ICI 182780 in Treating Women With Metastatic Breast Cancer

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
First received: March 3, 2001
Last updated: July 9, 2015
Last verified: July 2015

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 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: 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 Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • objective response rate [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • time to disease progression [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: May 2001
Study Completion Date: August 2008
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over


  • Female

Menopausal status:

  • See Disease Characteristics
  • Postmenopausal

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 3 months


  • WBC at least 2,000/mm^3
  • Platelet count at least 100,000/mm^3
  • No history of bleeding diathesis


  • 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


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


  • No unstable or uncompensated cardiac condition


  • No unstable or uncompensated respiratory condition


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


Biologic therapy:

  • Prior trastuzumab (Herceptin) allowed


  • 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


  • 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


  • See Disease Characteristics


  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00012025

  Show 25 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: James N. Ingle, MD Mayo Clinic
  More Information

Additional Information:
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.

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00012025     History of Changes
Other Study ID Numbers: NCCTG-N0032, CDR0000068473
Study First Received: March 3, 2001
Last Updated: July 9, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Alliance for Clinical Trials in Oncology:
stage IV breast cancer
recurrent breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

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

ClinicalTrials.gov processed this record on November 25, 2015