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

The Royal Marsden NHS Foundation Trust / The Institute of Cancer Research (UK)0 sites698 target enrollmentSeptember 8, 2003

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: ocally advanced/metastatic breast cancer
Sponsor: The Royal Marsden NHS Foundation Trust / The Institute of Cancer Research (UK)
Enrollment: 698
Status: Completed
Last Updated: 2 years ago

Registry

who.int

Start Date

September 8, 2003

End Date

January 1, 2006

Last Updated

2 years ago

Study Type

Interventional

Sex

Female

Sponsor

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

•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])

•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™)