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STARS Breast Trial (Study of Anastrozole and Radiotherapy Sequencing)

Information source: Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov processed this data on November 27, 2014
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: 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 2 9113 3934, 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 2 9113 3934, Email: Peter.Graham@sesiahs.health.nsw.gov.au

Auckland Hospital, Auckland, New Zealand; Recruiting
Maria Pearse, Phone: +6493074949, Ext: 23199
Maria Pearse, Principal Investigator

Christchurch Hopsital Oncology Sevice, Christchurch, New Zealand; Recruiting
Melissa James, Phone: +6433640236
Melissa James, Principal Investigator

Palmerston North, Palmerston North, New Zealand; Recruiting
Claire Hardie, Phone: +6463508098
Claire Hardie, Principal Investigator

The Canberra Hospital, Canberra, Australian Capital Territory 2605, Australia; Not yet recruiting
Lisa Sullivan, Phone: +61261745288
Lisa Sullivan, Principal Investigator

Campbelltown Hospital, Campbelltown, New South Wales 2560, Australia; Recruiting
George Papdatos, Phone: +61287389159
George Papadatos, Principal Investigator

Royal Prince Alfred Hospital, Camperdown, New South Wales 2050, Australia; Recruiting
Susan Carroll, Phone: +61295156229
Susan Carroll, Principal Investigator

North Coast Cancer Institute-Coffs Harbour, Coffs Harbour, New South Wales 2450, Australia; Withdrawn

St George Hospital, Kogarah, New South Wales 2217, Australia; 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; Recruiting
Geoff Delaney
Geoff Delaney, Principal Investigator

Calvary Mater Newcastle, Newcastle, New South Wales 2298, Australia; Recruiting
Anne Capp, Phone: +61 2 4041 3631
Anne Capp, Principal Investigator

Orange, Orange, New South Wales, Australia; Not yet recruiting

North Coast Cancer Institute-Port Macquarie, Port Macquarie, New South Wales 2444, Australia; Withdrawn

Prince of Wales Hospital, Randwick, New South Wales 2031, Australia; Recruiting
Michael Jackson, Phone: +61293822607
Michael Jackson, Principal Investigator

Royal North Shore Hospital, St Leonards, New South Wales 2065, Australia; Recruiting
Gillian Lamoury, Phone: +61299265032
Gillian Lamoury, Principal Investigator

Riverina Cancer Centre, Wagga Wagga, New South Wales 2650, Australia; Not yet recruiting
Kandeepan Thuraisingam, Phone: +61269321000
K Thuraisingam, Principal Investigator

Illawarra Cancer Care Centre, Wollongong, New South Wales 2500, Australia; Recruiting
Christopher Fox, Phone: +61242225774
Christopher Fox, Principal Investigator

Alan Walker Cancer Centre, Darwin, Northern Territory 811, Australia; Recruiting
Scott Carruthers, Phone: +61883227634
Scott Carruthers, Principal Investigator

Cairns ROQ, Cairns, Queensland 4350, Australia; Not yet recruiting
Luke McGhee, Phone: +61746145811
Luke McGhee, Principal Investigator

The Townsville Hospital, Douglas, Queensland 4810, Australia; Recruiting
Susan Hewitt, Phone: +61744334281
Susan Hewitt, Principal Investigator

Royal Brisbane and Women's Hospital, Herston, Queensland 4029, Australia; Recruiting
Robyn Cheuk, Phone: +61736363465
Robyn Cheuk, Principal Investigator

Premion Nambour, Nambour, Queensland, Australia; Not yet recruiting
Vidhya Ramani
Vidhyn Ramani, Principal Investigator

Radiation Oncology - Mater Centre, South Brisbane, Queensland 4101, Australia; Recruiting
Guy Bryant, Phone: +61738403281
Guy Bryant, Principal Investigator

Premion Southport, Southport, Queensland, Australia; Recruiting
David Christie
David Christie, Principal Investigator

St Andrew's Toowoomba Hospital, Toowoomba, Queensland 4350, Australia; Recruiting
Winnie Wong, Phone: +61746145811
Winni Wong, Principal Investigator

Premion, Tugan, Queensland 4224, Australia; Recruiting
David Christie, Phone: +61759880366
David Christie, Principal Investigator

Princess Alexandra Hospital, Woolloongabba, Queensland 4102, Australia; Recruiting
Jennifer Harvey
Jennifer Harvey, Principal Investigator

Royal Adelaide Hospital, Adelaide, South Australia 5000, Australia; Recruiting
Scott Carruthers, Phone: +61882225024
Scott Carruthers, Principal Investigator

Royal Hobart Hospital, Hobart, Tasmania 7000, Australia; Recruiting
Marketa Skala, Phone: +61 3 6222 8626
Marketa Skala, Principal Investigator

Bendigo Hospital Campus, Bendigo, Victoria 3550, Australia; Withdrawn

Geelong Hospital, Geelong, Victoria 3220, Australia; Recruiting
Michael Francis, Phone: +61 3 5226 7845
Michael Francis, Principal Investigator

Border Medical Oncology, Wodonga, Victoria 3690, Australia; Withdrawn

Bunbury, Bunbury, Western Australia, Australia; Not yet recruiting
Eugene Leong
Eugene Leong, Principal Investigator

Royal Perth Hospital, Perth, Western Australia 6001, Australia; Recruiting
Yvonne Zissiadis, Phone: +61892242389
Yvonne Zissiadis, Principal Investigator

Perth Radiation Oncology, Wembley, Western Australia 6014, Australia; Recruiting
Yvonne Zissiadis, Phone: +61893815655
Yvonne Zissiadis, Principal Investigator

Additional Information

Link to the TROG website where trial information can be found.

Starting date: September 2009
Last updated: July 31, 2014

Page last updated: November 27, 2014

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