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Active, not recruitingNCT00585507Updated May 22, 2026

Efficacy and Safety of 500mg of Fulvestrant

A Phase 2 interventional study of Fulvestrant in Breast Cancer, sponsored by Beth Israel Deaconess Medical Center. Active, not recruiting at 5 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by Beth Israel Deaconess Medical Center · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 8 months after the study started (first participant enrolled Apr 2004, registered Dec 2007).
Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the detailed description
  • Fulvestrant will be administered by intramuscular injection on day 1, day 15 and day 29 and then every 28 days thereafter.
  • Participants will have a physical examination and blood work performed on each treatment date. After teh study treatment has been completed, the physical examinations will be done every three months for the first 2 years, every 6 months for years 2-5, and annually after 5 years.
  • Participants may remain on study treatment until disease progression or until they experience serious side effects.
02

Conditions studied

  • Breast Cancer

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Keywords

  • hormone receptor positive breast cancer
  • Fulvestrant
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 40 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Beth Israel Deaconess Medical Center is the lead sponsor of 560 studies on the registry; 80 are open to participants now.

Of its 75 completed or terminated interventional studies of FDA-regulated products, 61 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Female
  • 18 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
  • May have had adjuvant endocrine therapy if discontinued at least 12 months prior to inclusion. Subjects who have had minimal exposure to adjuvant or first line metastatic endocrine treatment during the 12 months prior to study enrollment can be eligible with overall PI and sponsor permission
  • Prior trastuzumab and biologic therapy is allowed, but must be discontinued more than 2 weeks prior to inclusion
  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    single

    fulvestrant 500mg

    Drug: Fulvestrant

Interventions

  • DrugFulvestrant

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

    Also known as: Faslodex

06

What researchers measure

Primary outcomes

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

Secondary outcomes

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

  2. Assessment of adverse events

    Time frame: 4 years

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

    Time frame: 4 years

07

Study locations

5 sites
  • Massachusetts General Hosptial
    Boston, Massachusetts 02114, United States
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02115, United States
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02115, United States
  • Lowell General Hospital
    Lowell, Massachusetts 01854, United States
  • South Shore Hospital
    South Weymouth, Massachusetts 02190, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00585507
Lead sponsor
Beth Israel Deaconess Medical Center
Collaborators
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital, Lowell General Hospital, University of Colorado, Denver, University of Maryland Greenebaum Cancer Center, South Shore Hospital
Responsible party
Steven Come (Principal Investigator, Beth Israel Deaconess Medical Center) — Principal investigator
First posted
Jan 3, 2008
Start date
Apr 2004
Primary completion
Mar 15, 2027 (estimated)
Completion
Mar 15, 2027 (estimated)
Last update
May 22, 2026

Study contacts

Steven Come, MD
principal investigator · Beth Israel Deaconess Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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