Clinical Trials

The Breast Surgery group has been involved in clinical trials of breast cancer over the last 30 years - including, surgery, endocrine and growth factor therapies, radiotherapy, immune-based therapies. The group has over the last 25 years researched every class of endocrine agent and more recently also a number of the new growth factor therapies.

Professor John Robertson has been Chief Investigator on a large number of national and international multi-centre Phase 2 and Phase 3 randomised controlled trials. We have also participated in and contributed to many other phase 2 and 3 trials as local principal investigator(s).

clinicaltrials

Outcomes

Our research has led to the introduction of the first medical abalative therapy for pre-menopausal women with advanced breast cancer. Professor Robertson’s work over the last 20 years on the pure anti-oestrogens, particularly fulvestrant (Faslodex), has made a significant contribution to its clinical impact and uptake.

The group has been at the forefront of the clinical trials on anti-progresterone therapies – these have shown both the potential and also the side-effects as well as differences by type of anti-progesterone agent – and as a result it is clear further research is required before this class of agent is ready for routine clinical use. This is also true for other agents the Division has assessed – eg gefitinib and ganitumab.

Selected publications

Selected publications 2013-2008

2013

ROBERTSON JFR, FERRERO J-M, BOURGEOIS H, KENNECKE H, DE BOER RH, JACOT W, MCGREIVY J, SUZUKI S, ZHU M, MCCAFFERY I, LOH E, GANSERT JL, KAUFMAN PA. Ganitumab with either exemestane or fulvestrant for postmenopausal women with advanced, hormone receptor-positive breast cancer: a randomised, controlled, double-blind, phase 2 trial Lancet Oncology 2013; 14: 228-235 [IF: 22.59]

ROBERTSON JF, DIXON JM, SIBBERING DM, JAHAN A, ELLIS IO, CHANNON E, HYMAN-TAYLOR P, NICHOLSON RI, GEE JM. A randomized trial to assess the biological activity of short-term (pre-surgical) fulvestrant 500 mg plus anastrozole versus fulvestrant 500 mg alone or anastrozole alone on primary breast cancer. Breast Cancer Res. 2013 Mar 5;15(2):R18.

JONAT W, BACHELOT W, RUHSTALLER T, KUSS I, REIMANN U & ROBERTSON jfr. Randomized Phase II study of lonaprisan as second-line therapy for progesterone receptor-positive breast cancer. Annals of Oncology 2013; doi: 10.1093/annonc/mdt216

2012

S. J. JOHNSTON; F. S. KENNY; B. M. SYED; J.F.R. ROBERTSON; S. E. PINDER; L. WINTERBOTTOM; I. O. ELLIS; R. W. BLAMEY; K. L. CHEUNG. A randomised trial of primary tamoxifen versus mastectomy plus adjuvant tamoxifen in fit elderly women with invasive breast carcinoma of high oestrogen receptor content: long-term results at 20 years of follow-up Annals of Oncology 2012; 23(9), 2296-2300

ROBERTSON JF, LINDEMANN JP, LLOMBART-CUSSAC A, ROLSKI J, FELTL D, DEWAR J, EMERSON L, DEAN A, ELLIS MJ. Fulvestrant 500 mg versus anastrozole 1 mg for the first-line treatment of advanced breast cancer: follow-up analysis from the randomized 'FIRST' study. Breast Cancer Res Treat. 2012 Nov;136(2):503-11.

MASAKAZU TOI, JOHN R BENSON, ERIC P WINER, JOHN F FORBES, GUNTER VON MINCKWITZ, MEHRA GOLSHAN, JOHN FR ROBERTSON, HIRONOBU SASANO, BERNARD F COLE, LOUIS WC CHOW, MARK D PEGRAM, WONSHIK HAN, CHIUM-SHENG HUANG, TADASHI IDEDA, SHOTARO KANAO, EUN-SOOK LEE, SHINZABURO NOGUCHI, SHINJI OHNO, ANN H PARTRIDGE, ROMAN ROUZIER, MITSUHIRO TOZAKI, TOMAHARU SUGIE, AKIRA YAMAUCHI, TAKASHI INAMOTO. Preoperative systemic therapy in locoregional management of early breast cancer: highlights from the Kyoto Breast Cancer Concensus Conference Breast Cancer Res Treat (2012) 136:919-926

2010

GUTTERIDGE E, AGRAWAL A, NICHOLSON R, LEUNG CHEUNG K, ROBERTSON JFR, GEE J. The effects of gefitinib in tamoxifen-resistant and hormone-insensitive breast cancer: a phase II study Int J Cancer. 2010;126(8):1806-16.

CHEUNG KL, AGRAWAL A, FOLKERD E, DOWSETT M, ROBERTSON JF, WINTERBOTTOM L. Suppression of ovarian function in combination with an aromatase inhibitor as treatment for advanced breast cancer in pre-menopausal women. Eur J Cancer. 2010;46(16):2936-42.

2009

ROBERTSON JFR, LLOMBART-CUSSAC A, ROLSKI J, FELTL D, DEWAR J, MACPHERSON E, LINDEMANN J, ELLIS MJ. Activity of fulvestrant 500 mg versus anastrozole 1 mg as first-line treatment for advanced cancer: the results from the FIRST study J Clin Oncol. 2009: 27(27):4530-5.

GUTTERIDGE E, ROBERTSON JFR. Are current drug development programmes realising the full potential of new agents? Tyrosine kinase inhibitors. Breast Cancer Res. 2009;11 Suppl 3:S24

2008

CHIA S, GRADISHAR W, MAURIAC L, BINES J, AMANT F, FEDERICO M, FEIN L, ROMIEU G, BUZDAR A, ROBERTSON JFR, BRUFSKY A, POSSINGER K, RENNIE P, SAPUNAR F, LOWE E, PICCART M. Double -blind, randomized placebo controlled trial of Fulvestrant compared with Exemestane after prior nonsteroidal aromatase inhibitor therapy in postmenopausal women with hormone receptor-positive, advanced breast cancer: results from EFFECT J Clin Oncol. 2008; 26(10): 1664-70.