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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

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

Thank you

Trial Information

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

- 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.

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

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 assess the clinical benefit rate for subjects receiving this dose and schedule of fulvestrant.

Outcome Time Frame:


Safety Issue:


Principal Investigator

Steven Come, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beth Israel Deaconess Medical Center


United States: Institutional Review Board

Study ID:




Start Date:

April 2004

Completion Date:

August 2013

Related Keywords:

  • Breast Cancer
  • hormone receptor positive breast cancer
  • Fulvestrant
  • Breast Neoplasms



Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Lowell General Hospital Lowell, Massachusetts  01854
South Shore Hospital South Weymouth, Massachusetts  02190
Massachusetts General Hosptial Boston, Massachusetts  02114