Enzastaurin Plus Fulvestrant vs. Placebo Plus Fulvestrant in Breast Cancer

• Status: Completed
• Trial end date: 2018-10-18
• Target enrollment: 0
• Participant gender: Female

Summary

The primary purpose of this study is to help answer the following research question: whether enzastaurin given together with fulvestrant can help participants who have breast cancer and make the tumor smaller or disappear and for how long.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Estradiol; Fulvestrant

Criteria

Inclusion Criteria:

• Female participants with a histological-documented diagnosis of locally advanced or metastatic breast cancer. The primary or metastatic tumor must be estrogen response (ER) and/or parathyroid hormone receptor (PtR) 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

• Participants are resistant to aromatase inhibitors (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 hormone estrogen receptor (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.