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Gefitinib in Treating Patients With Metastatic Breast Cancer That Has Progressed After Antiestrogen and Nonsteroidal Aromatase Inhibitor Therapy

This study has been completed.
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC Identifier:
First received: August 6, 2003
Last updated: July 17, 2012
Last verified: July 2012

RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.

PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have metastatic breast cancer that has not responded to antiestrogen and nonsteroidal aromatase inhibitor therapy.

Condition Intervention Phase
Breast Cancer Drug: gefitinib Phase 2

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An IDBBC Single Arm Phase II Trial Evaluating The Activity Of Iressa (ZD1839) In Metastatic Breast Cancer Patients Pretreated With An Antiestrogen And A Non-Steroidal Aromatase Inhibitor (Anastrozole Or Letrozole)

Resource links provided by NLM:

Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Enrollment: 44
Study Start Date: May 2003
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
Detailed Description:


  • Determine the clinical benefit rate, defined as complete response, partial response, or stable disease after at least 24 weeks, in patients receiving gefitinib for metastatic breast cancer who progressed after prior antiestrogen and nonsteroidal aromatase inhibitor therapy.
  • Determine the best overall response rate of patients treated with this drug.
  • Determine the progression-free survival of patients treated with this drug.
  • Determine the duration of response in patients treated with this drug.
  • Determine the safety of this drug in these patients.

OUTLINE: This is a nonrandomized, open-label, multicenter study.

Patients receive oral gefitinib once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients who go off study in the absence of disease progression are followed every 8 weeks until disease progression.

PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed breast cancer
  • Radiological and/or clinical evidence of metastatic disease
  • Progressive disease after prior therapy with an antiestrogen (e.g., tamoxifen or faslodex) and a nonsteroidal aromatase inhibitor (e.g., anastrozole or letrozole) in the adjuvant and/or metastatic setting* NOTE: *Endocrine therapy must be the last treatment before study entry
  • Unidimensionally measurable disease
  • No rapidly progressive visceral metastases
  • No uncontrolled CNS metastases
  • Hormone receptor status:

    • Estrogen receptor and/or progesterone receptor positive



  • 18 and over


  • Not specified

Menopausal status

  • Postmenopausal, defined as any of the following:

    • Natural menopause with at least 1 year since last menses
    • Radiation-induced oophorectomy with last menses more than 1 year ago
    • Chemotherapy-induced menopause with 1 year since last menses and serum follicle-stimulating hormone, luteinizing hormone, and plasma estradiol levels in the postmenopausal range
    • Surgical castration

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified


  • Not specified


  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • Transaminases no greater than 2.5 times ULN
  • No severe or uncontrolled hepatic disease


  • No severe or uncontrolled renal disease


  • No severe or uncontrolled cardiac disease


  • No severe or uncontrolled respiratory disease
  • No evidence of clinically active interstitial lung disease

    • Asymptomatic chronic stable radiographic changes allowed


  • No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix, contralateral breast cancer, or nonmelanoma skin cancer
  • No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up
  • No other severe or uncontrolled systemic disease
  • No known hypersensitivity to any excipients of gefitinib
  • No unresolved chronic toxicity greater than grade 2


Biologic therapy

  • No concurrent biologic agents


  • No more than 1 prior chemotherapy regimen for metastatic breast cancer
  • No concurrent chemotherapy

Endocrine therapy

  • See Disease Characteristics
  • No concurrent hormonal therapy


  • Prior radiotherapy allowed
  • No concurrent radiotherapy to any metastatic site


  • No surgery within 4 days after study drug administration


  • No prior epidermal growth factor receptor inhibitor therapy
  • More than 30 days since prior investigational drugs
  • No concurrent use of any of the following:

    • Phenytoin
    • Carbamazepine
    • Rifampin
    • Phenobarbital
    • Hypericum perforatum (St. John's Wort)
  • No concurrent systemic retinoids
  • No other concurrent investigational drugs or treatments
  • No other concurrent anticancer treatments
  • Concurrent bisphosphonates for the treatment and prevention of bony metastases are allowed provided therapy was initiated before study enrollment* NOTE: *Bisphosphonates may be initiated during study participation for the treatment of hypercalcemia only
  Contacts and Locations
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Please refer to this study by its identifier: NCT00066339

Institut Jules Bordet
Brussels, Belgium, 1000
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Study Chair: Martine J. Piccart-Gebhart, MD, PhD Jules Bordet Institute
  More Information

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00066339     History of Changes
Other Study ID Numbers: EORTC-10012
Study First Received: August 6, 2003
Last Updated: July 17, 2012

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Aromatase Inhibitors
Estrogen Receptor Modulators
Estrogen Antagonists
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on September 21, 2017