Combination Chemotherapy of Gemcitabine and Paclitaxel for Metastatic Breast Cancer - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 6, 2006

Last Updated Date

January 20, 2009

Start Date ^†

June 2006

Current Primary Outcome Measures ^†

Response Rate [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00334802 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Duration of response [ Time Frame: time of response to progressive disease ] [ Designated as safety issue: No ]
Time to progressive disease [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
Median survival and 1 and 2 year survival [ Time Frame: baseline to date of death from any cause, evaluated at 1 year and 2 years ] [ Designated as safety issue: Yes ]
Adverse events [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
Pharmacokinetics [ Time Frame: cycle 1, day 1 and 8 ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^†

Time to PD
Overall Survival

Descriptive Information

Brief Title ^†

Combination Chemotherapy of Gemcitabine and Paclitaxel for Metastatic Breast Cancer

Official Title ^†

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

Brief Summary

To investigate efficacy, safety and PK of gemcitabine and paclitaxel combination in patients with metastatic breast cancer after adjuvant/neo-adjuvant chemotherapy with anthracycline regimen

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Metastatic Breast Cancer

Intervention ^†

Drug: gemcitabine
Drug: paclitaxel

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Estimated Completion Date

August 2009

Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

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
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)

Gender

Female

Ages

20 Years to 74 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Japan

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00334802

Responsible Party

Chief Medical Officer, Eli Lilly

Secondary IDs ^††

B9E-JE-MB22

Study Sponsor ^†

Eli Lilly and Company

Collaborators ^††

Investigators ^†

Study Director:

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)

Eli Lilly and Company

Information Provided By

Eli Lilly and Company

Verification Date

January 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.