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A Phase II Randomized Trial Of Gemcitabine Plus Paclitaxel And Gemcitabine Plus Docetaxel In Patients With Metastatic Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Breast Neoplasms

Thank you

Trial Information

A Phase II Randomized Trial Of Gemcitabine Plus Paclitaxel And Gemcitabine Plus Docetaxel In Patients With Metastatic Breast Cancer


Inclusion Criteria:



- Advanced or metastatic breast cancer

- Disease that can be measured by the physician or radiologic test.

- May have had one chemotherapy treatment for advanced or metastatic disease.

- Patients may have received any prior adjuvant chemotherapy, including taxane
containing regimens, provided this treatment was completed at least 6 months prior to
enrollment.

- Patients may have received prior hormone therapy or immunotherapy.

Exclusion Criteria:

- Patients with only non-measurable disease

- Cancer that has spread to the brain

- A patient who received a taxane with metastatic disease.

- Pregnancy

- Patients who received prior gemcitabine

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Estimate the response rate of two regimens separately.

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:

6966

NCT ID:

NCT00191672

Start Date:

December 2003

Completion Date:

November 2006

Related Keywords:

  • Breast Neoplasms
  • Breast Neoplasms
  • Neoplasms

Name

Location

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.Nashville, Tennessee  
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 - 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Katy, Texas