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

October 23, 2013 updated by: European Organisation for Research and Treatment of Cancer - EORTC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

71

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

  • Belgium
      • Antwerpen, Belgium, B-2020
        • Ziekenhuis Netwerk Antwerpen Middelheim
      • Brussels, Belgium, 1000
        • Institut Jules Bordet
      • Wilrijk, Belgium, 2610
        • Algemeen Ziekenhuis Sint-Augustinus
  • France
      • Bordeaux, France, 33076
        • Institut Bergonié
      • Rouen, France, 76038
        • Centre Henri Becquerel
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
      • Nijmegen, Netherlands, NL-6500 HB
        • Universitair Medisch Centrum St. Radboud - Nijmegen
  • Slovenia
      • Ljubljana, Slovenia, Sl-1000
        • Institute of Oncology - Ljubljana
  • United Kingdom
    • Scotland
      • Edinburgh, Scotland, United Kingdom, EH4 2XU
        • Edinburgh Cancer Centre at Western General Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: gefitinib
Drug: anastrozole
Active Comparator: Arimidex + Placebo
Treatment should be administered until documented disease progression, unacceptable toxicity as judged by the responsible physician or patient refusal
Drug: anastrozole

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival at 1 year
Time Frame: at 1 year
at 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Tumor response as measured by RECIST
Time Frame: from randomisation
from randomisation
Duration of response as measured by RECIST
Time Frame: response duration
response duration
Safety as measured by CTC v2.0
Time Frame: from randomization
from randomization

Collaborators and Investigators

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

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Study Chair: Martine J. Piccart, MD, PhD, Jules Bordet Institute

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, 2003

Primary Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

August 6, 2003

First Submitted That Met QC Criteria

August 6, 2003

First Posted (Estimate)

August 7, 2003

Study Record Updates

Last Update Posted (Estimate)

October 24, 2013

Last Update Submitted That Met QC Criteria

October 23, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-10021
  • IDBBC-10021

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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