ICI 182780 in Treating Women With Metastatic Breast Cancer

July 1, 2016 updated by: Alliance for Clinical Trials in Oncology

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: fulvestrant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
objective response rate
Time Frame: Up to 10 years
Up to 10 years

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: Up to 10 years
Up to 10 years
time to disease progression
Time Frame: Up to 10 years
Up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2001

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

March 3, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

July 6, 2016

Last Update Submitted That Met QC Criteria

July 1, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCCTG-N0032
  • CDR0000068473 (Registry Identifier: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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