NCT00250874

Brief Summary

To study the pharmacokinetic profile of the therapeutic schedule in order to demonstrate absence of negative interactions among the 3 drugs administered

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

December 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 7, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 8, 2005

Completed
Last Updated

November 8, 2005

Status Verified

November 1, 2005

First QC Date

November 7, 2005

Last Update Submit

November 7, 2005

Conditions

Metastatic Breast Cancer

Interventions

Liposomal Doxorubicin (Myocet), Docetaxel and TrastuzumabDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HER-2/neu overexpression assessed by FISH test or with immunohistochemical methods: Dako(the result must be 3+ with dakotest); if the immunohistochemical test results 2+ it is needed a positive FISH test
  • Female \< 70yrs
  • Histologically or cytologically proven breast cancer.
  • Metastatic or locally advanced breast cancer (clinical stage: III-IV)
  • Adequate hematological, hepatic, renal and cardiac function, the latter confirmed by echocardiography with FEVS ≥50%
  • Prior adjuvant chemotherapy if doxorubicin total dose ≤300 mg/m2, epirubicin total dose ≤450 mg/m2

You may not qualify if:

  • History of cardiopathy
  • Severe hepatic and renal diseases
  • Brain metastases as the only parameter of disease
  • Contraindication to the use of corticosteroids as premedication
  • Acute infectious diseases
  • Insulin-dependent diabetes
  • History of other cancers except for adequately treated basal cell skin cancer or in situ carcinoma of the cervix
  • Concurrent treatment with any other cancer therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale Pietrantoni

Forlì, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

liposomal doxorubicinDoxorubicinDocetaxelTrastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicDiterpenesTerpenesAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Professor Amadori

    Ospedale Pietrantoni, Forli, Italy

    PRINCIPAL INVESTIGATOR

  • Professor Gasparini

    San Filippo Neri, Rome, Italy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Professor Amadori

CONTACT

+39 0543 731737segronco@ausl.fo.it

Professor Gasparini

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 7, 2005

First Posted

November 8, 2005

Study Start

December 1, 2003

Last Updated

November 8, 2005

Record last verified: 2005-11

Locations

IT(1)