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CompletedNCT00191373Updated Sep 12, 2007

A Trial for HER2 Positive Breast Cancer Patients With Metastatic Disease

A Phase 2 interventional study of Gemcitabine and Trastuzumab in Breast Neoplasms, Cancer of the Breast and Breast Cancer, sponsored by Eli Lilly and Company. Completed at 13 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-09-12.

Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
66
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
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Study summary

This phase II trial that includes Gemcitabine 1,250mg/m2 to be administered over approximately 30 minutes on days 1 and 8, every 21 days and Trastuzumab 8 mg/kg IV to be administered over 90 minutes on day 1 of the first cycle, then 6mg/kg as a 30 minute infusion administered on subsequent cycles.

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Conditions studied

  • Breast Neoplasms
  • Cancer of the Breast
  • Breast Cancer

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03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 66 is close to the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Patients must have histologically or cytologically confirmed invasive breast cancer, with stage IV disease
  • Tumors tested by IHC must be 3+ positive for HER2 overexpression. Tumors tested by FISH must be positive by the specific FISH assay for genetic amplification of HER2. Tumors that are 3+ by IHC but negative by FISH assay are ineligible
  • Patients must have measurable disease
  • Patients may NOT have received prior chemotherapy or prior trastuzumab therapy for metastatic breast cancer.
  • Patients may have received prior chemotherapy and/or hormonal therapy for early stage breast cancer, including taxane-based chemotherapy regimens. Patients may NOT have received trastuzumab in the adjuvant setting unless disease free interval from completion of trastuzumab to time of relapse is greater than 12 months.

Exclusion criteria

Exclusion Criteria:

  • Patients who have had prior gemcitabine chemotherapy and adjuvant trastuzumab and had less than 12- month disease free interval
  • Patients with known leptomeningeal carcinomatosis
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
66 participants

Interventions

  • DrugGemcitabine
  • DrugTrastuzumab
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What researchers measure

Primary outcomes

  1. - Overall response rates

Secondary outcomes

  1. Time to disease progression,Time to treatment failure, Overall survival, Toxicity of the combination

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Study locations

13 sites
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Hot Springs, Arkansas 71913, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Pine Bluff, Arkansas 71603, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Redding, California 96001, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CT-LILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Hollywood, Florida, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Plantation, Florida 33324, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Baltimore, Maryland 21201, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Voorhees, New Jersey 08043, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Philadelphia, Pennsylvania 19141, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Pittsburgh, Pennsylvania 15213, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Knoxville, Tennessee 37920, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CT-LILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Logan, Utah, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CT-LILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Ogden, Utah, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Morgantown, West Virginia 26506, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 12, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00191373
Lead sponsor
Eli Lilly and Company
First posted
Sep 19, 2005
Start date
Mar 2002
Completion
Jul 2007
Last update
Sep 12, 2007

Study contacts

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)
study director · Eli Lilly and Company
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2007. You cannot join it, but the record below documents what was studied.

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