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RAZOR: a phase II open randomized trial of screening plus goserelin and raloxifene versus screening alone in premenopausal women at increased risk of breast cancer

RAZOR: a phase II open randomized trial of screening plus goserelin and raloxifene versus screening alone in premenopausal women at increased risk of breast cancer
RAZOR: a phase II open randomized trial of screening plus goserelin and raloxifene versus screening alone in premenopausal women at increased risk of breast cancer

Background: Ovarian suppression in premenopausal women is known to reduce breast cancer risk. This study aimed to assess uptake and compliance with ovarian suppression using the luteinizing hormone releasing hormone (LHRH) analogue, goserelin, with add-back raloxifene, as a potential regimen for breast cancer prevention.

Methods: Women at ≥30% lifetime risk breast cancer were approached and randomized to mammographic screening alone (C-Control) or screening in addition to monthly subcutaneous injections of 3.6 mg goserelin and continuous 60 mg raloxifene daily orally (T-Treated) for 2 years. The primary endpoint was therapy adherence. Secondary endpoints were toxicity/quality of life, change in bone density, and mammographic density.

Results: A total of 75/950 (7.9%) women approached agreed to randomization. In the T-arm, 20 of 38 (52%) of women completed the 2-year period of study compared with the C-arm (27/37, 73.0%). Dropouts were related to toxicity but also the wish to have established risk-reducing procedures and proven chemoprevention. As relatively few women completed the study, data are limited, but those in the T-arm reported significant increases in toxicity and sexual problems, no change in anxiety, and less cancer worry. Lumbar spine bone density declined by 7.0% and visually assessed mammographic density by 4.7% over the 2-year treatment period.

58-66
Howell, Anthony
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Ashcroft, Linda
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Fallowfield, Lesley
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Eccles, Diana M.
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Eeles, Rosalind A.
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Ward, Ann
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Brentnall, Adam R.
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Dowsett, Mitchell
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Cuzick, Jack M.
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Greenhalgh, Rosemary
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Boggis, Caroline
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Motion, Jamie
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Sergeant, Jamie C.
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Adams, Judith
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Evans, D. Gareth
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Howell, Anthony
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Ashcroft, Linda
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Fallowfield, Lesley
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Eccles, Diana M.
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Eeles, Rosalind A.
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Ward, Ann
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Brentnall, Adam R.
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Dowsett, Mitchell
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Cuzick, Jack M.
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Greenhalgh, Rosemary
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Boggis, Caroline
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Motion, Jamie
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Sergeant, Jamie C.
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Adams, Judith
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Evans, D. Gareth
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Howell, Anthony, Ashcroft, Linda, Fallowfield, Lesley, Eccles, Diana M., Eeles, Rosalind A., Ward, Ann, Brentnall, Adam R., Dowsett, Mitchell, Cuzick, Jack M., Greenhalgh, Rosemary, Boggis, Caroline, Motion, Jamie, Sergeant, Jamie C., Adams, Judith and Evans, D. Gareth (2018) RAZOR: a phase II open randomized trial of screening plus goserelin and raloxifene versus screening alone in premenopausal women at increased risk of breast cancer. Cancer Epidemiology, Biomarkers & Prevention, 27 (1), 58-66. (doi:10.1158/1055-9965.EPI-17-0158).

Record type: Article

Abstract

Background: Ovarian suppression in premenopausal women is known to reduce breast cancer risk. This study aimed to assess uptake and compliance with ovarian suppression using the luteinizing hormone releasing hormone (LHRH) analogue, goserelin, with add-back raloxifene, as a potential regimen for breast cancer prevention.

Methods: Women at ≥30% lifetime risk breast cancer were approached and randomized to mammographic screening alone (C-Control) or screening in addition to monthly subcutaneous injections of 3.6 mg goserelin and continuous 60 mg raloxifene daily orally (T-Treated) for 2 years. The primary endpoint was therapy adherence. Secondary endpoints were toxicity/quality of life, change in bone density, and mammographic density.

Results: A total of 75/950 (7.9%) women approached agreed to randomization. In the T-arm, 20 of 38 (52%) of women completed the 2-year period of study compared with the C-arm (27/37, 73.0%). Dropouts were related to toxicity but also the wish to have established risk-reducing procedures and proven chemoprevention. As relatively few women completed the study, data are limited, but those in the T-arm reported significant increases in toxicity and sexual problems, no change in anxiety, and less cancer worry. Lumbar spine bone density declined by 7.0% and visually assessed mammographic density by 4.7% over the 2-year treatment period.

Text RAZOR printed CEBP accepted April 2017 - Accepted Manuscript
Restricted to Repository staff only until 11 August 2018.
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More information

Accepted/In Press date: 17 October 2017
e-pub ahead of print date: 2 November 2017
Published date: 1 January 2018

Identifiers

Local EPrints ID: 414174
URI: https://eprints.soton.ac.uk/id/eprint/414174
PURE UUID: db4450b6-f7c7-4e93-accf-484881960c57

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Date deposited: 15 Sep 2017 16:30
Last modified: 04 May 2018 16:31

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Contributors

Author: Anthony Howell
Author: Linda Ashcroft
Author: Lesley Fallowfield
Author: Diana M. Eccles
Author: Rosalind A. Eeles
Author: Ann Ward
Author: Adam R. Brentnall
Author: Mitchell Dowsett
Author: Jack M. Cuzick
Author: Rosemary Greenhalgh
Author: Caroline Boggis
Author: Jamie Motion
Author: Jamie C. Sergeant
Author: Judith Adams
Author: D. Gareth Evans

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