Efficacy and Safety of 500mg of Fulvestrant

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00585507
• Other study ID #: 04-016
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: April 2004
• Est. completion date: March 15, 2025

Study information

• Verified date: March 2024
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: March 15, 2025
• Est. primary completion date: March 15, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hosptial	Boston	Massachusetts
United States	Lowell General Hospital	Lowell	Massachusetts
United States	South Shore Hospital	South Weymouth	Massachusetts

Sponsors (8)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Brigham and Women's Hospital, Dana-Farber Cancer Institute, Lowell General Hospital, Massachusetts General Hospital, South Shore Hospital, University of Colorado, Denver, University of Maryland Greenebaum Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the clinical benefit rate for subjects receiving this dose and schedule of fulvestrant.
Secondary	Overall objective response rate, time to response, duration of response, duration of clinical benefit, and time to progression.
Secondary	Assessment of adverse events		4 years
Secondary	Assessment of pharmacokinetics of this dose and schedule of fulvestrant.		4 years