Condition category
Cancer
Date applied
27/06/2003
Date assigned
08/09/2003
Last edited
08/09/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Ms Gill Coombes

ORCID ID

Contact details

Trial Manager
ICR Division of Clinical Studies (ICR-CTSU)
The Institute of Cancer Research
Sir Richard Doll Building
Cotswold Road
Sutton
Surrey
SM2 5NG
United Kingdom
+44 (0) 20 8722 4039
sofea-icrctsu@icr.ac.uk

Additional identifiers

EudraCT number

2004-000093-30

ClinicalTrials.gov number

NCT00253422

Protocol/serial number

N/A

Study information

Scientific title

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

Acronym

SoFEA

Study hypothesis

This randomised phase III trial is studying fulvestrant and anastrozole to see how well they work compared to fulvestrant and a placebo or exemestane alone in treating postmenopausal women with locally advanced or metastatic breast cancer.

Ethics approval

South West Multi-centre REC, 19/12/2003, ref: MREC/03/6/77

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Locally advanced/metastatic breast cancer

Intervention

The study will compare the progression-free survival of patients treated with Faslodex™ plus concomitant Arimidex™ (F+A) versus Faslodex™ (F) alone. All Faslodex™ treated patients will take either an Arimidex™ or an Arimidex™-placebo tablet once daily, and both patients and clinicians will be blinded to this treatment option (i.e., double-blind). A reference control arm will be included with the steroidal aromatase inhibitor exemestane (E) which is the current endocrine treatment of choice for such patients.

750 eligible patients will be randomised in a ratio of 1:1:1 to either:
1. Faslodex™ plus placebo or
2. Faslodex™ plus Arimidex™ or
3. Exemestane

Intervention type

Drug

Phase

Phase III

Drug names

Fulvestrant (Faslodex™), anastrozole (Arimidex™), exemestane

Primary outcome measures

Progression-free survival

Secondary outcome measures

1. Objective complete response (CR) and partial response (PR) rate
2. Duration of response
3. Clinical benefit (i.e., six-month CR, PR, and stable disease) rate
4. Duration of clinical benefit
5. Time to treatment failure
6. Overall survival
7. Tolerability

Overall trial start date

01/03/2004

Overall trial end date

01/01/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with locally advanced/metastatic breast cancer who have progressed on the non-steroidal aromatase inhibitors (Arimidex™ or letrozole [Femara™]):
1. Female postmenopausal patients defined as:
1.1. Aged 60 years or over
1.2. Aged 45 to 59 with intact uterus and amenorrhoeic for at least 12 months
1.3. Any age having had a bilateral oophorectomy
2. Histologically or cytologically confirmed adenocarcinoma of the breast
3. Patients with original ER positive and/or progesterone (PgR) positive breast cancer which has relapsed or progressed during endocrine therapy with a single-agent non-steroidal aromatase inhibitor (NSAI) given either:
3.1. As adjuvant treatment where the patient received at least 12 months therapy, or
3.2. As first-line therapy for metastatic disease. Patients treated with an NSAI as first-line therapy must have had either an objective response (complete response [CR]/partial response [PR]), or stabilisation of disease for at least six months.
4. Measurable/evaluable sites of metastatic disease (response evaluation criteria in solid tumours [RECIST])
5. World Health Organisation (WHO) performance status zero, one or two
6. Prior therapy permissible:
6.1. Tamoxifen given in the adjuvant or neo-adjuvant setting only
6.2. Prior chemotherapy in the adjuvant or neo-adjuvant setting
6.3. Prior chemotherapy as first-line treatment for metastatic breast cancer followed by NSAI alone for at least six months
6.4. Patients with bone-only metastases are eligible provided they have evaluable site of bone metastases that can be followed by skeletal survey or magnetic resonance imaging (MRI)/computed tomography (CT) scanning
6.5. Patients already established on bisphosphonate therapy for at least six months are eligible for the trial and may continue on bisphosphonates
7. Written informed consent and available for prolonged follow-up
8. Adequate haematological function defined by haemoglobin more than or equal to 10 g/dl, neutrophil count more than or equal to 1.5 x 10^9/l and platelets more than or equal to 100 x 10^9/l
9. Adequate hepatic function defined by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2.5 x upper limit of normal. Alkaline phosphatase less than or equal to 5 x upper limit of normal, unless bone metastases in the absence of liver disease. Renal function adequate defined by creatinine less than 175 mmol/l.
10. Life expectancy of more than three months and suitable for further endocrine therapy

Participant type

Patient

Age group

Not Specified

Gender

Female

Target number of participants

750

Participant exclusion criteria

1. Patients whose primary breast cancer was classified as:
1.1. ER negative and PgR natural killer (NK)
1.2. ER negative/PgR negative
1.3. ER NK
2. Rapidly progressive visceral disease (i.e., lymphangitis carcinomatosa, diffuse hepatic involvement)
3. Bone-only metastases where lesions are not evaluable (i.e., patients with the same scan but no lytic disease on skeletal survey or MRI/CT)
4. Patients with malignancies (other than breast cancer) within the last five years, except for adequately treated in situ carcinoma of the cervix or basal cell/squamous cell carcinoma of the skin
5. Systemic corticosteroids for more than 15 days within the last four weeks
6. Investigational drugs given within the previous four weeks
7. Patients with thrombocytopaenia (platelets less than 100 x 10^9/l ) or on anti-coagulant therapy (contra-indicated due to risk of bleeding with intramuscular injection of Faslodex™)

Recruitment start date

01/03/2004

Recruitment end date

01/01/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Trial Manager,
Sutton, Surrey
SM2 5NG
United Kingdom

Sponsor information

Organisation

The Royal Marsden NHS Foundation Trust / The Institute of Cancer Research (UK)

Sponsor details

c/o Institute of Cancer Research
Clinical Trials and Statistics Unit
Section of Epidemiology
Brookes Lawley Building
Cotswold Road
Sutton
Surrey
SM2 5NG
United Kingdom

Sponsor type

Charity

Website

http://www.icr.ac.uk/research/research_sections/clinical_trials/index.shtml

Funders

Funder type

Industry

Funder name

Educational grants from:

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

AstraZeneca (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United Kingdom

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United Kingdom

Funder name

AstraZeneca (Global)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United Kingdom

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23902874

Publication citations

  1. Results

    Johnston SR, Kilburn LS, Ellis P, Dodwell D, Cameron D, Hayward L, Im YH, Braybrooke JP, Brunt AM, Cheung KL, Jyothirmayi R, Robinson A, Wardley AM, Wheatley D, Howell A, Coombes G, Sergenson N, Sin HJ, 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., Lancet Oncol., 2013, 14, 10, 989-998, doi: 10.1016/S1470-2045(13)70322-X.

Additional files

Editorial Notes