Combination Chemotherapy and Filgrastim Before Surgery in Treating Patients With HER2-Positive Breast Cancer That Can Be Removed By Surgery

Summary

This phase II trial studies how well giving combination chemotherapy and filgrastim together before surgery works in treating patients with human epidermal growth receptor 2 (HER2)-positive breast cancer that can be removed by surgery. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, and paclitaxel work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Colony-stimulating factors, such as filgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving doxorubicin hydrochloride, cyclophosphamide, and filgrastim together followed by paclitaxel before surgery may be an effective treatment for breast cancer

Conditions

• Estrogen Receptor-negative Breast Cancer
• Estrogen Receptor-positive Breast Cancer
• HER2-positive Breast Cancer
• Progesterone Receptor-negative Breast Cancer
• Progesterone Receptor-positive Breast Cancer
• Stage IA Breast Cancer
• Stage IB Breast Cancer
• Stage II Breast Cancer
• Stage IIIA Breast Cancer

Interventions

DRUG

doxorubicin hydrochloride

Given IV

DRUG

cyclophosphamide

Given PO

DRUG

paclitaxel

Given IV

BIOLOGICAL

filgrastim

Given SC

DRUG

capecitabine

Given PO

DRUG

methotrexate

Given IV

DRUG

vinorelbine tartrate

Given IV

PROCEDURE

needle biopsy

Correlative studies

PROCEDURE

therapeutic conventional surgery

Undergo definitive breast surgery

OTHER

immunohistochemistry staining method

Correlative studies

BIOLOGICAL

trastuzumab

Given IV

DRUG

tamoxifen citrate

Given PO

DRUG

letrozole

Given PO

OTHER

laboratory biomarker analysis

Correlative studies

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• University of Washington

  lead OTHER

Principal Investigators

• Georgiana Ellis · Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2003-10-31

Primary Completion

2010-06-30

Completion

2011-06-30

Countries

• United States

Study Locations