Postmenopausal women with advanced breast cancer, progressing or relapsing after previous endocrine therapy
Conditions
Interventions
Trade Name: Faslodex 250 mg/5 ml solution for injection
Product Name: Faslodex 250 mg/5 ml solution for injection
Product Code: EU/1/03/269/0001
Pharmaceutical Form: Solution for injection
INN or Pro
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 oestrogen receptor status (ER +ve) of primary or metastatic tumour tissue, according to the local laboratory parameters. 4. Requiring hormonal treatment, defined as either: - Relapsing during, or within 12 months of completion of, adjuvant endocrine therapy (tamoxifen, toremifene or aromatase inhibitors such as anastrozole, letrozole and exemestane) - Progressing on an endocrine therapy (tamoxifen, toremifene or aromatase inhibitors such as anastrozole, letrozole and exemestane) given as first treatment for patients with de novo advanced breast cancer (defined as metastatic disease or locally advanced disease which is not amenable to treatment with curative intent) - Progressing on an endocrine therapy (tamoxifen, toremifene or aromatase inhibitors such as anastrozole, letrozole and exemestane) provided that this endocrine treatment was started at least 12 months after the completion of adjuvant endocrine treatment 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 greater than or equal to 20mm with conventional technique or as ïgreater than or equal to 10 mm with spiral CT scan or MRI - Patients with bone lesions, lytic or mixed (lytic + sclerotic), in the absence of measurable disease as defined by RECIST criteria 6. Postmenopausal woman, defined as a woman fulfilling any 1 of the following criteria: - Age greater than or equal to 60 years. - Age greater than or equal to 45 years with amenorrhoea of at least 12 months with an intact uterus. - Having undergone a bilateral oophorectomy. - FSH and oestradiol levels in postmenopausal range (utilising ranges from the testing 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, menses must not have restarted, and FSH and oestradiol levels must also be in the postmenopausal range (utilising ranges from the testing laboratory facility). 7. WHO performance status 0, 1 or 2. For inclusion in the translational research component of the study, patients must fulfil the following criteria: 1. Provision of informed consent for translational research component If a patient declines to participate in the translational research component of the study, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study described in this Clinical Study Protocol, so long as they consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Any of the following is regarded as a criterion for exclusion from the study: 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 compromised as a result of disease. 2. More than one regimen of chemotherapy for advanced disease. Note: Patients previously treated with one regimen of chemotherapy for advanced disease are allowed as long as their last treatment is an anti-oestrogen or an aromatase inhibitor. 3. More than one regimen of endocrine therapy for advanced disease. Note: Oophorectomy, ovarian ablation, or LH-RH analogue therapy do not count as endocrine treatments in this context and also do not render the patient ineligible for this study. 4. Extensive radiation therapy within the last 4 weeks (greater than or equal to 30% marrow or whole pelvis or spine) or cytotoxic treatment within the past 4 weeks prior to screening laboratory assessment, or strontium-90 (or other radiopharmaceuticals) within the past 3 months. 5. Treatment with a non-approved or experimental drug within 4 weeks before randomisation. 6. 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). 7. Any of the following laboratory values: - Platelets 1.5 x ULRR - ALT or AST > 2.5 x ULRR if no demonstrable liver metastases or > 5 x ULRR in presence of liver metastases 8. History of: - bleeding diathesis (i.e., disseminated intravascular coagulation [DIC], clotting factor deficiency), or - long-term anticoagulant therapy (other than antiplatelet therapy and low dose warfarin). 9. History of hypersensitivity to active or inactive excipients of fulvestrant and/or castor oil. 10. 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 |
|---|---|
| Main Objective: To compare the efficacy of fulvestrant 500 mg treatment with fulvestrant 250 mg treatment in terms of time to progression (TTP);Secondary Objective: To compare fulvestrant 500 mg treatment with fulvestrant 250 mg treatment in terms of the following parameters: 1. Objective Response rate (ORR) (defined by RECIST criteria) 2. Clinical Benefit Rate 3. Duration of response (DoR) 4. Duration of clinical benefit (DoCB) 5. Overall survival (OS) 6. Frequency and severity of adverse events 7. Quality of Life (QoL) ;Primary end point(s): The primary variable for this study is time to progression (TTP), which is defined as the time from randomization to the time of the earliest objective disease progression, including death from any cause. | — |
Countries
Czech Republic, Hungary, Italy, Malta, Slovakia, Spain
Outcome results
None listed