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Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase IV Treatment Active 18 and over Other STARS-Pilot (05/55 Graham) NCT00126360

Trial Description

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.

Further Study Information

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 in vitro and clinical data regarding the effects of different sequences on tamoxifen and radiotherapy in terms of both local control and enhancement of radiotherapy toxicities.

Aromatase inhibitors such as anastrazole 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%.This pilot study is preliminary to a planned long term study to investigate local failure.

For the pilot a period of 6 months with all contributing centres open will provide a good test of recruitment matching estimates. 100 patients will provide a good sample to compare to the 270 tamoxifen treated women in the breast boost study for quality of life. It will also provide a 95% CI on the proportion of complying women in the order of ± 5% if 85 to 90 % of women comply.

Eligibility 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.

Trial Contact Information

Trial Lead Organizations/Sponsors

St. George Hospital and Community Health Service

Ass. Prof. Peter H Graham, MBBS FRANZCR

Principal Investigator

Ass. Prof. Peter H Graham, MBBS FRANZCR		Ph: +61 293503934
		Email: GrahamP@sesahs.nsw.gov.au

Australia
New South Wales
	Sydney
	St. George Hospital and Community Health Service
		Peter Graham, MBBS FRANZCR	Ph: +61 2 9350 3912
			Email: GrahamP@sesahs.nsw.gov.au

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00126360
Information obtained from ClinicalTrials.gov on May 27, 2008