MedTrace Logo

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

NCT01750073 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2025-11-18

Study results available
· View outcomes & findings →

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.

Conditions

  • Estrogen Receptor Negative
  • Estrogen Receptor Positive
  • HER2/Neu Negative
  • HER2/Neu Positive
  • Invasive Breast Carcinoma
  • Progesterone Receptor Negative
  • Progesterone Receptor Positive
  • Stage IA Breast Cancer
  • Stage II Breast Cancer
  • Stage IIA Breast Cancer
  • Stage IIB Breast Cancer
  • Stage III Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer
  • Triple-Negative Breast Carcinoma

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Amulya C Yellala, MD · University of Nebraska

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-07
Primary Completion
2022-05-01
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01750073 on ClinicalTrials.gov