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Trial registered on ANZCTR


Registration number
ACTRN12610000307000
Ethics application status
Approved
Date submitted
12/05/2009
Date registered
19/04/2010
Date last updated
13/03/2020
Date data sharing statement initially provided
10/12/2019
Date results information initially provided
10/12/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
STARS Breast Trial (STudy of Anastrozole and Radiotherapy Sequencing)
Scientific title
Trans Tasman Radiation Oncology Group (TROG) 08.06 - 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] 863 0
ClinicalTrials.gov ID NCT00887380
Universal Trial Number (UTN)
Trial acronym
STARS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 4758 0
Condition category
Condition code
Cancer 237095 237095 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm A: Concurrent - Investigational treatment: Anastrozole commenced before and continued during radiotherapy.
Drug - Pre-radiotherapy commencement of anastrozole. Anastrozole: 1mg/day prescribed for 12 weeks, given orally. Commencing within 1 week of randomisation, to be administered from a minimum 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.
Other: Radiotherapy. Radiotherapy must commence within 1 month of randomisation. Radiotherapy planning and treatment is as per the protocol.
- Ant. Chest wall/breast: 42.5 Gy in 16 Fractions, or 45Gy in 20 Fractions, or 50 Gy in 25 fractions.
- Nodal Volumes: 25 fractions not exceeding 2Gy/fraction.
- Supraclavicular Fossa: 45-50Gy in 25 fractions, 1.8-2Gy/fraction
- SClav/Axilla: 45Gy in 25 Fractions, 1.8Gy/fraction
- Internal Mammory Chain: 40Gy in 25 fractions; modified wide tangent technique: 50Gy in 25 Fractions; Seperate Int. Mammary Chain + tangent technique: 50Gy in 25 Fractions.
- Boost Treatment: 66Gy in 33 fractions (total) Breast/chestwall: 50Gy in 25 fractions; electron boost: 16Gy in 8 fractions

Duration of Radiotherapy will depend on extent of disease.
Intervention code [1] 4532 0
Treatment: Drugs
Intervention code [2] 4533 0
Treatment: Other
Comparator / control treatment
Arm B: Sequential - Standard treatment: Anastrozole and subsequent anti-oestrogen therapy delayed until after radiotherapy.
Other: Radiotherapy. Radiotherapy must commence within 1 month of randomistaion. Radiotherapy planning and treatment is as per the protocol.
- Ant. Chest wall/breast: 42.5 Gy in 16 Fractions, or 45Gy in 20 Fractions, or 50 Gy in 25 fractions.
- Nodal Volumes: 25 fractions not exceeding 2Gy/fraction.
- Supraclavicular Fossa: 45-50Gy in 25 fractions, 1.8-2Gy/fraction
- SClav/Axilla: 45Gy in 25 Fractions, 1.8Gy/fraction
- Internal Mammory Chain: 40Gy in 25 fractions; modified wide tangent technique: 50Gy in 25 Fractions; Seperate Int. Mammary Chain + tangent technique: 50Gy in 25 Fractions.
- Boost Treatment: 66Gy in 33 fractions (total) Breast/chestwall: 50Gy in 25 fractions; electron boost: 16Gy in 8 fractions
Drug: Post radiotherapy commencement of anastrozole. Anastrozole 1mg/day prescribed for 12 weeks, given orally, 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.
Control group
Active

Outcomes
Primary outcome [1] 5926 0
To determine if commencement of anastrozole prior to radiotherapy results in improveed local control compared to anastrozole commenced after radiotherapy. Local or regional in-field failure will be confirmed on fine needle aspiration (FNA) (or other form of biopsy) and medical imaging.
Timepoint [1] 5926 0
10 years post raditherapy
Secondary outcome [1] 242018 0
Rates of distant failure. This will be confirmed by positive cytology, histology or radiology.
Timepoint [1] 242018 0
10 years post raditherapy
Secondary outcome [2] 242019 0
Overall survival
Timepoint [2] 242019 0
10 years post raditherapy
Secondary outcome [3] 242020 0
Normal tissue complications. Confirmed on plain film, Computed Tomography (CT) or bone scan, or histology
Timepoint [3] 242020 0
10 years post raditherapy
Secondary outcome [4] 242021 0
Cosmesis measured using digital photographs taken at baseline, years 1, 3, 5 and 10.
Timepoint [4] 242021 0
10 years post raditherapy

Eligibility
Key inclusion criteria
1. Women aged 18 years and older.
2. Post total mastectomy or lumpectomy. All planned cancer resection surgery complete.
3. Histologic or pathologic reports must verify either:
a) no tumour contacting the inked margin of surgically removed tissue, or
b) focal involvement (<2mm fron) if the margin is at the deep (posterior part) of the breast and the surgeon confirms that surgery extended to the deep fascia, or
c) focal involvement (<2mm front) if the margin is superficial (anterior part of the braest or subcutaneous) and the surgeon confirms that surgery extended to the subcutis.
NB: In the case of focally involved deep or superficiail 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.
4. Tumour oestrogen receptor and/or progesterone receptor positive (>= 10% cells positive).
5. Radiotherapy not yet commenced.
6. Planned radiotherapy dose prescribed to International Commision on Radiation Units (ICRU) reference points in the irradiated breast/chest wall volumes at least the biological equivalent of 45Gy in 25 fractions or more (Biologically Effective Dose (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).
7. An Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less.
8. Female and post menopausal shown by satisfying at least one of the following criteria (as per the Arimidex, Tamoxifen Alone or in Combination (ATAC) study criteria 16):
a) bilateral oophorectomy
b) age > 60 years
c) age 45-59 years with intact uterus and amenorrhoeic at least 12 months.
d) Amenorrhoeic less than 12 months with follicle stimulating hormone (FSH) levels within the post menopausal range (including patients with amenorrhoea due to chemotherapy, Luteinizing hormone releaseing hormone (LHRH) use or who have had hormone replacement following hysterectomy).
NB: It is recommended for older 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.
9. Is not receiving chemotherpy, or is receiving chemotherapy but the course will be completed at least 3 weeks prior to commencing radiotherapy.
10. Unilateral treatment.
11. Has provided written informed consent for participation in this trial.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Previous radiotherapy to the area.
2. Previous invasive malignancy within 5 years of current breast cancer diagnosis with the exception of cervix in situ or skin cancer other than melanoma.
3. Patients with clinical evidence of metastaic disease.
4. Previous hormonal breast cancer therapy.
5. 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)
Computer generated Randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Starification:
1. Sites of planned radiotherapy volume: may include breast/chest wall, supraclavicular fossa, axilla, internal mammary chain and/or lumpectomy boost (the use of a boost is a stratification factor in breast conservation patients).
2. Planned ongoing adjuvant hormone therapy after initial 3 months of anastrozole: nil, tamoxifen or anastrozole.
3. Surgery: lumpectomy (partial mastectomy) or mastectomy (total mastectomy).
4. Whether chemotherapy has been used.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
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)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 1019 0
The Canberra Hospital - Garran
Recruitment hospital [2] 1020 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [3] 1021 0
Liverpool Hospital - Liverpool
Recruitment hospital [4] 1022 0
Wollongong Hospital - Wollongong
Recruitment hospital [5] 1023 0
Prince of Wales Hospital - Randwick
Recruitment hospital [6] 1024 0
Riverina Cancer Care Centre - Wagga Wagga
Recruitment hospital [7] 1025 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [8] 1026 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [9] 1027 0
St George Hospital - Kogarah
Recruitment hospital [10] 1028 0
Royal Darwin Hospital - Tiwi
Recruitment hospital [11] 1029 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [12] 1030 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [13] 1031 0
The Townsville Hospital - Douglas
Recruitment hospital [14] 1032 0
St Andrew's Toowoomba Hospital - Toowoomba
Recruitment hospital [15] 1033 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [16] 1034 0
Royal Hobart Hospital - Hobart
Recruitment hospital [17] 1035 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment hospital [18] 2783 0
Royal Perth Hospital - Perth
Recruitment hospital [19] 4664 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [20] 4665 0
Orange Health Service - Orange
Recruitment hospital [21] 4666 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [22] 4667 0
Genesis Cancer Care QLD - Tugun
Recruitment hospital [23] 4668 0
Genesis Cancer Care QLD - Southport
Recruitment hospital [24] 4669 0
The Wesley Hospital - Auchenflower
Recruitment hospital [25] 4670 0
Chermside Day Hospital - Chermside
Recruitment hospital [26] 4671 0
Cairns Base Hospital - Cairns
Recruitment hospital [27] 4672 0
St John of God Hospital, Bunbury - Bunbury
Recruitment hospital [28] 6233 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 6894 0
4870 - Cairns
Recruitment postcode(s) [2] 6895 0
4224 - Tugun
Recruitment postcode(s) [3] 6896 0
4101 - South Brisbane
Recruitment postcode(s) [4] 6897 0
6014 - Wembley
Recruitment postcode(s) [5] 8476 0
2560 - Campbelltown
Recruitment postcode(s) [6] 8477 0
4215 - Southport
Recruitment postcode(s) [7] 12233 0
6230 - Bunbury
Recruitment postcode(s) [8] 12234 0
6000 - Perth
Recruitment postcode(s) [9] 12235 0
4066 - Auchenflower
Recruitment postcode(s) [10] 12236 0
4032 - Chermside
Recruitment postcode(s) [11] 12237 0
4006 - Herston
Recruitment postcode(s) [12] 12238 0
4814 - Douglas
Recruitment postcode(s) [13] 12239 0
4350 - Toowoomba
Recruitment postcode(s) [14] 12240 0
5000 - Adelaide
Recruitment postcode(s) [15] 12241 0
7000 - Hobart
Recruitment postcode(s) [16] 12242 0
3220 - Geelong
Recruitment postcode(s) [17] 12243 0
2800 - Orange
Recruitment postcode(s) [18] 12244 0
2605 - Garran
Recruitment postcode(s) [19] 12245 0
2298 - Waratah
Recruitment postcode(s) [20] 12246 0
2170 - Liverpool
Recruitment postcode(s) [21] 12247 0
2520 - Wollongong
Recruitment postcode(s) [22] 12248 0
2031 - Randwick
Recruitment postcode(s) [23] 12249 0
2650 - Wagga Wagga
Recruitment postcode(s) [24] 12250 0
2065 - St Leonards
Recruitment postcode(s) [25] 12251 0
2050 - Camperdown
Recruitment postcode(s) [26] 12252 0
2217 - Kogarah
Recruitment postcode(s) [27] 12253 0
0810 - Tiwi
Recruitment postcode(s) [28] 12254 0
4102 - Woolloongabba
Recruitment postcode(s) [29] 13652 0
6150 - Murdoch
Recruitment postcode(s) [30] 13653 0
2220 - Hurstville
Recruitment outside Australia
Country [1] 5089 0
New Zealand
State/province [1] 5089 0
Christchurch
Country [2] 5090 0
New Zealand
State/province [2] 5090 0
Palmerston North
Country [3] 5091 0
New Zealand
State/province [3] 5091 0
Auckland

Funding & Sponsors
Funding source category [1] 4942 0
Commercial sector/Industry
Name [1] 4942 0
AstraZeneca
Address [1] 4942 0
Alma Road
North Ryde NSW 2113 Australia
Country [1] 4942 0
Australia
Funding source category [2] 287308 0
Government body
Name [2] 287308 0
Cancer Australia - Research Project Grant
Address [2] 287308 0
Level 14, 300 Elizabeth Street, Surry Hills NSW 2010

Country [2] 287308 0
Australia
Primary sponsor type
Individual
Name
Assoc. Prof. Peter Graham
Address
Cancer Care Centre
St George Hospital
Kogarah NSW 2217, Australia
Country
Australia
Secondary sponsor category [1] 4463 0
Other Collaborative groups
Name [1] 4463 0
Trans Tasman Radiation Oncology Group (TROG)
Address [1] 4463 0
TROG Central Operations
PO Box 88
Waratah NSW 2298
Country [1] 4463 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 7043 0
Cancer Institute NSW Clinical Research Ethics Committee (EC00414)
Ethics committee address [1] 7043 0
Ethics Committee Secretariat
Cancer Institute NSW
PO BOX 41
Alexandria
NSW 2015
Ethics committee country [1] 7043 0
Australia
Date submitted for ethics approval [1] 7043 0
Approval date [1] 7043 0
04/02/2009
Ethics approval number [1] 7043 0

Summary
Brief summary
This study compares the effectiveness of treatment with the drug anastrozole before and during adjuvant radiotherapy compared with anastrozole therapy delayed until after radiotherapy. Who is it for? You can join this study if you are a woman who has had a mastectomy or lumpectomy for breast cancer, and all planned surgery is now complete and radiotherapy is recommended. Trial details Participants will be divided into two groups. One group will receive anastrozole orally before and during radiotherapy. The other group will receive standard treatment, where anastrozole and subsequent anti-oestrogen therapy is delayed until after radiotherapy. Participants will be monitored for 10 years after radiotherapy. The study aims to determine if commencement of anastrozole before radiotherapy results in improved local control of the disease.
Trial website
www.trog.com.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29592 0
A/Prof Peter Graham
Address 29592 0
Cancer Care Centre
St George Hospital
Grey St
Kogarah NSW 2217, Australia
Country 29592 0
Australia
Phone 29592 0
+61 2 9113 3934
Fax 29592 0
Email 29592 0
Peter.Graham@health.nsw.gov.au
Contact person for public queries
Name 12839 0
Ms Helen Cox
Address 12839 0
St George Clinical Trials Unit
St George Hospital
Kogarah, NSW 2217
Country 12839 0
Australia
Phone 12839 0
+61 2 9113 1922
Fax 12839 0
+61 2 9113 4822
Email 12839 0
Helen.Cox2@health.nsw.gov.au
Contact person for scientific queries
Name 3767 0
A/Prof Peter Graham
Address 3767 0
Cancer Care Centre
St George Hospital
Kogarah NSW 2217, Australia
Country 3767 0
Australia
Phone 3767 0
+61 2 9113 3934
Fax 3767 0
+61 2 9113 3958
Email 3767 0
Peter.Graham@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary