NCT00002679

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. PURPOSE: Phase II trial to study the effectiveness of high-dose sequential chemotherapy as adjuvant therapy in treating patients with stage II or stage III breast cancer who have four or more positive axillary lymph nodes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
Completed

Started Feb 1994

Longer than P75 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

February 1, 1994

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2002

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

February 6, 2004

Completed
Last Updated

August 26, 2009

Status Verified

August 1, 2009

Enrollment Period

7.9 years

First QC Date

November 1, 1999

Last Update Submit

August 24, 2009

Conditions

Breast Cancer

Keywords

stage II breast cancerstage IIIA breast cancermale breast cancer

Interventions

filgrastimBIOLOGICAL
cyclophosphamideDRUG
doxorubicin hydrochlorideDRUG
paclitaxelDRUG
tamoxifen citrateDRUG
radiation therapyRADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically proven adenocarcinoma of the breast with involvement of 4 or more axillary nodes, including any T N1 M0 Concurrent bilateral breast cancer allowed Complete resection required Total mastectomy or breast conserving surgery Adjuvant radiotherapy planned after protocol chemotherapy Clear surgical margins Axillary dissection yielding at least 9 lymph nodes Entry required within 8 weeks of definitive surgery Hormone receptor status: Any status PATIENT CHARACTERISTICS: Age: Over 18 Sex: Not specified Menopausal status: Not specified Performance status: Karnofsky 80%-100% ECOG 0 or 1 Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no greater than 1.5 times normal AST no greater than 2 times normal Alkaline phosphatase no greater than 2 times normal Renal: Creatinine no greater than 1.8 mg/dL OR Creatinine clearance at least 60 mL/min Urinalysis normal Cardiovascular: Left ventricular ejection fraction normal on MUGA or echocardiogram No congestive heart failure requiring medical therapy No serious arrhythmia No first-, second-, or third-degree heart block Other: No abnormal CT of chest or abdomen No uncontrolled infection No serious medical condition that would prevent treatment No second malignancy except curatively treated: Nonmelanomatous skin cancer Carcinoma in situ of the cervix Not pregnant Negative pregnancy test Barrier contraception required of fertile patients before, during, and for 6 months after protocol therapy PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior systemic chemotherapy Endocrine Therapy: No concurrent hormonal therapy unless unrelated to cancer Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics Other: No concurrent medication affecting conduction unless cleared by a cardiologist, e.g.: Beta blockers Digoxin Antiarrhythmia agents Calcium channel blockers

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

Sponsors & Collaborators

Study Sites (1)

Yale Comprehensive Cancer Center

New Haven, Connecticut, 06520-8028, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsBreast Neoplasms, Male

Interventions

FilgrastimCyclophosphamideDoxorubicinPaclitaxelTamoxifenRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsAminoglycosidesGlycosidesTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicDiterpenesTerpenesStilbenesBenzylidene CompoundsBenzene DerivativesTherapeutics

Study Officials

  • Maysa Abu-Khalaf, MD

    Yale University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

February 6, 2004

Study Start

February 1, 1994

Primary Completion

January 1, 2002

Study Completion

January 1, 2002

Last Updated

August 26, 2009

Record last verified: 2009-08

Locations

US(1)