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Comparison of Fulvestrant (FASLODEX™) 250 mg and 500 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy.
Phase 3 trial testing Fulvestrant in Breast Cancer in 736 participants. Participants enrolled and being followed up; not accepting new ones.
| Lead sponsor | AstraZeneca |
|---|---|
| Phase | Phase 3 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 736 |
| Start date | 13 February 2005 |
| Primary completion | 27 February 2009 |
| Estimated completion | 31 December 2026 |
| Sites | 106 locations across Italy, Colombia, Slovakia, Russia, Ukraine, India, Belgium, Chile |
AstraZeneca — full company profile →
Adults 45 to 130, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Median time (in months) from randomisation until objective disease progression or death (in the absence of objective progression).
| Group | Value | 95% CI |
|---|---|---|
| Fulvestrant 250 mg | 5.5 | 0 – NA |
| Fulvestrant 500 mg | 6.5 | 0 – NA |
Using the RECIST scan data, an objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR) which is subsequently confirmed as per RECIST. ORR is defined as the percentage of patients with OR.
| Group | Value | 95% CI |
|---|---|---|
| Fulvestrant 250 mg | 14.6 | |
| Fulvestrant 500 mg | 13.8 |
A Clinical Benefit (CB) responder is defined as a patient having a best overall response of CR, PR or SD (stable disease) \>=24 weeks. The Clinical Benefit Rate is the percentage of patients with CB.
| Group | Value | 95% CI |
|---|---|---|
| Fulvestrant 250 mg | 39.6 | |
| Fulvestrant 500 mg | 45.6 |
Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieve a confirmed complete response (CR) or confirmed partial response (PR)
| Group | Value | 95% CI |
|---|---|---|
| Fulvestrant 250 mg | 16.4 | 3.7 – NA |
| Fulvestrant 500 mg | 19.4 | 5.7 – NA |
Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieve a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) \>=24 weeks
| Group | Value | 95% CI |
|---|---|---|
| Fulvestrant 250 mg | 13.9 | 3.7 – NA |
| Fulvestrant 500 mg | 16.6 | 2.5 – NA |
Median time (in months) from randomisation until death (from any cause) (analysis at 50% deaths )
| Group | Value | 95% CI |
|---|---|---|
| Fulvestrant 250 mg | 22.8 | 0.2 – NA |
| Fulvestrant 500 mg | 25.1 | 0.1 – NA |
Mean (and standard deviation) change from randomisation until treatment discontinuation in TOI (defined as the first visit response of 'worsened' which is a decrease in TOI from baseline of 5 points or more) using the Kaplan-Meier method. If a subject has not shown a reduction of 5 points or more at the time of analysis then the observation will be right censored using the last QOL assessment date. Trial Outcome Index (TOI) is derived from the FACT-B questionnaire (Cella et al, 1993) by adding together the scores from the following 3 subscales; Physical well-being (PWB), Functional well-being
| Group | Value | 95% CI |
|---|---|---|
| Fulvestrant 250 mg | -5.9 | ± 9.89 |
| Fulvestrant 500 mg | -7.5 | ± 13.72 |
Overall Survival is equivalent to time to death. For this endpoint, all deaths occurring during the study as a whole until the data cut-off for the survival extension (31st October 2011) are presented (analysis at 75% deaths)
| Group | Value | 95% CI |
|---|---|---|
| Fulvestrant 250 mg | 22.3 | 0.2 – NA |
| Fulvestrant 500 mg | 26.4 | 0.1 – NA |
Time frame: SAE- From baseline up to October 31st 2011; AE- From baseline up to 28th February 2009. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Fulvestrant 250 mg | Fulvestrant 500 mg |
|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Acute Myocardial Infarction | Cardiac disorders | — | — |
| Bronchitis | Infections and infestations | — | — |
| Pneumonia | Infections and infestations | — | — |
| Femur Fracture | Injury, poisoning and procedural complications | — | — |
| Hyperglycaemia | Metabolism and nutrition disorders | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — |
| Neutropenia | Blood and lymphatic system disorders | — | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — | — |
| Febrile Neutropenia | Blood and lymphatic system disorders | — | — |
| Cardiopulmonary Failure | Cardiac disorders | — | — |
| Myocardial Ischaemia | Cardiac disorders | — | — |
| Abdominal Pain | Gastrointestinal disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Duodenal Ulcer Perforation | Gastrointestinal disorders | — | — |
| Peritonitis | Gastrointestinal disorders | — | — |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | — | — |
| Adverse Drug Reaction | General disorders | — | — |
| Death | General disorders | — | — |
| General Physical Health Deterioration | General disorders | — | — |
| Pyrexia | General disorders | — | — |
| Hyperbilirubinaemia | Hepatobiliary disorders | — | — |
| Bronchopneumonia | Infections and infestations | — | — |
| Urinary Tract Infection | Infections and infestations | — | — |
| Reaction | System | Fulvestrant 250 mg | Fulvestrant 500 mg |
|---|---|---|---|
| Nausea | Gastrointestinal disorders | — | — |
| Injection Site Pain | Gastrointestinal disorders | — | — |
| Back Pain | Musculoskeletal and connective tissue disorders | — | — |
| Bone Pain | Musculoskeletal and connective tissue disorders | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Fatigue | Gastrointestinal disorders | — | — |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | — | — |
| Hot Flush | Vascular disorders | — | — |
| Asthenia | Gastrointestinal disorders | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
Most-reported serious reactions: Anaemia, Vomiting, Acute Myocardial Infarction, Bronchitis, Pneumonia, Femur Fracture, Hyperglycaemia, Dyspnoea.
Data from ClinicalTrials.gov NCT00099437 adverse events section.
The purpose of this study is to evaluate the efficacy of a new dose of 500 mg Fulvestrant with the standard dose of 250 mg in postmenopausal women with oestrogen receptor positive advanced breast cancer who have failed on a previous endocrine treatment.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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