Enzastaurin Plus Fulvestrant vs. Placebo Plus Fulvestrant in Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00451555
First received: March 21, 2007
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Breast Cancer
Drug: enzastaurin
Drug: placebo
Drug: fulvestrant
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rates [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Duration of clinical benefit [ Time Frame: time of clinical benefit to progressive disease ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Safety and adverse event profile [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
  • Assess biomarkers relevant to enzastaurin and the disease state as well as their correlation to clinical outcome [ Time Frame: baseline, cycle 2, end of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: March 2007
Estimated Study Completion Date: June 2014
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Enzastaurin/Fulvestrant Drug: enzastaurin
1125 mg loading dose then 250 mg, oral, twice daily (for a total of 500 mg), until disease progression
Other Name: LY317615
Drug: fulvestrant
500 mg, IM, day 1, 1250 mg, IM, day 15 cycle 1 then 250 mg, IM, q 28 days, until disease progression
Placebo Comparator: Placebo/Fulvestrant Drug: placebo
oral, daily
Drug: fulvestrant
500 mg, IM, day 1, 1250 mg, IM, day 15 cycle 1 then 250 mg, IM, q 28 days, until disease progression

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00451555

Locations
France
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Besancon, France, 25030
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Paris, France, 75231
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Saint Herblain, France, 44805
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Toulouse, France, 31052
Germany
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bielefeld, Germany, 33604
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Dresden, Germany, 01127
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Guetersloh, Germany, 33332
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Kiel, Germany, D-24105
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Mannheim, Germany, 68161
Italy
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Meldola, Italy, 47014
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Milano, Italy, 20133
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Modena, Italy, 41100
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Rome, Italy, 00144
Netherlands
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Amsterdam, Netherlands, 1066 CX
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Den Haag, Netherlands, 2545 CH
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Groningen, Netherlands, 9728 NT
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Maastricht, Netherlands, 6229 HX
Spain
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Barcelona, Spain, 08036
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Lleida, Spain, 25198
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Madrid, Spain, 28033
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Valencia, Spain, 46010
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company
  More Information

Additional Information:
No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00451555     History of Changes
Other Study ID Numbers: 10736, H6Q-MC-S023
Study First Received: March 21, 2007
Last Updated: November 7, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
France: Institutional Ethical Committee
Italy: Ministry of Health
Netherlands: Independent Ethics Committee
Spain: Ministry of Health
United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Estradiol
Aromatase Inhibitors
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Estrogens
Hormones
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014