NCT00289263

Brief Summary

This is a randomized, prospective and multicenter phase III study. Two-hundred-sixty-two (262) patients on each arm will be recruited in the study.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
524

participants targeted

Target at P50-P75 for phase_3 breast-cancer

Timeline
Completed

Started Apr 1998

Geographic Reach
1 country

7 active sites

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

April 1, 1998

Completed
5.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2003

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 9, 2006

Completed
Last Updated

February 9, 2006

Status Verified

November 1, 2003

First QC Date

February 8, 2006

Last Update Submit

February 8, 2006

Conditions

Breast Cancer

Keywords

metastatic breast cancermaintenance chemotherapy

Outcome Measures

Primary Outcomes (1)

  • Time to disease progression with maintenance paclitaxel versus observation

Secondary Outcomes (4)

  • Overall survival

  • Toxicity

  • Quality of live

  • Conversion to a better response

Interventions

PaclitaxelDRUG

Eligibility Criteria

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

You may qualify if:

  • Written informed consent.
  • Patients with metastatic breast cancer in response or stable disease after six to eight courses of first line induction chemotherapy treatment
  • Measurable and/or evaluable disease
  • Performance status ECOG 0, 1, 2.
  • Normal cardiac function, confirmed by left ventricular ejection fraction (LVEF).

You may not qualify if:

  • Presence of peripheral neuropathy \> grade 2 by NCI Common Toxicity Criteria (NCI-CTC) following induction chemotherapy
  • Adjuvant taxane-based therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Azienda Ospedaliera Pisana

Pisa, PI, 56100, Italy

Location

Oncology Institute

Bari, 70010, Italy

Location

Morgagni-Pierantoni Hospital

Forlì, 47100, Italy

Location

National Cancer Research Institute

Genoa, Italy

Location

S. Carlo Hospital

Potenza, Italy

Location

Santa Maria Nuova Hospital

Reggio Emilia, Italy

Location

University of Rome

Rome, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • PierFranco Conte, MD

    University of Modena, Italy

    PRINCIPAL INVESTIGATOR

  • Dino Amadori, MD

    Morgagni-Pierantoni Hospital, Forli, Italy

    PRINCIPAL INVESTIGATOR

  • Mario Delena, MD

    Oncology Institute, Bari, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 8, 2006

First Posted

February 9, 2006

Study Start

April 1, 1998

Study Completion

October 1, 2003

Last Updated

February 9, 2006

Record last verified: 2003-11

Locations

IT(7)