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A phase 3 trial of Fulvestrant in HR-positive / HER2-negative breast cancer, run by AstraZeneca, active and no longer recruiting.
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. is a phase 3 interventional study registered as NCT00099437 by AstraZeneca, with 736 participants enrolled, started 2005-02-13 and due to reach its primary completion in 2009-02-27. Interventions recorded: Fulvestrant. Results have been posted on the registry.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
736 enrolled.
range 0 to NA; Figures from the ClinicalTrials.gov results section (first posted 2010-06-15), not from a publication · range 0 to NA
Sourcerange 0.2 to NA; Figures from the ClinicalTrials.gov results section (first posted 2010-06-15), not from a publication · range 0.1 to NA
SourceFigures from the ClinicalTrials.gov results section (first posted 2010-06-15), not from a publication
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Time to Progression (TTP)primary | Fulvestrant 250 mg | 374 | 5.5 months | - | - | link |
| Fulvestrant 500 mg | 362 | 6.5 months | ||||
| Overall Survival (OS) | Fulvestrant 250 mg | 374 | 22.8 time (in months) | - | - | link |
| Fulvestrant 500 mg | 362 | 25.1 time (in months) | ||||
| Objective Response Rate (ORR) | Fulvestrant 250 mg | 261 | 14.6% | - | - | link |
| Fulvestrant 500 mg | 240 | 13.8% |
Shares Fulvestrant, Endocrine therapy (SERMs, AIs, SERDs) and the tag pipeline.
Shares Fulvestrant, Endocrine therapy (SERMs, AIs, SERDs) and the tag pipeline.
Shares Fulvestrant, Endocrine therapy (SERMs, AIs, SERDs), AstraZeneca, HR-positive / HER2-negative breast cancer and the tag pipeline.
Shares Fulvestrant, Endocrine therapy (SERMs, AIs, SERDs), AstraZeneca and the tag pipeline.
Shares Fulvestrant, Endocrine therapy (SERMs, AIs, SERDs), AstraZeneca and the tag pipeline.
Shares Fulvestrant, Endocrine therapy (SERMs, AIs, SERDs) and the tag pipeline.
Shares Fulvestrant, Endocrine therapy (SERMs, AIs, SERDs), AstraZeneca, HR-positive / HER2-negative breast cancer and the tag pipeline.
Shares AstraZeneca, HR-positive / HER2-negative breast cancer and the tag pipeline.