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Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy (FACT)

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ClinicalTrials.gov Identifier: NCT00256698
Recruitment Status : Completed
First Posted : November 22, 2005
Results First Posted : February 9, 2011
Last Update Posted : August 1, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE November 20, 2005
First Posted Date  ICMJE November 22, 2005
Results First Submitted Date  ICMJE April 29, 2010
Results First Posted Date  ICMJE February 9, 2011
Last Update Posted Date August 1, 2012
Study Start Date  ICMJE January 2004
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2011)
Time to Progression (TTP) [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 20, 2005)
Time to progression
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2011)
  • Percentage of Evaluable Participants With Objective Response Rate (ORR) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2005)
  • Objective tumour response
  • clinical benefit, safety
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy
Official Title  ICMJE FACT: Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy; an Open Randomized, Comparative, Phase III Multicentre Study in Postmenopausal Women With Hormone Receptor Positive Breast Cancer in First Relapse After Primary Treatment of Localized Tumor.
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: Fulvestrant
    intramuscular injection 250 mg loading dose (LD) regimen
    Other Names:
    • Faslodex
    • ZD9238
  • Drug: Anastrozole
    1 mg oral tablet
    Other Names:
    • Arimidex
    • ZD1033
Study Arms  ICMJE
  • Active Comparator: 1
    Anastrozole
    Intervention: Drug: Anastrozole
  • Experimental: 2
    Anastrozole + Fulvestrant
    Interventions:
    • Drug: Fulvestrant
    • Drug: Anastrozole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 12, 2011)
514
Original Enrollment  ICMJE
 (submitted: November 20, 2005)
512
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Costa Rica,   Finland,   France,   Germany,   Guatemala,   Iceland,   Italy,   Norway,   Portugal,   Sweden,   Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00256698
Other Study ID Numbers  ICMJE D6997L00002
9238SW/0001
FACT
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Roger Henriksson, MD AstraZeneca
PRS Account AstraZeneca
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP