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Trial of Neoadjuvant EndoTAG-1 in Combination With Paclitaxel in HER2-negative Breast Cancer

NCT01537536 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2013-06-17

No results posted yet for this study

Summary

The study hypothesis is that the new drug EndoTAG-1 will improve tumor volume reduction as measured by Magnetic Resonance Imaging when added to a standard chemotherapy regimen of weekly paclitaxel. This is a prospective single-center study that will investigate the activity of EndoTAG-1 + paclitaxel combination therapy in patients with HER2-negative breast cancer that are candidate for receiving chemotherapy before surgery (neoadjuvant chemotherapy).

Conditions

Interventions

DRUG

EndoTAG-1

EndoTAG-1 (22 mg/m2 liposomal paclitaxel) + Paclitaxel (70 mg/m2) Weekly i.v. infusions of EndoTAG-1 and paclitaxel for 12 weeks followed by subsequent treatment with the standard FEC regimen (Fluorouracil 500 mg/m2, Epirubicin 100 mg/m2, Cyclophosphamide 500 mg/m2) once every 3 weeks for 3 cycles of therapy followed by surgery.

Sponsors & Collaborators

  • Jules Bordet Institute

    lead OTHER

Principal Investigators

  • Michail Ignatiadis, MD, PhD · Jules Bordet Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-09-30
Completion
2012-11-30

Countries

  • Belgium

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01537536 on ClinicalTrials.gov