Hormone Receptor Positive Advanced Breast Cancer MedDRA version: 16.1 Level: LLT Classification code 10072737 Term: Advanced breast cancer System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Faslodex
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Fulvestrant
CAS Number: 129453-61-8
Current Sponsor code: ZD9238
Other descriptive name: ICI 182,780
Concentratio
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Provision of written informed consent 2.Histological/cytological confirmation of breast cancer 3.Documented positive hormone receptor status (ER +ve and/or PgR + ve) of primary or metastatic tumour tissue, according to the local laboratory parameters 4.Patients with metastatic or locally advanced disease not amenable to therapy with curative intent: (a)who have never had hormonal therapy for locoregionally advanced or metastatic disease and (b)For patients who have received previous adjuvant or neoadjuvant hormonal treatment, this must have been completed more than 12 months prior to randomisation. 5.Patients fulfilling one of the following criteria: ·Patients with measurable disease as per RECIST criteria. This is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as = 20 mm with conventional techniques or as = 10 mm with spiral CT scan ·Patients with bone lesions, lytic or mixed (lytic + sclerotic), in the absence of measurable disease as defined by RECIST criteria. Bone lesions must be evaluable by plain X-ray, CT or MRI. Patients with lesions identified only on radionucleotide bone scan are not eligible 6. Postmenopausal woman, defined as a woman fulfilling any 1 of the following criteria: ·Age = 60 years ·Age = 45 years with amenorrhoea = 12 months with an intact uterus ·Having undergone a bilateral oophorectomy ·FSH and oestradiol levels in postmenopausal range (utilising ranges from the local laboratory facility)* * In patients who have previously been treated with an LH-RH analogue, the last depot must have been administered more than 4 months prior to randomisation and menses must not have restarted. 7.WHO performance status 0, 1 or 2. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: 1.Presence of life-threatening metastatic visceral disease, defined as extensive hepatic involvement, or any degree of brain or leptomeningeal involvement (past or present), or symptomatic pulmonary lymphangitic spread. Patients with discrete pulmonary parenchymal metastases are eligible, provided their respiratory function is not significantly compromised as a result of disease 2.Previous systemic therapy for advanced breast cancer. 3.Treatment with a non-approved or experimental drug within 4 weeks before randomisation 4.Current or prior malignancy within previous 3 years (other than breast cancer or adequately treated basal cell or squamous cell carcinoma of the skin or in-situ carcinoma of the cervix) 5.Any of the following laboratory values within 3 weeks of randomisation: ·Platelets 1.5 x ULRR** ** Patients with confirmed Gilbert’s syndrome may be included in the study ·ALT or AST > 2.5 x ULRR if no demonstrable liver metastases or > 5 x ULRR in presence of liver metastases 6.History of : ·bleeding diathesis (ie, disseminated intravascular coagulation [DIC], clotting factor deficiency) or ·long-term anticoagulant therapy (other than antiplatelet therapy and low dose warfarin ) 7.History of hypersensitivity to active or inactive excipients of fulvestrant, aromatase inhibitors or castor oil 8.Any severe concomitant condition which makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the trial protocol. e.g., uncontrolled cardiac disease or uncontrolled diabetes mellitus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 1. To compare the objective response rate of patients treated with fulvestrant 500 mg with the objective response rate of patients treated with anastrozole 1 mg 2. To compare the time to progression of patients treated with fulvestrant 500 mg with the time to progression of patients treated with anastrozole 1 mg 3. To describe the duration of response of patients treated with fulvestrant 500 mg and the duration of response of patients treated with anastrozole 1 mg. 4. To describe the duration of clinical benefit of patients treated with fulvestrant 500 mg and the duration of clinical benefit of patients treated with anastrozole 1 mg. 5. To assess the safety and tolerability of fulvestrant 500mg treatment compared with anastrozole 1 mg. ;Main Objective: To compare the clinical benefit rate of patients treated with fulvestrant 500 mg with the clinical benefit rate of patients treated with anastrozole 1 mg;Primary end point(s): Clinical benefit (CB) will be obtained for those patients who have a best response (as defined by RECIST) of either CR, PR or SD as defined by the RECIST criteria.;Timepoint(s) of evaluation of this end point: = 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): For patients with measurable disease at baseline, the RECIST criteria will be used to perform the objective tumour assessments and to categorise best overall objective tumour response for target and non-target lesions. Response will be classified as CR, PR, SD, or progressive disease (PD).;Timepoint(s) of evaluation of this end point: Within 4 weeks of disease assessment. | — |
Countries
Brazil, Bulgaria, Czech Republic, France, Italy, Poland, Spain, United Kingdom, United States
Contacts
Public ContactInformation Centre
AstraZeneca
Outcome results
None listed