Arimidex/Faslodex/Iressa Study: A Trial Using Arimidex, Faslodex and Iressa in Women With Breast Cancer

Inclusion Criteria:

1. All subjects must be female
2. Postmenopausal status, defined as any one of the following criteria:

   1. documented history of bilateral oophorectomy;
   2. age 60 years or more;
   3. ages 45 to 59 and satisfying one or more of the following criteria:

      * amenorrhea for at least 12 months and intact uterus;
      * amenorrhea for less than 12 months and a follicle stimulating hormone (FSH) concentration within premenopausal range including:

        * patients who have had a hysterectomy;
        * patients who have received hormone replacement.
3. Patients must have histologically confirmed invasive breast cancer with a primary tumor of 3 cm or more in greatest dimension as measured by clinical examination.
4. Estrogen receptor and/or progesterone receptor positive disease
5. Patients must not have received any prior treatment for current or newly diagnosed breast cancer.
6. Patients must have not received previous treatment with any of the study medications or similar drugs.
7. No use of selective estrogen receptor modulators (SERM) such as raloxifene or similar agents in the past 2 years.
8. World Health Organization (WHO) performance status of 0, 1, or 2
9. Adequate organ function defined as follows:

   1. adequate renal function, defined by a serum creatinine within 3 times the upper limits of normal;
   2. adequate liver function, defined by total bilirubin, AST, ALT, and alkaline phosphatase within 3 times the upper limits of normal;
   3. adequate bone marrow function, defined as a white blood cell (WBC) \> 3.0 ml, platelet (PLT) \> 75,000/ul, hemoglobin (Hb) \> 9 gm/l
10. Willing to undergo breast core biopsies as required by the study protocol
11. Ability to understand and sign a written informed consent for participation in the trial
12. Life expectancy of at least 1 year.

Exclusion Criteria:

1. Known severe hypersensitivity to Iressa or any of the excipients of this product
2. Premenopausal status
3. Patients with synchronous bilateral breast cancer
4. Patients with diffuse tumors that cannot be clearly measurable, such as inflammatory breast cancer
5. Other coexisting malignancies with the exception of basal cell carcinoma or cervical cancer in situ
6. Patients with brain metastasis
7. WHO performance status of 3 or 4
8. As judged by the investigator, uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
9. Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the clinical trial.
10. Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St. John's wort
11. Concurrent treatment with estrogens or progestins. Patients must stop these drugs at least two weeks prior to study entry.
12. Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment
13. Platelet count less than 75,000
14. In the opinion of the investigator, bleeding diathesis or anticoagulation therapy that would preclude intramuscular injections.
15. History of hypersensitivity to castor oil
16. Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded).
17. Patients with recurrent breast cancer. Patients with contralateral second primary breast cancers are eligible.