A Randomized, Double-Blind, Phase 2 Trial of Fulvestrant Plus Enzastaurin versus Fulvestrant Plus Placebo in Aromatase Inhibitor-Resistant Metastatic Breast Cancer - ND

• Conditions: locally advanced or metastatic breast cancer; MedDRA version: 9.1Level: LLTClassification code 10006187Term: Breast cancer

• Registration Number: EUCTR2006-005305-58-IT
• Lead Sponsor: ELI LILLY

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-15
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 132

Inclusion Criteria

1)Female patients with a histological-documented diagnosis of locally advanced or metastatic breast cancer. The primary or metastatic tumor must be ER and/or PtR receptor positive.

Note: Hormone receptor positivity is defined as ER or PtR >10 fmol/mg by biochemical assay or 10% positive cells by immunohistochemistry

2)Patients are resistant to AI therapy

In the case of adjuvant therapy: patient should have been on treatment for at least 1 year and have had an objective recurrence during this treatment or in the first year after finishing it

In the case of treatment in advanced disease: patients must have achieved a tumor response or stabilization lasting at least 6 months and have had an objective progression after treatment

3)Females with postmenopausal status defined as:

?Age >= 60 years or age >= 45 years and 24 months from the last menstrual period with intact uterus

?(Or) follicle-stimulating hormone level within postmenopausal range

?(Or) prior radiation, medical or surgical castration (such as bilateral salpingo-oophorectomy)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1)Have received treatment with more than 1 line of hormonal therapy in the metastatic setting

2)Have had prior treatment with fulvestrant or enzastaurin

3)Have received chemotherapy for metastatic disease

4)Are HER2-positive

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the clinical benefit rate (CR+PR+SD for &#61619;24 weeks) between fulvestrant plus enzastaurin and fulvestrant plus placebo in AI-resistant MBC;Primary end point(s): clinical benefit rate (CR+PR+SD for &#61619;24 weeks) between fulvestrant plus enzastaurin and fulvestrant plus placebo in AI-resistant MBC.;Secondary Objective: ?to compare the following between the randomized treatment arms:<br><br><br><br>oresponse rates (RR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines (Therasse et al. 2000; Protocol Attachment S023.5) <br><br>oduration of clinical benefit <br><br>oprogression-free survival (PFS) <br><br>osafety and adverse event profile in both treatment arms using Common Terminology Criteria for Adverse Events (CTCAE; v3.0; NCI 2006)<br><br>?To assess biomarkers relevant to enzastaurin and the disease state, as well as their correlation to clinical outcome.