Efficacy and Safety of 500mg of Fulvestrant

• ClinicalTrials.gov Identifier: NCT00585507
• Recruitment Status: Active, not recruiting
• First Posted: January 3, 2008
• Last Update Posted: June 21, 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
• Information provided by (Responsible Party): Steven Come, MD, Beth Israel Deaconess Medical Center

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Drug: Fulvestrant	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: April 2004
• Estimated Primary Completion Date: June 30, 2023
• Estimated Study Completion Date: June 30, 2023

Arms and Interventions

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 Name: Faslodex

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Overall objective response rate, time to response, duration of response, duration of clinical benefit, and time to progression.
2. Assessment of adverse events [ Time Frame: 4 years ]
3. Assessment of pharmacokinetics of this dose and schedule of fulvestrant. [ Time Frame: 4 years ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Massachusetts

Massachusetts General Hosptial

Boston, Massachusetts, United States, 02114

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02115

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02115

Lowell General Hospital

Lowell, Massachusetts, United States, 01854

South Shore Hospital

South Weymouth, Massachusetts, United States, 02190

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

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

Investigators

• Principal Investigator: Steven Come, MD; Beth Israel Deaconess Medical Center

More Information

• Responsible Party: Steven Come, MD, Principal Investigator, Beth Israel Deaconess Medical Center
• ClinicalTrials.gov Identifier: NCT00585507
• Other Study ID Numbers: 04-016
• First Posted: January 3, 2008
• Last Update Posted: June 21, 2022
• Last Verified: June 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Steven Come, MD, Beth Israel Deaconess Medical Center:

hormone receptor positive breast cancer; Fulvestrant

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Fulvestrant; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Estrogen Receptor Antagonists; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs