NCT01206881

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Timeline
Completed

Started Mar 2009

Shorter than P25 for phase_2 breast-cancer

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2010

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

July 4, 2011

Status Verified

June 1, 2011

Enrollment Period

2.2 years

First QC Date

September 13, 2010

Last Update Submit

June 30, 2011

Conditions

Breast Cancer

Keywords

breast cancerneoadjuvantliposomal doxorubicinPET scan

Outcome Measures

Primary Outcomes (1)

  • clinical response rate

    evaluation of treatment efficacy every 2.cycle

    24 weeks

Secondary Outcomes (1)

  • pathological response rate, response rate as defined by PET-CT scan, mammography and ultrasound, evaluation of toxicity of the combination regimen

    up to 30 weeks

Interventions

pegylated liposomal doxorubicinDRUG

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

Also known as: cyclophosphamide, 4 cycles, docetaxel, 4 cycles, trastuzumab, 8 cycles

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • pathologically proven breast cancer
  • inflammatory, locally advanced breast cancer or a tumor \> 5 cm
  • ECOG performance status \< 2
  • LVEF \> 50% measured by MUGA (HER2 positive patients)
  • adequate bone marrow, liver and renal function
  • written informed consent must be obtained

You may not qualify if:

  • another malignancy within 5 years prior to study entry
  • concurrent treatment with an investigational agent
  • other disease or condition that contraindicates participation in the study
  • pregnant or lactating females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Herlev Hospital

Herlev, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (1)

  • Tuxen MK, Cold S, Tange UB, Balslev E, Nielsen DL. Phase II study of neoadjuvant pegylated liposomal doxorubicin and cyclophosphamide +/- trastuzumab followed by docetaxel in locally advanced breast cancer. Acta Oncol. 2014 Oct;53(10):1440-5. doi: 10.3109/0284186X.2014.921727. Epub 2014 Jul 3. No abstract available.

    PMID: 24991893DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

liposomal doxorubicinCyclophosphamideDocetaxelTrastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicDiterpenesTerpenesAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Malgorzata K Tuxen, MD

    Herlev Hospital, Department of Oncology

    PRINCIPAL INVESTIGATOR

  • Ulla B Tange, MD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

  • Soeren Cold, MD

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

  • Susanne B Søndergaard, MD

    Herlev Hospital

    PRINCIPAL INVESTIGATOR

  • Henrik Petersen, MD

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

  • Inger Hoejris, MD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

  • Anni Eskild-Jensen, MD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2010

First Posted

September 22, 2010

Study Start

March 1, 2009

Primary Completion

May 1, 2011

Study Completion

June 1, 2011

Last Updated

July 4, 2011

Record last verified: 2011-06

Locations

DK(4)