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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
Treatment: Drugs - Timing of Anastrozole in respect to radiotherapy

Treatment: Drugs: Timing of Anastrozole in respect to radiotherapy


Intervention code [1] 0 0
Treatment: Drugs
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
Gender
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 status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
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/show/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
GrahamP@sesahs.nsw.gov.au
Contact person for scientific queries

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