Phase II Neoadjuvant ER+/PgR + Arimidex +/- Iressa Study

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to compare the changes in a proliferation biomarker in subjects receiving Anastrozole or Anastrozole/ZD1839 combination.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Anastrozole; Gefitinib

Criteria

Inclusion Criteria:

• Measurable (stage I-IIIB) non meta static non inflammatory breast cancer

• Patients must post menopausal women who in the opinion of investigator would be likely to benefit from endocrine therapy. Postmenopausal patients are defined as:

• Natural menopause with last menses > 1 year ago,

• Radiation induced oophorectomy with last menses > 1 year ago,

• Serum FSH and LH levels clearly in the postmenopausal range for the institution.

• Bilateral oophorectomy

Exclusion Criteria:

• Other current or previous (to last 5 years) malignancies, other metastases, abnormal blood chemistry, lung/ heart/kidney/liver abnormalities,

• Hormonal treatment within the last 2 weeks, previous hormonal treatment for invasive cancer