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STARS Breast Trial (Study of Anastrozole and Radiotherapy Sequencing)

Information source: Trans-Tasman Radiation Oncology Group (TROG)
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Cancer

Intervention: Pre-radiotherapy commencement of anastrozole (Drug); Radiotherapy (Radiation); Post radiotherapy commencement of anastrozole (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: Trans-Tasman Radiation Oncology Group (TROG)

Official(s) and/or principal investigator(s):
Peter Graham, MBBS, Study Chair, Affiliation: Trans-Tasman Radiation Oncology Group (TROG)

Overall contact:
Peter Graham, Phone: +61 02 9113 3912, Email: Peter.Graham@sesiahs.health.nsw.gov.au

Summary

The purpose of this study is to determine whether starting anastrozole prior to radiotherapy, so that it is taken during radiotherapy, decreases local recurrence of breast cancer in post-menopausal women in comparison to waiting until after radiotherapy to commence anastrozole.

Clinical Details

Official title: A Randomised Comparison of Anastrozole Commenced Before and Continued During Adjuvant Radiotherapy for Breast Cancer Versus Anastrozole and Subsequent Anti-oestrogen Therapy Delayed Until After Radiotherapy.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To determine if commencement of anastrozole prior to radiotherapy results in improved local control compared to anastrozole commenced after radiotherapy.

Secondary outcome:

Rates of distant failure

Overall Survival

Normal tissue complications

Cosmesis

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 invitro and clinical data regarding the effects or different sequences on tamoxifen and radiotherapy in terms of both local control and enhancement of radiotherapy toxicities.

Aromatase inhibitors such as anastrozole 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%.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Women aged 18 years or older

- Post total mastectomy or lumpectomy. All planned cancer resection surgery complete.

- Histologic or pathologic reports must verify either:

- No tumour contacting the inked margin of surgically removed tissue, or

- Focal involvement (<2mm front) if the margin is at the deep (posterior part) of

the breast and the surgeon confirms that surgery extended to the deep fascia, or

- Focal involvement (<2mm front) if the margin is superficial (anterior part of

the breast or subcutaneous) and the surgeon confirms that surgery extended to the subcutis NB: In the case of focally involved deep or superficial 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.

- Tumour oestrogen receptor and/or progesterone receptor positive (≥10% cells

positive).

- Radiotherapy not yet commenced

- Planned radiotherapy dose prescribed to ICRU reference points in the irradiated

breast / chest wall volumes at least the biological equivalent of 45 Gy in 25 fractions or more. (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)

- An ECOG performance status score of 2 or less.

- Female and post menopausal shown by satisfying at least one of the following criteria

(as per the ATAC study criteria16):

- bilateral oophorectomy

- age greater than 60

- age 45-59 years with intact uterus and amenorrhoeic at least 12 months

- Amenorrhoeic less than 12 months with follicle stimulating hormone (FSH) levels

within the post menopausal range (including patients with amenorrhoea due to chemotherapy, LHRH use or who have had hormone replacement following hysterectomy) Note: it is recommended for 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.

- Is not receiving chemotherapy, or is receiving chemotherapy but the course will be

completed at least 3 weeks prior to commencing radiotherapy

- Unilateral treatment

- Has provided written informed consent for participation in this trial

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 cancer therapy.

- Ongoing hormone replacement therapy

Locations and Contacts

Peter Graham, Phone: +61 02 9113 3912, Email: Peter.Graham@sesiahs.health.nsw.gov.au

Campbelltown Hospital, Campbelltown, New South Wales 2560, Australia; Not yet recruiting
George Papdatos
George Papadatos, Principal Investigator

Royal Prince Alfred Hospital, Camperdown, New South Wales 2050, Australia; Not yet recruiting
Susan Carroll
Susan Carroll, Principal Investigator

North Coast Cancer Institute-Coffs Harbour, Coffs Harbour, New South Wales 2450, Australia; Not yet recruiting
Karen Briscoe, Phone: +61 2 6656 5737
Karen Briscoe, Principal Investigator

St George Hospital, Kogarah, New South Wales 2217, Australia; Not yet recruiting
Peter Graham, Phone: +61 02 9113 3934, Email: Peter.Graham@sesiahs.health.nsw.gov.au
Peter Graham, Principal Investigator

Liverpool Hospital, Liverpool, New South Wales 2170, Australia; Not yet recruiting
Geoff Delaney
Geoff Delaney, Principal Investigator

Calvary Mater Newcastle, Newcastle, New South Wales 2298, Australia; Not yet recruiting
Anne Capp, Phone: +61 2 4041 3631
Anne Capp, Principal Investigator

North Coast Cancer Institute-Port Macquarie, Port Macquarie, New South Wales 2444, Australia; Not yet recruiting
Andrew Last, Phone: +61 2 6580 1807
Andrew Last, Principal Investigator

Prince of Wales Hospital, Randwick, New South Wales 2031, Australia; Not yet recruiting
Michael Jackson
Michael Jackson, Principal Investigator

Royal North Shore Hospital, St Leonards, New South Wales 2065, Australia; Not yet recruiting
Gillian Lamoury

Illawarra Cancer Care Centre, Wollongong, New South Wales 2500, Australia; Not yet recruiting
CHristopher Fox
Christopher Fox, Principal Investigator

Royal Brisbane and Women's Hospital, Herston, Queensland 4029, Australia; Not yet recruiting
Robyn Cheuk
Robyn Cheuk, Principal Investigator

Radiation Oncology - Mater Centre, South Brisbane, Queensland 4101, Australia; Not yet recruiting
Guy Bryant
Guy Bryant, Principal Investigator

St Andrew's Toowoomba Hospital, Toowoomba, Queensland 4350, Australia; Not yet recruiting
Winni Wong
Winni Wong, Principal Investigator

Princess Alexandra Hospital, Woolloongabba, Queensland 4102, Australia; Not yet recruiting
Jennifer Harvey
Jennifer Harvey, Principal Investigator

Royal Adelaide Hospital, Adelaide, South Australia 5000, Australia; Not yet recruiting
Scott Carruthers
Scott Carruthers, Principal Investigator

Royal Hobart Hospital, Hobart, Tasmania 7000, Australia; Not yet recruiting
Marketa Skala, Phone: +61 3 6222 8626
Marketa Skala, Principal Investigator

Bendigo Hospital Campus, Bendigo, Victoria 3550, Australia; Not yet recruiting

Geelong Hospital, Geelong, Victoria 3220, Australia; Not yet recruiting
Michael Francis, Phone: +61 3 5226 7845
Michael Francis, Principal Investigator

Border Medical Oncology, Wodonga, Victoria 3690, Australia; Not yet recruiting
Kerrie Clarke, Phone: +61 2 6051 5300
Kerrie Clarke, Principal Investigator

Royal Perth Hospital, Perth, Western Australia 6001, Australia; Not yet recruiting
Yvonne Zissiadis
Yvonne Zissiadis, Principal Investigator

Additional Information

Starting date: December 2009
Last updated: September 30, 2009

Page last updated: February 07, 2013

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