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Primary Chemotherapy in Patients With HER2-positive Early Breast Cancer

NCT01172223 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2016-11-02

No results posted yet for this study

Summary

Open-label, multicenter phase I/II trial. Patients with HER2-positive (overexpressing or amplified), invasive breast cancer with T1c N1-2 or T2 N0-2 disease will be treated with

* Non-pegylated liposomal doxorubicin (NPLD; Myocet, 60 mg/m\^2 i.v. day 1 q3 weeks),
* Paclitaxel (175 mg/m\^2 i.v. day 1 q3 weeks), and
* Lapatinib (GW572016, Tykerb, 750-1500 mg/d orally daily until the day of the definitive surgery) Treatment is planned for 6 cycles unless there is evidence of unacceptable toxicity, disease progression or inadequate efficacy (defined as a decrease in tumor size \<25% after 4 courses measured by ultrasound or MR-mammography), or if the patient requested to be released.

Conditions

Interventions

DRUG

Myocet (Non-pegylated liposomal doxorubicin (NPLD))

60 mg/m\^2 i.v. day 1 q3 weeks

DRUG

Paclitaxel

175 mg/m\^2 i.v. day 1 q3 weeks

DRUG

Lapatinib (GW572016, Tykerb)

750-1500 mg/d orally daily until the day of the definitive surgery

Sponsors & Collaborators

  • Prof Dirk Elling

    lead OTHER

Principal Investigators

  • Dirk Elling · Sana Klinikum Lichtenberg, Berlin

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2013-01-31
Completion
2013-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
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 NCT01172223 on ClinicalTrials.gov