NCT00008034

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells and shrink tumors so they can be removed during surgery. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy before surgery in treating women who have locally advanced, inflammatory, or large surgically removable breast cancer.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_1 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2000

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2000

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 6, 2001

Completed
3.1 years until next milestone

First Posted

Study publicly available on registry

February 3, 2004

Completed
Last Updated

July 18, 2012

Status Verified

July 1, 2012

Enrollment Period

10 months

First QC Date

January 6, 2001

Last Update Submit

July 17, 2012

Conditions

Breast Cancer

Keywords

stage II breast cancerstage IIIA breast cancerstage IIIB breast cancerinflammatory breast cancer

Interventions

capecitabineDRUG
cyclophosphamideDRUG
epirubicin hydrochlorideDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed carcinoma of the breast Locally advanced or inflammatory disease (T4, any N or any T, N2 or N3 or T4d) OR Large operable disease (large T2 or T3 for which tumor shrinkage is needed) No distant metastasis on chest x-ray, liver ultrasound, or bone scan except for ipsilateral supraclavicular nodes No abnormal bone scintigrams that cannot be confirmed as benign Hormone Receptor Status Not specified PATIENT CHARACTERISTICS: Age: 18 to 70 Sex: Female Menopausal status: Not specified Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.25 times upper limit of normal (ULN) SGOT no greater than 2 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: LVEF normal by echocardiography or MUGA Other: Not pregnant or nursing Fertile patients must use effective contraception No other serious uncontrolled illnesses No uncontrolled psychiatric or addictive disorders No other concurrent or prior malignancy within the past 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Hopital Cantonal Universitaire de Geneva

Geneva, CH-1211, Switzerland

Location

MeSH Terms

Conditions

Breast NeoplasmsInflammatory Breast Neoplasms

Interventions

CapecitabineCyclophosphamideEpirubicin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsDoxorubicinDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Herve Bonnefoi, MD

    Hopital Cantonal Universitaire de Geneve

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2001

First Posted

February 3, 2004

Study Start

February 1, 2000

Primary Completion

December 1, 2000

Last Updated

July 18, 2012

Record last verified: 2012-07

Locations

CH(1)