Breast Cancer Clinical Trial
— STARSOfficial 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.
Verified date | November 2022 |
Source | Trans Tasman Radiation Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 2023 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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. - Is not receiving chemotherapy, or is receiving chemotherapy but the course will be completed at least 3 weeks prior to commencing radiotherapy - Unilateral treatment - Has provided written informed consent for participation in this trial Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Australia | Royal Adelaide Hospital | Adelaide | South Australia |
Australia | Genesis Cancer Care | Auchenflower | Queensland |
Australia | Genesis Cancer Care | Bunbury | Western Australia |
Australia | Cairns ROQ | Cairns | Queensland |
Australia | Campbelltown Hospital | Campbelltown | New South Wales |
Australia | Royal Prince Alfred Hospital | Camperdown | New South Wales |
Australia | The Canberra Hospital | Canberra | Australian Capital Territory |
Australia | Genesis Cancer Care | Chermside | Queensland |
Australia | Alan Walker Cancer Centre | Darwin | Northern Territory |
Australia | The Townsville Hospital | Douglas | Queensland |
Australia | Geelong Hospital | Geelong | Victoria |
Australia | Radiation Oncology Gold Coast | Gold Coast | Queensland |
Australia | Royal Brisbane and Women's Hospital | Herston | Queensland |
Australia | Royal Hobart Hospital | Hobart | Tasmania |
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 | Fiona Stanley Hospital | Murdoch | Western Australia |
Australia | Calvary Mater Newcastle | Newcastle | New South Wales |
Australia | Central West Cancer Service | Orange | New South Wales |
Australia | Royal Perth Hospital | Perth | Western Australia |
Australia | Prince of Wales Hospital | Randwick | New South Wales |
Australia | Radiation Oncology - Mater Centre | South Brisbane | Queensland |
Australia | Genesis Southport | Southport | Queensland |
Australia | Royal North Shore Hospital | St Leonards | New South Wales |
Australia | St Andrew's Toowoomba Hospital | Toowoomba | Queensland |
Australia | Genesis Care | Tugun | Queensland |
Australia | Riverina Cancer Centre | Wagga Wagga | New South Wales |
Australia | Perth Radiation Oncology | Wembley | Western Australia |
Australia | Illawarra Cancer Care Centre | Wollongong | New South Wales |
Australia | Princess Alexandra Hospital | Woolloongabba | Queensland |
New Zealand | Auckland Hospital | Auckland | |
New Zealand | Christchurch Hopsital Oncology Sevice | Christchurch | |
New Zealand | Palmerston North | Palmerston North |
Lead Sponsor | Collaborator |
---|---|
Trans Tasman Radiation Oncology Group |
Australia, New Zealand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Rates of distant failure | 10 years post radiotherapy | ||
Secondary | Overall Survival | 10 years post radiotherapy | ||
Secondary | Normal tissue complications | 10 years post radiotherapy | ||
Secondary | Cosmesis | 10 years post radiotherapy |
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