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Neoadjuvant Docetaxel in Treating Women With Newly Diagnosed Breast Cancer

NCT00080626 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2019-03-21

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed.

PURPOSE: This phase II trial is studying how well neoadjuvant docetaxel works in treating women who are undergoing surgery for breast cancer.

Conditions

Interventions

BIOLOGICAL

pegfilgrastim

6 mg injection on day 1 of each cycle

DRUG

docetaxel

100 mg per meter-squared, every 14 days for 4 cycles

PROCEDURE

conventional surgery

lumpectomy or mastectomy at end of treatment

PROCEDURE

neoadjuvant therapy

treatment prior to definitive breast surgery

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Vered Stearns, MD · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-08-11
Primary Completion
2006-05-01
Completion
2006-05-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT00080626 on ClinicalTrials.gov