Tamoxifen for prevention of breast cancer: extended long-term follow-up of the IBIS-I breast cancer prevention trial.

Ivana Sestak; Kaija Holli; John F Forbes; E Abdi; E Anderson; C Atkinson; M Baum; J Beith; A Bird; S Birrell; R Blamey; R Blum; J Boyages; K Buser; I Campbell; S Cawthorn; C Chapman; M Chipman; A Coates; J P Collins; P Craft; J Cuzick; L Denton; J Dewar; M Dowsett; H Earl; D Eccles; R Edwards; G Evans; L Fallowfield; I Fentiman; J F Forbes; M Friedlander; J Garcia; W George; F J Gilbert; P Godbolt; A Goldhirsch; H Hamed; A Hanby; S Hart; J Hearne; A Henry; C Hirst; C Holcombe; A Howell; J Kirk; M Lansdown; M Lee; T Lennard; F MacNeil; P Maddox; R Mansel; P McAleese; J MacKay; K MacMichael; C Mitine; C Normand; W Odling-Smee; T Oivanen; O Pagani; Beata Vergine; T Powles; Z Raytor; B Richmond; J Robertson; R Sainsbury; P Sauven; R J Simes; R Stewart; A Stotter; A Thompson; J Toy; P Twentyman; C Underhill; R Ward; S White; A Wilkinson; S Wilkinson; J Williamson; C Wynne; R Kealy; V Gebski; D Lindsay; A Melmeth; A Newton; L Paksec; M Seccombe; R Thornto; Simon Cawthorne

doi:10.1016/S1470-2045(14)71171-4

Tamoxifen for prevention of breast cancer: extended long-term follow-up of the IBIS-I breast cancer prevention trial.

Ivana Sestak, Kaija Holli, John F Forbes, E Abdi (Collaborator), E Anderson (Collaborator), C Atkinson (Collaborator), M Baum (Collaborator), J Beith (Collaborator), A Bird (Collaborator), S Birrell (Collaborator), R Blamey (Collaborator), R Blum (Collaborator), J Boyages (Collaborator), K Buser (Collaborator), I Campbell (Collaborator), S Cawthorn (Collaborator), C Chapman (Collaborator), M Chipman (Collaborator), A Coates (Collaborator), J P Collins (Collaborator)P Craft (Collaborator), J Cuzick (Collaborator), L Denton (Collaborator), J Dewar (Collaborator), M Dowsett (Collaborator), H Earl (Collaborator), D Eccles (Collaborator), R Edwards (Collaborator), G Evans (Collaborator), L Fallowfield (Collaborator), I Fentiman (Collaborator), J F Forbes (Collaborator), M Friedlander (Collaborator), J Garcia (Collaborator), W George (Collaborator), F J Gilbert (Collaborator), P Godbolt (Collaborator), A Goldhirsch (Collaborator), H Hamed (Collaborator), A Hanby (Collaborator), S Hart (Collaborator), J Hearne (Collaborator), A Henry (Collaborator), C Hirst (Collaborator), C Holcombe (Collaborator), A Howell (Collaborator), J Kirk (Collaborator), M Lansdown (Collaborator), M Lee (Collaborator), T Lennard (Collaborator), F MacNeil (Collaborator), P Maddox (Collaborator), R Mansel (Collaborator), P McAleese (Collaborator), J MacKay (Collaborator), K MacMichael (Collaborator), C Mitine (Collaborator), C Normand (Collaborator), W Odling-Smee (Collaborator), T Oivanen (Collaborator), O Pagani (Collaborator), Beata Vergine (Collaborator), T Powles (Collaborator), Z Raytor (Collaborator), B Richmond (Collaborator), J Robertson (Collaborator), R Sainsbury (Collaborator), P Sauven (Collaborator), R J Simes (Collaborator), R Stewart (Collaborator), A Stotter (Collaborator), A Thompson (Collaborator), J Toy (Collaborator), P Twentyman (Collaborator), C Underhill (Collaborator), R Ward (Collaborator), S White (Collaborator), A Wilkinson (Collaborator), S Wilkinson (Collaborator), J Williamson (Collaborator), C Wynne (Collaborator), R Kealy (Collaborator), V Gebski (Collaborator), D Lindsay (Collaborator), A Melmeth (Collaborator), A Newton (Collaborator), L Paksec (Collaborator), M Seccombe (Collaborator), R Thornto (Collaborator), Simon Cawthorne

Research output: Contribution to journal › Article › peer-review

Abstract

BACKGROUND: Four previously published randomised clinical trials have shown that tamoxifen can reduce the risk of breast cancer in healthy women at increased risk of breast cancer in the first 10 years of follow-up. We report the long-term follow-up of the IBIS-I trial, in which the participants and investigators remain largely masked to treatment allocation. METHODS: In the IBIS-I randomised controlled trial, premenopausal and postmenopausal women 35-70 years of age deemed to be at an increased risk of developing breast cancer were randomly assigned (1:1) to receive oral tamoxifen 20 mg daily or matching placebo for 5 years. Patients were randomly assigned to the two treatment groups by telephone or fax according to a block randomisation schedule (permuted block sizes of six or ten). Patients and investigators were masked to treatment assignment by use of central randomisation and coded drug supply. The primary endpoint was the occurrence of breast cancer (invasive breast cancer and ductal carcinoma in situ), analysed by intention to treat. Cox proportional hazard models were used to assess breast cancer occurrence and mortality. The trial is closed to recruitment and active treatment is completed, but long-term follow-up is ongoing. This trial is registered with controlledtrials.com, number ISRCTN91879928. FINDINGS: Between April 14, 1992, and March 30, 2001, 7154 eligible women recruited from genetics clinics and breast care clinics in eight countries were enrolled into the IBIS-I trial and were randomly allocated to the two treatment groups: 3579 to tamoxifen and 3575 to placebo. After a median follow up of 16.0 years (IQR 14.1-17.6), 601 breast cancers have been reported (251 [7.0%] in 3579 patients in the tamoxifen group vs 350 [9.8%] in 3575 women in the placebo group; hazard ratio [HR] 0.71 [95% CI 0.60-0.83], p

Original language	English
Pages (from-to)	67-75
Number of pages	8
Journal	The Lancet Oncology
Volume	16
Issue number	1
DOIs	https://doi.org/10.1016/S1470-2045(14)71171-4
Publication status	Published - 11 Dec 2014

Keywords

breast cancer

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/S1470-2045(14)71171-4

http://www.thelancet.com/pdfs/journals/lanonc/PIIS1470-2045(14)71171-4.pdf

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Sestak, I., Holli, K., Forbes, J. F., Abdi, E., Anderson, E., Atkinson, C., Baum, M., Beith, J., Bird, A., Birrell, S., Blamey, R., Blum, R., Boyages, J., Buser, K., Campbell, I., Cawthorn, S., Chapman, C., Chipman, M., Coates, A., ... Cawthorne, S. (2014). Tamoxifen for prevention of breast cancer: extended long-term follow-up of the IBIS-I breast cancer prevention trial. The Lancet Oncology, 16(1), 67-75. https://doi.org/10.1016/S1470-2045(14)71171-4

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title = "Tamoxifen for prevention of breast cancer: extended long-term follow-up of the IBIS-I breast cancer prevention trial.",

abstract = "BACKGROUND: Four previously published randomised clinical trials have shown that tamoxifen can reduce the risk of breast cancer in healthy women at increased risk of breast cancer in the first 10 years of follow-up. We report the long-term follow-up of the IBIS-I trial, in which the participants and investigators remain largely masked to treatment allocation. METHODS: In the IBIS-I randomised controlled trial, premenopausal and postmenopausal women 35-70 years of age deemed to be at an increased risk of developing breast cancer were randomly assigned (1:1) to receive oral tamoxifen 20 mg daily or matching placebo for 5 years. Patients were randomly assigned to the two treatment groups by telephone or fax according to a block randomisation schedule (permuted block sizes of six or ten). Patients and investigators were masked to treatment assignment by use of central randomisation and coded drug supply. The primary endpoint was the occurrence of breast cancer (invasive breast cancer and ductal carcinoma in situ), analysed by intention to treat. Cox proportional hazard models were used to assess breast cancer occurrence and mortality. The trial is closed to recruitment and active treatment is completed, but long-term follow-up is ongoing. This trial is registered with controlledtrials.com, number ISRCTN91879928. FINDINGS: Between April 14, 1992, and March 30, 2001, 7154 eligible women recruited from genetics clinics and breast care clinics in eight countries were enrolled into the IBIS-I trial and were randomly allocated to the two treatment groups: 3579 to tamoxifen and 3575 to placebo. After a median follow up of 16.0 years (IQR 14.1-17.6), 601 breast cancers have been reported (251 [7.0%] in 3579 patients in the tamoxifen group vs 350 [9.8%] in 3575 women in the placebo group; hazard ratio [HR] 0.71 [95% CI 0.60-0.83], p",

keywords = "breast cancer",

author = "Ivana Sestak and Kaija Holli and Forbes, {John F} and E Abdi and E Anderson and C Atkinson and M Baum and J Beith and A Bird and S Birrell and R Blamey and R Blum and J Boyages and K Buser and I Campbell and S Cawthorn and C Chapman and M Chipman and A Coates and Collins, {J P} and P Craft and J Cuzick and L Denton and J Dewar and M Dowsett and H Earl and D Eccles and R Edwards and G Evans and L Fallowfield and I Fentiman and Forbes, {J F} and M Friedlander and J Garcia and W George and Gilbert, {F J} and P Godbolt and A Goldhirsch and H Hamed and A Hanby and S Hart and J Hearne and A Henry and C Hirst and C Holcombe and A Howell and J Kirk and M Lansdown and M Lee and T Lennard and F MacNeil and P Maddox and R Mansel and P McAleese and J MacKay and K MacMichael and C Mitine and C Normand and W Odling-Smee and T Oivanen and O Pagani and Beata Vergine and T Powles and Z Raytor and B Richmond and J Robertson and R Sainsbury and P Sauven and Simes, {R J} and R Stewart and A Stotter and A Thompson and J Toy and P Twentyman and C Underhill and R Ward and S White and A Wilkinson and S Wilkinson and J Williamson and C Wynne and R Kealy and V Gebski and D Lindsay and A Melmeth and A Newton and L Paksec and M Seccombe and R Thornto and Simon Cawthorne",

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Sestak, I, Holli, K, Forbes, JF, Abdi, E, Anderson, E, Atkinson, C, Baum, M, Beith, J, Bird, A, Birrell, S, Blamey, R, Blum, R, Boyages, J, Buser, K, Campbell, I, Cawthorn, S, Chapman, C, Chipman, M, Coates, A, Collins, JP, Craft, P, Cuzick, J, Denton, L, Dewar, J, Dowsett, M, Earl, H, Eccles, D, Edwards, R, Evans, G, Fallowfield, L, Fentiman, I, Forbes, JF, Friedlander, M, Garcia, J, George, W, Gilbert, FJ, Godbolt, P, Goldhirsch, A, Hamed, H, Hanby, A, Hart, S, Hearne, J, Henry, A, Hirst, C, Holcombe, C, Howell, A, Kirk, J, Lansdown, M, Lee, M, Lennard, T, MacNeil, F, Maddox, P, Mansel, R, McAleese, P, MacKay, J, MacMichael, K, Mitine, C, Normand, C, Odling-Smee, W, Oivanen, T, Pagani, O, Vergine, B, Powles, T, Raytor, Z, Richmond, B, Robertson, J, Sainsbury, R, Sauven, P, Simes, RJ, Stewart, R, Stotter, A, Thompson, A, Toy, J, Twentyman, P, Underhill, C, Ward, R, White, S, Wilkinson, A, Wilkinson, S, Williamson, J, Wynne, C, Kealy, R, Gebski, V, Lindsay, D, Melmeth, A, Newton, A, Paksec, L, Seccombe, M, Thornto, R & Cawthorne, S 2014, 'Tamoxifen for prevention of breast cancer: extended long-term follow-up of the IBIS-I breast cancer prevention trial.', The Lancet Oncology, vol. 16, no. 1, pp. 67-75. https://doi.org/10.1016/S1470-2045(14)71171-4

TY - JOUR

T1 - Tamoxifen for prevention of breast cancer: extended long-term follow-up of the IBIS-I breast cancer prevention trial.

AU - Sestak, Ivana

AU - Holli, Kaija

AU - Forbes, John F

AU - Cawthorne, Simon

A2 - Abdi, E

A2 - Anderson, E

A2 - Atkinson, C

A2 - Baum, M

A2 - Beith, J

A2 - Bird, A

A2 - Birrell, S

A2 - Blamey, R

A2 - Blum, R

A2 - Boyages, J

A2 - Buser, K

A2 - Campbell, I

A2 - Cawthorn, S

A2 - Chapman, C

A2 - Chipman, M

A2 - Coates, A

A2 - Collins, J P

A2 - Craft, P

A2 - Cuzick, J

A2 - Denton, L

A2 - Dewar, J

A2 - Dowsett, M

A2 - Earl, H

A2 - Eccles, D

A2 - Edwards, R

A2 - Evans, G

A2 - Fallowfield, L

A2 - Fentiman, I

A2 - Forbes, J F

A2 - Friedlander, M

A2 - Garcia, J

A2 - George, W

A2 - Gilbert, F J

A2 - Godbolt, P

A2 - Goldhirsch, A

A2 - Hamed, H

A2 - Hanby, A

A2 - Hart, S

A2 - Hearne, J

A2 - Henry, A

A2 - Hirst, C

A2 - Holcombe, C

A2 - Howell, A

A2 - Kirk, J

A2 - Lansdown, M

A2 - Lee, M

A2 - Lennard, T

A2 - MacNeil, F

A2 - Maddox, P

A2 - Mansel, R

A2 - McAleese, P

A2 - MacKay, J

A2 - MacMichael, K

A2 - Mitine, C

A2 - Normand, C

A2 - Odling-Smee, W

A2 - Oivanen, T

A2 - Pagani, O

A2 - Vergine, Beata

A2 - Powles, T

A2 - Raytor, Z

A2 - Richmond, B

A2 - Robertson, J

A2 - Sainsbury, R

A2 - Sauven, P

A2 - Simes, R J

A2 - Stewart, R

A2 - Stotter, A

A2 - Thompson, A

A2 - Toy, J

A2 - Twentyman, P

A2 - Underhill, C

A2 - Ward, R

A2 - White, S

A2 - Wilkinson, A

A2 - Wilkinson, S

A2 - Williamson, J

A2 - Wynne, C

A2 - Kealy, R

A2 - Gebski, V

A2 - Lindsay, D

A2 - Melmeth, A

A2 - Newton, A

A2 - Paksec, L

A2 - Seccombe, M

A2 - Thornto, R

N1 - C569/A16891, Cancer Research UK, United Kingdom

PY - 2014/12/11

Y1 - 2014/12/11

N2 - BACKGROUND: Four previously published randomised clinical trials have shown that tamoxifen can reduce the risk of breast cancer in healthy women at increased risk of breast cancer in the first 10 years of follow-up. We report the long-term follow-up of the IBIS-I trial, in which the participants and investigators remain largely masked to treatment allocation. METHODS: In the IBIS-I randomised controlled trial, premenopausal and postmenopausal women 35-70 years of age deemed to be at an increased risk of developing breast cancer were randomly assigned (1:1) to receive oral tamoxifen 20 mg daily or matching placebo for 5 years. Patients were randomly assigned to the two treatment groups by telephone or fax according to a block randomisation schedule (permuted block sizes of six or ten). Patients and investigators were masked to treatment assignment by use of central randomisation and coded drug supply. The primary endpoint was the occurrence of breast cancer (invasive breast cancer and ductal carcinoma in situ), analysed by intention to treat. Cox proportional hazard models were used to assess breast cancer occurrence and mortality. The trial is closed to recruitment and active treatment is completed, but long-term follow-up is ongoing. This trial is registered with controlledtrials.com, number ISRCTN91879928. FINDINGS: Between April 14, 1992, and March 30, 2001, 7154 eligible women recruited from genetics clinics and breast care clinics in eight countries were enrolled into the IBIS-I trial and were randomly allocated to the two treatment groups: 3579 to tamoxifen and 3575 to placebo. After a median follow up of 16.0 years (IQR 14.1-17.6), 601 breast cancers have been reported (251 [7.0%] in 3579 patients in the tamoxifen group vs 350 [9.8%] in 3575 women in the placebo group; hazard ratio [HR] 0.71 [95% CI 0.60-0.83], p

AB - BACKGROUND: Four previously published randomised clinical trials have shown that tamoxifen can reduce the risk of breast cancer in healthy women at increased risk of breast cancer in the first 10 years of follow-up. We report the long-term follow-up of the IBIS-I trial, in which the participants and investigators remain largely masked to treatment allocation. METHODS: In the IBIS-I randomised controlled trial, premenopausal and postmenopausal women 35-70 years of age deemed to be at an increased risk of developing breast cancer were randomly assigned (1:1) to receive oral tamoxifen 20 mg daily or matching placebo for 5 years. Patients were randomly assigned to the two treatment groups by telephone or fax according to a block randomisation schedule (permuted block sizes of six or ten). Patients and investigators were masked to treatment assignment by use of central randomisation and coded drug supply. The primary endpoint was the occurrence of breast cancer (invasive breast cancer and ductal carcinoma in situ), analysed by intention to treat. Cox proportional hazard models were used to assess breast cancer occurrence and mortality. The trial is closed to recruitment and active treatment is completed, but long-term follow-up is ongoing. This trial is registered with controlledtrials.com, number ISRCTN91879928. FINDINGS: Between April 14, 1992, and March 30, 2001, 7154 eligible women recruited from genetics clinics and breast care clinics in eight countries were enrolled into the IBIS-I trial and were randomly allocated to the two treatment groups: 3579 to tamoxifen and 3575 to placebo. After a median follow up of 16.0 years (IQR 14.1-17.6), 601 breast cancers have been reported (251 [7.0%] in 3579 patients in the tamoxifen group vs 350 [9.8%] in 3575 women in the placebo group; hazard ratio [HR] 0.71 [95% CI 0.60-0.83], p

KW - breast cancer

U2 - 10.1016/S1470-2045(14)71171-4

DO - 10.1016/S1470-2045(14)71171-4

M3 - Article

C2 - 25497694

SN - 1470-2045

VL - 16

SP - 67

EP - 75

JO - The Lancet Oncology

JF - The Lancet Oncology

IS - 1

ER -

Tamoxifen for prevention of breast cancer: extended long-term follow-up of the IBIS-I breast cancer prevention trial.

Abstract

Keywords

UN SDGs

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