NCT00352378

Brief Summary

This is an open labeled phase III randomized trial. The patients with clinical stage II and III will undergo mammotome biopsy of breast tumor for histologic diagnosis, immunohistochemical studies for estrogen receptor(ER), progesterone receptor(PR), HER-2/neu and others. PET results will determine the positivity of lymph node metastasis.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
209

participants targeted

Target at P25-P50 for phase_3 breast-cancer

Timeline
Completed

Started Jun 2002

Shorter than P25 for phase_3 breast-cancer

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

June 1, 2002

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 14, 2006

Completed
Last Updated

June 27, 2011

Status Verified

September 1, 2007

Enrollment Period

3.3 years

First QC Date

July 13, 2006

Last Update Submit

June 23, 2011

Conditions

Breast Cancer

Keywords

Primary

Outcome Measures

Primary Outcomes (1)

  • pathologic complete remission

    5 years

Study Arms (2)

Adriamycin plus Cyclophosphamide

EXPERIMENTAL

Intravenous infusion of Adriamycin 60mg/m2 , over 30 min, onD1 and Intravenous infusion of cyclophosphamide 600 mg/m2 over 30 min on D1.

Drug: Anthracycline, Cyclophosphamide, Docetaxel, Capecitabine

Taxotere plus Xeloda

EXPERIMENTAL

Intravenous infusion of Taxotere 75 mg/m2 over 1 hr, on D1, and Xeloda 1000mg/m2.p.o. BID x 14days on D1-D14

Drug: Anthracycline, Cyclophosphamide, Docetaxel, Capecitabine

Interventions

Anthracycline, Cyclophosphamide, Docetaxel, CapecitabineDRUG

Patients will be randomized to receive regimen A (AC) and regimen B(TX),preoperatively as follows: Regimen A (AC): Intravenous infusion of Adriamycin 60mg/m2 , over 30 min, onD1 and Intravenous infusion of cyclophosphamide 600 mg/m2 over 30 min on D1. Regimen B(TX): Intravenous infusion of Taxotere 75 mg/m2 over 1 hr, on D1, and Xeloda 1000mg/m2.p.o. BID x 14days on D1-D14

Also known as: Taxotere, Xeloda, Cytoxan, doxorubicin
Adriamycin plus CyclophosphamideTaxotere plus Xeloda

Eligibility Criteria

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

You may qualify if:

  • All patients must have histologically confirmed and newly diagnosed breast cancer: stage II and III breast cancer.
  • PET results will determine node positivity.
  • No prior hormonal , chemotherapy or radiotherapy is allowed.
  • No breast operation other than biopsy to make diagnosis is allowed.
  • Age:18-years and older, not pregnant pre-, and postmenopausal women with good performance status (ECOG 0-1)
  • Adequate hematopoietic function:
  • Absolute granulocyte count \>=1500/mm3,
  • platelet \>=100,000/mm3, Hemoglobin \>=10 g/mm3
  • Adequate renal function: Serum creatinine \<=1.5 mg/dl
  • Adequate hepatic function:
  • total bilirubin: \<=1.5 mg/dl
  • AST/ALT: \<=three times normal
  • Alkaline phosphatase: \<=three times normal
  • Adequate cardiac function: normal or nonspecific EKG taken within 1 mo of enrollment

You may not qualify if:

  • Patients who received hormonal , chemotherapy or radiotherapy for breast cancer
  • Patients who underwent surgery for breast cancer
  • Patients who have history of cancer other than in situ uterine cervix cancer or nonmelanotic skin cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Interventions

AnthracyclinesCyclophosphamideDocetaxelCapecitabineDoxorubicin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

NaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicDiterpenesTerpenesDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDaunorubicin

Study Officials

  • Jungsil Ro, MD,PhD

    National Cancer Center, Korea

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 13, 2006

First Posted

July 14, 2006

Study Start

June 1, 2002

Primary Completion

October 1, 2005

Study Completion

January 1, 2006

Last Updated

June 27, 2011

Record last verified: 2007-09