Breast CancerPhase 4NCT00126360
STARS Breast Trial (Study of Anastrozole and Radiotherapy Sequencing Pilot)
A Phase 4 study testing Timing of Anastrozole in respect to radiotherapy in people with Breast Cancer, run by St George Hospital, Australia at 4 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Timing of Anastrozole in respect to radiotherapy
- How many people
- 100 participants
- Where
- 4 sitesAustralia
- Study dates
- Aug 2005to May 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Australia4 sites, 4 recruiting
- Not yet recruiting
Princess Alexandra Hospital
Brisbane, Queensland, 4102
Dr Jennifer Harvey, MBBS FRANZCR, +61 732402 111, J.Harvey@mailbox.uq.edu.au
Dr Jennifer Harvey, MBBS FRANZCR
- Not yet recruiting
Liverpool Hospital
Sydney, New South Wales, 2170
Dr Geoff Delaney, MBBS FRANZCR, +61 29828 5276, Geoff.Delaney@swsahs.nsw.gov.au
Dr Geoff Delaney, MBBS FRANZCR
- Recruiting
St George Hospital
Sydney, New South Wales, 2217
Peter Graham, MBBS FRANZCR, +61 2 9350 3912, GrahamP@sesahs.nsw.gov.au
- Not yet recruiting
Campbelltown Hospital
Sydney, New South Wales, 2560
Dr George Papadatos, MBBS FRANZCR, +61 246344355, George.papadatos@swsahs.nsw.gov.au
Dr George Papadatos, MBBS FRANZCR
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Timing of Anastrozole in respect to radiotherapy
- Keywords
- Breast Cancer, Timing of Radiotherapy, Local Control
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timing of Anastrozole in respect to radiotherapyDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Local failure within irradiation volume
Secondary outcomes (3)
Early quality of life
Lung fibrosis
Also demonstration of recruitment capacity at lead trial centres
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2005 (estimated)
- Study startAug 2005
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- St George Hospital, Australia
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Investigators
- Ass. Prof. Peter H Graham, MBBS FRANZCR, Principal investigator, Cancer Care Centre, St George Hospital, Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00126360
- Sponsor's protocol ID
- STARS-Pilot (05/55 Graham)
- Status last verified
- Aug 2005
- First submitted
- 2 Aug 2005
- Last updated
- 10 Nov 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00126360
- Acronym / sponsor ID
- STARS-Pilot (05/55 Graham)
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Timing of Radiotherapy, Local Control
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants
- Lead sponsor
- St George Hospital, AustraliaUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Aug 2005
- Study completion
- May 2016
- First posted
- 3 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Timing of Anastrozole in respect to radiotherapy | Drug | – |
Primary outcome
Local failure within irradiation volume
3 secondary outcomes
Early quality of life
Lung fibrosis
Also demonstration of recruitment capacity at lead trial centres
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ass. Prof. Peter H Graham, MBBS FRANZCR principal investigator
Cancer Care Centre, St George Hospital, Sydney
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Timing of Anastrozole in respect to radiotherapy in people with Breast Cancer, run by St George Hospital, Australia at 4 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ass. Prof. Peter H Graham, MBBS FRANZCR (+61 293503934, GrahamP@sesahs.nsw.gov.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local failure within irradiation volume. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2005.