NCT00524810

Brief Summary

Evaluation of safety and efficacy of a treatment associating Pegylated Liposomal Doxorubicin + Docetaxel in patients with metastatic breast cancer

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2004

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

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

February 1, 2004

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

September 3, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 5, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

June 30, 2011

Status Verified

June 1, 2011

Enrollment Period

5.3 years

First QC Date

September 3, 2007

Last Update Submit

June 29, 2011

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Non-progression rate after 6 cycles

    6 months

Secondary Outcomes (4)

  • tolerance and toxicity

    6 months

  • Tumor response and duration

    5 years

  • Time to Progression

    5 years

  • Overall survival

    5 years

Study Arms (1)

Caelyx - Taxotere

EXPERIMENTAL
Drug: Pegylated liposomal doxorubicinDrug: Docetaxel

Interventions

Pegylated liposomal doxorubicinDRUG

Caelyx 30 mg/m² day 1 every 3 weeks

Also known as: Caelyx
Caelyx - Taxotere
DocetaxelDRUG

Taxotere 75 mg/m² day 2 every 3 weeks

Also known as: Taxotere
Caelyx - Taxotere

Eligibility Criteria

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

You may qualify if:

  • first metastatic chemo line
  • presence of measurable or bone lesion
  • at least one lesion outside the radiated areas
  • can have previously received hormonotherapy, chemotherapy in adjuvant phase, radiotherapy if older than 4 weeks

You may not qualify if:

  • only local tumoral progression
  • symptomatic cerebral metastasis
  • neuropathy \> NCI-CTC 2
  • previous cancer within 10 years \_ previous cancer within 10 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital HOTEL DIEU

Paris, 75004, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

liposomal doxorubicinDocetaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Laure CHAUVENET, MD, PHD

    Hôpital HOTEL DIEU - Paris

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 3, 2007

First Posted

September 5, 2007

Study Start

February 1, 2004

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

June 30, 2011

Record last verified: 2011-06

Locations

FR(1)