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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2005 by St George Hospital, Australia
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
St George Hospital, Australia
ClinicalTrials.gov Identifier:
NCT00126360
First received: August 2, 2005
Last updated: November 7, 2005
Last verified: August 2005
  Purpose

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 Intervention Phase
Breast Cancer
Drug: Timing of Anastrozole in respect to radiotherapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by St George Hospital, Australia:

Primary Outcome Measures:
  • Local failure within irradiation volume

Secondary Outcome Measures:
  • Early quality of life
  • Lung fibrosis
  • Also demonstration of recruitment capacity at lead trial centres

Estimated Enrollment: 100
Study Start Date: August 2005
Estimated Study Completion Date: May 2016
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00126360

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

Locations
Australia, New South Wales
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         
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   
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

No publications provided

ClinicalTrials.gov Identifier: NCT00126360     History of Changes
Other Study ID Numbers: STARS-Pilot (05/55 Graham)
Study First Received: August 2, 2005
Last Updated: November 7, 2005
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

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
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014