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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
317
Strata 1: To compare the time to progression between 2 treatment arms (ZD1839/Nolvadex vs placebo/Nolvadex)
Time frame: Time to progression (progressive disease or death; equivalent to progression-free survival)
Strata 2: To compare the clinical benefit rate between 2 treatment arms (ZD1839/Nolvadex vs placebo/Nolvadex)
Time frame: Overall clinical benefit rate: Complete Response, Partial Response or Stable Disease > 24weeks after each combination
To compare the clinical benefit rate between 2 treatment arms (ZD1839/Nolvadex vs placebo/Nolvadex) in Strata 1 and overall
Time frame: Overall clinical benefit rate: Complete Response, Partial Response or Stable Disease >24 weeks after each combination. Objective tumour resp defined according to RECIST criteria
To compare time to progression between 2 treatment arms (ZD1839/Nolvadex vs placebo/Nolvadex) in Strata 2 and overall
Time frame: Time to progression (progressive disease or death)
To compare the objective response rate between ZD1839/Nolvadex and placebo/Nolvadex in each strata and overall
Time frame: Objective tumour response (OR) defined according to RECIST criteria
To estimate duration of response for the ZD1839/Nolvadex and placebo/Nolvadex treatments in each strata and overall
Time frame: Duration of response (CR and PR)
To compare overall survival between the ZD1839/Nolvadex and placebo/Nolvadex in each strata
Time frame: Overall survival
To assess whether patients with high tumour levels of HER-2 and/or AIB1 demonstrate de novo resistance to Nolvadex therapy or have shorter TTP or response duration when compared with Nolvadex/ZD1839 treatment
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Research Site
Berkeley, California, United States
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
...and 45 more locations
Time frame: Time to progression (progressive disease or death), duration of response (CR and PR)
To compare the objective response rate between the ZD1839/Nolvadex and placebo/Nolvadex treatment arms in the subset of all patients with ER+ tumours staining 2+/3+ for Her2neu by IHC
Time frame: Objective tumour response (OR) defined according to RECIST criteria
To compare the safety and tolerability of ZD1839/Nolvadex to placebo/Nolvadex
Time frame: Safety (frequency and severity of adverse events)
To determine steady-state plasma trough concentrations of tamoxifen in all patients and to compare between the ZD1839/Nolvadex and placebo/Nolvadex treatment arms
Time frame: Tamoxifen (Cmin) steady-state plasma concentration
To determine steady-state plasma trough concentrations of ZD1839 and relate values to historical data
Time frame: ZD1839 (Cmin) steady-state plasma concentration
To relate steady-state plasma trough concentrations of ZD1839 to demographic, response, and safety variables
Time frame: ZD1839 (Cmin) steady-state plasma concentration
To assess the quality of life (QOL) and symptom relief based on the Functional Assessment of Cancer Therapy - Breast (FACT-B) on both treatment arms
Time frame: FACT-B questionnaire, FBSI (FACT-B Symptom Index)
To investigate subject hospital resource use and health status
Time frame: Hospitalisations and EQ-5D
Characterization of specific adverse events
Time frame: Characterization of adverse events such as alopecia, rash and diarrhea
To obtain tumour tissue for biologic studies in this patient population
Time frame: ER receptor, ErbB-1 &2 (immunohistochemistry) and other biological markers including Her2/neu, AIB1