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| 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 |
| ISRCTN | ISRCTN44195747 |
| ClinicalTrials.gov identifier | NCT00253422 |
| Public 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 |
| Scientific title | |
| Acronym | SoFEA |
| Serial number at source | N/A |
| 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 | Not provided at time of registration |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Locally advanced/metastatic breast cancer |
| Participants - 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 |
| Participants - 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™) |
| Anticipated start date | 01/03/2004 |
| Anticipated end date | 01/01/2006 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 750 |
| Interventions |
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 (ie. 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 |
| Primary outcome measure(s) | Progression-free survival |
| Secondary outcome measure(s) |
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 |
| Sources of funding |
Educational grants from:
1. AstraZeneca (UK) 2. AstraZeneca (Global) |
| Trial website | |
| Publications | |
| Contact name | Ms Sejal Patel |
| Address |
Institute of Cancer Research Clinical Trials and Statistics Unit (ICR-CTSU)
Section of Epidemiology Brookes Lawley Building Cotswold Road |
| City/town | Sutton, Surrey |
| Zip/Postcode | SM2 5NG |
| Country | United Kingdom |
| Tel | +44 (0)20 8722 4039/4062 |
| Fax | +44 (0)20 8770 7876 |
| sofea-icrctsu@icr.ac.uk | |
| Sponsor | Sponsor not defined - Record supplied by Institute of Cancer Research (UK) |
| Address |
c/o Institute of Cancer Research
Clinical Trials and Statistics Unit Section of Epidemiology Brookes Lawley Building Cotswold Road |
| City/town | Sutton, Surrey |
| Zip/Postcode | SM2 5NG |
| Country | United Kingdom |
| Date applied | 27/06/2003 |
| Last edited | 07/03/2008 |
| Date ISRCTN assigned | 08/09/2003 |
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| © 2010 ISRCTN unless otherwise stated. | |
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