The purpose of this study is to determine the efficacy of anastrozole monotherapy versus maximal oestrogen blockade with combinated therapy of fulvestrant and anastrozole compared with in treatment of hormone receptor positive women with first relapse of breast cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
514
intramuscular injection 250 mg loading dose (LD) regimen
1 mg oral tablet
Time to Progression (TTP)
RECIST (Response Evaluation Criteria in Solid Tumours) assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009. TTP, time in months to worsen 'progression' according to RECIST criteria. (RECIST is a set of published rules that define when cancer patients improve "respond", stay the same "stable"or worsen "progression" during treatments.
Time frame: RECIST assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
Percentage of Evaluable Participants With Objective Response Rate (ORR)
No. of patients who were objective responders over the no. of patients evaluable for response x100. An objective responder = a patient whose best response is either CR (disappearance of all lesions) or PR (\>= 30% shrinkage in the sum of the longest diamemeters of the measurable lesions + no new lesions + no progression of non-measurable lesions)
Time frame: RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
Percentage of Clinical Benefit Rate (CBR) Responders
No. of patients who were clinical benefit responders over the no. of randomised patients x100. A clinical benefit responder = a patient whose best response is CR, PR or SD\>=24 weeks (where a best response of SD = no new lesions and for existing lesions; neither suffient shrinkage to count as PR nor sufficient growth to count as progression)
Time frame: RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
Duration of Response (DoR)
Median time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who are objective responders
Time frame: RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
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Research Site
Brampton, Canada
Research Site
Halifax, Canada
Research Site
Kingston, Canada
Research Site
Ontario, Canada
Research Site
Toronto, Canada
Research Site
San José, Costa Rica
Research Site
Hämeenlinna, Finland
Research Site
Turku, Finland
Research Site
Avignon, France
Research Site
Caen, France
...and 75 more locations
Duration of Clinical Benefit (DoCB)
Median time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who are clinical benefit responders
Time frame: RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
Time to Treatment Failure (TTF)
Time from randomisation until the date of discontinuation of randomised treatment for any reason
Time frame: From randomisation until data cut-off on 30th April 2009
Overall Survival (OS)
Overall survival is equivalent to time to death. Time from randomisation until the date of death
Time frame: All deaths occurring between randomisation and data cut-off on 30th April 2009 are included.