Faslodex 500mg Multiple Dose Tolerability Study in BC Patients

November 16, 2010 updated by: AstraZeneca

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chiba, Japan
        • Research Site
      • Fukuoka, Japan
        • Research Site
      • Nagoyata, Japan
        • Research Site
      • Osaka, Japan
        • Research Site
      • Tokyo, Japan
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
assessed when all patients have been in the study for 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics
Time Frame: each visit
each visit
Time to progression
Time Frame: assessed when all patients have been in the study for 6 months
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
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
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
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
assessed when all patients have been in the study for 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

April 1, 2006

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

May 18, 2006

First Submitted That Met QC Criteria

May 18, 2006

First Posted (Estimate)

May 19, 2006

Study Record Updates

Last Update Posted (Estimate)

November 17, 2010

Last Update Submitted That Met QC Criteria

November 16, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D6995C00004
  • 9238IL/0062

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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