None listed
Conditions
Interventions
ANZ 0201 (TIBER) is a multicentre, open label, non-comparative, two arm phase II trial of ZD 1839 (Iressa TM) 500mg (two 250mg tablets) orally once daily, in two separate patient groups. Treatment will be administered continuously until clinical or radiological evidence of disease progression, unacceptable toxicity or withdrawal of consent.
Sponsors
AstraZeneca Australia
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Histologically or cytologically confirmed metastatic or inoperable locally advanced breast cancer in one of the following groups:1. Hormone receptor negative (ER and PgR) breast cancer.2. Hormone receptor positive (ER and/or PgR) disease progressing after at least two previous hormonal treatments (tamoxifen and an aromatase inhibitor)Patients must not have had more than one previous chemotherapy regimen for advanced disease; patients must have at least one measurable lesion as defined by RECIST criteria.
Exclusion criteria
Disease progression within 6 months of completion of adjuvant chemotherapy; last dose of systemic anticancer therapy within 21 days before the start of ZD 1839 treatment; newly diagnosed intracerebral metastases; other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ.
Outcome results
None listed