Trial Information
Combination Study of LY188011 and Paclitaxel in Patients With Metastatic/Recurrent Breast Cancer After Neo-adjuvant/Adjuvant Chemotherapy With Anthracycline
Inclusion Criteria:
- Histologically and/or cytologically confirmed breast cancer
- Received adjuvant/neo-adjuvant chemotherapy for breast cancer with anthracycline
regimen
- To have at least one measurable region
- Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
- To have adequate organ function (bone marrow, liver and renal function)
Exclusion Criteria:
- To have interstitial pneumonia or pulmonary fibrosis
- To have inflammatory breast cancer
- Within 28 days after the latest chemotherapy or radiotherapy, 14 days after the
latest hormonal/immunotherapy or 7 days after surgery
- To have brain metastases with symptoms
- To have severe complication (cardiac infarction, infection, drug hypersensitivity or
diabetes)
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Tumor Response
Outcome Description:
Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment. Responders are patients with complete response or partial response.
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:
Japan: Ministry of Health, Labor and Welfare
Study ID:
9066
NCT ID:
NCT00334802
Start Date:
June 2006
Completion Date:
March 2010
Related Keywords:
- Metastatic Breast Cancer
- Breast Neoplasms
