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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Drug: Timing of Anastrozole in respect to radiotherapy	Phase 4

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 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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	100 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Pilot for a Randomised Comparison of Anastrozole Commenced Before and Continued During Adjuvant Radiotherapy for Breast Cancer Versus Anastrozole and Subsequent Ant-Oestrogen Therapy Delayed Until After Radiotherapy
Study Start Date :	August 2005
Study Completion Date :	May 2016

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

1. Local failure within irradiation volume

Secondary Outcome Measures :

1. Early quality of life
2. Lung fibrosis
3. Also demonstration of recruitment capacity at lead trial centres

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

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

Locations

Australia, New South Wales
Liverpool Hospital	Not yet recruiting
Sydney, New South Wales, Australia, 2170
Contact: Dr Geoff Delaney, MBBS FRANZCR +61 29828 5276 Geoff.Delaney@swsahs.nsw.gov.au
Principal Investigator: Dr Geoff Delaney, MBBS FRANZCR
St George Hospital	Recruiting
Sydney, New South Wales, Australia, 2217
Contact: Peter Graham, MBBS FRANZCR +61 2 9350 3912 GrahamP@sesahs.nsw.gov.au
Campbelltown Hospital	Not yet recruiting
Sydney, New South Wales, Australia, 2560
Contact: Dr George Papadatos, MBBS FRANZCR +61 246344355 George.papadatos@swsahs.nsw.gov.au
Principal Investigator: Dr George Papadatos, MBBS FRANZCR
Australia, Queensland
Princess Alexandra Hospital	Not yet recruiting
Brisbane, Queensland, Australia, 4102
Contact: Dr Jennifer Harvey, MBBS FRANZCR +61 732402 111 J.Harvey@mailbox.uq.edu.au
Principal Investigator: Dr Jennifer Harvey, MBBS FRANZCR

Sponsors and Collaborators

St George Hospital, Australia

AstraZeneca

Investigators

Principal Investigator:	Ass. Prof. Peter H Graham, MBBS FRANZCR	Cancer Care Centre, St George Hospital, Sydney

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00126360 History of Changes
Other Study ID Numbers:	STARS-Pilot (05/55 Graham)
First Posted:	August 3, 2005
Last Update Posted:	November 10, 2005
Last Verified:	August 2005

Keywords provided by St George Hospital, Australia:

Breast Cancer; Timing of Radiotherapy; Local Control

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Anastrozole; Antineoplastic Agents, Hormonal; Antineoplastic Agents	Aromatase Inhibitors; Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs