MedDataX Logo

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

NCT ID: NCT00126360

Last Updated: 2005-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2016-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Breast Cancer Timing of Radiotherapy Local Control

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Timing of Anastrozole in respect to radiotherapy

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role collaborator

St George Hospital, Australia

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ass. Prof. Peter H Graham, MBBS FRANZCR

Role: PRINCIPAL_INVESTIGATOR

Cancer Care Centre, St George Hospital, Sydney

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Liverpool Hospital

Sydney, New South Wales, Australia

Site Status NOT_YET_RECRUITING

St George Hospital

Sydney, New South Wales, Australia

Site Status RECRUITING

Campbelltown Hospital

Sydney, New South Wales, Australia

Site Status NOT_YET_RECRUITING

Princess Alexandra Hospital

Brisbane, Queensland, Australia

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Australia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ass. Prof. Peter H Graham, MBBS FRANZCR

Role: CONTACT

Phone: +61 293503934

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Dr Geoff Delaney, MBBS FRANZCR

Role: primary

Peter Graham, MBBS FRANZCR

Role: primary

Dr George Papadatos, MBBS FRANZCR

Role: primary

Dr Jennifer Harvey, MBBS FRANZCR

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STARS-Pilot (05/55 Graham)

Identifier Type: -

Identifier Source: org_study_id