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

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

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Timing of Anastrozole in respect to radiotherapy

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 Type: Interventional
• Enrollment: 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ass. Prof. Peter H Graham, MBBS FRANZCR; Phone Number: +61 293503934; Email: GrahamP@sesahs.nsw.gov.au

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Local failure within irradiation volume

Secondary Outcome Measures

Outcome Measure
Early quality of life
Lung fibrosis
Also demonstration of recruitment capacity at lead trial centres

Collaborators and Investigators

• Sponsor: St George Hospital, Australia
• Collaborators: AstraZeneca
• Investigators: Principal Investigator: Ass. Prof. Peter H Graham, MBBS FRANZCR, Cancer Care Centre, St George Hospital, Sydney

Study record dates

Study Major Dates

• Study Start: August 1, 2005
• Study Completion: May 1, 2016

Study Registration Dates

• First Submitted: August 2, 2005
• First Submitted That Met QC Criteria: August 2, 2005
• First Posted (Estimate): August 3, 2005

Study Record Updates

• Last Update Posted (Estimate): November 10, 2005
• Last Update Submitted That Met QC Criteria: November 7, 2005
• Last Verified: August 1, 2005

More Information

Terms related to this study

• Keywords: Breast Cancer; Timing of Radiotherapy; Local Control
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Anastrozole
• Other Study ID Numbers: STARS-Pilot (05/55 Graham)