ICI 182780 in Treating Women With Metastatic Breast Cancer

NCT ID: NCT00012025

Last Updated: 2016-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-05-31
• Study Completion Date: 2008-08-31

Brief Summary

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using ICI 182780 may fight breast cancer by blocking the activity of estrogen in the tumor cells.

PURPOSE: Phase II trial to study the effectiveness of ICI 182780 in treating patients who have metastatic breast cancer that has not responded to previous hormone therapy.

Detailed Description

OBJECTIVES:

• 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 years.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

fulvestrant

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.

Group Type: EXPERIMENTAL

fulvestrant

Intervention Type: DRUG

Interventions

fulvestrant

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James N. Ingle, MD

Role: STUDY_CHAIR

Mayo Clinic

Locations

MBCCOP - Gulf Coast

Mobile, Alabama, United States

CCOP - Mayo Clinic Scottsdale Oncology Program

Scottsdale, Arizona, United States

Mayo Clinic

Jacksonville, Florida, United States

CCOP - Illinois Oncology Research Association

Peoria, Illinois, United States

Carle Foundation Hospital - Carle Cancer Center

Urbana, Illinois, United States

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, United States

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, United States

Siouxland Hematology-Oncology

Sioux City, Iowa, United States

CCOP - Wichita

Wichita, Kansas, United States

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, United States

CCOP - Duluth

Duluth, Minnesota, United States

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, United States

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, United States

Medcenter One Health System

Bismarck, North Dakota, United States

CCOP - Merit Care Hospital

Fargo, North Dakota, United States

Altru Cancer Center

Grand Forks, North Dakota, United States

CCOP - Toledo Community Hospital

Toledo, Ohio, United States

CCOP - Geisinger Clinic and Medical Center

Danville, Pennsylvania, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

CCOP - Upstate Carolina

Spartanburg, South Carolina, United States

Rapid City Regional Hospital

Rapid City, South Dakota, United States

CCOP - Sioux Community Cancer Consortium

Sioux Falls, South Dakota, United States

CCOP - St. Vincent Hospital Cancer Center, Green Bay

Green Bay, Wisconsin, United States

Allan Blair Cancer Centre

Regina, Saskatchewan, Canada

Countries

United States; Canada

References

Ingle JN, Suman VJ, Rowland KM, Mirchandani D, Bernath AM, Camoriano JK, Fishkin PA, Nikcevich DA, Perez EA; North Central Cancer Treatment Group Trial N0032. Fulvestrant in women with advanced breast cancer after progression on prior aromatase inhibitor therapy: North Central Cancer Treatment Group Trial N0032. J Clin Oncol. 2006 Mar 1;24(7):1052-6. doi: 10.1200/JCO.2005.04.1053.

Reference Type: RESULT

PMID: 16505423 (View on PubMed)

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.

Reference Type: RESULT

Other Identifiers

CDR0000068473

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCCTG-N0032

Identifier Type: -

Identifier Source: org_study_id