ICI 182780 in Treating Women With Metastatic Breast Cancer

NCT00012025 | Completed Phase 2

• 2 other identifiers: NCCTG-N0032CDR0000068473
• Study Type: interventional
• Target: 80
• Locations: 2 countries
• Sites: 25

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.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer; stage IIIB breast cancer; stage IIIC breast cancer

Outcome Measures

Primary Outcomes (1)

• objective response rate

  Up to 10 years

Secondary Outcomes (2)

• overall survival

  Up to 10 years

• time to disease progression

  Up to 10 years

Study Arms (1)

fulvestrant

EXPERIMENTAL

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.

Drug: fulvestrant

Interventions

fulvestrant DRUG

fulvestrant

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (25)

MBCCOP - Gulf Coast

Mobile, Alabama, 36607, United States

Location

CCOP - Mayo Clinic Scottsdale Oncology Program

Scottsdale, Arizona, 85259-5404, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61602, United States

Location

Carle Foundation Hospital - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, 52403-1206, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309-1016, United States

Location

Siouxland Hematology-Oncology

Sioux City, Iowa, 51101-1733, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, 48106, United States

Location

CCOP - Duluth

Duluth, Minnesota, 55805, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68106, United States

Location

Medcenter One Health System

Bismarck, North Dakota, 58501-5505, United States

Location

CCOP - Merit Care Hospital

Fargo, North Dakota, 58122, United States

Location

Altru Cancer Center

Grand Forks, North Dakota, 58201, United States

Location

CCOP - Toledo Community Hospital

Toledo, Ohio, 43623-3456, United States

Location

CCOP - Geisinger Clinic and Medical Center

Danville, Pennsylvania, 17822-2001, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212-4772, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57709, United States

Location

CCOP - Sioux Community Cancer Consortium

Sioux Falls, South Dakota, 57104, United States

Location

CCOP - St. Vincent Hospital Cancer Center, Green Bay

Green Bay, Wisconsin, 54301, United States

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Related Publications (2)

• 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.

  PMID: 16505423 RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Fulvestrant

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• James N. Ingle, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2001
• First Posted: January 27, 2003
• Study Start: May 1, 2001
• Primary Completion: March 1, 2006
• Study Completion: August 1, 2008
• Last Updated: July 6, 2016

Record last verified: 2016-07

Locations

CA (1); US (24)