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Neoadjuvant Pegylated Liposomal Doxorubicin and Cyclophosphamide +/- Trastuzumab Followed by Docetaxel in Breast Cancer

NCT01206881 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2011-07-04

No results posted yet for this study

Summary

The purpose of this study is to determine the efficacy of neoadjuvant treatment with pegylated liposomal doxorubicin (Caelyx) and cyclophosphamide +/- trastuzumab followed by docetaxel in patients with locally advanced, inflammatory breast cancer or with a primary tumor \> 5 cm.

Conditions

Interventions

DRUG

pegylated liposomal doxorubicin

35 mg/m2, IV, day 1 every 21 days, 4 cycles

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Odense University Hospital

    collaborator OTHER

  • Aarhus University Hospital

    collaborator OTHER

  • Herlev Hospital

    lead OTHER

Principal Investigators

  • Malgorzata K Tuxen, MD · Herlev Hospital, Department of Oncology

  • Ulla B Tange, MD · Rigshospitalet, Denmark

  • Soeren Cold, MD · Odense University Hospital

  • Susanne B Søndergaard, MD · Herlev Hospital

  • Henrik Petersen, MD · Odense University Hospital

  • Inger Hoejris, MD · Aarhus University Hospital

  • Anni Eskild-Jensen, MD · Aarhus University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2011-05-31
Completion
2011-06-30

Countries

  • Denmark

Study Locations

More Related Trials

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 NCT01206881 on ClinicalTrials.gov