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Efficacy and Safety of 500mg of Fulvestrant

Primary Purpose

Breast Cancer

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fulvestrant
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring hormone receptor positive breast cancer, Fulvestrant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hosptial
  • Beth Israel Deaconess Medical Center
  • Dana-Farber Cancer Institute
  • Lowell General Hospital
  • South Shore Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

single

Arm Description

fulvestrant 500mg

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall objective response rate, time to response, duration of response, duration of clinical benefit, and time to progression.
Assessment of adverse events
Assessment of pharmacokinetics of this dose and schedule of fulvestrant.

Full Information

First Posted
December 22, 2007
Last Updated
June 16, 2022
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
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1. Study Identification

Unique Protocol Identification Number
NCT00585507
Brief Title
Efficacy and Safety of 500mg of Fulvestrant
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 2004 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
hormone receptor positive breast cancer, Fulvestrant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
single
Arm Type
Experimental
Arm Description
fulvestrant 500mg
Intervention Type
Drug
Intervention Name(s)
Fulvestrant
Other Intervention Name(s)
Faslodex
Intervention Description
500mg into the muscle on days 1, 15 and 29 and then every 28 days thereafter.
Primary Outcome Measure Information:
Title
To assess the clinical benefit rate for subjects receiving this dose and schedule of fulvestrant.
Secondary Outcome Measure Information:
Title
Overall objective response rate, time to response, duration of response, duration of clinical benefit, and time to progression.
Title
Assessment of adverse events
Time Frame
4 years
Title
Assessment of pharmacokinetics of this dose and schedule of fulvestrant.
Time Frame
4 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Come, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hosptial
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Lowell General Hospital
City
Lowell
State/Province
Massachusetts
ZIP/Postal Code
01854
Country
United States
Facility Name
South Shore Hospital
City
South Weymouth
State/Province
Massachusetts
ZIP/Postal Code
02190
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy and Safety of 500mg of Fulvestrant

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