NCT00003680

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known whether high-dose chemotherapy plus peripheral stem cell transplantation is more effective than standard chemotherapy for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of standard chemotherapy with that of high-dose chemotherapy plus peripheral stem cell transplantation in treating women who have advanced breast cancer or inflammatory breast cancer.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
300

participants targeted

Target at P25-P50 for phase_3 breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 1998

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.5 years until next milestone

First Posted

Study publicly available on registry

May 3, 2004

Completed
Last Updated

November 6, 2013

Status Verified

May 1, 2007

First QC Date

November 1, 1999

Last Update Submit

November 5, 2013

Conditions

Breast Cancer

Keywords

stage III breast cancerinflammatory breast cancer

Interventions

CMF regimenDRUG
cyclophosphamideDRUG
fluorouracilDRUG
methotrexateDRUG
tamoxifen citrateDRUG
thiotepaDRUG
peripheral blood stem cell transplantationPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
DISEASE CHARACTERISTICS: Histologically proven locally advanced, inflammatory, or operable large primary breast cancer (greater than 3 cm) following 2-6 courses of primary anthracycline-containing chemotherapy Potentially curative surgery At least 1 axillary lymph node involvement at surgery No metastatic disease Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 to 60 Sex: Female Menopausal status: Not specified Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1500/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 9 g/dL Hepatic: Normal prothrombin time Normal activated partial thromboplastin time Normal bilirubin (except for patients with benign congenital hyperbilirubinemia) AST/ALT no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 1.5 times ULN No active hepatitis B or C infection Renal: Normal creatinine Cardiovascular: Adequate cardiac function No active cardiac disease Left ventricular ejection fraction within normal range Other: No other serious medical or psychiatric disease Not pregnant No prior/concurrent malignancy except basal cell carcinoma of the skin or carcinoma in situ of the cervix HIV negative OR asymptomatic for HIV disease PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Prior surgery required

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

Sponsors & Collaborators

Study Sites (1)

C.R.C. Beatson Laboratories

Glasgow, Scotland, G61 1BD, United Kingdom

Location

MeSH Terms

Conditions

Breast NeoplasmsInflammatory Breast Neoplasms

Interventions

CMF regimenCyclophosphamideFluorouracilMethotrexateTamoxifenThiotepaPeripheral Blood Stem Cell TransplantationRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicTriethylenephosphoramideAziridinesAzirinesHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • T.R.J. Evans

    Beatson Institute for Cancer Research - Glasgow

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

May 3, 2004

Study Start

November 1, 1998

Last Updated

November 6, 2013

Record last verified: 2007-05

Locations

GB(1)