Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00126360




Registration number
NCT00126360
Ethics application status
Date submitted
2/08/2005
Date registered
3/08/2005
Date last updated
10/11/2005

Titles & IDs
Public title
STARS Breast Trial (Study of Anastrozole and Radiotherapy Sequencing Pilot)
Scientific 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
Secondary ID [1] 0 0
STARS-Pilot (05/55 Graham)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Local failure within irradiation volume
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Early quality of life
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Lung fibrosis
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Also demonstration of recruitment capacity at lead trial centres
Timepoint [3] 0 0

Eligibility
Key inclusion criteria
* Age 18 or more years. No upper limit.
* Post total mastectomy or lumpectomy. All planned surgery complete.
* Margins clear (no tumour contacting the inked margin)
* Tumour oestrogen or progesterone receptor positive
* Planned dose to irradiated volumes at least the biological equivalent of 45 Gy in 25 fractions or more.
* ECOG 0-2
* Patients post menopausal using same criteria as ATAC study.
* Written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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 therapy.
* Ongoing hormone replacement therapy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Liverpool Hospital - Sydney
Recruitment hospital [2] 0 0
St George Hospital - Sydney
Recruitment hospital [3] 0 0
Campbelltown Hospital - Sydney
Recruitment hospital [4] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment postcode(s) [1] 0 0
2170 - Sydney
Recruitment postcode(s) [2] 0 0
2217 - Sydney
Recruitment postcode(s) [3] 0 0
2560 - Sydney
Recruitment postcode(s) [4] 0 0
4102 - Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
St George Hospital, Australia
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
AstraZeneca
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00126360
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ass. Prof. Peter H Graham, MBBS FRANZCR
Address 0 0
Cancer Care Centre, St George Hospital, Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ass. Prof. Peter H Graham, MBBS FRANZCR
Address 0 0
Country 0 0
Phone 0 0
+61 293503934
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00126360