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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

Phase 2
Open (Enrolling)
Breast Cancer

Thank you

Trial Information

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


- 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

- 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

Inclusion Criteria


- 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



- Postmenopausal


- 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


- Not specified


- 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


- No unstable or uncompensated renal disease


- No unstable or uncompensated cardiac disease


- No unstable or uncompensated pulmonary disease

- No clinically active interstitial lung disease

- Asymptomatic chronic stable radiographic changes are allowed


- 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


Biologic therapy

- No prior trastuzumab (Herceptin)

- No concurrent biologic therapy


- 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


- No concurrent radiotherapy to any metastatic site


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


- 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

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression-free survival at 1 year

Outcome Time Frame:

at 1 year

Safety Issue:


Principal Investigator

Martine J. Piccart, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Institut Jules Bordet


United States: Federal Government

Study ID:




Start Date:

May 2003

Completion Date:

Related Keywords:

  • Breast Cancer
  • recurrent breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage IV breast cancer
  • Breast Neoplasms