None listed
Conditions
Brief summary
This study compares the effectiveness of treatment with the drug anastrozole before and during adjuvant radiotherapy compared with anastrozole therapy delayed until after radiotherapy. Who is it for? You can join this study if you are a woman who has had a mastectomy or lumpectomy for breast cancer, and all planned surgery is now complete and radiotherapy is recommended. Trial details Participants will be divided into two groups. One group will receive anastrozole orally before and during radiotherapy. The other group will receive standard treatment, where anastrozole and subsequent anti-oestrogen therapy is delayed until after radiotherapy. Participants will be monitored for 10 years after radiotherapy. The study aims to determine if commencement of anastrozole before radiotherapy results in improved local control of the disease.
Interventions
Arm A: Concurrent - Investigational treatment: Anastrozole commenced before and continued during radiotherapy.
Drug - Pre-radiotherapy commencement of anastrozole. Anastrozole: 1mg/day prescribed for 12 weeks, given orally. Commencing within 1 week of randomisation, to be administered from a minimum 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 c
Arm A: Concurrent - Investigational treatment: Anastrozole commenced before and continued during radiotherapy. Drug - Pre-radiotherapy commencement of anastrozole. Anastrozole: 1mg/day prescribed for 12 weeks, given orally. Commencing within 1 week of randomisation, to be administered from a minimum 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. Other: Radiotherapy. Radiotherapy must commence within 1 month of randomisation. Radiotherapy planning and treatment is as per the protocol. - Ant. Chest wall/breast: 42.5 Gy in 16 Fractions, or 45Gy in 20 Fractions, or 50 Gy in 25 fractions. - Nodal Volumes: 25 fractions not exceeding 2Gy/fraction. - Supraclavicular Fossa: 45-50Gy in 25 fractions, 1.8-2Gy/fraction - SClav/Axilla: 45Gy in 25 Fractions, 1.8Gy/fraction - Internal Mammory Chain: 40Gy in 25 fractions; modified wide tangent technique: 50Gy in 25 Fractions; Seperate Int. Mammary Chain + tangent technique: 50Gy in 25 Fractions. - Boost Treatment: 66Gy in 33 fractions (total) Breast/chestwall: 50Gy in 25 fractions; electron boost: 16Gy in 8 fractions Duration of Radiotherapy will depend on extent of disease.
Sponsors
Assoc. Prof. Peter Graham
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Women aged 18 years and older. 2. Post total mastectomy or lumpectomy. All planned cancer resection surgery complete. 3. Histologic or pathologic reports must verify either: a) no tumour contacting the inked margin of surgically removed tissue, or b) focal involvement (<2mm fron) if the margin is at the deep (posterior part) of the breast and the surgeon confirms that surgery extended to the deep fascia, or c) focal involvement (<2mm front) if the margin is superficial (anterior part of the braest or subcutaneous) and the surgeon confirms that surgery extended to the subcutis. NB: In the case of focally involved deep or superficiail 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. 4. Tumour oestrogen receptor and/or progesterone receptor positive (>= 10% cells positive). 5. Radiotherapy not yet commenced. 6. Planned radiotherapy dose prescribed to International Commision on Radiation Units (ICRU) reference points in the irradiated breast/chest wall volumes at least the biological equivalent of 45Gy in 25 fractions or more (Biologically Effective Dose (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). 7. An Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less. 8. Female and post menopausal shown by satisfying at least one of the following criteria (as per the Arimidex, Tamoxifen Alone or in Combination (ATAC) study criteria 16): a) bilateral oophorectomy b) age > 60 years c) age 45-59 years with intact uterus and amenorrhoeic at least 12 months. d) Amenorrhoeic less than 12 months with follicle stimulating hormone (FSH) levels within the post menopausal range (including patients with amenorrhoea due to chemotherapy, Luteinizing hormone releaseing hormone (LHRH) use or who have had hormone replacement following hysterectomy). NB: It is recommended for older 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. 9. Is not receiving chemotherpy, or is receiving chemotherapy but the course will be completed at least 3 weeks prior to commencing radiotherapy. 10. Unilateral treatment. 11. Has provided written informed consent for participation in this trial.
Exclusion criteria
1. Previous radiotherapy to the area. 2. Previous invasive malignancy within 5 years of current breast cancer diagnosis with the exception of cervix in situ or skin cancer other than melanoma. 3. Patients with clinical evidence of metastaic disease. 4. Previous hormonal breast cancer therapy. 5. Ongoing hormone replacement therapy.
Outcome results
None listed