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Faslodex 500mg Multiple Dose Tolerability Study in BC Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00328120
First Posted: May 19, 2006
Last Update Posted: November 17, 2010
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.
Information provided by:
AstraZeneca
  Purpose
The primary objective of this study is to assess the tolerability of 500mg fulvestrant in postmenopausal women with hormone receptor positive, advanced or recurrent breast cancer

Condition Intervention Phase
Advanced Breast Cancer Drug: Fulvestrant Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open, Multicentre Phase I Clinical Study to Assess the Tolerability of Fulvestrant 500 mg in Postmenopausal Women With Hormone Receptor Positive Advanced or Recurrent Breast Cancer

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • The primary objective of this study is to assess the tolerability of 500mg fulvestrant [ Time Frame: assessed when all patients have been in the study for 6 months ]

Secondary Outcome Measures:
  • Pharmacokinetics [ Time Frame: each visit ]
  • Time to progression [ Time Frame: assessed when all patients have been in the study for 6 months ]
  • ORR [ Time Frame: assessed when all patients have been in the study for 6 months ]
  • Clinical benefit rate [ Time Frame: assessed when all patients have been in the study for 6 months ]
  • Time to response [ Time Frame: assessed when all patients have been in the study for 6 months ]
  • duration of response and changes in serum tumour markers [ Time Frame: assessed when all patients have been in the study for 6 months ]

Enrollment: 20
Study Start Date: April 2004
Study Completion Date: June 2010
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Fulvestrant
    500 mg intramuscular injection
    Other Names:
    • Faslodex
    • ZD9238
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Provision of written informed consent
  • Postmenopausal woman who fulfils any one of the following criteria:
  • Histological or cytological confirmation of breast cancer
  • Estrogen receptor positive (ER+) or progesterone receptor positive (PgR+).

Exclusion Criteria:

  • Having received any one of the following therapy for advanced or recurrent breast cancer
  • 2 or more regimens of hormonal therapy or immunotherapy or 2 or more regimens of chemotherapy, etc
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00328120


Locations
Japan
Research Site
Chiba, Japan
Research Site
Fukuoka, Japan
Research Site
Nagoyata, Japan
Research Site
Osaka, Japan
Research Site
Tokyo, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Breast Cancer Established Brands Team Medical Science Director, MD AstraZeneca
  More Information

ClinicalTrials.gov Identifier: NCT00328120     History of Changes
Other Study ID Numbers: D6995C00004
9238IL/0062
First Submitted: May 18, 2006
First Posted: May 19, 2006
Last Update Posted: November 17, 2010
Last Verified: November 2010

Keywords provided by AstraZeneca:
Advanced breast cancer
Faslodex

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs