XRP9881 in Combination With Trastuzumab in Metastatic Breast Cancer

Open Label, Uncontrolled Study of XRP9881 in Combination With Trastuzumab (Herceptin®) in Patients With HER2 Positive Metastatic Breast Cancer (MBC)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00386685

Enrollment

Registered

2006-10-11

Start date

2006-07-31

Completion date

2011-01-31

Last updated

2011-04-12

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

Conditions

Breast Neoplasms

Keywords

Cancer, Breast, metastatic breast cancer

Brief summary

The primary objective of the study is to assess the activity of XRP9881 in combination with trastuzumab. The secondary objectives are safety and pharmacokinetic interaction

Interventions

DRUGlarotaxel (XRP9881)

intravenous administration

DRUGtrastuzumab

intravenous administration

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Metastatic breast cancer (MBC) * HER2 (Human Epidermal Growth Factor Receptor 2) positive: FISH (Fluorescent In Situ Hybridization) positive or IHC (Immunohistochemistry) 3+ * Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) * Adequate organs functions

Exclusion criteria

* More than one previous chemotherapy regimen for metastatic disease * Cardiac dysfunction

Design outcomes

Primary

Measure	Time frame
Response rate (best overall response under treatment)	study period

Secondary

Measure	Time frame
Incidence of grade 3-4 toxicities, pharmacokinetic interaction	study period

Countries

Belgium, France, Sweden, Switzerland

Outcome results

None listed

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