STARS Breast Trial (Study of Anastrozole and Radiotherapy Sequencing Pilot)
This is a randomized study comparing the use of Anastrozole before and continuing during radiotherapy for breast cancer compared to the use of anastrozole after irradiation.
Drug: Timing of Anastrozole in respect to radiotherapy
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot for a Randomised Comparison of Anastrozole Commenced Before and Continued During Adjuvant Radiotherapy for Breast Cancer Versus Anastrozole and Subsequent Ant-Oestrogen Therapy Delayed Until After Radiotherapy|
- Local failure within irradiation volume
- Early quality of life
- Lung fibrosis
- Also demonstration of recruitment capacity at lead trial centres
|Study Start Date:||August 2005|
|Estimated Study Completion Date:||May 2016|
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 in vitro and clinical data regarding the effects of different sequences on tamoxifen and radiotherapy in terms of both local control and enhancement of radiotherapy toxicities.
Aromatase inhibitors such as anastrazole 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%.This pilot study is preliminary to a planned long term study to investigate local failure.
For the pilot a period of 6 months with all contributing centres open will provide a good test of recruitment matching estimates. 100 patients will provide a good sample to compare to the 270 tamoxifen treated women in the breast boost study for quality of life. It will also provide a 95% CI on the proportion of complying women in the order of ± 5% if 85 to 90 % of women comply.
|Contact: Ass. Prof. Peter H Graham, MBBS FRANZCR||+61 293503934||GrahamP@sesahs.nsw.gov.au|
|Australia, New South Wales|
|Campbelltown Hospital||Not yet recruiting|
|Sydney, New South Wales, Australia, 2560|
|Contact: Dr George Papadatos, MBBS FRANZCR +61 246344355 George.firstname.lastname@example.org|
|Principal Investigator: Dr George Papadatos, MBBS FRANZCR|
|Liverpool Hospital||Not yet recruiting|
|Sydney, New South Wales, Australia, 2170|
|Contact: Dr Geoff Delaney, MBBS FRANZCR +61 29828 5276 Geoff.Delaney@swsahs.nsw.gov.au|
|Principal Investigator: Dr Geoff Delaney, MBBS FRANZCR|
|St George Hospital||Recruiting|
|Sydney, New South Wales, Australia, 2217|
|Contact: Peter Graham, MBBS FRANZCR +61 2 9350 3912 GrahamP@sesahs.nsw.gov.au|
|Princess Alexandra Hospital||Not yet recruiting|
|Brisbane, Queensland, Australia, 4102|
|Contact: Dr Jennifer Harvey, MBBS FRANZCR +61 732402 111 J.Harvey@mailbox.uq.edu.au|
|Principal Investigator: Dr Jennifer Harvey, MBBS FRANZCR|
|Principal Investigator:||Ass. Prof. Peter H Graham, MBBS FRANZCR||Cancer Care Centre, St George Hospital, Sydney|