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Completed

NCT Number: NCT00327769

Faslodex Advanced Breast Cancer Local Chinese Study

This study will evaluate the efficacy and safety of Faslodex as secondary-line treatment compared with Arimidex in oestrogen receptor positive postmenopausal advanced breast cancer.

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Key information

Conditions

Advanced Breast Cancer

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Beijing, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Postmenopausal advanced breast cancer with oestrogen receptor positive
  • Progression under first-line anti-oestrogen therapy.

Exclusion criteria

  • Life-threatening metastasis; contraindication to anastrozole
  • >2 regimens of hormonotherapy for advanced breast cancer

Treatment and study plan

Fulvestrant

Drug

250 mg intramuscular injection

Other names: Faslodex, ZD9238

Anastrozole

Drug

1 mg tablet

Other names: Arimidex, ZD1033

Primary outcomes

  1. Time to Disease Progression (TTP)

Secondary outcomes

  1. Objective Response Rate (ORR)

  2. Clinical Benefit Rate (CBR)

  3. Time to Treatment Failure (TTF)

  4. Safety & Tolerability.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Double Blind, Double Dummy, Randomised, Multicentre Study to Compare the Efficacy and Safety of Fulvestrant 250mg With Arimidex 1mg as a Secondary-line Therapy in the Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer

Important dates

Study start
2005
Study completion
2007
First posted
May 19, 2006
Registry last updated
Jan 25, 2011

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.

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