NCT00305448

Brief Summary

This study will assess the relationship between fulvestrant dose and efficacy, and determine the dosing regimen as a second line therapy for Japanese postmenopausal women with oestrogen receptor positive advanced breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
143

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2006

Longer than P75 for phase_2

Geographic Reach
1 country

35 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

March 1, 2006

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

August 29, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

February 15, 2012

Status Verified

February 1, 2012

Enrollment Period

2 years

First QC Date

March 20, 2006

Results QC Date

March 17, 2009

Last Update Submit

February 14, 2012

Conditions

Advanced Breast CancerMetastatic Breast Cancer

Keywords

oncologycancerbreast cancer

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate (ORR)

    An objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR). A patient has best overall response of CR if she had overall response of CR or PR on one visit and met the confirmation criteria per RECIST. ORR is defined as percentage of patients with objective response. Each patient with measurable disease at baseline was assessed for OR from the sequence of Response Evaluation Criteria in Solid Tumors (RECIST) scan data up to data cut-off. RECIST scans were performed every 12 weeks (+/- 2weeks) from randomization

    baseline and every 12 weeks (+/- 2weeks) from randomization data up to data cut-off (19th march 2008)

Secondary Outcomes (5)

  • Time to Progression (TTP)

    every 12 weeks from randomization (+/- 2 weeks) until data cut-off (19th march 2008)

  • Duration of Response (DoR)

    RECIST tumour assessments carried out every 12 weeks from randomisation (+/- 2 weeks) until data cut-off on19th March 2008.

  • Clinical Benefit Rate (CBR)

    every 12 weeks(+/- 2 weeks) from randomization to data up to data cut-off, 19th March 2008.

  • Pharmacokinetic Parameter: Mean Population Clearance, a Measure of the Efficiency With Which Fulvestrant is Eliminated From the Body

    Baseline to 12 weeks

  • Pharmacokinetic Parameter: Mean Volume of Distribution at Steady State, a Measure of the Apparent Volume in the Body Into Which Fulvestrant Distributes

    Baseline to 12 weeks

Study Arms (3)

1

EXPERIMENTAL

Fulvestrant 250 mg intramuscular injection

Drug: Fulvestrant

2

EXPERIMENTAL

Fulvestrant 250mg (Plus 250mg Loading Regimen)

Drug: Fulvestrant

3

EXPERIMENTAL

Fulvestrant 500 mg

Drug: Fulvestrant

Interventions

FulvestrantDRUG

250 intramuscular injection

Also known as: Faslodex, ZD9238
12

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Breast Cancer has continued to grow after having received treatment with an anti-estrogen hormonal treatment such as tamoxifen or an aromatase inhibitor
  • Requiring hormonal treatment
  • Postmenopausal women defined as a woman who has stopped having menstrual periods

You may not qualify if:

  • Treatment with more than one previous regimen of systemic anticancer therapy other than endocrine therapy for advanced breast cancer
  • Treatment with more than one previous regimen of endocrine therapy for advanced breast cancer
  • An existing serious disease, illness, or condition that will prevent participation or compliance with study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (35)

Research Site

Nagoya, Aichi-ken, Japan

Location

Research Site

Asahi, Chiba, Japan

Location

Research Site

Chiba, Chiba, Japan

Location

Research Site

Matsuyama, Ehime, Japan

Location

Research Site

Fukuoka, Fukuoka, Japan

Location

Research Site

Kitakyushu, Fukuoka, Japan

Location

Research Site

Kurume, Fukuoka, Japan

Location

Research Site

Daito, Fukushima, Japan

Location

Research Site

Kōriyama, Fukushima, Japan

Location

Research Site

Ōta, Gunma, Japan

Location

Research Site

Fukuyama, Hiroshima, Japan

Location

Research Site

Hiroshima, Hiroshima, Japan

Location

Research Site

Kure, Hiroshima, Japan

Location

Research Site

Sapporo, Hokkaido, Japan

Location

Research Site

Amagasaki, Hyōgo, Japan

Location

Research Site

Matsubaracho, Kagoshima-ken, Japan

Location

Research Site

Isehara, Kanagawa, Japan

Location

Research Site

Sagamihara, Kanagawa, Japan

Location

Research Site

Yokohama, Kanagawa, Japan

Location

Research Site

Kumamoto, Kumamoto, Japan

Location

Research Site

Sendai, Miyagi, Japan

Location

Research Site

Niigata, Niigata, Japan

Location

Research Site

Ōita, Oita Prefecture, Japan

Location

Research Site

Kurashiki, Okayama-ken, Japan

Location

Research Site

Izumisano, Osaka, Japan

Location

Research Site

Osaka, Osaka, Japan

Location

Research Site

Sakai, Osaka, Japan

Location

Research Site

Suita, Osaka, Japan

Location

Research Site

Morohongō, Saitama, Japan

Location

Research Site

Shinden, Saitama, Japan

Location

Research Site

Shizuoka, Shizuoka, Japan

Location

Research Site

Shimotsuke, Tochigi, Japan

Location

Research Site

Chūō, Tokyo, Japan

Location

Research Site

Koto-ku, Tokyo, Japan

Location

Research Site

Kawasaki, Japan

Location

MeSH Terms

Conditions

Breast NeoplasmsNeoplasms

Interventions

Fulvestrant

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Gerard Lynch
Organization
Astrazeneca
AZTrial_Results_Posting@astrazeneca.com

Study Officials

  • AstraZeneca Japan Medical Director, MD

    AstraZeneca

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2006

First Posted

March 22, 2006

Study Start

March 1, 2006

Primary Completion

March 1, 2008

Study Completion

February 1, 2012

Last Updated

February 15, 2012

Results First Posted

August 29, 2011

Record last verified: 2012-02

Locations

JP(35)