Efficacy and Safety of 500mg of Fulvestrant

A Phase II Multi-Center Study to Evaluate the Efficacy and Safety of 500mg of Fulvestrant (Faslodex) as a First Line Hormonal Treatment in Postmenopausal Women With Hormone Receptor Positive Metastatic Breast Cancer

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Fulvestrant

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: single; fulvestrant 500mg	Drug: Fulvestrant; 500mg into the muscle on days 1, 15 and 29 and then every 28 days thereafter.; Other Names: Faslodex

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: University of Colorado, Denver; Massachusetts General Hospital; Dana-Farber Cancer Institute; Brigham and Women's Hospital; Lowell General Hospital; University of Maryland Greenebaum Cancer Center; South Shore Hospital
• Investigators: Principal Investigator: Steven Come, MD, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2004
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): March 15, 2027

Study Registration Dates

• First Submitted: December 22, 2007
• First Submitted That Met QC Criteria: December 22, 2007
• First Posted (Estimated): January 3, 2008

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Fulvestrant; hormone receptor positive breast cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Polycyclic Compounds; Steroids; Fused-Ring Compounds; Estradiol; Estrenes; Estranes; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Fulvestrant
• Other Study ID Numbers: 04-016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No