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Faslodex 500mg Multiple Dose Tolerability Study in BC Patients

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00328120
First received: May 18, 2006
Last updated: November 16, 2010
Last verified: November 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics [ Time Frame: each visit ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: assessed when all patients have been in the study for 6 months ] [ Designated as safety issue: Yes ]
  • ORR [ Time Frame: assessed when all patients have been in the study for 6 months ] [ Designated as safety issue: Yes ]
  • Clinical benefit rate [ Time Frame: assessed when all patients have been in the study for 6 months ] [ Designated as safety issue: No ]
  • Time to response [ Time Frame: assessed when all patients have been in the study for 6 months ] [ Designated as safety issue: Yes ]
  • duration of response and changes in serum tumour markers [ Time Frame: assessed when all patients have been in the study for 6 months ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
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: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00328120     History of Changes
Other Study ID Numbers: D6995C00004, 9238IL/0062
Study First Received: May 18, 2006
Last Updated: November 16, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by AstraZeneca:
Advanced breast cancer
Faslodex

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

ClinicalTrials.gov processed this record on November 20, 2014