Phase 2
Completed N=144
A Clinical Trial to Compare Efficacy and Tolerability of Fulvestrant 250mg, 250mg Plus 250mg Loading Regimen and 500mg
Source: ClinicalTrials.gov NCT00313170 ↗Enrolled (actual)
144
Serious AEs
11.9%
Results posted
Aug 2011
Primary outcomePrimary: Objective Response (ORR) — 8.5; 5.9; 15.2 Percentage of patients
Summary
This study will assess the relationship between fulvestrant dose and efficacy in postmenopausal women with oestrogen receptor positive advanced breast cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response (ORR) |
8.5; 5.9; 15.2 | — |
| SECONDARY Time to Progression (TTP) |
88; 172; 169 | — |
| SECONDARY Duration of Response (DoR) |
NA; NA; 539 | — |
| SECONDARY Clinical Benefit Rate (CBR) |
31.9; 47.1; 47.8 | — |
| SECONDARY Pharmacokinetic Parameter: Mean Population Clearance, a Measure of the Efficiency With Which Fulvestrant is Eliminated From the Body |
31 | — |
| SECONDARY Pharmacokinetic Parameter: Mean Volume of Distribution at Steady State, a Measure of the Apparent Volume in the Body Into Which Fulvestrant Distributes |
20600; 35700 | — |
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 (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 BC.
- Treatment with more than one previous regimen of endocrine therapy for advanced BC.
- An existing condition that prevents compliance.
Data sourced from ClinicalTrials.gov (NCT00313170). 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.