NCT00004175

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 combining docetaxel, doxorubicin, and cyclophosphamide in treating women who have previously untreated stage III breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Nov 1998

Typical duration for phase_2 breast-cancer

Geographic Reach
1 country

4 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

November 1, 1998

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 10, 1999

Completed
4.2 years until next milestone

First Posted

Study publicly available on registry

March 3, 2004

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2004

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
Last Updated

June 6, 2012

Status Verified

May 1, 2012

Enrollment Period

5.8 years

First QC Date

December 10, 1999

Last Update Submit

May 31, 2012

Conditions

Breast Cancer

Keywords

stage IIIA breast cancerstage IIIB breast cancer

Interventions

cyclophosphamideDRUG
docetaxelDRUG
doxorubicin hydrochlorideDRUG
conventional surgeryPROCEDURE

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed previously untreated, stage III adenocarcinoma of the breast At least one bidimensionally and/or unidimensionally measurable lesion No evidence of disease outside the breast or chest wall, except for ipsilateral axillary lymph nodes Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) SGOT no greater than 3 times ULN Alkaline phosphatase no greater than 5 times ULN No acute hepatitis Renal: Creatinine no greater than 1.5 mg/dL No uncontrolled hypercalcemia Cardiovascular: No congestive heart failure LVEF normal No angina pectoris No uncontrolled cardiac arrhythmias No other significant heart disease No myocardial infarction within the past year No superior vena cava syndrome No deep vein thrombosis requiring anticoagulant therapy Neurologic: No dementia No seizures No concurrent grade 2 or greater peripheral neuropathy Other: No medical instability No active infection No gastrointestinal bleeding No uncontrolled diabetes No psychological, familial, sociological, or geographical conditions or other circumstances that would preclude study No other malignancy within the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the cervix No history of hypersensitivity to polysorbate 80 Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy for breast cancer Chemotherapy: No prior chemotherapy for breast cancer Endocrine therapy: No prior hormonal therapy for breast cancer No concurrent corticosteroids except for chronic methylprednisolone or equivalent for more than 6 months duration at no more than 20 mg/day Radiotherapy: Not specified Surgery: Not specified Other: At least 3 weeks since prior investigational drugs

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

Sponsors & Collaborators

Study Sites (4)

Stanford University Medical Center

Stanford, California, 94305-5408, United States

Location

Monroe Medical Associates

Chicago, Illinois, 60603, United States

Location

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

Albert Einstein Comprehensive Cancer Center

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

CyclophosphamideDocetaxelDoxorubicin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicDiterpenesTerpenesDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • William J. Gradishar, MD

    Robert H. Lurie Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 1999

First Posted

March 3, 2004

Study Start

November 1, 1998

Primary Completion

September 1, 2004

Study Completion

June 1, 2005

Last Updated

June 6, 2012

Record last verified: 2012-05

Locations

US(4)