Breast Cancer, Metastasis
Conditions
Keywords
Locally advanced breast cancer or metastatic breast cancer
Brief summary
The purpose of this study is to compare the efficacy of Faslodex (fulvestrant) to Nolvadex (tamoxifen) as first-line treatment for postmenopausal women with advanced breast cancer. Patients will be treated until disease progression or until the investigator has determined that treatment is not in the best interest of the patient, whichever occurs first.
Interventions
DRUGFulvestrant
intramuscular injection 250 mg
DRUGTamoxifen
20 mg oral tablet
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Biopsy confirmation of breast cancer. Evidence of breast cancer that is not considered amenable to curative treatment. Postmenopausal women. Written informed consent to participate in the study.
Exclusion criteria
* Previous treatment with hormonal therapy unless that therapy was tamoxifen for adjuvant breast cancer. The use of tamoxifen must have ceased at least one year before this study. Previous treatment with Faslodex. Any existing serious disease, illness, or condition that will prevent participation or compliance with the study procedures. Treatment with an investigational or non-approved drug within one month of then start of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to disease progression (TTP) | At the time of data cut-off for this trial, the median overall duration of follow-up was 441 days, with a total of 434 (73.9%) randomised patients, including 47 patients from Japanese centres having progressed. | It is considered that these results indicate that adequate data were available for obtaining clinically meaningful information for the primary efficacy endpoint of time to disease progression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | At the time of data cut-off for this trial, the median overall duration of follow-up was 441 days, with a total of 434 (73.9%) randomised patients, including 47 patients from Japanese centres having progressed. | It is considered that these results indicate that adequate data were available for obtaining clinically meaningful information for the primary efficacy endpoint of time to disease progression |
| Duration of response (DoR) | At the time of data cut-off for this trial, the median overall duration of follow-up was 441 days, with a total of 434 (73.9%) randomised patients, including 47 patients from Japanese centres having progressed. | — |
| Time to treatment failure (TTF) | At the time of data cut-off for this trial, the median overall duration of follow-up was 441 days, with a total of 434 (73.9%) randomised patients, including 47 patients from Japanese centres having progressed. | — |
| Overall survival (OS) | At the time of data cut-off for this trial, the median overall duration of follow-up was 441 days, with a total of 434 (73.9%) randomised patients, including 47 patients from Japanese centres having progressed. | — |
| Quality of Life (QOL) and Tolerability. | At the time of data cut-off for this trial, the median overall duration of follow-up was 441 days, with a total of 434 (73.9%) randomised patients, including 47 patients from Japanese centres having progressed. | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Finland, France, Germany, Hungary, Ireland, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Poland, Portugal, Russia, South Africa, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States
Outcome results
None listed