Spots Global Cancer Trial Database for STARS Breast Trial (Study of Anastrozole and Radiotherapy Sequencing)
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Trial Identification
Brief Title: STARS Breast Trial (Study of Anastrozole and Radiotherapy Sequencing)
Official Title: A Randomised Comparison of Anastrozole Commenced Before and Continued During Adjuvant Radiotherapy for Breast Cancer Versus Anastrozole and Subsequent Anti-oestrogen Therapy Delayed Until After Radiotherapy.
Study ID: NCT00887380
Conditions
Study Description
Brief Summary: The purpose of this study is to determine whether starting anastrozole prior to radiotherapy, so that it is taken during radiotherapy, decreases local recurrence of breast cancer in post-menopausal women in comparison to waiting until after radiotherapy to commence anastrozole.
Detailed Description: Adjuvant radiotherapy is well established as the primary modality to enhance local control in breast cancer. The use of adjuvant hormone therapy such as tamoxifen has shown to improve local control to a relatively minor amount on its own and does enhance local control of adjuvant radiotherapy. There is, however, conflicting invitro and clinical data regarding the effects or different sequences on tamoxifen and radiotherapy in terms of both local control and enhancement of radiotherapy toxicities. Aromatase inhibitors such as anastrozole are establishing themselves as a class of drug superior to tamoxifen for the control of estrogen dependent breast cancers and overall are better tolerated with the exception of greater bone loss. As the key question is whether the sequencing of the aromatase inhibitor anastrozole alters local control by acting as an enhancer of the radiation breast cancer cell kill, it is therefore the aim of this study to compare 3 months of anastrozole prior to radiotherapy versus 3 months of anastrozole after radiotherapy with a specific objective of reducing the baseline ratio of in-field radiotherapy failure from 6% to 3%.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
The Canberra Hospital, Canberra, Australian Capital Territory, Australia
Campbelltown Hospital, Campbelltown, New South Wales, Australia
Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia
Genesis Cancer Care Hurstville, Hurstville, New South Wales, Australia
St George Hospital, Kogarah, New South Wales, Australia
Liverpool Hospital, Liverpool, New South Wales, Australia
Calvary Mater Newcastle, Newcastle, New South Wales, Australia
Central West Cancer Service, Orange, New South Wales, Australia
Prince of Wales Hospital, Randwick, New South Wales, Australia
Royal North Shore Hospital, St Leonards, New South Wales, Australia
Riverina Cancer Centre, Wagga Wagga, New South Wales, Australia
Illawarra Cancer Care Centre, Wollongong, New South Wales, Australia
Alan Walker Cancer Centre, Darwin, Northern Territory, Australia
Genesis Cancer Care, Auchenflower, Queensland, Australia
Cairns ROQ, Cairns, Queensland, Australia
Genesis Cancer Care, Chermside, Queensland, Australia
The Townsville Hospital, Douglas, Queensland, Australia
Radiation Oncology Gold Coast, Gold Coast, Queensland, Australia
Royal Brisbane and Women's Hospital, Herston, Queensland, Australia
Radiation Oncology - Mater Centre, South Brisbane, Queensland, Australia
Genesis Southport, Southport, Queensland, Australia
St Andrew's Toowoomba Hospital, Toowoomba, Queensland, Australia
Genesis Care, Tugun, Queensland, Australia
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Royal Hobart Hospital, Hobart, Tasmania, Australia
Geelong Hospital, Geelong, Victoria, Australia
Genesis Cancer Care, Bunbury, Western Australia, Australia
Fiona Stanley Hospital, Murdoch, Western Australia, Australia
Royal Perth Hospital, Perth, Western Australia, Australia
Perth Radiation Oncology, Wembley, Western Australia, Australia
Auckland Hospital, Auckland, , New Zealand
Christchurch Hopsital Oncology Sevice, Christchurch, , New Zealand
Palmerston North, Palmerston North, , New Zealand
Contact Details
Name: Peter Graham, MBBS
Affiliation: Trans Tasman Radiation Oncology Group
Role: STUDY_CHAIR
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