NCT00126360

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for phase_4 breast-cancer

Timeline
Completed

Started Aug 2005

Longer than P75 for phase_4 breast-cancer

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 2, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 3, 2005

Completed
10.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

November 10, 2005

Status Verified

August 1, 2005

First QC Date

August 2, 2005

Last Update Submit

November 7, 2005

Conditions

Breast Cancer

Keywords

Breast CancerTiming of RadiotherapyLocal Control

Outcome Measures

Primary Outcomes (1)

  • Local failure within irradiation volume

Secondary Outcomes (3)

  • Early quality of life

  • Lung fibrosis

  • Also demonstration of recruitment capacity at lead trial centres

Interventions

Timing of Anastrozole in respect to radiotherapyDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Liverpool Hospital

Sydney, New South Wales, 2170, Australia

NOT YET RECRUITING

St George Hospital

Sydney, New South Wales, 2217, Australia

RECRUITING

Campbelltown Hospital

Sydney, New South Wales, 2560, Australia

NOT YET RECRUITING

Princess Alexandra Hospital

Brisbane, Queensland, 4102, Australia

NOT YET RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Ass. Prof. Peter H Graham, MBBS FRANZCR

    Cancer Care Centre, St George Hospital, Sydney

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ass. Prof. Peter H Graham, MBBS FRANZCR

CONTACT

+61 293503934GrahamP@sesahs.nsw.gov.au

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 2, 2005

First Posted

August 3, 2005

Study Start

August 1, 2005

Study Completion

May 1, 2016

Last Updated

November 10, 2005

Record last verified: 2005-08

Locations

AU(4)