Phase 2
Completed N=143
A Clinical Trial to Compare Efficacy and Tolerability of Fulvestrant 250mg, 250mg (Plus 250mg Loading Regimen) and 500mg
Source: ClinicalTrials.gov NCT00305448 ↗Enrolled (actual)
143
Serious AEs
5.6%
Results posted
Aug 2011
Primary outcomePrimary: Objective Response Rate (ORR) — 11.1; 17.6; 10.6 percentage of participants
Summary
This study will assess the relationship between fulvestrant dose and efficacy, and determine the dosing regimen as a second line therapy for Japanese postmenopausal women with oestrogen receptor positive advanced breast cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) |
11.1; 17.6; 10.6 | — |
| SECONDARY Time to Progression (TTP) |
169; 211; 169 | — |
| SECONDARY Duration of Response (DoR) |
— | — |
| SECONDARY Clinical Benefit Rate (CBR) |
42.2; 54.9; 46.8 | — |
| SECONDARY Pharmacokinetic Parameter: Mean Population Clearance, a Measure of the Efficiency With Which Fulvestrant is Eliminated From the Body |
34.4 | — |
| SECONDARY Pharmacokinetic Parameter: Mean Volume of Distribution at Steady State, a Measure of the Apparent Volume in the Body Into Which Fulvestrant Distributes |
35300 | — |
Eligibility Criteria
Inclusion Criteria
- 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
- Postmenopausal women defined as a woman who has stopped having menstrual periods
Exclusion Criteria
- Treatment with more than one previous regimen of systemic anticancer therapy other than endocrine therapy for advanced breast cancer
- Treatment with more than one previous regimen of endocrine therapy for advanced breast cancer
- An existing serious disease, illness, or condition that will prevent participation or compliance with study procedures
Data sourced from ClinicalTrials.gov (NCT00305448). 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.