Status:
UNKNOWN
STARS Breast Trial (Study of Anastrozole and Radiotherapy Sequencing Pilot)
Lead Sponsor:
St George Hospital, Australia
Collaborating Sponsors:
AstraZeneca
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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.
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
End Date :
May 1 2016
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00126360
Start Date
August 1 2005
End Date
May 1 2016
Last Update
November 10 2005
Active Locations (4)
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1
Liverpool Hospital
Sydney, New South Wales, Australia, 2170
2
St George Hospital
Sydney, New South Wales, Australia, 2217
3
Campbelltown Hospital
Sydney, New South Wales, Australia, 2560
4
Princess Alexandra Hospital
Brisbane, Queensland, Australia, 4102