Full Text View
Tabular View
No Study Results Posted
Related Studies
ICI 182780 in Treating Women With Metastatic Breast Cancer
This study is ongoing, but not recruiting participants.
First Received: March 3, 2001   Last Updated: July 23, 2008   History of Changes
Sponsor: North Central Cancer Treatment Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00012025
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: fulvestrant
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Trial Of Fulvestrant (Faslodex) In Women With Metastatic Breast Cancer And Failure on Aromatase Inhibitor Therapy

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: May 2001
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.

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00012025

  Hide Study Locations
Locations
United States, Alabama
MBCCOP - Gulf Coast
Mobile, Alabama, United States, 36607
United States, Arizona
CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale, Arizona, United States, 85259-5404
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
United States, Illinois
Carle Foundation Hospital - Carle Cancer Center
Urbana, Illinois, United States, 61801
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61602
United States, Iowa
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States, 52403-1206
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309-1016
Siouxland Hematology-Oncology
Sioux City, Iowa, United States, 51101-1733
United States, Kansas
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
United States, Michigan
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
United States, Minnesota
CCOP - Duluth
Duluth, Minnesota, United States, 55805
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Nebraska
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
United States, North Dakota
Altru Cancer Center
Grand Forks, North Dakota, United States, 58201
CCOP - Merit Care Hospital
Fargo, North Dakota, United States, 58122
Medcenter One Health System
Bismarck, North Dakota, United States, 58501-5505
United States, Ohio
CCOP - Toledo Community Hospital
Toledo, Ohio, United States, 43623-3456
United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212-4772
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, United States, 17822-2001
United States, South Carolina
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States, 57104
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57709
United States, Wisconsin
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, United States, 54301
Canada, Saskatchewan
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Study Chair: James N. Ingle, MD Mayo Clinic
  More Information

Additional Information:
Publications:
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.
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.

Study ID Numbers: CDR0000068473, NCCTG-N0032
Study First Received: March 3, 2001
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00012025     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
recurrent breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Additional relevant MeSH terms:
Estrogen Antagonists
Antineoplastic Agents, Hormonal
Skin Diseases
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Fulvestrant
Hormones, Hormone Substitutes, and Hormone Antagonists
Breast Neoplasms
Pharmacologic Actions
Estrogen Receptor Modulators
Neoplasms
Neoplasms by Site
Therapeutic Uses
Breast Diseases

ClinicalTrials.gov processed this record on November 22, 2009