A Randomized, Double-Blind, Phase 2 Trial of Fulvestrant Plus Enzastaurin versus Fulvestrant Plus Placebo in Aromatase Inhibitor-Resistant Metastatic Breast Cancer - N/A
- Conditions
- metastatic breast cancer, resistant to aromatase inhibitorsMedDRA version: 8.1 Level: LLT Classification code 10027475 Term: Metastatic breast cancer
- Registration Number
- EUCTR2006-005305-58-NL
- Lead Sponsor
- Eli Lilly and Company limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 152
[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
•AI was administered in the adjuvant setting: 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
•AI was administered in advanced disease:
?If patients have not received previous chemotherapy for MBC, they must have achieved a tumor response or stabilization lasting at least 6 months and have had an objective progression during treatment
?If patients have received previous chemotherapy for MBC, they can have 3 different situations :
•Chemotherapy ? AI (as maintenance of response).
They must have received the AI lasting at least 6 months and have had an objective progression during treatment
•Chemotherapy ? AI (at progression).
They must have achieved a tumor response or stabilization lasting at least 6 months and have had an objective progression during treatment
•AI ? Chemotherapy.
They must have achieved a tumor response or stabilization to the AI and have had an objective progression after chemotherapy.
[5]Measurable or nonmeasurable disease defined by:
•At least 1 unidimensionally measurable lesion meeting RECIST (Protocol Attachment S023.5; Therasse et al. 2000) Guidelines. Positron emission tomography (PET) scans and ultrasounds may not be used
•At least 1 nonmeasurable lesion whose presence is assessable using standard techniques or a spiral CT scan even though the lesion is smaller than the minimum size required for measurability (PET scans and ultrasounds may not be used). Patients with bone lesion(s) in the absence of measurable disease can be recruited provided they can be evaluated by X-ray, CT or MRI (patients with lesions assessed only by bone scan cannot be included)
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
[13]Have received treatment with more than 1 line of hormonal therapy in the metastatic setting
[14]Have had prior treatment with fulvestrant, or enzastaurin
[30]Patients with osteoporosis, defined as bone mineral density (BMD)
T score <2.5 SD (standard deviation) or receiving treatment for osteoporosis. Note: Patients with BMD T score between 1 to 2.5 are defined as osteopenia, which, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient’s ability to complete the study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method