Study of Larotaxel in Combination With Weekly Herceptin®... | NCT00387907

Studies
Study of Larotaxel in Combination With Weekly Herceptin® in Patients With HER2 Positive Metastatic Breast Cancer

NCT00387907

Sponsor

Sanofi

Status

Completed

Last Update Posted

May 5, 2016Estimated

Enrollment

6Actual

Phase

Phase 2

Conditions

Advanced Breast Cancer
Breast Cancer
Metastatic Breast Cancer

Interventions

larotaxel (XRP9881)
trastuzumab

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
XRP9881

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2006

Primary Completion Date

Mar 2008Actual

Completion Date

Mar 2008Actual

First Submitted Date

Oct 12, 2006

First Submission Date that Met QC Criteria

Oct 12, 2006

First Posted Date

Oct 13, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Apr 6, 2016

Certification/Extension First Submitted that Passed QC Review

Apr 6, 2016

Certification/Extension First Posted Date

May 5, 2016Estimated

Last Update Submitted Date

Apr 6, 2016

Last Update Posted Date

May 5, 2016Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Larotaxel + Trastuzumab	Experimental		Drug: larotaxel (XRP9881) Drug: trastuzumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
larotaxel (XRP9881)	Drug	administered as a 1-hour IV infusion on Day 1 of every 3 weeks (q3w)	Larotaxel + Trastuzumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Tumor response measured		every 2 cycles during treatment phase

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eric Winer, MD	Dana-Farber Cancer Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sanofi-Aventis Administrative Office		Malvern	Pennsylvania	19355	United States

Label	URL
Related Info	View source

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C531079	larotaxel
D000068878	Trastuzumab

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided