Faslodex Advanced Breast Cancer Local Chinese Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00327769
Recruitment Status : Completed
First Posted : May 19, 2006
Last Update Posted : January 25, 2011
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Advanced Breast Cancer Drug: Fulvestrant Drug: Anastrozole Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 234 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : November 2005
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: 1
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

Primary Outcome Measures :
  1. Time to Disease Progression (TTP)

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00327769

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
Study Director: Breast Cancer Established Brands Team Medical Science Director, MD AstraZeneca

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00327769     History of Changes
Other Study ID Numbers: D6997L00004
First Posted: May 19, 2006    Key Record Dates
Last Update Posted: January 25, 2011
Last Verified: January 2011

Keywords provided by AstraZeneca:
Advanced breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action