Fulvestrant in Premenopausal Women With Hormone Receptor-Positive Breast Cancer

This study has been completed.

First Received: September 6, 2005 Last Updated: December 20, 2007 History of Changes

Sponsors and Collaborators:	Dana-Farber Cancer Institute Beth Israel Deaconess Medical Center Massachusetts General Hospital Lowell General Hospital Brigham and Women's Hospital
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00146601

Purpose

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

Condition	Intervention	Phase
Breast Cancer	Drug: Fulvestrant	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Study of Fulvestrant in Premenopausal Women With Hormone Receptor-Positive Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Ici 182780

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

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 Outcome Measures:

To determine the safety, time-to-progression, and duration of response for this patient population

Estimated Enrollment:	35
Study Start Date:	June 2004
Study Completion Date:	July 2007
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00146601

Locations

United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Lowell General Hospital
Lowell, Massachusetts, United States, 01854

Sponsors and Collaborators

Dana-Farber Cancer Institute

Beth Israel Deaconess Medical Center

Massachusetts General Hospital

Lowell General Hospital

Brigham and Women's Hospital

Investigators

Principal Investigator:

Craig A. Bunnell, MD

Dana-Farber Cancer Institute

More Information

No publications provided

Study ID Numbers:	04-075
Study First Received:	September 6, 2005
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00146601 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

Fulvestrant
Advanced breast cancer
Invasive breast cancer
Stage IV Breast Cancer
Hormone Receptor-Positive Breast Cancer

Study placed in the following topic categories:

Estrogen Receptor Modulators
Estrogen Antagonists
Estrogens
Antineoplastic Agents, Hormonal
Skin Diseases
Hormone Antagonists

Hormones, Hormone Substitutes, and Hormone Antagonists
Fulvestrant
Breast Neoplasms
Hormones
Breast Diseases

Additional relevant MeSH terms:

Estrogen Antagonists
Antineoplastic Agents, Hormonal
Skin Diseases
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Fulvestrant
Hormones, Hormone Substitutes, and Hormone Antagonists

Breast Neoplasms
Hormones
Pharmacologic Actions
Estrogen Receptor Modulators
Neoplasms
Neoplasms by Site
Therapeutic Uses
Breast Diseases

ClinicalTrials.gov processed this record on September 04, 2009