STARS Breast Trial (Study of Anastrozole and Radiotherapy Sequencing)
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT00887380
- Lead Sponsor
- Trans Tasman Radiation Oncology Group
- 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%.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 2023
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A: Concurrent Radiotherapy Investigational treatment: Anastrozole commenced before (Pre-radiotherapy commencement of anastrozole) and continued during radiotherapy. Arm B: Sequential Radiotherapy Standard Treatment: Anastrozole and subsequent anti-oestrogen therapy delayed until after radiotherapy (Post radiotherapy commencement of anastrozole) Arm A: Concurrent Pre-radiotherapy commencement of anastrozole Investigational treatment: Anastrozole commenced before (Pre-radiotherapy commencement of anastrozole) and continued during radiotherapy. Arm B: Sequential Post radiotherapy commencement of anastrozole Standard Treatment: Anastrozole and subsequent anti-oestrogen therapy delayed until after radiotherapy (Post radiotherapy commencement of anastrozole)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Rates of distant failure 10 years post radiotherapy Overall Survival 10 years post radiotherapy Cosmesis 10 years post radiotherapy Normal tissue complications 10 years post radiotherapy
Trial Locations
- Locations (32)
Royal Perth Hospital
🇦🇺Perth, Western Australia, Australia
Perth Radiation Oncology
🇦🇺Wembley, Western Australia, Australia
Genesis Cancer Care
🇦🇺Bunbury, Western Australia, Australia
Liverpool Hospital
🇦🇺Liverpool, New South Wales, Australia
Royal Brisbane and Women's Hospital
🇦🇺Herston, Queensland, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Fiona Stanley Hospital
🇦🇺Murdoch, Western Australia, Australia
Genesis Southport
🇦🇺Southport, Queensland, Australia
Genesis Care
🇦🇺Tugun, Queensland, Australia
Auckland Hospital
🇳🇿Auckland, New Zealand
Geelong Hospital
🇦🇺Geelong, Victoria, Australia
The Canberra Hospital
🇦🇺Canberra, Australian Capital Territory, Australia
Genesis Cancer Care Hurstville
🇦🇺Hurstville, New South Wales, Australia
St George Hospital
🇦🇺Kogarah, 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
Alan Walker Cancer Centre
🇦🇺Darwin, Northern Territory, Australia
Cairns ROQ
🇦🇺Cairns, Queensland, Australia
The Townsville Hospital
🇦🇺Douglas, Queensland, Australia
Radiation Oncology Gold Coast
🇦🇺Gold Coast, Queensland, Australia
Radiation Oncology - Mater Centre
🇦🇺South Brisbane, Queensland, Australia
Princess Alexandra Hospital
🇦🇺Woolloongabba, Queensland, Australia
Royal Hobart Hospital
🇦🇺Hobart, Tasmania, Australia
Christchurch Hopsital Oncology Sevice
🇳🇿Christchurch, New Zealand
Palmerston North
🇳🇿Palmerston North, New Zealand
St Andrew's Toowoomba Hospital
🇦🇺Toowoomba, Queensland, Australia
Campbelltown Hospital
🇦🇺Campbelltown, New South Wales, Australia
Riverina Cancer Centre
🇦🇺Wagga Wagga, New South Wales, Australia
Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
Illawarra Cancer Care Centre
🇦🇺Wollongong, New South Wales, Australia