Page last updated: 19-AUG-2010

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Study Title

A partially-blind phase III randomised trial of Fulvestrant (FaslodexTM) with or without concomitant Anastrozole (ArimidexTM) compared with exemestane in postmenopausal women with ER+ve locally advanced/metastatic breast cancer following progression on non-steroidal aromatase inhibitors

Basic Study Information

Chief Investigator: Dr Stephen RD Johnston
Sponsor:The Royal Marsden NHS Foundation Trust & The Institute of Cancer

Phase: III
Study Status: follow-up
Cancer Type: Advanced/metastatic breast cancer
EudraCT No: 2004-000093-30
ISRCTN No: 44195747
Ethical Approval: South West Research Ethics Committee

Study Schema

SOFEA2

Objectives

Primary:

To compare the progression-free survival of patients treated with Faslodex plus concomitant Arimidex (F+A) versus Faslodex (F) alone.
To compare the progression-free survival of patients treated with Faslodex (F) alone versus those treated with the current standard exemestane (E)

Secondary:

To assess the objective tumour response rate (CR + PR), duration of response, clinical benefit rate (CR/PR + SD >6 months), duration of clinical benefit, time to treatment failure, and overall survival of patients treated with Faslodex plus concomitant Arimidex (F+A) compared with Faslodex (F) alone.
To assess the objective response rate, duration of response, clinical benefit rate, duration of clinical benefit, time to treatment failure, progression-free and overall survival of patients treated with Faslodex (without concomitant Arimidex) compared with exemestane.
In the case that concomitant use of Arimidex with Faslodex provides equivalent outcome to Faslodex alone, to compare the progression-free survival of all Faslodex treated patients with those treated with exemestane.
To determine the tolerability of Faslodex with or without concomitant Arimidex and compared with exemestane.

Eligibility Criteria

Inclusion Criteria

Female postmenopausal patients defined as:
-   Age = 60 years or
-   Aged 45-59 with intact uterus and amenorrhoeic for at least 12 months or
-   Any age having had a bilateral oophorectomy
Histologically or cytologically confirmed adenocarcinoma of the breast
Patients with original ER+ve and/or PgR+ve breast cancer which has relapsed or
progressed during endocrine therapy with a single agent non-steroidal aromatase inhibitor
(NSAI) given as either:
adjuvant treatment where the patient received at least 12 months therapy, or
first-line therapy for locally advanced / metastatic disease. Patients treated with an
NSAI as first-line therapy must have had either an objective response (CR/PR) or
stabilisation of disease for at least 6 months.
Sites of metastatic disease which are measurable / evaluable (according to Response
Evaluation Criteria in Solid Tumours (RECIST)) should be assessed and followed as
either:
Measurable disease: must include at least one target marker lesion OR:
Non-measurable disease (ie evaluable disease): must include at least one nontarget
marker lesion
Patients with bone only metastases are eligible provided they have evaluable site of bone
metastases that can be followed by Xray or MRI / CT scanning
Patients already established on bisphosphonate therapy for at least 6 months may
continue on bisphosphonates
Patients who will be started on bisphosphonates for bone metastases must have
concurrent soft tissue / visceral sites of disease as the measurable / evaluable target
marker lesion(s)
WHO performance status 0, 1 or 2
Prior therapy permissible:
Tamoxifen given in the adjuvant or neo-adjuvant setting only
Prior chemotherapy in the adjuvant or neo-adjuvant setting
Prior chemotherapy as first-line treatment for metastatic breast cancer followed by
NSAI alone for at least 6 months
Adequate haematological function defined by haemoglobin =10 g/dl, neutrophil count =1.5
x 109/l and platelets = 100 x 109/l
Adequate hepatic function defined by AST and ALT = 2.5 x upper limit of normal. Alkaline
phosphatase = 5 x upper limit of normal, unless bone metastases in the absence of liver
disease. Renal function adequate defined by creatinine
Life expectancy of >3 months and suitable for further endocrine therapy
Have given written informed consent and are available for prolonged follow-up.

Exclusion Criteria

Patients whose primary breast cancer was classified as:
-   ER -ve and PgR NK
-   ER -ve and PgR -ve
-   ER NK
Rapidly progressive visceral disease (i.e. lymphangitis carcinomatosa, diffuse hepatic
involvement)
Patients with malignancies (other than breast cancer) within the last 5 years, except for
adequately treated in situ carcinoma of the cervix or basal cell / squamous cell carcinoma
of the skin
Systemic corticosteroids for > 15 days within the last 4 weeks
Investigational drugs given within the previous 4 weeks
Patients known to be on any unlicensed non-cancer investigational agent
Patients with thrombocytopaenia (platelets (contra-indicated due to risk of bleeding with i.m. injection of Faslodex)