NCT00328120

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2004

Longer than P75 for phase_1

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 19, 2006

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

November 17, 2010

Status Verified

November 1, 2010

Enrollment Period

2 years

First QC Date

May 18, 2006

Last Update Submit

November 16, 2010

Conditions

Advanced Breast Cancer

Keywords

Advanced breast cancerFaslodex

Outcome Measures

Primary Outcomes (1)

  • The primary objective of this study is to assess the tolerability of 500mg fulvestrant

    assessed when all patients have been in the study for 6 months

Secondary Outcomes (6)

  • Pharmacokinetics

    each visit

  • Time to progression

    assessed when all patients have been in the study for 6 months

  • ORR

    assessed when all patients have been in the study for 6 months

  • Clinical benefit rate

    assessed when all patients have been in the study for 6 months

  • Time to response

    assessed when all patients have been in the study for 6 months

  • +1 more secondary outcomes

Interventions

FulvestrantDRUG

500 mg intramuscular injection

Also known as: Faslodex, ZD9238

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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+).

You may not qualify if:

  • Having received any one of the following therapy for advanced or recurrent breast cancer
  • or more regimens of hormonal therapy or immunotherapy or 2 or more regimens of chemotherapy, etc

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Research Site

Chiba, Japan

Location

Research Site

Fukuoka, Japan

Location

Research Site

Nagoyata, Japan

Location

Research Site

Osaka, Japan

Location

Research Site

Tokyo, Japan

Location

MeSH Terms

Interventions

Fulvestrant

Intervention Hierarchy (Ancestors)

EstradiolEstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Breast Cancer Established Brands Team Medical Science Director, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 18, 2006

First Posted

May 19, 2006

Study Start

April 1, 2004

Primary Completion

April 1, 2006

Study Completion

June 1, 2010

Last Updated

November 17, 2010

Record last verified: 2010-11

Locations

JP(5)