NCT00540800

Brief Summary

Some chemotherapies, including docetaxel, are better tolerated and just as effective when giving the dose weekly rather than on an every three week basis. The purpose of this study is to compare 2 schedules of combination chemotherapy with docetaxel for the effects on quality of life. Standard every three week chemotherapy will be compared with weekly chemotherapy for metastatic or locally advanced breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
139

participants targeted

Target at below P25 for phase_3 breast-cancer

Timeline
Completed

Started Feb 2004

Geographic Reach
1 country

3 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

February 1, 2004

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 8, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

January 14, 2016

Status Verified

January 1, 2016

Enrollment Period

5.6 years

First QC Date

October 5, 2007

Last Update Submit

January 13, 2016

Conditions

Breast Cancer

Keywords

anthracycline pre-treatedchemotherapyfirst-linemetastatic breast cancerlocally advanced breast cancer

Outcome Measures

Primary Outcomes (1)

  • quality of life

    during first 6 weeks of chemotherapy

Secondary Outcomes (3)

  • Response rate

    After 12 and 24 weeks of chemotherapy

  • Toxicity

    every 3 weeks

  • overall survival

    2 years

Study Arms (2)

A

ACTIVE COMPARATOR

Three-weekly chemotherapy

Drug: docetaxelDrug: epirubicinDrug: capecitabine

B

EXPERIMENTAL

Weekly chemotherapy

Drug: docetaxelDrug: epirubicinDrug: capecitabine

Interventions

docetaxelDRUG

given in combination with epirubicin or capecitabine

AB
epirubicinDRUG

for patients with locally advanced breast cancer, or metastatic breast cancer not previously treated with anthracyclines

AB
capecitabineDRUG

for metastatic breast cancer patients previously treated with anthracyclines

AB

Eligibility Criteria

AgeUp to 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Histological diagnosis of breast cancer
  • Inoperable locally advanced or metastatic disease not yet treated with first-line chemotherapy
  • Age \< 70 years
  • ECOG performance status \< 2
  • Written informed consent

You may not qualify if:

  • Previous or concomitant malignant neoplasm (excluding adequately treated baso or spinocellular skin carcinoma or carcinoma in situ of the cervix)
  • Previous treatment with docetaxel
  • Symptomatic brain metastases
  • Neutrophil \< 2000/mm3, platelets \< 100,000/mm3, haemoglobin \< 10 g/dl
  • Creatinine \> 1.25 x the upper normal limits
  • GOT and/or GPT \> 1.25 x the upper normal limits in absence of hepatic metastases
  • GOT and/or GPT \> 2.5 x the upper normal limits in presence of hepatic metastases
  • Bilirubin \> 1.5 x the upper normal limit
  • Any concomitant pathology that would, in the investigator's opinion, contraindicate the use of the drugs in this study
  • Inability to provide informed consent
  • Inability to comply with follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B

Napoli, 80131, Italy

Location

Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C

Napoli, 80131, Italy

Location

Ospedale S. Luca ASL SA 3

Vallo della Lucania, Italy

Location

Related Publications (1)

  • Nuzzo F, Morabito A, Gravina A, Di Rella F, Landi G, Pacilio C, Labonia V, Rossi E, De Maio E, Piccirillo MC, D'Aiuto G, Thomas R, Rinaldo M, Botti G, Di Bonito M, Di Maio M, Gallo C, Perrone F, de Matteis A. Effects on quality of life of weekly docetaxel-based chemotherapy in patients with locally advanced or metastatic breast cancer: results of a single-centre randomized phase 3 trial. BMC Cancer. 2011 Feb 16;11:75. doi: 10.1186/1471-2407-11-75.

    PMID: 21324184RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

DocetaxelEpirubicinCapecitabine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesDoxorubicinDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Andrea de Matteis, M.D.

    NCI Naples, Division of Medical Oncology C

    PRINCIPAL INVESTIGATOR

  • Francesco Perrone, M.D., Ph.D.

    NCI Naples, Clinical Trials Office

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2007

First Posted

October 8, 2007

Study Start

February 1, 2004

Primary Completion

September 1, 2009

Study Completion

December 1, 2009

Last Updated

January 14, 2016

Record last verified: 2016-01

Locations

IT(3)