hormone receptor positive breast cancer, hormone naive, breast, cancer, neoplasm breast cancer, metastatic, tumour, neoplasm
Conditions
Interventions
Trade Name: Faslodex 250 mg solution for injection
Product Name: Faslodex 250 mg solution for injection
Product Code: ZD9238
Pharmaceutical Form: Solution for injection
INN or Proposed INN: FULVESTRAN
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Histological confirmation of breast cancer in post menopausal women (age >=60) 2 Positive hormone receptor status (ER +ve and/or PgR +ve) of primary or metastatic tumour tissue based on local laboratory assessment. 3 EITHER locally advanced disease (1 line of chemotherapy allowed only if remain unsuitable for therapy of curative intent) OR Metastatic disease. (1 line of chemotherapy for breast cancer allowed only if subsequent evidence of further progressive disease) 4 At least 1 lesion (measurable and/or non-measurable) that can be accurately assessed at baseline and is suitable for repeated assessment. 5 Postmenopausal woman, fulfilling 1 of: Prior bilateral oophorectomy/Age =60 years/Age =65 years) yes F.1.3.1 Number of subjects for this age range 225
Exclusion criteria
Exclusion criteria: 1 Presence of life-threatening metastatic disease - Any of: Extensive hepatic involvement/ involving brain or meninges/ symptomatic pulmonary lymph spread. Discrete lung metastases are acceptable if respiratory function is not significantly compromised 2 Prior systemic therapy for breast cancer other than one line of cytotoxic chemotherapy (the last dose of chemotherapy must have been received more than 28 days prior to randomisation). 3 Radiation therapy if not completed within 28 days prior to randomisation (with the exception of radiotherapy given for control of bone pain, started prior to randomisation). 4 Prior hormonal treatment for breast cancer. 5 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).
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1 Compare the Overall Survival (OS, death due to any cause) in patients treated with fulvestrant with those treated with anastrozole when 50% of patients are recorded as having died. 2 Measure objective response rate (ORR) for fulvestrant treatment versus anastrozole. (ORR =% of patients recording partial (PR) or complete response (CR) 3 Measure the duration of response (DoR) for fulvestrant treatment versus anastrozole. (DoR = days from PR/CR response to objective disease progression) 4 Measure expected duration of response (EDoR) for fulvestrant treatment versus anastrozole. (EDoR = p Efp(x), where x=DoR, p=proportion of responders, Efp(x) is mean duration of response) 5 Measure clinical benefit rate (CBR) for fulvestrant treatment versus anastrozole. (CBR= proportion of patients recording RECIST assessments of CR/PR or stable disease (SD) over at least 154 days 6 Measure the duration of clinical benefit (DoCB) for fulvestrant versus anastrozole treatment. (DoCB = for patients recording clinical benefit responses only; days from randomization to date of disease progression) 7 Measure expected duration of clinical benefit (EDoCB) for fulvestrant treatment versus anastrozole. (EDoCB = p Efp(x), where x=DoCB, p=proportion of responders, Efp(x) is mean duration of clinical benefit) 8 Compare the effect of fulvestrant treatment versus anastrozole treatment on Health Related Quality of Life (HRQoL) 9 Compare the safety of fulvestrant treatment versus anastrozole by assessing a panel of adverse events measures: physical examination, electrocardiogram, pulse and blood pressure, weight and haematology and clinical chemistry assessments ;Timepoint(s) of evaluation of this end point: 1 Following progression, patients will be contacted at 12 weekly intervals to determine survival status Nos 2-7 Baseline RECIST 1.1 assessments and then every 12 weeks 8 Quality of life questionnaires completed at baseline, 12 weekly whilst | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate superior progression free survival for patients treated with fulvestrant 500mg versus patients treated with anastrozole 1mg;Secondary Objective: To compare the overall survival, objective responses, clinical benefit responses, quality of life and safety profile for study patients ;Primary end point(s): Compare the progression free survival (PFS) in patients treated with fulvestrant with those treated with anastrozole ;Timepoint(s) of evaluation of this end point: Baseline RECIST 1.1 assessments and then every 12 weeks until the earliest of disease progression evident, patient dies or has surgery/radiotherapy for their disease. | — |
Countries
Argentina, Brazil, Canada, China, Czech Republic, India, Italy, Japan, Mexico, Peru, Poland, Russian Federation, Slovakia, South Africa, Spain, Taiwan, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactInformation Centre
AstraZeneca
Outcome results
None listed