STARS Breast Trial (STudy of Anastrozole and Radiotherapy Sequencing)

Phase 3

Active, not recruiting

• Conditions: Breast Cancer; Cancer - Breast

• Registration Number: ACTRN12610000307000
• Lead Sponsor: Assoc. Prof. Peter Graham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-04-19
• Last Update Posted: 12 December 2022

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Female
• Target Recruitment: 2000

Inclusion Criteria

1. Women aged 18 years and older.
2. Post total mastectomy or lumpectomy. All planned cancer resection surgery complete.
3. Histologic or pathologic reports must verify either:
a) no tumour contacting the inked margin of surgically removed tissue, or
b) focal involvement (<2mm fron) if the margin is at the deep (posterior part) of the breast and the surgeon confirms that surgery extended to the deep fascia, or
c) focal involvement (<2mm front) if the margin is superficial (anterior part of the braest or subcutaneous) and the surgeon confirms that surgery extended to the subcutis.
NB: In the case of focally involved deep or superficiail margins, the medical records or multidisciplinary meeting notes or correspondence from the surgeon must indicate that the surgeon confirms the surgery extended to the deep fascia or subcutis as appropriate. patients should routinely receive a lumpectomy bed boost in the conserved breast setting if there is focal superficial or focal deep involvement as defined above.
4. Tumour oestrogen receptor and/or progesterone receptor positive (>= 10% cells positive).
5. Radiotherapy not yet commenced.
6. Planned radiotherapy dose prescribed to International Commision on Radiation Units (ICRU) reference points in the irradiated breast/chest wall volumes at least the biological equivalent of 45Gy in 25 fractions or more (Biologically Effective Dose (BED) Gy4 >=65, BED Gyx=D(1+n/x) where D=total dose, n=dose per fraction, x=alpha beta ratio, Gy4 selected as appropriate alpha beta ratio for human breast cancer lines).
7. An Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less.
8. Female and post menopausal shown by satisfying at least one of the following criteria (as per the Arimidex, Tamoxifen Alone or in Combination (ATAC) study criteria 16):
a) bilateral oophorectomy
b) age > 60 years
c) age 45-59 years with intact uterus and amenorrhoeic at least 12 months.
d) Amenorrhoeic less than 12 months with follicle stimulating hormone (FSH) levels within the post menopausal range (including patients with amenorrhoea due to chemotherapy, Luteinizing hormone releaseing hormone (LHRH) use or who have had hormone replacement following hysterectomy).
NB: It is recommended for older women under the age of 45 who have been rendered menopausal by chemotherapy that they be enrolled onto the strata which switches to Tamoxifen after the initial 3 months of anastrozole.
9. Is not receiving chemotherpy, or is receiving chemotherapy but the course will be completed at least 3 weeks prior to commencing radiotherapy.
10. Unilateral treatment.
11. Has provided written informed consent for participation in this trial.

Exclusion Criteria

1. Previous radiotherapy to the area.
2. Previous invasive malignancy within 5 years of current breast cancer diagnosis with the exception of cervix in situ or skin cancer other than melanoma.
3. Patients with clinical evidence of metastaic disease.
4. Previous hormonal breast cancer therapy.
5. Ongoing hormone replacement therapy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine if commencement of anastrozole prior to radiotherapy results in improveed local control compared to anastrozole commenced after radiotherapy. Local or regional in-field failure will be confirmed on fine needle aspiration (FNA) (or other form of biopsy) and medical imaging.[10 years post raditherapy]

Secondary Outcome Measures

Name	Time	Method
Rates of distant failure. This will be confirmed by positive cytology, histology or radiology.[10 years post raditherapy];Overall survival[10 years post raditherapy];Normal tissue complications. Confirmed on plain film, Computed Tomography (CT) or bone scan, or histology[10 years post raditherapy];Cosmesis measured using digital photographs taken at baseline, years 1, 3, 5 and 10.[10 years post raditherapy]