment received will be taken from patient notes and pharmacy data at study entry. Patient notes and pharmacy data will also be used to monitor compliance post treatment. Side effects and tolerability will be monitored throughout each patients chosen treatment using patient notes and pharmacy data. Disease free and overall survival status will be monitored for each patient throughout the study with final patient status noted at 2 years from their commencement into study.

Eligibility
Key inclusion criteria
1.Provision of written informed consent 2.Diagnosis of endocrine receptor (ER) positive and/or progesterone receptor (PgR) positive low-risk breast cancer (defined by tumour size <2cm; Grade I or II; No nodal involvement) 3. Women under 47 years and known to be pre-menopausal. Defied by regular menses and/or follicle stimulating hormone(FSH)/luetenizing hormone(LH)/oestradiol levels consistent with pre-menopausal status) 4.Able to understand and comply with the requirements of the study
Minimum age
18 Years
Maximum age
47 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Unstable or inadequately treated medical illness as judged by the investigator
2.Involvement in the planning and conduct of the study
3.Previous enrolment or randomisation of treatment in the present study.
4.Advanced disease at presentation (Locally advanced disease or distant metastases)
5.Pregnancy at presentation
6.Lack of informed consent
7.Life expectancy under 2 years
8.Prior chemotherapy
9.Known hypersensitivity to Goserelin

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
16/02/2009
Actual
28/03/2009
Date of last participant enrolment
Anticipated
Actual
31/12/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
28
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 1518 0
Royal Perth Hospital - Perth
Recruitment hospital [2] 1519 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [3] 1520 0
St John of God Hospital, Subiaco - Subiaco
Recruitment hospital [4] 1521 0
St John of God Hospital, Bunbury - Bunbury
Recruitment hospital [5] 1522 0
Maroondah Hospital - Ringwood East
Recruitment hospital [6] 1523 0
Box Hill Hospital - Box Hill
Recruitment postcode(s) [1] 1441 0
6000
Recruitment postcode(s) [2] 1442 0
6009
Recruitment postcode(s) [3] 7358 0
6008 - Subiaco
Recruitment postcode(s) [4] 7359 0
6230 - Bunbury
Recruitment postcode(s) [5] 7360 0
3135 - Ringwood East
Recruitment postcode(s) [6] 7361 0
3128 - Box Hill

Funding & Sponsors
Funding source category [1] 4445 0
Commercial sector/Industry
Name [1] 4445 0
AstraZeneca Pty Ltd
Country [1] 4445 0
Australia
Primary sponsor type
Individual
Name
Professor Christobel Saunders
Address
School of Surgery
University of Western Australia
35 Stirling Highway
CRAWLEY WA 6009
Country
Australia
Secondary sponsor category [1] 4006 0
None
Name [1] 4006 0
Address [1] 4006 0
Country [1] 4006 0
Other collaborator category [1] 549 0
Individual
Name [1] 549 0
Dr Belinda THEWES
Address [1] 549 0
Prince of Wales Hospital
Dept Medical Oncology
Barker Street Randwick
SYDNEY NSW 2031
Country [1] 549 0
Australia
Other collaborator category [2] 550 0
Individual
Name [2] 550 0
Dr Anna Nowak
Address [2] 550 0
University of Western Australia
35 Stirling Highway
CRAWLEY WA 6009
Country [2] 550 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6499 0
Sir Charles Gairdner Hospital Human Research Ethics Committee
Ethics committee address [1] 6499 0
Ethics committee country [1] 6499 0
Australia
Date submitted for ethics approval [1] 6499 0
Approval date [1] 6499 0
11/09/2008
Ethics approval number [1] 6499 0
2008-098
Ethics committee name [2] 289892 0
St John of God Health Care Ethics Committee
Ethics committee address [2] 289892 0
Ethics committee country [2] 289892 0
Australia
Date submitted for ethics approval [2] 289892 0
02/05/2011
Approval date [2] 289892 0
08/06/2011
Ethics approval number [2] 289892 0
Ref: 419
Ethics committee name [3] 289893 0
Eastern Health Research and Ethics Committee
Ethics committee address [3] 289893 0
Ethics committee country [3] 289893 0
Australia
Date submitted for ethics approval [3] 289893 0
17/05/2010
Approval date [3] 289893 0
17/06/2010
Ethics approval number [3] 289893 0
E111/0910

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29244 0
Prof Christobel Saunders
Address 29244 0
School of Surgery
University of Western Australia
35 Stirling Highway (M507)
CRAWLEY WA 6009
Country 29244 0
Australia
Phone 29244 0
+61 8 6151 1122
Fax 29244 0
Email 29244 0
[email protected]
Contact person for public queries
Name 12491 0
Laura Emery
Address 12491 0
School of Surgery
University of Western Australia
35 Stirling Highway (M507)
CRAWLEY WA 6009
Country 12491 0
Australia
Phone 12491 0
+61 8 6151 1108
Fax 12491 0
+61 8 6151 1199
Email 12491 0
[email protected]
Contact person for scientific queries
Name 3419 0
Professor Christobel Saunders
Address 3419 0
School of Surgery
University of Western Australia
35 Stirling Highway (M507)
CRAWLEY WA 6009
Country 3419 0
Australia
Phone 3419 0
+61 8 6151 1122
Fax 3419 0
+61 8 6151 1199
Email 3419 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

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