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Official Title

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The purpose of this study is to evaluate the efficacy of a new dose of 500 mg Fulvestrant with the standard dose of 250 mg in postmenopausal women with oestrogen receptor positive advanced breast cancer who have failed on a previous endocrine treatment.

Comparison of Fulvestrant (FASLODEX™) 250 mg and 500 mg in Postmenopausal Women with Oestrogen Receptor positive Advanced Breast Cancer Progressing or Relapsing after Previous Endocrine Therapy.

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A Randomised, Double-Blind, Parallel-group, Multicentre, Phase III Study Comparing the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 500 mg with Fulvestrant (FASLODEX™) 250 mg in Postmenopausal Women with Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing after Previous Endocrine Therapy

Units on the scale: median time (in months) from date of randomisation to the date of the earliest objective disease progression, including death from any cause (in the absence of objective progression) to compare the efficacy of fulvestrant 500 mg treatment with fulvestrant 250 mg treatment. Full range units on scale: from 0 (minimum value) to 48 months (maximum value). Higher value of median (higher TTP) indicates better treatment outcome. Tumor progression (deterioration) for patient with measurable disease was determinated by the investigator based on RECIST as an at least a 20% increase in the sum of the longest diameters (LD) of the target lesions compared to the smallest sum of LD since the study treatment started. Tumor progression (deterioration) for patient without measurable disease at baseline was determinated by the investigators assessment of the apperance of one or more new lytic lensions in and outside of the bone and unequvocal progression of existing bone lensions.

Age Continuous

Sex: Female, Male

Median time (in months) from randomisation until objective disease progression or death (in the absence of objective progression).

Time to Progression (TTP)

Using the RECIST scan data, an objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR) which is subsequently confirmed as per RECIST. ORR is defined as the percentage of patients with OR.

All patients with measurable disease at baseline.

Objective Response Rate (ORR)

A Clinical Benefit (CB) responder is defined as a patient having a best overall response of CR, PR or SD (stable disease) >=24 weeks. The Clinical Benefit Rate is the percentage of patients with CB.

Clinical Benefit Rate (CBR)

Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieve a confirmed complete response (CR) or confirmed partial response (PR)

Duration of Response (DoR)

Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieve a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) >=24 weeks

Duration of Clinical Benefit (DoCB)

Median time (in months) from randomisation until death (from any cause) (analysis at 50% deaths )

Overall Survival (OS)

Mean (and standard deviation) change from randomisation until treatment discontinuation in TOI (defined as the first visit response of 'worsened' which is a decrease in TOI from baseline of 5 points or more) using the Kaplan-Meier method. If a subject has not shown a reduction of 5 points or more at the time of analysis then the observation will be right censored using the last QOL assessment date. Trial Outcome Index (TOI) is derived from the FACT-B questionnaire (Cella et al, 1993) by adding together the scores from the following 3 subscales; Physical well-being (PWB), Functional well-being (FWB) and Breast cancer subscale (BCS). The TOI score range is 0-92 with the higher scores representing the more favourable outcomes. Data were collected from a subgroup of patients.

Change from randomisation in Trial Outcome Index (TOI) over the course of the study

Overall Survival is equivalent to time to death. For this endpoint, all deaths occurring during the study as a whole until the data cut-off for the survival extension (31st October 2011) are presented (analysis at 75% deaths)

Overall Survival (OS) - follow-up

Overall Study

Gerard Lynch

To compare ORR of patients treated with fulvestrant 500 mg with ORR of patients treated with fulvestrant 250 mg. ORR is define as percentage of patients with objective response (OR). Units on the scale: from 0% (minimum value) to 100% (maximum values). Higher value of ORR indicates greater number of patients with Best Overall Response and better treatment outcome. OR is defined as sum of patients having a best overall response of either complete response (CR defined as disapperance of all target or nontarget lesions) or partial response (PR definded as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter) which is subsequently confirmed as per RECIST. The best overall response is the best response recorded from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started).

To compare CBR of patients treated with fulvestrant 500 mg with CBR of patients treated with fulvestrant 250 mg. A Clinical Benefit (CB) responder is defined as a sum of patients having a best overall response of CR, PR or SD >=24 weeks. The Clinical Benefit Rate is the percentage of patients with CB. Units on the scale: from 0% (minimum value) to 100% (maximum value). Higer value of DoR indicates greater number of patients with a best objective tumour response and better treatment outcome.

To compare DoR of patients treated with fulvestrant 500 mg with DoR of patients treated with fulvestrant 250 mg. Median time (in months) of DoR will be defined in 2 ways: 1)from date of first response (Complete Response or Partial Response) until the date of disease progression or death from any cause. 2) From date of randomization until the date of disease progression or death from any cause. Duration of overall response applies only to patients whose best overall response was complete response (CR) or partial response (PR). Units on the scale: from 0 months (minimum value) to 48 months (maximum value). Higher value of DoR indicates better treatment outcome.

To compare DoCB of patients treated with fulvestrant 500 mg with DoCB of patients treated with fulvestrant 250 mg. Units on the scale: Median time (in months) from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieve a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) >=24 weeks. Range of units on the scale: from 0 (minimum value) to 48 months (maximum value). Higher value of DoCB indicates better treatment outcome.

To compare the overall survival of patients treated with fulvestrant 500 mg with the overall survival of patients treated with fulvestrant 250 mg. Overall Survival is equivalent to time to death. Units of the scale: Median time (in months) from randomisation until death (from any cause) (analysis at 50% deaths ). Range of units on the scale: from 0 (minimum value) to 48 months (maximum value). Higher value of OS indicates better treatment outcome.

To assess the quality of life (QoL) of patients treated with fulvestrant 500mg as compared to fulvestrant 250 mg in a subgroup of patients. Units on the scale: median time (in months) from randomisation until deterioration in TOI (defined as the first visit response of 'worsened') using the Kaplan-Meier method. Range of units on the scale: from 0 (minimum value) to 48 months (maximum value). Higher value of TOI indicates better treatment outcome. Trial Outcome Index (TOI) is derived from the FACT-B questionnaire. Data were collected from a subgroup of patients. TOI is summary score of subscales: 1) Physical well-being (PWB), 2) Functional well-being (FWB), 3) Breast cancer subscale (BCS). For each individual patient a deterioration in Quality of Life (QOL) is defined as a decrease in TOI from baseline of 5 points or more.

To compare the overall survival of patients treated with fulvestrant 500 mg with the overall survival of patients treated with fulvestrant 250 mg. Overall Survival is equivalent to time to death. For this endpoint, all deaths occurring during the study as a whole until the data cut-off for the survival extension (31st October 2011) are presented (analysis at 75% deaths). Range of units on the scale: from 0 (minimum value) to 80 months (maximum value). Higher value of OS-follow-up indicates better treatment outcome.

Arms	Assigned Interventions
Experimental: 1 Fulvestrant 500 mg	Drug: Fulvestrant intramuscular injection Other Name: Faslodex Other Name: ZD9238
Experimental: 2 Fulvestrant 250 mg	Drug: Fulvestrant intramuscular injection Other Name: Faslodex Other Name: ZD9238

Comparison of Fulvestrant (FASLODEX™) 250 mg and 500 mg in Postmenopausal Women with Oestrogen Receptor positive Advanced Breast Cancer Progressing or Relapsing after Previous Endocrine Therapy. - CONFIRM

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CSP-D6997C00002.PDF

D6997C00002 Study Report Synopsis

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