Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy

Phase 3

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Anastrozole; Drug: Fulvestrant

• Registration Number: NCT00256698
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2005-11-20
• Study First Submitted QC: 2005-11-20
• Study First Posted: 2005-11-22
• Primary Completion: 2009-04
• Results First Submitted: 2010-04-29
• Results First Submitted QC: 2011-01-12
• Results First Posted: 2011-02-09
• Study Completion: 2012-02
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-27
• Last Update Posted: 2012-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 514

Inclusion Criteria

• Signed informed consent, postmenopausal females, histological or cytological confirmed oestrogene and/or progesterone (PgR) receptor positive breast cancer, local recurrence or metastasis

Exclusion Criteria

• Previous systemic endocrine therapy for advanced or recurrent disease; prior fulvestrant therapy
• Premenopausal women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Anastrozole	Anastrozole
2	Fulvestrant	Anastrozole + Fulvestrant
2	Anastrozole	Anastrozole + Fulvestrant

Primary Outcome Measures

Name	Time	Method
Time to Progression (TTP)	RECIST assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Evaluable Participants With Objective Response Rate (ORR)	RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009	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)
Percentage of Clinical Benefit Rate (CBR) Responders	RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009	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)
Duration of Response (DoR)	RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009	Median time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who are objective responders
Duration of Clinical Benefit (DoCB)	RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009	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 to Treatment Failure (TTF)	From randomisation until data cut-off on 30th April 2009	Time from randomisation until the date of discontinuation of randomised treatment for any reason
Overall Survival (OS)	All deaths occurring between randomisation and data cut-off on 30th April 2009 are included.	Overall survival is equivalent to time to death. Time from randomisation until the date of death

Trial Locations

Locations (1)

Research Site; 🇹🇷 Istanbul, Turkey