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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Compare clinical benefit rate (CR+PR+SD for greater than or equal to 24 weeks)between fulvestrant plus enzastaurin and fulvestrant plus placebo in aromatase inhibitor resistant metastatic breast cancer

Outcome Time Frame:

baseline to measured progressive disease

Safety Issue:

No

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

10736

NCT ID:

NCT00451555

Start Date:

March 2007

Completion Date:

December 2013

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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