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Anastrozole With or Without Gefitinib in Treating Postmenopausal Women With Metastatic or Locally Recurrent Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00066378
Recruitment Status : Completed
First Posted : August 7, 2003
Last Update Posted : October 24, 2013
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Tracking Information
First Submitted Date  ICMJE August 6, 2003
First Posted Date  ICMJE August 7, 2003
Last Update Posted Date October 24, 2013
Study Start Date  ICMJE May 2003
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2012)
Progression-free survival at 1 year [ Time Frame: at 1 year ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00066378 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2012)
  • Tumor response as measured by RECIST [ Time Frame: from randomisation ]
  • Duration of response as measured by RECIST [ Time Frame: response duration ]
  • Safety as measured by CTC v2.0 [ Time Frame: from randomization ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anastrozole With or Without Gefitinib in Treating Postmenopausal Women With Metastatic or Locally Recurrent Breast Cancer
Official Title  ICMJE An EORTC Randomized, Double Blind, Placebo-Controlled, Phase II Multi-Center Trial Of Anastrozole (Arimidex) In Combination With ZD 1839 (Iressa) Or Placebo In Patients With Advanced Breast Cancer
Brief Summary

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using anastrozole may fight breast cancer by reducing the production of estrogen. Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining anastrozole with gefitinib may kill more tumor cells.

PURPOSE: Randomized phase II trial to compare the effectiveness of anastrozole with or without gefitinib in treating postmenopausal women who have metastatic or locally recurrent breast cancer.

Detailed Description

OBJECTIVES:

  • Compare the 1 year antitumor activity of anastrozole with vs without gefitinib, in terms of progression-free survival, in postmenopausal women with metastatic or locally recurrent advanced breast cancer.
  • Compare the objective tumor response and duration of tumor response in patients treated with these regimens.
  • Compare the progression-free survival of patients treated with these regimens.
  • Compare the safety of these regimens in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center, dominant site of metastatic disease (bone alone vs other), prior chemotherapy (no vs yes), stage (metastatic vs locally recurrent), and measurability (measurable vs evaluable). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral anastrozole and oral gefitinib once daily.
  • Arm II: Patients receive oral anastrozole and an oral placebo once daily. In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 8 weeks until disease progression.

PROJECTED ACCRUAL: A total of 108 patients (54 per treatment arm) will be accrued for this study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: anastrozole
  • Drug: gefitinib
Study Arms  ICMJE
  • Experimental: Arimidex + Iressa® 250 mg
    Arimidex + Iressa® 250 mg Treatment should be administered until documented disease progression, unacceptable toxicity as judged by the responsible physician or patient refusal
    Interventions:
    • Drug: anastrozole
    • Drug: gefitinib
  • Active Comparator: Arimidex + Placebo
    Treatment should be administered until documented disease progression, unacceptable toxicity as judged by the responsible physician or patient refusal
    Intervention: Drug: anastrozole
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 19, 2012)
71
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically confirmed breast cancer

    • Radiologically or clinically evident metastatic or locally recurrent disease
    • Locally advanced disease in elderly patients
    • Bone metastases only allowed
  • Failed prior tamoxifen therapy
  • No rapidly progressive visceral metastases
  • No uncontrolled CNS metastases
  • Hormone receptor status:

    • Estrogen receptor and/or progesterone receptor positive

PATIENT CHARACTERISTICS:

Age

  • Postmenopausal

Sex

  • Female

Menopausal status

  • Postmenopausal, defined by any of the following:

    • Natural menopause with last menses more than 1 year ago
    • Radiotherapy-induced oophorectomy with last menses more than 1 year ago
    • Chemotherapy-induced menopause with last menses more than 1 year ago AND serum follicle-stimulating hormone and luteinizing hormone and plasma estradiol levels clearly in the postmenopausal range
    • Surgical castration

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

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

Renal

  • No unstable or uncompensated renal disease

Cardiovascular

  • No unstable or uncompensated cardiac disease

Pulmonary

  • No unstable or uncompensated pulmonary disease
  • No clinically active interstitial lung disease

    • Asymptomatic chronic stable radiographic changes are allowed

Other

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior trastuzumab (Herceptin)
  • No concurrent biologic therapy

Chemotherapy

  • No more than 1 line of prior chemotherapy in the adjuvant or metastatic setting
  • No concurrent chemotherapy

Endocrine therapy

  • At least 2 years since prior aromatase inhibitors (e.g., anastrozole, letrozole, or exemestane) in the adjuvant setting
  • Prior tamoxifen or fulvestrant in the adjuvant and/or metastatic setting allowed
  • No prior aromatase inhibitors for metastatic disease
  • No other concurrent hormonal therapy

Radiotherapy

  • No concurrent radiotherapy to any metastatic site

Surgery

  • No surgery during and within 4 days after the last dose of gefitinib

Other

  • At least 30 days since prior investigational drugs
  • No prior anti-epidermal growth factor therapy
  • No prior anti-vascular endothelial growth factor therapy (i.e., tyrosine kinase inhibitor receptor)
  • No concurrent administration of any of the following drugs:

    • Phenytoin
    • Carbamazepine
    • Rifampin
    • Phenobarbital
    • Hypericum perforatum (St John's Wort)
  • No other concurrent investigational drugs or treatment
  • No other concurrent cancer treatment
  • No concurrent systemic retinoids
  • Concurrent bisphosphonate therapy for the treatment and prevention of bony metastases is allowed provided therapy was initiated prior to study entry

    • Bisphosphonates may be initiated during study only for the treatment of hypercalcemia
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France,   Netherlands,   Slovenia,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00066378
Other Study ID Numbers  ICMJE EORTC-10021
EORTC-10021
IDBBC-10021
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party European Organisation for Research and Treatment of Cancer - EORTC
Study Sponsor  ICMJE European Organisation for Research and Treatment of Cancer - EORTC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Martine J. Piccart, MD, PhD Jules Bordet Institute
PRS Account European Organisation for Research and Treatment of Cancer - EORTC
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP