Phase II Metastatic ER+/PgR+ Nolvadex +/- Iressa Study

AstraZeneca

Status and phase

Completed

Phase 2

Conditions

Breast Neoplasms

Treatments

Drug: Tamoxifen

Drug: Gefitinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT00229697

D7917C00225

1839IL/0225

Details and patient eligibility

About

This study is being carried out to see if ZD1839 is effective in treating metastatic breast cancer in combination with Nolvadex, and if so, how it compares with Nolvadex alone.

Enrollment

317 patients

Sex

Female

Ages

18 to 130 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically confirmed metastatic adenocarcinoma of the breast (seeTNM staging Appendix I) that is ER and/or PR positive as determined in local laboratories at each investigator site (central verification of ER status will be performed after the patient starts treatment
A tissue block from either the metastatic or primary tumor site is required.
WHO performance status (PS) 0-2
Patients must not be pregnant or breast-feeding. A negative pregnancy test is required within 7 days prior to randomization if pre- or peri-menopausal. Postmenopausal patients are defined as:
natural menopause with last menses > 1 year ago,
radiation induced oophorectomy with last menses > 1 year ago,
chemotherapy induced menopause with 1 year interval since last menses, or
serum FSH and LH and plasma estradiol levels in the postmenopausal range for the institution.
bilateral oophorectomy

Exclusion criteria

Patients cannot be on hormone replacement therapy or received prior chemotherapy for metastatic disease.
Patients previously treated with a Tyrosine Kinase inhibitor or have evidence of an active interstitial lung disease are not eligible.
Treatment with LH-RH analog.
Laboratory values as follow Bilirubin >1.5 times upper limit of normal ULN, alanine amino transferase (ALT) or aspartate amino transferase (AST) >2.5 times the ULN if no demonstrable liver metastases, or >5 times the ULN in the presence of liver metastases
Bone marrow function: WBC <1500 mm3