NCT00270491

Brief Summary

Tolerance and efficacy of administration of capecitabine 5 out of 7 days associated with weekly paclitaxel compared to the recommended treatment plan of weekly paclitaxel - capecitabine, 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
130

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
Completed

Started Dec 2005

Typical duration for phase_2 breast-cancer

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

December 1, 2005

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

December 26, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 28, 2005

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

February 25, 2011

Status Verified

February 1, 2011

Enrollment Period

3.8 years

First QC Date

December 26, 2005

Last Update Submit

February 24, 2011

Conditions

Breast CancerNeoplasm Metastasis

Outcome Measures

Primary Outcomes (1)

  • tolerance of the patients in the both groups.

Secondary Outcomes (4)

  • - Response rates and duration of response.

  • - Haematological and non-haematological toxicities.

  • - Progression free survival.

  • - Overall survival.

Interventions

PaclitaxelDRUG
CapecitabineDRUG

Eligibility Criteria

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

You may qualify if:

  • Femal patient aged \> 18 years
  • Histologically proven breast adenocarcinoma
  • HER2 negative receptors
  • previously received first or second line chemotherapy for metastatic disease
  • previously treated with anthracycline and/or docetaxel in adjuvant and/or as first or second line therapy
  • presence of one or several evaluable metastatic lesion(s)
  • presence of at least one target lesion not previously irradiated
  • previously treated with hormonotherapy in adjuvant or in metastatic line (treatment will be ceased upon patient registration in the study)
  • ECOG Performance status \< 2
  • adequate biological values
  • patient who has clearly given her consent by signing on informed consent form prior to participation

You may not qualify if:

  • patient previously treated with paclitaxel or capecitabine for metastatic breast cancer
  • patient with only local metastatic disease (with the exception of axillary lymph nodes)
  • active symptomatic brain metastasis
  • patient with an history of significant cardiovascular impairment (congestive heart failure\> NYHA grade II, unstable angina or myocardial infraction within the past six months or serious cardiac arrhythmia)
  • peripheric neuropathy grade ≥ 2
  • history of another malignancy within past 5 years that could confound diagnosis or staging of breast cancer (with the exception of in situ cacinoma of the cervix or adequately treated basel cell carcinoma of the skin)
  • patient with any medical or psychiatric condition that, in the opinion of the Principal Investigator, would preclude her from participating in this study
  • patient with a known allergy to one or several of the study compounds
  • patients who may not be regularly available due to geographical, social or family reasons
  • history of renal, hepatic or metabolic pathology that could preclude with metabolism or elimination of the study product
  • deficiencies of the upper intestinal tract, malabsorption syndrome
  • patient who is pregnant, breast-feeding or using inadequate contraception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital HOTEL DIEU

Paris, 75004, France

Location

MeSH Terms

Conditions

Breast NeoplasmsNeoplasm Metastasis

Interventions

PaclitaxelCapecitabine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Rémy LARGILLIER, Physician

    Centre ANTOINE LACASSAGNE - NICE (FRANCE)

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 26, 2005

First Posted

December 28, 2005

Study Start

December 1, 2005

Primary Completion

October 1, 2009

Study Completion

October 1, 2010

Last Updated

February 25, 2011

Record last verified: 2011-02

Locations

FR(1)