Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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)
Query!
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.
Query!
Secondary ID [1]
0
0
ACTRN12610000307000
Query!
Secondary ID [2]
0
0
TROG 08.06
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
STARS
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Breast
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Intervention code [2]
0
0
Treatment: Other
Query!
Comparator / control treatment
Query!
Control group
Query!
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.
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
10 years post radiotherapy
Query!
Secondary outcome [1]
0
0
Rates of distant failure
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
10 years post radiotherapy
Query!
Secondary outcome [2]
0
0
Overall Survival
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
10 years post radiotherapy
Query!
Secondary outcome [3]
0
0
Normal tissue complications
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
10 years post radiotherapy
Query!
Secondary outcome [4]
0
0
Cosmesis
Query!
Assessment method [4]
0
0
Query!
Timepoint [4]
0
0
10 years post radiotherapy
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
16/09/2009
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/12/2024
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
2023
Query!
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,VIC,WA
Query!
Recruitment hospital [1]
0
0
The Canberra Hospital - Canberra
Query!
Recruitment hospital [2]
0
0
Campbelltown Hospital - Campbelltown
Query!
Recruitment hospital [3]
0
0
Royal Prince Alfred Hospital - Camperdown
Query!
Recruitment hospital [4]
0
0
Genesis Cancer Care Hurstville - Hurstville
Query!
Recruitment hospital [5]
0
0
St George Hospital - Kogarah
Query!
Recruitment hospital [6]
0
0
Liverpool Hospital - Liverpool
Query!
Recruitment hospital [7]
0
0
Calvary Mater Newcastle - Newcastle
Query!
Recruitment hospital [8]
0
0
Central West Cancer Service - Orange
Query!
Recruitment hospital [9]
0
0
Prince of Wales Hospital - Randwick
Query!
Recruitment hospital [10]
0
0
Royal North Shore Hospital - St Leonards
Query!
Recruitment hospital [11]
0
0
Riverina Cancer Centre - Wagga Wagga
Query!
Recruitment hospital [12]
0
0
Illawarra Cancer Care Centre - Wollongong
Query!
Recruitment hospital [13]
0
0
Alan Walker Cancer Centre - Darwin
Query!
Recruitment hospital [14]
0
0
Genesis Cancer Care - Auchenflower
Query!
Recruitment hospital [15]
0
0
Cairns ROQ - Cairns
Query!
Recruitment hospital [16]
0
0
Genesis Cancer Care - Chermside
Query!
Recruitment hospital [17]
0
0
The Townsville Hospital - Douglas
Query!
Recruitment hospital [18]
0
0
Radiation Oncology Gold Coast - Gold Coast
Query!
Recruitment hospital [19]
0
0
Royal Brisbane and Women's Hospital - Herston
Query!
Recruitment hospital [20]
0
0
Radiation Oncology - Mater Centre - South Brisbane
Query!
Recruitment hospital [21]
0
0
Genesis Southport - Southport
Query!
Recruitment hospital [22]
0
0
St Andrew's Toowoomba Hospital - Toowoomba
Query!
Recruitment hospital [23]
0
0
Genesis Care - Tugun
Query!
Recruitment hospital [24]
0
0
Princess Alexandra Hospital - Woolloongabba
Query!
Recruitment hospital [25]
0
0
Royal Adelaide Hospital - Adelaide
Query!
Recruitment hospital [26]
0
0
Royal Hobart Hospital - Hobart
Query!
Recruitment hospital [27]
0
0
Geelong Hospital - Geelong
Query!
Recruitment hospital [28]
0
0
Genesis Cancer Care - Bunbury
Query!
Recruitment hospital [29]
0
0
Fiona Stanley Hospital - Murdoch
Query!
Recruitment hospital [30]
0
0
Royal Perth Hospital - Perth
Query!
Recruitment hospital [31]
0
0
Perth Radiation Oncology - Wembley
Query!
Recruitment postcode(s) [1]
0
0
2605 - Canberra
Query!
Recruitment postcode(s) [2]
0
0
2560 - Campbelltown
Query!
Recruitment postcode(s) [3]
0
0
2050 - Camperdown
Query!
Recruitment postcode(s) [4]
0
0
2220 - Hurstville
Query!
Recruitment postcode(s) [5]
0
0
2217 - Kogarah
Query!
Recruitment postcode(s) [6]
0
0
2170 - Liverpool
Query!
Recruitment postcode(s) [7]
0
0
2298 - Newcastle
Query!
Recruitment postcode(s) [8]
0
0
- Orange
Query!
Recruitment postcode(s) [9]
0
0
2031 - Randwick
Query!
Recruitment postcode(s) [10]
0
0
2065 - St Leonards
Query!
Recruitment postcode(s) [11]
0
0
2650 - Wagga Wagga
Query!
Recruitment postcode(s) [12]
0
0
2500 - Wollongong
Query!
Recruitment postcode(s) [13]
0
0
811 - Darwin
Query!
Recruitment postcode(s) [14]
0
0
4066 - Auchenflower
Query!
Recruitment postcode(s) [15]
0
0
4350 - Cairns
Query!
Recruitment postcode(s) [16]
0
0
4032 - Chermside
Query!
Recruitment postcode(s) [17]
0
0
4810 - Douglas
Query!
Recruitment postcode(s) [18]
0
0
4217 - Gold Coast
Query!
Recruitment postcode(s) [19]
0
0
4029 - Herston
Query!
Recruitment postcode(s) [20]
0
0
4101 - South Brisbane
Query!
Recruitment postcode(s) [21]
0
0
- Southport
Query!
Recruitment postcode(s) [22]
0
0
4350 - Toowoomba
Query!
Recruitment postcode(s) [23]
0
0
4224 - Tugun
Query!
Recruitment postcode(s) [24]
0
0
4102 - Woolloongabba
Query!
Recruitment postcode(s) [25]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [26]
0
0
7000 - Hobart
Query!
Recruitment postcode(s) [27]
0
0
3220 - Geelong
Query!
Recruitment postcode(s) [28]
0
0
- Bunbury
Query!
Recruitment postcode(s) [29]
0
0
6150 - Murdoch
Query!
Recruitment postcode(s) [30]
0
0
6001 - Perth
Query!
Recruitment postcode(s) [31]
0
0
6014 - Wembley
Query!
Recruitment outside Australia
Country [1]
0
0
New Zealand
Query!
State/province [1]
0
0
Auckland
Query!
Country [2]
0
0
New Zealand
Query!
State/province [2]
0
0
Christchurch
Query!
Country [3]
0
0
New Zealand
Query!
State/province [3]
0
0
Palmerston North
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
Trans Tasman Radiation Oncology Group
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT00887380
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Peter Graham, MBBS
Query!
Address
0
0
Trans Tasman Radiation Oncology Group
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00887380
Download to PDF