Fulvestrant in Premenopausal Women With Hormone Receptor-Positive Breast Cancer

This study has been completed.
Sponsor:
Collaborators:
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
First received: September 6, 2005
Last updated: December 20, 2007
Last verified: December 2007
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Fulvestrant in Premenopausal Women With Hormone Receptor-Positive Breast Cancer

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov Identifier: NCT00146601     History of Changes
Other Study ID Numbers: 04-075
Study First Received: September 6, 2005
Last Updated: December 20, 2007
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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hormones
Fulvestrant
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014