Skip to main content
OpenTrials
Completed

NCT Number: NCT00256698

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Disease Attributes Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Brampton, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fulvestrant

Drug

intramuscular injection 250 mg loading dose (LD) regimen

Other names: Faslodex, ZD9238

Anastrozole

Drug

1 mg oral tablet

Other names: Arimidex, ZD1033

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. 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)

  3. 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

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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.

Acronym: FACT

Important dates

Study start
2004
Primary completion
2009
Study completion
2012
First posted
Nov 22, 2005
Registry last updated
Aug 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.