Phase 3
Completed N=221
Comparing the Efficacy and Tolerability of Fulvestrant 500 mg Versus 250 mg in Advanced Breast Cancer Women
Source: ClinicalTrials.gov NCT01300351 ↗Enrolled (actual)
221
Serious AEs
5.9%
Results posted
Apr 2015
Primary outcomePrimary: Progression-free Survival — 8.0; 4.0 months — p=0.078
Summary
The purpose of this study is to evaluate the efficacy of a new dose of 500mg Fulvestrant with the standard dose of 250mg in Chinese postmenopausal women with oestrogen receptor positive advanced breast cancer who have failed a prior endocrine treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival |
8.0; 4.0 | 0.078 |
| SECONDARY Objective Response Rate |
16; 11 | 0.107 |
| SECONDARY Clinical Benefit Rate |
53; 36 | 0.023 sig |
| SECONDARY Duration of Response |
16.6; 22.2 | — |
| SECONDARY Duration of Clinical Benefit |
14.3; 13.8 | — |
Eligibility Criteria
Inclusion Criteria
- Postmenopausal women defined as a woman who has stopped having menstrual periods
- Breast Cancer has continued to grow after having received treatment with an anti-estrogen hormonal treatment such as tamoxifen or an aromatase inhibitor
- Requiring hormonal treatment
- Oestrogen-receptor positive tumour
- Written informed consent to participate in the trial
Exclusion Criteria
- Treatment with an investigational or non-approved drug within one month
- An existing serious disease, illness, or condition that will prevent participation or compliance with study procedures
- A history of allergies to any active or inactive ingredients of fulvestrant (i.e. castor oil)
- Treatment with more than one regimen of chemotherapy for advanced breast cancer
- Treatment with more than one regimen of hormonal treatment for advanced breast cancer
Data sourced from ClinicalTrials.gov (NCT01300351). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.