A Randomized, Double-Blind, Phase II Trial of Fulvestrant Plus Enzastaurin Versus Fulvestrant Plus Placebo in Aromatase Inhibitor-Resistant Metastatic Breast Cancer
Inclusion Criteria:
- 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 greater than 10 fmol/mg by
biochemical assay or 10% positive cells by immunohistochemistry
- Patients are resistant to AI therapy
- Females with postmenopausal status
- Previous radiation therapy is allowed, but should have been limited
- Measurable or non-measurable disease
- Have a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group
(ECOG) scale
- Have adequate organ function
- Have an estimated life expectancy of at least 24 weeks
- Must sign an informed consent document
Exclusion Criteria:
- Have had prior treatment with fulvestrant or enzastaurin
- Are receiving concurrent administration of any other antitumor therapy, with the
exception of gonadotropin-releasing hormone (GnRH) antagonists.
- Have received treatment within the last 4 weeks with a drug that has not received
regulatory approval for any indication at the time of study entry
- Have received supplemental estrogen or progesterone within 4 weeks prior to study
entry
- Are HER2-positive
- Are unable to discontinue use of anticoagulants
- Have hypercalcemia
- Have a second primary malignancy that is clinically detectable at the time of
consideration for study enrollment
- Have documented central nervous system (CNS) metastases, symptomatic pulmonary
lymphangitis, or involvement of more than 1/3 of the liver
- Have a serious concomitant systemic disorder
- Have a serious cardiac condition
- Are unwilling or unable to discontinue use of carbamazepine, phenobarbital, or
phenytoin at least 14 days prior to study therapy
- Are unable to swallow tablets.