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STARS Breast Trial (Study of Anastrozole and Radiotherapy Sequencing) (STARS)

Primary Purpose

Breast Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pre-radiotherapy commencement of anastrozole
Radiotherapy
Post radiotherapy commencement of anastrozole
Sponsored by
Trans Tasman Radiation Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast Cancer, Timing of Radiotherapy, Local control

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

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

Sites / Locations

  • The Canberra Hospital
  • Campbelltown Hospital
  • Royal Prince Alfred Hospital
  • Genesis Cancer Care Hurstville
  • St George Hospital
  • Liverpool Hospital
  • Calvary Mater Newcastle
  • Central West Cancer Service
  • Prince of Wales Hospital
  • Royal North Shore Hospital
  • Riverina Cancer Centre
  • Illawarra Cancer Care Centre
  • Alan Walker Cancer Centre
  • Genesis Cancer Care
  • Cairns ROQ
  • Genesis Cancer Care
  • The Townsville Hospital
  • Radiation Oncology Gold Coast
  • Royal Brisbane and Women's Hospital
  • Radiation Oncology - Mater Centre
  • Genesis Southport
  • St Andrew's Toowoomba Hospital
  • Genesis Care
  • Princess Alexandra Hospital
  • Royal Adelaide Hospital
  • Royal Hobart Hospital
  • Geelong Hospital
  • Genesis Cancer Care
  • Fiona Stanley Hospital
  • Royal Perth Hospital
  • Perth Radiation Oncology
  • Auckland Hospital
  • Christchurch Hopsital Oncology Sevice
  • Palmerston North

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Arm A: Concurrent

Arm B: Sequential

Arm Description

Investigational treatment: Anastrozole commenced before (Pre-radiotherapy commencement of anastrozole) and continued during radiotherapy.

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

Outcomes

Primary Outcome Measures

To determine if commencement of anastrozole prior to radiotherapy results in improved local control compared to anastrozole commenced after radiotherapy.

Secondary Outcome Measures

Rates of distant failure
Overall Survival
Normal tissue complications
Cosmesis

Full Information

First Posted
April 23, 2009
Last Updated
November 16, 2022
Sponsor
Trans Tasman Radiation Oncology Group
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1. Study Identification

Unique Protocol Identification Number
NCT00887380
Brief Title
STARS Breast Trial (Study of Anastrozole and Radiotherapy Sequencing)
Acronym
STARS
Official 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.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 16, 2009 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Trans Tasman Radiation Oncology Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Adjuvant radiotherapy is well established as the primary modality to enhance local control in breast cancer. The use of adjuvant hormone therapy such as tamoxifen has shown to improve local control to a relatively minor amount on its own and does enhance local control of adjuvant radiotherapy. There is, however, conflicting invitro and clinical data regarding the effects or different sequences on tamoxifen and radiotherapy in terms of both local control and enhancement of radiotherapy toxicities. Aromatase inhibitors such as anastrozole are establishing themselves as a class of drug superior to tamoxifen for the control of estrogen dependent breast cancers and overall are better tolerated with the exception of greater bone loss. As the key question is whether the sequencing of the aromatase inhibitor anastrozole alters local control by acting as an enhancer of the radiation breast cancer cell kill, it is therefore the aim of this study to compare 3 months of anastrozole prior to radiotherapy versus 3 months of anastrozole after radiotherapy with a specific objective of reducing the baseline ratio of in-field radiotherapy failure from 6% to 3%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer, Timing of Radiotherapy, Local control

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2023 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Concurrent
Arm Type
Active Comparator
Arm Description
Investigational treatment: Anastrozole commenced before (Pre-radiotherapy commencement of anastrozole) and continued during radiotherapy.
Arm Title
Arm B: Sequential
Arm Type
Active Comparator
Arm Description
Standard Treatment: Anastrozole and subsequent anti-oestrogen therapy delayed until after radiotherapy (Post radiotherapy commencement of anastrozole)
Intervention Type
Drug
Intervention Name(s)
Pre-radiotherapy commencement of anastrozole
Other Intervention Name(s)
Arimidex
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Other Intervention Name(s)
RT, Radiation Therapy
Intervention Description
Radiotherapy must commence within 1 month of randomisation. Radiotherapy planning and treatment is as per the protocol.
Intervention Type
Drug
Intervention Name(s)
Post radiotherapy commencement of anastrozole
Other Intervention Name(s)
Arimidex
Intervention Description
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.
Primary Outcome Measure Information:
Title
To determine if commencement of anastrozole prior to radiotherapy results in improved local control compared to anastrozole commenced after radiotherapy.
Time Frame
10 years post radiotherapy
Secondary Outcome Measure Information:
Title
Rates of distant failure
Time Frame
10 years post radiotherapy
Title
Overall Survival
Time Frame
10 years post radiotherapy
Title
Normal tissue complications
Time Frame
10 years post radiotherapy
Title
Cosmesis
Time Frame
10 years post radiotherapy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Graham, MBBS
Organizational Affiliation
Trans Tasman Radiation Oncology Group
Official's Role
Study Chair
Facility Information:
Facility Name
The Canberra Hospital
City
Canberra
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
Facility Name
Campbelltown Hospital
City
Campbelltown
State/Province
New South Wales
ZIP/Postal Code
2560
Country
Australia
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Genesis Cancer Care Hurstville
City
Hurstville
State/Province
New South Wales
ZIP/Postal Code
2220
Country
Australia
Facility Name
St George Hospital
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Liverpool Hospital
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Calvary Mater Newcastle
City
Newcastle
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Central West Cancer Service
City
Orange
State/Province
New South Wales
Country
Australia
Facility Name
Prince of Wales Hospital
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Royal North Shore Hospital
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Riverina Cancer Centre
City
Wagga Wagga
State/Province
New South Wales
ZIP/Postal Code
2650
Country
Australia
Facility Name
Illawarra Cancer Care Centre
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
Alan Walker Cancer Centre
City
Darwin
State/Province
Northern Territory
ZIP/Postal Code
811
Country
Australia
Facility Name
Genesis Cancer Care
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
4066
Country
Australia
Facility Name
Cairns ROQ
City
Cairns
State/Province
Queensland
ZIP/Postal Code
4350
Country
Australia
Facility Name
Genesis Cancer Care
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
The Townsville Hospital
City
Douglas
State/Province
Queensland
ZIP/Postal Code
4810
Country
Australia
Facility Name
Radiation Oncology Gold Coast
City
Gold Coast
State/Province
Queensland
ZIP/Postal Code
4217
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Radiation Oncology - Mater Centre
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Genesis Southport
City
Southport
State/Province
Queensland
Country
Australia
Facility Name
St Andrew's Toowoomba Hospital
City
Toowoomba
State/Province
Queensland
ZIP/Postal Code
4350
Country
Australia
Facility Name
Genesis Care
City
Tugun
State/Province
Queensland
ZIP/Postal Code
4224
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Royal Hobart Hospital
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
Geelong Hospital
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Facility Name
Genesis Cancer Care
City
Bunbury
State/Province
Western Australia
Country
Australia
Facility Name
Fiona Stanley Hospital
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6001
Country
Australia
Facility Name
Perth Radiation Oncology
City
Wembley
State/Province
Western Australia
ZIP/Postal Code
6014
Country
Australia
Facility Name
Auckland Hospital
City
Auckland
Country
New Zealand
Facility Name
Christchurch Hopsital Oncology Sevice
City
Christchurch
Country
New Zealand
Facility Name
Palmerston North
City
Palmerston North
Country
New Zealand

12. IPD Sharing Statement

Citations:
PubMed Identifier
25023199
Citation
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.
Results Reference
derived
Links:
URL
http://www.trog.com.au
Description
Link to the TROG website where trial information can be found.

Learn more about this trial

STARS Breast Trial (Study of Anastrozole and Radiotherapy Sequencing)

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