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

• Status: Unknown status
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St George Hospital, Australia
• Collaborator: AstraZeneca
• Treatments: Anastrozole

Criteria

Inclusion Criteria:

• 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 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 therapy.

• Ongoing hormone replacement therapy.