STARS Breast Trial (Study of Anastrozole and Radiotherapy Sequencing Pilot)
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|ClinicalTrials.gov Identifier: NCT00126360|
Recruitment Status : Unknown
Verified August 2005 by St George Hospital, Australia.
Recruitment status was: Recruiting
First Posted : August 3, 2005
Last Update Posted : November 10, 2005
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Timing of Anastrozole in respect to radiotherapy||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||August 2005|
|Estimated Study Completion Date :||May 2016|
- Local failure within irradiation volume
- Early quality of life
- Lung fibrosis
- Also demonstration of recruitment capacity at lead trial centres
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00126360
|Contact: Ass. Prof. Peter H Graham, MBBS FRANZCR||+61 293503934||GrahamP@sesahs.nsw.gov.au|
|Australia, New South Wales|
|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|
|Campbelltown Hospital||Not yet recruiting|
|Sydney, New South Wales, Australia, 2560|
|Contact: Dr George Papadatos, MBBS FRANZCR +61 246344355 George.email@example.com|
|Principal Investigator: Dr George Papadatos, MBBS FRANZCR|
|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|