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STARS Breast Trial (Study of Anastrozole and Radiotherapy Sequencing)

NCT00887380 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2023

Last updated 2022-11-18

No results posted yet for this study

Summary

The purpose of this study is to determine whether starting anastrozole prior to radiotherapy, so that it is taken during radiotherapy, decreases local recurrence of breast cancer in post-menopausal women in comparison to waiting until after radiotherapy to commence anastrozole.

Conditions

Interventions

DRUG

Pre-radiotherapy commencement of anastrozole

Anastrozole: 1mg per day will be prescribed for 12 weeks. Commencing within 1 week of randomisation, to be administered from a min of 1 week before and a max of 4 weeks before commencement of radiotherapy and continued throughout radiotherapy. After 12 weeks administration of anastrozole according to trial regimen, anastrozole can be continued at the treating clinician's discretion and in accordance with the preference selected at the time of randomisation and stratification. The alternative options to long-term anastrozole are tamoxifen or cessation of anti-oestrogen therapy.

RADIATION

Radiotherapy

Radiotherapy must commence within 1 month of randomisation. Radiotherapy planning and treatment is as per the protocol.

DRUG

Post radiotherapy commencement of anastrozole

Anastrozole 1mg per day will be prescribed for 12 weeks after radiotherapy is completed. Anastrozole should commence within 1 week of the last fraction of radiotherapy and be continued for a total of 12 weeks. After 12 weeks administration according to the trial regimen, any subsequent hormone therapy is as for the concurrent arm.

Sponsors & Collaborators

  • Trans Tasman Radiation Oncology Group

    lead OTHER

Principal Investigators

  • Peter Graham, MBBS · Trans Tasman Radiation Oncology Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-16
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Australia
  • New Zealand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00887380 on ClinicalTrials.gov