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ACTIVE NOT RECRUITING
NCT01750073
PHASE2

Paclitaxel & Cyclophosphamide With or Without Trastuzumab Before Surgery in Treating Previously Untreated Breast Cancer

Sponsor: University of Nebraska

View on ClinicalTrials.gov

Summary

This phase II trial studies the side effects and how well giving paclitaxel and cyclophosphamide with or without trastuzumab before surgery works in treating patients with previously untreated breast cancer. Drugs used in chemotherapy, such as paclitaxel and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, may block tumor growth in different ways by targeting certain cells. Giving combination chemotherapy with or without trastuzumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Official title: A Phase II Study of Neoadjuvant Chemotherapy With and Without Trastuzumab in Patients With Breast Cancer

Key Details

Gender

FEMALE

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

92

Start Date

2012-12-07

Completion Date

2026-06

Last Updated

2025-11-18

Healthy Volunteers

No

Interventions

DRUG

Cyclophosphamide

Given IV

DRUG

Doxorubicin Hydrochloride

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Paclitaxel

Given IV

RADIATION

Radiation Therapy

Undergo RT

PROCEDURE

Therapeutic Conventional Surgery

Undergo mastectomy or breast conserving surgery

BIOLOGICAL

Trastuzumab

Given IV

Locations (4)

Nebraska Medicine-Bellevue

Bellevue, Nebraska, United States

CHI Health Saint Francis

Grand Island, Nebraska, United States

Nebraska Medicine-Village Pointe Cancer Center

Omaha, Nebraska, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States