Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00126360
Status:
UNKNOWN
Last Update Posted:
2005-11-10
First Post:
2005-08-02
Brief Title:
STARS Breast Trial Study of Anastrozole and Radiotherapy Sequencing Pilot
Sponsor:
St George Hospital Australia
Organization:
St George Hospital Australia
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2005-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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 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 3This 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
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 3This 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None