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

Phase 2
18 Years
Not Enrolling
Breast Cancer

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Trial Information

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

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

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.

Inclusion Criteria:

- Histologically or cytologically confirmed invasive breast cancer, with stage IV

- 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

Type of Study:


Study Design:

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

Outcome 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

Principal Investigator

Craig A. Bunnell, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

June 2004

Completion Date:

July 2007

Related Keywords:

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



Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617
Lowell General Hospital Lowell, Massachusetts  01854