SOFEA

A partially-blind phase III randomised trial of fulvestrant (Faslodex™) with or without concomitant anastrozole (Arimidex™) compared with exemestane in post-menopausal women with oestrogen receptor (ER) positive locally advanced/metastatic breast cancer following progression on non-steroidal aromatase inhibitors.

Disease site: Breast cancer

Treatment modality: Chemotherapy

Status: Closed

Trial details

This is an NCRI phase III randomised trial in postmenopausal women with oestrogen receptor (ER) and/or progesterone receptor (PgR) positive locally advanced/metastatic breast cancer following progression on non-steroidal aromatase inhibitors (NSAIs).

The primary aims of the trial are progression-free survival of patients treated with faslodex (fulvestrant) plus concomitant arimidex (anastrozole) versus faslodex alone, and to compare the progression-free survival of patients treated with faslodex alone versus those treated with the current standard treatment exemestane.

The trial aimed to recruit 750 patients who will be randomly allocated to receive faslodex (given by monthly injection) together with arimidex or arimidex-placebo tablets taken daily or to daily exemestane tablets. The trial has the support of oncologists from more than 100 centres throughout the UK. Trial recruitment commenced in March 2004 and closed in August 2010.

Patients eligible for this trial had metastatic breast cancer. Their life expectancy was therefore limited and the majority have died. A very small number of patients (2) survived for an unexpected length of time, but the Chief Investigator decided no further knowledge could be gained in continuing follow-up and the trial was therefore closed in November 2022.

This trial is supported by the NCRI Breast Clinical Studies Group and was run in collaboration with ISD Cancer Clinical Trials Team, Scotland.

Further information for participants

Patient Information Sheet

Patient Information Sheet

Patient Summary of Trial Results 

Further information for healthcare professionals

Protocol

Chief Investigator: Professor S. Johnston, Royal Marsden NHS Foundation Trust

ICR-CTSU Scientific Lead: Professor Judith Bliss

Trial management contact: SoFEA Trial Team, [email protected]

ISRCTN: 44195747

Sponsor: Institute of Cancer Research and Royal Marsden NHS Foundation Trust

Funding: Cancer Research UK (CRUKE/03/021 & CRUK/09/007) and AstraZeneca 

Publications and presentations

Johnston SRD, Kilburn LS, Ellis P, Dodwell D, Cameron D, Hayward L, Im Y-H, Braybrooke JP, Brunt AM, Cheung K-L, Jyothirmayi R, Robinson A, Wardley AM, Wheatley D, Howell A, Coombes G, Sergenson N, Sin H-J, Folkerd E, Dowsett M, Bliss JM. Fulvestrant plus anastrozole or placebo versus exemestane alone after progression on non-steroidal aromatase inhibitors in postmenopausal patients with hormone-receptor-positive locally advanced or metastatic breast cancer (SoFEA): a composite, multicentre, phase 3 randomised trial. Lanc Oncol. 2013;14(10):989-98.

Johnston S, Kilburn LS, Ellis P, Cameron D, Dodwell D, Howell A, Im Y-H, Coombes G, Dowsett M, Bliss JM. Fulvestrant alone or with concomitant anastrazole vs exemestane following progression on non-steroidal aromatase inhibitor - First results of the SoFEA Trial (CRUKE/03/021 & CRUK/09/007) (ISRCTN441957747). Eur. J. Cancer 2012;48(Suppl 1):S2 #2LBA

Dodwell D, Coombes G, Bliss JM, Kilburn LS, Johnston S, on behalf of the SoFEA Trial Management Group. Combining fulvestrant (FaslodexTM) with continued oestrogen suppression in endocrine sensitive advanced breast cancer: The SoFea trial. Clin. Oncol. 2008;20:321-24

Kerson G, Coombes G, Dowsett M, Cameron D, Johnston S, Bliss J. Is Faslodex more effective used alone or in combination with Arimadex for treating postmenopausal women who have locally advanced/metastatic ER/PgR+ve breast cancer following progression on non-steroidal aromatase inhibitors such as Arimadex or Letrosole? Nottingham Breast Cancer Conference; 2005.

Coombes G, Bliss JM, Patel S, Dowsett M, Cameron D, Johnston S, for the So FEATMG. Is faslodex more effective used alone or in combination with arimidex for treating postmenopausal women who have locally advanced/metastatic breast cancer following progression on non-steroidal aromatase inhibitors such as arimidex or letrozole? Clin. Oncol. (R. Coll. Radiol). 2004;16(6):S24 #P1.02