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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00387907

Enrollment

Registered

2006-10-13

Start date

2006-10-31

Completion date

2008-03-31

Last updated

2016-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Breast Cancer, Breast Cancer, Metastatic Breast Cancer

Keywords

Herceptin, Taxane, Breast Cancer

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.

Interventions

DRUGlarotaxel (XRP9881)

administered as a 1-hour IV infusion on Day 1 of every 3 weeks (q3w)

DRUGtrastuzumab

administered as a 90-minute IV infusion on Day 1 of every week (qw)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Tumor response measured	every 2 cycles during treatment phase

Secondary

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026