Study of Larotaxel in Combination With Weekly Herceptin® in Patients With HER2 Positive Metastatic Breast Cancer
Open Label, Uncontrolled, Study of XRP9881 (Larotaxel) in Combination With Weekly Trastuzumab (Herceptin®) in Patients With HER2 Positive Metastatic Breast Cancer (MBC)
2 other identifiers
interventional
6
1 country
1
Brief Summary
The purpose of this study is to evaluate the anti-tumor activity of the combination of experimental drug (larotaxel) when combined with Herceptin® in patients with advanced breast cancer. Anti-tumor activity will be determined by looking at changes in tumor size on CT or MRI scans. Additional goals of this study are to look at patient safety, to determine how long the study drugs (larotaxel and Herceptin®) stay in the patient's body and what effects the study medications may have on each other, and to find out how long patients remain cancer free on this study treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2006
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 12, 2006
CompletedFirst Posted
Study publicly available on registry
October 13, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedMay 5, 2016
April 1, 2016
1.4 years
October 12, 2006
April 6, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tumor response measured
every 2 cycles during treatment phase
Secondary Outcomes (1)
Progression Free Survival and Overall Survival
measured every 3 weeks during study treatment, then every 6 weeks after a patient has stopped the study treatment until the patient's cancer worsens, then every 3 months
Study Arms (1)
Larotaxel + Trastuzumab
EXPERIMENTALInterventions
administered as a 1-hour IV infusion on Day 1 of every 3 weeks (q3w)
administered as a 90-minute IV infusion on Day 1 of every week (qw)
Eligibility Criteria
You may qualify if:
- Diagnosis of breast cancer
- Evidence that cancer has spread beyond its original location or has come back and cannot be removed by surgery
- No more than one prior treatment for advanced disease
- Her2 positive status
- Adequate liver and kidney function
- No remaining severe harmful effects to prior treatments
You may not qualify if:
- Certain heart condition
- Pregnant Women
- History of another cancer except some skin cancers and cervical cancer
- Taking other treatments for your cancer at the time you enter the trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (1)
Sanofi-Aventis Administrative Office
Malvern, Pennsylvania, 19355, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Winer, MD
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2006
First Posted
October 13, 2006
Study Start
October 1, 2006
Primary Completion
March 1, 2008
Study Completion
March 1, 2008
Last Updated
May 5, 2016
Record last verified: 2016-04