ClinicalTrials.gov
ClinicalTrials.gov Menu

Faslodex 500mg Multiple Dose Tolerability Study in BC Patients

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.
ClinicalTrials.gov Identifier: NCT00328120
Recruitment Status : Completed
First Posted : May 19, 2006
Last Update Posted : November 17, 2010
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
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 or disease Intervention/treatment Phase
Advanced Breast Cancer Drug: Fulvestrant Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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
Study Start Date : April 2004
Actual Primary Completion Date : April 2006
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Fulvestrant
U.S. FDA Resources


Intervention Details:
    Drug: Fulvestrant
    500 mg intramuscular injection
    Other Names:
    • Faslodex
    • ZD9238


Primary Outcome Measures :
  1. 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 :
  1. Pharmacokinetics [ Time Frame: each visit ]
  2. Time to progression [ Time Frame: assessed when all patients have been in the study for 6 months ]
  3. ORR [ Time Frame: assessed when all patients have been in the study for 6 months ]
  4. Clinical benefit rate [ Time Frame: assessed when all patients have been in the study for 6 months ]
  5. Time to response [ Time Frame: assessed when all patients have been in the study for 6 months ]
  6. duration of response and changes in serum tumour markers [ Time Frame: assessed when all patients have been in the study for 6 months ]


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

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

ClinicalTrials.gov Identifier: NCT00328120     History of Changes
Other Study ID Numbers: D6995C00004
9238IL/0062
First Posted: May 19, 2006    Key Record Dates
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