Faslodex Advanced Breast Cancer Local Chinese Study

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00327769
First received: May 18, 2006
Last updated: January 24, 2011
Last verified: January 2011
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Time to Disease Progression (TTP)

Secondary Outcome Measures:
  • Objective Response Rate (ORR)
  • Clinical Benefit Rate (CBR)
  • Time to Treatment Failure (TTF)
  • Safety & Tolerability.

Enrollment: 234
Study Start Date: November 2005
Study Completion Date: September 2007
Arms Assigned Interventions
Active Comparator: 1
Anastrozole
Drug: Anastrozole
1 mg tablet
Other Names:
  • Arimidex
  • ZD1033
Experimental: 2
Anastrozole + Fulvestrant
Drug: Fulvestrant
250 mg intramuscular injection
Other Names:
  • Faslodex
  • ZD9238
Drug: Anastrozole
1 mg tablet
Other Names:
  • Arimidex
  • ZD1033

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00327769

Locations
China
Research Site
Beijing, China
Research Site
Dalian, China
Research Site
Fuzhou, China
Research Site
Guangzhou, China
Research Site
Hankou, China
Research Site
He Fei, China
Research Site
Huangzhou, China
Research Site
Ji Nan, China
Research Site
Nanjing, China
Research Site
Shanghai, China
Research Site
Wuhan, China
Research Site
Xi AN, China
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Breast Cancer Established Brands Team Medical Science Director, MD AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00327769     History of Changes
Other Study ID Numbers: D6997L00004
Study First Received: May 18, 2006
Last Updated: January 24, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by AstraZeneca:
Advanced breast cancer
fulvestrant
anastrozole

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

ClinicalTrials.gov processed this record on July 20, 2014