Clinical trial NCT00585507: Efficacy and Safety of 500mg of Fulvestrant
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Breast Cancer
Keywords: hormone receptor positive breast cancer
Fulvestrant
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Dana-Farber Cancer Institute
name: Brigham and Women's Hospital
name: Massachusetts General Hospital
name: Lowell General Hospital
name: University of Colorado, Denver
name: University of Maryland Greenebaum Cancer Center
name: South Shore Hospital
First posted: 2008-01-03
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: To assess the clinical benefit rate for subjects receiving this dose and schedule of fulvestrant.
Secondary outcomes:
measure: Overall objective response rate, time to response, duration of response, duration of clinical benefit, and time to progression.
measure: Assessment of adverse events
timeFrame: 4 years
measure: Assessment of pharmacokinetics of this dose and schedule of fulvestrant.
timeFrame: 4 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hosptial
state: Massachusetts
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: Lowell
country: United States
facility: Lowell General Hospital
state: Massachusetts
city: South Weymouth
country: United States
facility: South Shore Hospital
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Steven Come, MD
role: PRINCIPAL_INVESTIGATOR
References: