NCT00585507

Brief Summary

Fulvestrant has proven effective in the treatment of hormone receptor positive metastatic breast cancer. The dose used in studies so far has been well tolerated and may be too low for optimal effectiveness. In this study, a higher dose will be used to see whether an improved outcome will result.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Timeline
Completed

Started Apr 2004

Longer than P75 for phase_2 breast-cancer

Geographic Reach
1 country

5 active sites

Status
active not recruiting

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
3.7 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2007

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 3, 2008

Completed
18.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2026

Completed
Last Updated

July 10, 2025

Status Verified

July 1, 2025

Enrollment Period

22 years

First QC Date

December 22, 2007

Last Update Submit

July 7, 2025

Conditions

Breast Cancer

Keywords

hormone receptor positive breast cancerFulvestrant

Outcome Measures

Primary Outcomes (1)

  • To assess the clinical benefit rate for subjects receiving this dose and schedule of fulvestrant.

Secondary Outcomes (3)

  • Overall objective response rate, time to response, duration of response, duration of clinical benefit, and time to progression.

  • Assessment of adverse events

    4 years

  • Assessment of pharmacokinetics of this dose and schedule of fulvestrant.

    4 years

Study Arms (1)

single

EXPERIMENTAL

fulvestrant 500mg

Drug: Fulvestrant

Interventions

FulvestrantDRUG

500mg into the muscle on days 1, 15 and 29 and then every 28 days thereafter.

Also known as: Faslodex
single

Eligibility Criteria

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

You may qualify if:

  • Female
  • years of age or older
  • Histologically confirmed adenocarcinoma of the breast progressing local-regional or metastatic disease that is not considered amenable to curative treatment
  • Evidence of hormone sensitivity of primary or secondary tumor tissue
  • Postmenopausal as defined by criteria listed in protocol
  • Presence of measurable or evaluable, nonmeasurable, disease. Any x-rays and scans for assessment of measurable disease must be performed with 28 days prior to registration
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2

You may not qualify if:

  • Presence of life-threatening metastatic disease
  • Endocrine therapy the advanced disease setting
  • Systemic chemotherapy, whether as adjuvant therapy or for advanced disease, within previous 4 weeks
  • Trastuzumab or biologic therapy within previous 2 weeks
  • Extensive radiation therapy within the last 2 weeks
  • Prior adjuvant or neoadjuvant treatment with fulvestrant is not allowed
  • Concomitant anticancer treatments
  • Chronic bisphosphonates for hypercalcemia or prevention of bone metastases
  • Subjects receiving long-term anticoagulant therapy with warfarin
  • Estrogen replacement therapy within 6 months of trial entry
  • Previous or current systems malignancy within the past 3 years
  • Treatment with non approved or investigational drug within 2 weeks before study entry
  • Any evidence of severe or uncontrolled systemic disease
  • History of bleeding diathesis
  • Any severe concomitant condition which makes it undesirable for the subject to participate in the study or which would jeopardize compliance with the study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Massachusetts General Hosptial

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Lowell General Hospital

Lowell, Massachusetts, 01854, United States

Location

South Shore Hospital

South Weymouth, Massachusetts, 02190, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Fulvestrant

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Steven Come, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 22, 2007

First Posted

January 3, 2008

Study Start

April 1, 2004

Primary Completion

March 15, 2026

Study Completion

March 15, 2026

Last Updated

July 10, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(5)