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Phase II Study of Gemcitabine and Trastuzumab Therapy in Patients With HER2 Overexpressing Metastatic Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Neoplasms, Cancer of the Breast, Breast Cancer

Thank you

Trial Information

Phase II Study of Gemcitabine and Trastuzumab Therapy in Patients With HER2 Overexpressing Metastatic Breast Cancer


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:

- Patients who have had prior gemcitabine chemotherapy and adjuvant trastuzumab and had
less than 12- month disease free interval

- Patients with known leptomeningeal carcinomatosis

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

- Overall response rates

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:

United States: Food and Drug Administration

Study ID:

6133

NCT ID:

NCT00191373

Start Date:

March 2002

Completion Date:

July 2007

Related Keywords:

  • Breast Neoplasms
  • Cancer of the Breast
  • Breast Cancer
  • Breast Neoplasms
  • Neoplasms

Name

Location

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
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
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  
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
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
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
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
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
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  
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