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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00887380




Registration number
NCT00887380
Ethics application status
Date submitted
23/04/2009
Date registered
24/04/2009
Date last updated
18/11/2022

Titles & IDs
Public title
STARS Breast Trial (Study of Anastrozole and Radiotherapy Sequencing)
Scientific title
A Randomised Comparison of Anastrozole Commenced Before and Continued During Adjuvant Radiotherapy for Breast Cancer Versus Anastrozole and Subsequent Anti-oestrogen Therapy Delayed Until After Radiotherapy.
Secondary ID [1] 0 0
ACTRN12610000307000
Secondary ID [2] 0 0
TROG 08.06
Universal Trial Number (UTN)
Trial acronym
STARS
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 - Pre-radiotherapy commencement of anastrozole
Treatment: Other - Radiotherapy
Treatment: Drugs - Post radiotherapy commencement of anastrozole

Active comparator: Arm A: Concurrent - Investigational treatment: Anastrozole commenced before (Pre-radiotherapy commencement of anastrozole) and continued during radiotherapy.

Active comparator: Arm B: Sequential - Standard Treatment: Anastrozole and subsequent anti-oestrogen therapy delayed until after radiotherapy (Post radiotherapy commencement of anastrozole)


Treatment: Drugs: Pre-radiotherapy commencement of anastrozole
Anastrozole: 1mg per day will be prescribed for 12 weeks. Commencing within 1 week of randomisation, to be administered from a min of 1 week before and a max of 4 weeks before commencement of radiotherapy and continued throughout radiotherapy. After 12 weeks administration of anastrozole according to trial regimen, anastrozole can be continued at the treating clinician's discretion and in accordance with the preference selected at the time of randomisation and stratification. The alternative options to long-term anastrozole are tamoxifen or cessation of anti-oestrogen therapy.

Treatment: Other: Radiotherapy
Radiotherapy must commence within 1 month of randomisation. Radiotherapy planning and treatment is as per the protocol.

Treatment: Drugs: Post radiotherapy commencement of anastrozole
Anastrozole 1mg per day will be prescribed for 12 weeks after radiotherapy is completed. Anastrozole should commence within 1 week of the last fraction of radiotherapy and be continued for a total of 12 weeks. After 12 weeks administration according to the trial regimen, any subsequent hormone therapy is as for the concurrent arm.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To determine if commencement of anastrozole prior to radiotherapy results in improved local control compared to anastrozole commenced after radiotherapy.
Timepoint [1] 0 0
10 years post radiotherapy
Secondary outcome [1] 0 0
Rates of distant failure
Timepoint [1] 0 0
10 years post radiotherapy
Secondary outcome [2] 0 0
Overall Survival
Timepoint [2] 0 0
10 years post radiotherapy
Secondary outcome [3] 0 0
Normal tissue complications
Timepoint [3] 0 0
10 years post radiotherapy
Secondary outcome [4] 0 0
Cosmesis
Timepoint [4] 0 0
10 years post radiotherapy

Eligibility
Key inclusion criteria
* Women aged 18 years or older
* Post total mastectomy or lumpectomy. All planned cancer resection surgery complete.
* Histologic or pathologic reports must verify either:

* No tumour contacting the inked margin of surgically removed tissue, or
* Focal involvement (<2mm front) if the margin is at the deep (posterior part) of the breast and the surgeon confirms that surgery extended to the deep fascia, or
* Focal involvement (<2mm front) if the margin is superficial (anterior part of the breast or subcutaneous) and the surgeon confirms that surgery extended to the subcutis NB: In the case of focally involved deep or superficial margins, the medical records or multidisciplinary meeting notes or correspondence from the surgeon must indicate that the surgeon confirms the surgery extended to the deep fascia or subcutis as appropriate. Patients should routinely receive a lumpectomy bed boost in the conserved breast setting if there is focal superficial or focal deep involvement as defined above.
* Tumour oestrogen receptor and/or progesterone receptor positive (=10% cells positive).
* Radiotherapy not yet commenced
* Planned radiotherapy dose prescribed to ICRU reference points in the irradiated breast / chest wall volumes at least the biological equivalent of 45 Gy in 25 fractions or more. (BED Gy4 = 65, BED Gyx=D(1+n/x) where D=total dose, n=dose per fraction, x=alpha beta ratio, Gy4 selected as appropriate alpha-beta ratio for human breast cancer lines)
* An ECOG performance status score of 2 or less.
* Female and post menopausal shown by satisfying at least one of the following criteria (as per the ATAC study criteria16):

* bilateral oophorectomy
* age greater than 60
* age 45-59 years with intact uterus and amenorrhoeic at least 12 months
* Amenorrhoeic less than 12 months with follicle stimulating hormone (FSH) levels within the post menopausal range (including patients with amenorrhoea due to chemotherapy, LHRH use or who have had hormone replacement following hysterectomy) Note: it is recommended for women under the age of 45 who have been rendered menopausal by chemotherapy that they be enrolled onto the strata which switches to Tamoxifen after the initial 3 months of anastrozole.
* Is not receiving chemotherapy, or is receiving chemotherapy but the course will be completed at least 3 weeks prior to commencing radiotherapy
* Unilateral treatment
* Has provided written informed consent for participation in this trial
Minimum age
18 Years
Maximum age
No limit
Sex
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 cancer 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 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/09/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
Accrual to date
Final
2023
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
The Canberra Hospital - Canberra
Recruitment hospital [2] 0 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [3] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [4] 0 0
Genesis Cancer Care Hurstville - Hurstville
Recruitment hospital [5] 0 0
St George Hospital - Kogarah
Recruitment hospital [6] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [7] 0 0
Calvary Mater Newcastle - Newcastle
Recruitment hospital [8] 0 0
Central West Cancer Service - Orange
Recruitment hospital [9] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [10] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [11] 0 0
Riverina Cancer Centre - Wagga Wagga
Recruitment hospital [12] 0 0
Illawarra Cancer Care Centre - Wollongong
Recruitment hospital [13] 0 0
Alan Walker Cancer Centre - Darwin
Recruitment hospital [14] 0 0
Genesis Cancer Care - Auchenflower
Recruitment hospital [15] 0 0
Cairns ROQ - Cairns
Recruitment hospital [16] 0 0
Genesis Cancer Care - Chermside
Recruitment hospital [17] 0 0
The Townsville Hospital - Douglas
Recruitment hospital [18] 0 0
Radiation Oncology Gold Coast - Gold Coast
Recruitment hospital [19] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [20] 0 0
Radiation Oncology - Mater Centre - South Brisbane
Recruitment hospital [21] 0 0
Genesis Southport - Southport
Recruitment hospital [22] 0 0
St Andrew's Toowoomba Hospital - Toowoomba
Recruitment hospital [23] 0 0
Genesis Care - Tugun
Recruitment hospital [24] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [25] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [26] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [27] 0 0
Geelong Hospital - Geelong
Recruitment hospital [28] 0 0
Genesis Cancer Care - Bunbury
Recruitment hospital [29] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [30] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [31] 0 0
Perth Radiation Oncology - Wembley
Recruitment postcode(s) [1] 0 0
2605 - Canberra
Recruitment postcode(s) [2] 0 0
2560 - Campbelltown
Recruitment postcode(s) [3] 0 0
2050 - Camperdown
Recruitment postcode(s) [4] 0 0
2220 - Hurstville
Recruitment postcode(s) [5] 0 0
2217 - Kogarah
Recruitment postcode(s) [6] 0 0
2170 - Liverpool
Recruitment postcode(s) [7] 0 0
2298 - Newcastle
Recruitment postcode(s) [8] 0 0
- Orange
Recruitment postcode(s) [9] 0 0
2031 - Randwick
Recruitment postcode(s) [10] 0 0
2065 - St Leonards
Recruitment postcode(s) [11] 0 0
2650 - Wagga Wagga
Recruitment postcode(s) [12] 0 0
2500 - Wollongong
Recruitment postcode(s) [13] 0 0
811 - Darwin
Recruitment postcode(s) [14] 0 0
4066 - Auchenflower
Recruitment postcode(s) [15] 0 0
4350 - Cairns
Recruitment postcode(s) [16] 0 0
4032 - Chermside
Recruitment postcode(s) [17] 0 0
4810 - Douglas
Recruitment postcode(s) [18] 0 0
4217 - Gold Coast
Recruitment postcode(s) [19] 0 0
4029 - Herston
Recruitment postcode(s) [20] 0 0
4101 - South Brisbane
Recruitment postcode(s) [21] 0 0
- Southport
Recruitment postcode(s) [22] 0 0
4350 - Toowoomba
Recruitment postcode(s) [23] 0 0
4224 - Tugun
Recruitment postcode(s) [24] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [25] 0 0
5000 - Adelaide
Recruitment postcode(s) [26] 0 0
7000 - Hobart
Recruitment postcode(s) [27] 0 0
3220 - Geelong
Recruitment postcode(s) [28] 0 0
- Bunbury
Recruitment postcode(s) [29] 0 0
6150 - Murdoch
Recruitment postcode(s) [30] 0 0
6001 - Perth
Recruitment postcode(s) [31] 0 0
6014 - Wembley
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch
Country [3] 0 0
New Zealand
State/province [3] 0 0
Palmerston North

Funding & Sponsors
Primary sponsor type
Other
Name
Trans Tasman Radiation Oncology Group
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine whether starting anastrozole prior to radiotherapy, so that it is taken during radiotherapy, decreases local recurrence of breast cancer in post-menopausal women in comparison to waiting until after radiotherapy to commence anastrozole.
Trial website
https://clinicaltrials.gov/study/NCT00887380
Trial related presentations / publications
Browne LH, Graham PH. Good intentions and ICH-GCP: Trial conduct training needs to go beyond the ICH-GCP document and include the intention-to-treat principle. Clin Trials. 2014 Dec;11(6):629-34. doi: 10.1177/1740774514542620. Epub 2014 Jul 14.
Public notes

Contacts
Principal investigator
Name 0 0
Peter Graham, MBBS
Address 0 0
Trans Tasman Radiation Oncology Group
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00887380