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Phase II Trial Of Fulvestrant (Faslodex) In Women With Metastatic Breast Cancer And Failure on Aromatase Inhibitor Therapy

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Phase II Trial Of Fulvestrant (Faslodex) In Women With Metastatic Breast Cancer And Failure on Aromatase Inhibitor Therapy


- Determine the complete and partial objective response rate and duration of response in
women with metastatic breast cancer who have failed aromatase inhibitor therapy treated
with fulvestrant.

- Determine the time to disease progression and overall survival of women treated with
this drug.

- Determine the toxicity of this drug in these women.

OUTLINE: Patients receive fulvestrant intramuscularly on day 1. Courses repeat approximately
every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 5 years or until disease progression. After disease
progression, patients are followed every 3 months for 2 years and then every 6 months for 3

PROJECTED ACCRUAL: Approximately 41-94 patients will be accrued for this study within 10

Inclusion Criteria


- Histologically or cytologically confirmed adenocarcinoma of the breast

- Progressive local-regional or metastatic disease

- Unconfirmed new or progressive multiple pulmonary nodules or unequivocal
radiographic evidence of multiple bone metastases allowed

- At least 1 measurable lesion

- At least 20 mm by CT scan or MRI OR at least 10 mm by spiral CT scan

- Nonmeasurable disease includes the following:

- Bone lesions

- Leptomeningeal disease

- Ascites

- Pleural/pericardial effusions

- Lymphangitis cutis/pulmonis

- Inflammatory breast disease

- Abdominal masses not confirmed and followed by imaging techniques

- Cystic lesions

- Disease progression after prior third-generation aromatase inhibitor (e.g.,
anastrozole, exemestane, letrozole, or vorozole)

- Failed no more than 1 prior additive hormonal therapy (e.g., aromatase inhibitor
with or without tamoxifen)

- Disease recurrence identified no more than 12 months since the last prior
adjuvant tamoxifen treatment

- Oophorectomy, ovarian radiotherapy, and luteinizing hormone-releasing
hormone (LH-RH) analogs not considered hormonal therapy regimens

- No brain or leptomeningeal metastases

- No hepatic metastases involving more than one-third of the liver

- No symptomatic pulmonary lymphangitic disease

- Evidence of hormone sensitivity as defined by:

- Relapse after at least 12 months of adjuvant hormonal treatment

- Tumor remission or stabilization before progression for at least 6 months after
prior hormonal therapy for advanced disease

- Postmenopausal as defined by one of the following:

- At least 12 months since last menstrual period

- 4-11 months since last menstrual period and follicle-stimulating hormone (FSH)
in the postmenopausal range

- Prior castration and castrate FSH levels within the postmenopausal range

- Hysterectomy without oophorectomy (FSH in postmenopausal range if age 60 and

- Hormone receptor status:

- Estrogen-receptor and/or progesterone-receptor positive

- At least 10 fmol/mg cytosol protein OR

- Positive by immunohistochemistry



- 18 and over


- Female

Menopausal status:

- See Disease Characteristics

- Postmenopausal

Performance status:

- ECOG 0-2

Life expectancy:

- At least 3 months


- WBC at least 2,000/mm^3

- Platelet count at least 100,000/mm^3

- No history of bleeding diathesis


- See Disease Characteristics

- Bilirubin no greater than 0.8 mg/dL above upper limit of normal (ULN)

- INR no greater than 1.6

- No hepatitis B or C

- No severe hepatic impairment


- Calcium no greater than 10% above ULN

- Creatinine no greater than 1 mg/dL above ULN

- No severe renal impairment


- No unstable or uncompensated cardiac condition


- No unstable or uncompensated respiratory condition


- HIV negative


- No other severe condition or systemic disease that would preclude study participation


Biologic therapy:

- Prior trastuzumab (Herceptin) allowed


- Prior adjuvant chemotherapy allowed

- No more than 1 prior chemotherapy regimen for metastatic disease

Endocrine therapy:

- See Disease Characteristics

- More than 4 weeks since prior estrogen replacement therapy

- More than 3 months since prior LH-RH analogs

- No other prior additive hormonal therapy except third-generation aromatase inhibitors
or tamoxifen


- See Disease Characteristics

- Concurrent radiotherapy for control of bone pain or other reasons due to established
bone lesions allowed if radiotherapy field is no more than 30% of bone marrow


- See Disease Characteristics


- More than 4 weeks since prior investigational drug for breast cancer

- No concurrent long-term warfarin

- Concurrent bisphosphonates allowed if dose stable

- Concurrent long-term antiplatelet therapy allowed

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

James N. Ingle, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

May 2001

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • Breast Neoplasms



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