Fulvestrant in Premenopausal Women With Hormone Receptor-Positive Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Phase II Study of Fulvestrant in Premenopausal Women With Hormone Receptor-Positive Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00146601
• Other study ID #: 04-075
• Status: Completed
• Phase: Phase 2
• First received: September 6, 2005
• Last updated: December 20, 2007
• Start date: June 2004
• Est. completion date: July 2007

Study information

• Verified date: December 2007
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test the effectiveness and safety of fulvestrant in premenopausal women with advanced breast cancer.

Description:

Patients will receive an injection of fulvestrant on first day of treatment and then again 2 weeks later and again 2 weeks after that. Then patients will receive injections every 4 weeks.

Routine blood tests will be performed each time an injection is given.

Patients will be required to complete a hot flash diary, recording the number and severity of hot flashes they experience on a daily basis.

After every 12 weeks of treatment, patients' disease will be assessed by x-rays or scans. If there is no disease progression, the patient will continue to receive injections every 4 weeks with reassessment every 8 weeks.

Patients will continue to receive treatment as long as there is no disease progression or serious side effects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically or cytologically confirmed invasive breast cancer, with stage IV disease.

• Tumors must be positive for estrogen receptors, progesterone receptors, or both.

• Patients must be premenopausal.

• Prior anti-estrogen therapy (with or without ovarian suppression)

• Platelet count > 100,000/mm3

• Age older than 18 years

• ECOG performance status 0-2

Exclusion Criteria:

• Hormonal treatment for metastatic disease

• Pregnant or breast-feeding women

• Postmenopausal

• Concurrent hormonal therapy or chemotherapy

• Prior fulvestrant therapy

• More than three prior chemotherapy regimens for metastatic disease

• Concurrent, long-term anticoagulation therapy

• Severe, uncontrolled intercurrent illness

• History of hypersensitivity to castor oil

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Fulvestrant

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 Hospital	Boston	Massachusetts
United States	Lowell General Hospital	Lowell	Massachusetts

Sponsors (5)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Lowell General Hospital, Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To examine the clinical benefit and response rate of hormone receptor-positive metastatic breast cancer previously treated with anti-estrogen therapy in premenopausal women to treatment with fulvestrant
Secondary	To determine the safety, time-to-progression, and duration of response for this patient population