Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

ICI 182780 in Treating Women With Metastatic Breast Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI NCCTG-N0032 N0032, NCT00012025

Objectives

1. 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.
2. Determine the time to disease progression and overall survival of women treated with this drug.
3. Determine the toxicity of this drug in these women.

Entry Criteria

Disease Characteristics:

• 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 under)



• Hormone receptor status:
  • Estrogen-receptor and/or progesterone-receptor positive
    • At least 10 fmol/mg cytosol protein

      OR

    • Positive by immunohistochemistry

Prior/Concurrent Therapy:

Biologic therapy:

• Prior trastuzumab (Herceptin) allowed

Chemotherapy:

• 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

Radiotherapy:

• 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

Surgery:

• See Disease Characteristics

Other:

• 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

Patient Characteristics:

Age:

• 18 and over

Sex:

• Female

Menopausal status:

• See Disease Characteristics
• Postmenopausal

Performance status:

• ECOG 0-2

Life expectancy:

• At least 3 months

Hematopoietic:

• WBC at least 2,000/mm³
• Platelet count at least 100,000/mm³
• No history of bleeding diathesis

Hepatic:

• 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

Renal:

• Calcium no greater than 10% above ULN
• Creatinine no greater than 1 mg/dL above ULN
• No severe renal impairment

Cardiovascular:

• No unstable or uncompensated cardiac condition

Pulmonary:

• No unstable or uncompensated respiratory condition

Other:

• HIV negative
• No AIDS
• No other severe condition or systemic disease that would preclude study participation

Expected Enrollment

Approximately 41-94 patients will be accrued for this study within 10 months.

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 years.

Ingle JN, Suman VJ, Rowland KM, et al.: Fulvestrant in women with advanced breast cancer after progression on prior aromatase inhibitor therapy: North Central Cancer Treatment Group Trial N0032. J Clin Oncol 24 (7): 1052-6, 2006.[PUBMED Abstract]

Ingle JN, Rowland KM, Suman VJ, et al.: Evaluation of fulvestrant in women with advanced breast cancer and progression on prior aromatase inhibitor therapy: a phase II trial of the North Central Cancer Treatment Group. [Abstract] Breast Cancer Res Treat 88 (1): A-409, 2004.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

James Ingle, MD, Protocol chair		Ph: 507-284-8432 Email: ingle.james@mayo.edu

Registry Information
Official Title		Phase II Trial Of Fulvestrant (Faslodex) In Women With Metastatic Breast Cancer And Failure on Aromatase Inhibitor Therapy
Trial Start Date		2001-05-18
Registered in ClinicalTrials.gov		NCT00012025
Date Submitted to PDQ		2001-01-03
Information Last Verified		2004-04-26
NCI Grant/Contract Number		U10-CA25224

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