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Phase II Trial of Neoadjuvant Metronomic Chemotherapy in Triple-Negative Breast Cancer

NCT00542191 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-05-26

Study results available
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Summary

This neoadjuvant chemotherapy protocol focusing on "triple-negative" breast cancers alone will gather a foundation of primary tumor and axillary lymph nodal response to primary chemotherapy and ongoing correlated disease-free (DFS) and overall survival (OS) outcome data. This comparative data can then be used in building subsequent trials.

Conditions

Interventions

DRUG

Doxorubicin / Cyclophosphamide / Paclitaxel / Carboplatin

DOXORUBICIN 24mg/m2 IV plus CYCLOPHOSPHAMIDE 60mg/m2 PO weekly x 12 successive weeks followed by PACLITAXEL 80mg/m2 IV over 1 hour plus CARBOPLATIN AUC 2 IV weekly x 12 successive weeks

PROCEDURE

Definitive Surgery

Standard of care definitive surgery as determined by medical provider

RADIATION

Radiotherapy

Standard of care RADIATION THERAPY as indicated

Sponsors & Collaborators

  • Leo W. Jenkins Cancer Center

    lead OTHER

Principal Investigators

  • Paul Walker, MD · Brody School of Medicine at East Carolina University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2016-08-02
Completion
2016-08-02

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00542191 on ClinicalTrials.gov