None listed
Conditions
Brief summary
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. Recruitment is over 24-months at multiple sites in Australia and patients with "low risk" breast cancer will be invited to participate after they have chosen their treatment.
Interventions
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
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).
Sponsors
Professor Christobel Saunders
Eligibility
Sex/Gender
All
Age
18 Years to 47 Years
Healthy volunteers
No
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
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
Outcome results
None listed