Evaluative Study of Quality of Life in pre-menopausal women with low-risk early breast cancer (Goserelin Study)

Not Applicable

Completed

• Conditions: Breast Cancer; Cancer - Breast

• Registration Number: ACTRN12609000237280
• Lead Sponsor: Professor Christobel Saunders

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-05-11
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.[Surveys implemented at study entry (baseline), 6 12 and 24 months.]