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

Completed · Phase 2

Conditions studied: Breast Neoplasms

In brief

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.

Key facts

Study ID

NCT00229697

Run by

AstraZeneca

People needed

317

Starts

2003-10-01

Expected to finish

2015-06-01

Last updated by the study team

2015-10-05

Who can join

Age: 18 and older, up to 130. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Palm Springs, California, United States
• Research Site — St Louis, Missouri, United States
• Research Site — New York, New York, United States
• Research Site — Bahía Blanca, Argentina
• Research Site — Ciudad de Buenos Aires, Argentina
• Research Site — Córdoba, Argentina
• Research Site — El Palomar, Argentina
• Research Site — Resistencia, Argentina
• Research Site — Rosario, Argentina
• Research Site — San Miguel de Tucumán, Argentina
• Research Site — Santa Fe, Argentina
• Research Site — Vicente López, Argentina
• Research Site — Bentleigh East, Australia
• Research Site — Newcastle, Australia
• Research Site — Randwick, Australia
• Research Site — Westmead, Australia
• Research Site — Wodonga, Australia
• Research Site — Brussels, Belgium
• Research Site — Leuven, Belgium
• Research Site — Wilrijk, Belgium
• Research Site — Belo Horizonte, Brazil
• Research Site — Curitiba, Brazil
• Research Site — Porto Alegre, Brazil
• Research Site — São Paulo, Brazil
• Research Site — Berkeley, California, United States

Full record on ClinicalTrials.gov

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