Clinical trial · Interventional
A Trial Comparing the Efficacy and Tolerability of Faslodex With Nolvadex in Postmenopausal Women With Advanced Breast Cancer
A Double-blind, Randomized, Multicentre Trial Comparing the Efficacy and Tolerability of 250mg of Faslodex (Long Acting ICI 182,780) With 20mg of Nolvadex (Tamoxifen) in Postmenopausal Women With Advanced Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Metastasis | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fulvestrant | Drug | Fulvestrant | ALIAS |
| Tamoxifen | Drug | Tamoxifen | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Tamoxifen
- interventionNames
- Drug: Tamoxifen
- type
- EXPERIMENTAL
- label
- 2
- description
- Fulvestrant
- interventionNames
- Drug: Fulvestrant
Primary outcomes (1)
- measure
- Time to disease progression (TTP)
- timeFrame
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available