Efficacy and Safety of 500mg of Fulvestrant

March 16, 2024 updated by: Steven Come, Beth Israel Deaconess Medical Center

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 4 years
4 years
Assessment of pharmacokinetics of this dose and schedule of fulvestrant.
Time Frame: 4 years
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2004

Primary Completion (Estimated)

March 15, 2025

Study Completion (Estimated)

March 15, 2025

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)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 16, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on Fulvestrant

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe