Efficacy and Safety of 500mg of Fulvestrant

Phase 2

Active, not recruiting

• Conditions: Breast Cancer
• Interventions: Drug: Fulvestrant

• Registration Number: NCT00585507
• Lead Sponsor: Beth Israel Deaconess Medical Center

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.

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2007-12-22
• Study First Submitted QC: 2007-12-22
• Study First Posted: 2008-01-03
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-16
• Last Update Posted: 2024-03-19
• Primary Completion: 2025-03-15
• Study Completion: 2025-03-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single	Fulvestrant	fulvestrant 500mg

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Overall objective response rate, time to response, duration of response, duration of clinical benefit, and time to progression.
Assessment of pharmacokinetics of this dose and schedule of fulvestrant.	4 years
Assessment of adverse events	4 years

Trial Locations

Locations (5)

Massachusetts General Hosptial; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

South Shore Hospital; 🇺🇸 South Weymouth, Massachusetts, United States

Lowell General Hospital; 🇺🇸 Lowell, Massachusetts, United States