Clinical trial NCT00146601: Fulvestrant in Premenopausal Women With Hormone Receptor-Positive Breast Cancer
Official title: A Phase II Study of Fulvestrant in Premenopausal Women With Hormone Receptor-Positive Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Fulvestrant
Advanced breast cancer
Invasive breast cancer
Stage IV Breast Cancer
Hormone Receptor-Positive Breast Cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Beth Israel Deaconess Medical Center
name: Massachusetts General Hospital
name: Lowell General Hospital
name: Brigham and Women's Hospital
First posted: 2005-09-07
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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 outcomes:
measure: To determine the safety, time-to-progression, and duration of response for this patient population
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Lowell
country: United States
facility: Lowell General Hospital
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Craig A. Bunnell, MD
role: PRINCIPAL_INVESTIGATOR
References: