STARS Breast Trial (Study of Anastrozole and Radiotherapy Sequencing)
STARS
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.
2 other identifiers
interventional
2,023
2 countries
34
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 breast-cancer
Started Sep 2009
Longer than P75 for phase_3 breast-cancer
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2009
CompletedFirst Posted
Study publicly available on registry
April 24, 2009
CompletedStudy Start
First participant enrolled
September 16, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedNovember 18, 2022
November 1, 2022
15.2 years
April 23, 2009
November 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine if commencement of anastrozole prior to radiotherapy results in improved local control compared to anastrozole commenced after radiotherapy.
10 years post radiotherapy
Secondary Outcomes (4)
Rates of distant failure
10 years post radiotherapy
Overall Survival
10 years post radiotherapy
Normal tissue complications
10 years post radiotherapy
Cosmesis
10 years post radiotherapy
Study Arms (2)
Arm A: Concurrent
ACTIVE COMPARATORInvestigational treatment: Anastrozole commenced before (Pre-radiotherapy commencement of anastrozole) and continued during radiotherapy.
Arm B: Sequential
ACTIVE COMPARATORStandard Treatment: Anastrozole and subsequent anti-oestrogen therapy delayed until after radiotherapy (Post radiotherapy commencement of anastrozole)
Interventions
Anastrozole: 1mg per day will be prescribed for 12 weeks. Commencing within 1 week of randomisation, to be administered from a min of 1 week before and a max of 4 weeks before commencement of radiotherapy and continued throughout radiotherapy. After 12 weeks administration of anastrozole according to trial regimen, anastrozole can be continued at the treating clinician's discretion and in accordance with the preference selected at the time of randomisation and stratification. The alternative options to long-term anastrozole are tamoxifen or cessation of anti-oestrogen therapy.
Radiotherapy must commence within 1 month of randomisation. Radiotherapy planning and treatment is as per the protocol.
Anastrozole 1mg per day will be prescribed for 12 weeks after radiotherapy is completed. Anastrozole should commence within 1 week of the last fraction of radiotherapy and be continued for a total of 12 weeks. After 12 weeks administration according to the trial regimen, any subsequent hormone therapy is as for the concurrent arm.
Eligibility Criteria
You may qualify if:
- Women aged 18 years or older
- Post total mastectomy or lumpectomy. All planned cancer resection surgery complete.
- Histologic or pathologic reports must verify either:
- No tumour contacting the inked margin of surgically removed tissue, or
- Focal involvement (\<2mm front) if the margin is at the deep (posterior part) of the breast and the surgeon confirms that surgery extended to the deep fascia, or
- Focal involvement (\<2mm front) if the margin is superficial (anterior part of the breast or subcutaneous) and the surgeon confirms that surgery extended to the subcutis NB: In the case of focally involved deep or superficial margins, the medical records or multidisciplinary meeting notes or correspondence from the surgeon must indicate that the surgeon confirms the surgery extended to the deep fascia or subcutis as appropriate. Patients should routinely receive a lumpectomy bed boost in the conserved breast setting if there is focal superficial or focal deep involvement as defined above.
- Tumour oestrogen receptor and/or progesterone receptor positive (≥10% cells positive).
- Radiotherapy not yet commenced
- Planned radiotherapy dose prescribed to ICRU reference points in the irradiated breast / chest wall volumes at least the biological equivalent of 45 Gy in 25 fractions or more. (BED Gy4 ≥ 65, BED Gyx=D(1+n/x) where D=total dose, n=dose per fraction, x=alpha beta ratio, Gy4 selected as appropriate alpha-beta ratio for human breast cancer lines)
- An ECOG performance status score of 2 or less.
- Female and post menopausal shown by satisfying at least one of the following criteria (as per the ATAC study criteria16):
- bilateral oophorectomy
- age greater than 60
- age 45-59 years with intact uterus and amenorrhoeic at least 12 months
- Amenorrhoeic less than 12 months with follicle stimulating hormone (FSH) levels within the post menopausal range (including patients with amenorrhoea due to chemotherapy, LHRH use or who have had hormone replacement following hysterectomy) Note: it is recommended for women under the age of 45 who have been rendered menopausal by chemotherapy that they be enrolled onto the strata which switches to Tamoxifen after the initial 3 months of anastrozole.
- +3 more criteria
You may not qualify if:
- Previous radiotherapy to the area to be treated
- Previous invasive malignancy within 5 years of current breast cancer diagnosis with the exception of cervix in-situ or skin cancer other than melanoma.
- Patients with clinical evidence of metastatic disease.
- Previous hormonal breast cancer therapy.
- Ongoing hormone replacement therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
The Canberra Hospital
Canberra, Australian Capital Territory, 2605, Australia
Campbelltown Hospital
Campbelltown, New South Wales, 2560, Australia
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
Genesis Cancer Care Hurstville
Hurstville, New South Wales, 2220, Australia
St George Hospital
Kogarah, New South Wales, 2217, Australia
Liverpool Hospital
Liverpool, New South Wales, 2170, Australia
Calvary Mater Newcastle
Newcastle, New South Wales, 2298, Australia
Central West Cancer Service
Orange, New South Wales, Australia
Prince of Wales Hospital
Randwick, New South Wales, 2031, Australia
Royal North Shore Hospital
St Leonards, New South Wales, 2065, Australia
Riverina Cancer Centre
Wagga Wagga, New South Wales, 2650, Australia
Illawarra Cancer Care Centre
Wollongong, New South Wales, 2500, Australia
Alan Walker Cancer Centre
Darwin, Northern Territory, 811, Australia
Genesis Cancer Care
Auchenflower, Queensland, 4066, Australia
Cairns ROQ
Cairns, Queensland, 4350, Australia
Genesis Cancer Care
Chermside, Queensland, 4032, Australia
The Townsville Hospital
Douglas, Queensland, 4810, Australia
Radiation Oncology Gold Coast
Gold Coast, Queensland, 4217, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029, Australia
Radiation Oncology - Mater Centre
South Brisbane, Queensland, 4101, Australia
Genesis Southport
Southport, Queensland, Australia
St Andrew's Toowoomba Hospital
Toowoomba, Queensland, 4350, Australia
Genesis Care
Tugun, Queensland, 4224, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Royal Hobart Hospital
Hobart, Tasmania, 7000, Australia
Geelong Hospital
Geelong, Victoria, 3220, Australia
Genesis Cancer Care
Bunbury, Western Australia, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
Royal Perth Hospital
Perth, Western Australia, 6001, Australia
Perth Radiation Oncology
Wembley, Western Australia, 6014, Australia
Auckland Hospital
Auckland, New Zealand
Christchurch Hopsital Oncology Sevice
Christchurch, New Zealand
Palmerston North
Palmerston North, New Zealand
Related Publications (1)
Browne LH, Graham PH. Good intentions and ICH-GCP: Trial conduct training needs to go beyond the ICH-GCP document and include the intention-to-treat principle. Clin Trials. 2014 Dec;11(6):629-34. doi: 10.1177/1740774514542620. Epub 2014 Jul 14.
PMID: 25023199DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Peter Graham, MBBS
Trans Tasman Radiation Oncology Group
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2009
First Posted
April 24, 2009
Study Start
September 16, 2009
Primary Completion
December 1, 2024
Study Completion
December 1, 2024
Last Updated
November 18, 2022
Record last verified: 2022-11