Clinical trial NCT00126360: STARS Breast Trial (Study of Anastrozole and Radiotherapy Sequencing Pilot)
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Breast Cancer
Keywords: Breast Cancer
Timing of Radiotherapy
Local Control
Lead sponsor: St George Hospital, Australia
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2005-08-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Local failure within irradiation volume
Secondary outcomes:
measure: Early quality of life
measure: Lung fibrosis
measure: Also demonstration of recruitment capacity at lead trial centres
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Sydney
country: Australia
facility: St George Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Campbelltown Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
Study officials:
affiliation: Cancer Care Centre, St George Hospital, Sydney
name: Ass. Prof. Peter H Graham, MBBS FRANZCR
role: PRINCIPAL_INVESTIGATOR
References: