Know Cancer

or
forgot password

Combination Study of LY188011 and Paclitaxel in Patients With Metastatic/Recurrent Breast Cancer After Neo-adjuvant/Adjuvant Chemotherapy With Anthracycline


Phase 2
20 Years
74 Years
Not Enrolling
Female
Metastatic Breast Cancer

Thank you

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

Name

Location