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

July 27, 2012 updated by: AstraZeneca

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

514

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Brampton, Canada
        • Research Site
      • Halifax, Canada
        • Research Site
      • Kingston, Canada
        • Research Site
      • Ontario, Canada
        • Research Site
      • Toronto, Canada
        • Research Site
  • Costa Rica
      • San Jose, Costa Rica
        • Research Site
  • Finland
      • Hameenlinna, Finland
        • Research Site
      • Turku, Finland
        • Research Site
  • France
      • Avignon, France
        • Research Site
      • Caen, France
        • Research Site
      • Creteil, France
        • Research Site
      • Grenoble, France
        • Research Site
      • La Chaussee Saint Victor, France
        • Research Site
      • Perigueux, France
        • Research Site
      • Perpignan, France
        • Research Site
      • Saint Cyr Sur Louire, France
        • Research Site
      • Toulouse, France
        • Research Site
  • Germany
      • Augsburg, Germany
        • Research Site
      • Dusseldorf, Germany
        • Research Site
      • Erlangen, Germany
        • Research Site
      • Frankfurt, Germany
        • Research Site
      • Gifhorn, Germany
        • Research Site
      • Grosshadern, Germany
        • Research Site
      • Halle, Germany
        • Research Site
      • Hamburg, Germany
        • Research Site
      • Hannover, Germany
        • Research Site
      • Heidelberg, Germany
        • Research Site
      • Ingolstadt, Germany
        • Research Site
      • Kassel, Germany
        • Research Site
      • Kiel, Germany
        • Research Site
      • Koln, Germany
        • Research Site
      • Leipzig, Germany
        • Research Site
      • Leverkusen, Germany
        • Research Site
      • Magdeburg, Germany
        • Research Site
      • Mannheim, Germany
        • Research Site
      • Marburg, Germany
        • Research Site
      • Munchen, Germany
        • Research Site
      • Rostock, Germany
        • Research Site
      • Trier, Germany
        • Research Site
      • Ulm, Germany
        • Research Site
      • Ziwicken, Germany
        • Research Site
  • Guatemala
      • Guatemala, Guatemala
        • Research Site
  • Iceland
      • Reykjavik, Iceland
        • Research Site
  • Italy
      • Como, Italy
        • Research Site
      • Fabriano, Italy
        • Research Site
      • Ferrara, Italy
        • Research Site
      • Firenze, Italy
        • Research Site
      • Lugo, Italy
        • Research Site
      • Milano, Italy
        • Research Site
      • Taormina, Italy
        • Research Site
      • Treviglio, Italy
        • Research Site
      • Vicenza, Italy
        • Research Site
  • Norway
      • Drammen, Norway
        • Research Site
      • Ilesund, Norway
        • Research Site
      • Oslo, Norway
        • Research Site
      • Porsgrunn, Norway
        • Research Site
      • Stavanger, Norway
        • Research Site
      • Troms, Norway
        • Research Site
      • Trondheim, Norway
        • Research Site
  • Portugal
      • Cascais, Portugal
        • Research Site
      • Coimbra, Portugal
        • Research Site
      • Lisboa, Portugal
        • Research Site
      • Santa Maria da Feira, Portugal
        • Research Site
  • Sweden
      • Halmstad, Sweden
        • Research Site
      • Helsingborg, Sweden
        • Research Site
      • Kalmar, Sweden
        • Research Site
      • Karlskrona, Sweden
        • Research Site
      • Kristianstad, Sweden
        • Research Site
      • Link'ping, Sweden
        • Research Site
      • M'lndal, Sweden
        • Research Site
      • Malm, Sweden
        • Research Site
      • Norrk'ping, Sweden
        • Research Site
      • Skelleftea, Sweden
        • Research Site
      • Skovde, Sweden
        • Research Site
      • Stockholm, Sweden
        • Research Site
      • Sunderbyn, Sweden
        • Research Site
      • Sundsvall, Sweden
        • Research Site
      • Umea, Sweden
        • Research Site
      • V'rnamo, Sweden
        • Research Site
      • V'stervik, Sweden
        • Research Site
      • Varberg, Sweden
        • Research Site
  • Turkey
      • Ankara, Turkey
        • Research Site
      • Edirne, Turkey
        • Research Site
      • Gaziantep, Turkey
        • Research Site
      • Istanbul, Turkey
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Anastrozole
Drug: Anastrozole
1 mg oral tablet
Other Names:
  • ZD1033
  • Arimidex
Experimental: 2
Anastrozole + Fulvestrant
Drug: Anastrozole
1 mg oral tablet
Other Names:
  • ZD1033
  • Arimidex
Drug: Fulvestrant
intramuscular injection 250 mg loading dose (LD) regimen
Other Names:
  • Faslodex
  • ZD9238

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
RECIST assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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
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)
RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
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
RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
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
RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
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
From randomisation until data cut-off on 30th April 2009
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
All deaths occurring between randomisation and data cut-off on 30th April 2009 are included.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Roger Henriksson, MD, AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

November 20, 2005

First Submitted That Met QC Criteria

November 20, 2005

First Posted (Estimate)

November 22, 2005

Study Record Updates

Last Update Posted (Estimate)

August 1, 2012

Last Update Submitted That Met QC Criteria

July 27, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D6997L00002
  • 9238SW/0001
  • FACT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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