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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00256698
First received: November 20, 2005
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: Fulvestrant
Drug: Anastrozole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Time to Progression (TTP) [ Time Frame: RECIST assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    Overall survival is equivalent to time to death. Time from randomisation until the date of death


Enrollment: 514
Study Start Date: January 2004
Study Completion Date: February 2012
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Anastrozole
Drug: Anastrozole
1 mg oral tablet
Other Names:
  • Arimidex
  • ZD1033
Experimental: 2
Anastrozole + Fulvestrant
Drug: Fulvestrant
intramuscular injection 250 mg loading dose (LD) regimen
Other Names:
  • Faslodex
  • ZD9238
Drug: Anastrozole
1 mg oral tablet
Other Names:
  • Arimidex
  • ZD1033

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00256698

  Show 85 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Roger Henriksson, MD AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00256698     History of Changes
Other Study ID Numbers: D6997L00002, 9238SW/0001, FACT
Study First Received: November 20, 2005
Results First Received: April 29, 2010
Last Updated: July 27, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Sweden: Medical Products Agency

Keywords provided by AstraZeneca:
Hormone
receptor
positive
breast
cancer
first
relapse

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Anastrozole
Estrogens
Fulvestrant
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Aromatase Inhibitors
Enzyme Inhibitors
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014