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Sponsors and Collaborators: |
University of Nebraska National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00499083 |
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, cyclophosphamide, and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Injecting the patient's dendritic cells directly into the tumor may stimulate the immune system and stop tumor cells from growing. Radiation therapy uses high-energy x-rays to kill tumor cells. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving combination chemotherapy together with autologous dendritic cells before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving radiation therapy and hormone therapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying the side effects and how well giving paclitaxel together with cyclophosphamide and doxorubicin followed by autologous dendritic cells and surgery with or without radiation therapy and/or hormone therapy works in treating women with stage II or stage III breast cancer.
Condition | Intervention | Phase |
Breast Cancer |
Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: paclitaxel Drug: tamoxifen citrate Drug: therapeutic autologous lymphocytes Procedure: aromatase inhibition therapy Procedure: biopsy Procedure: conventional surgery Procedure: gene expression analysis Procedure: immunoenzyme technique Procedure: immunohistochemistry staining method Procedure: laboratory biomarker analysis Procedure: protein expression analysis Procedure: radiation therapy Procedure: reverse transcriptase-polymerase chain reaction |
Phase II |
Genetics Home Reference related topics: | breast cancer |
MedlinePlus related topics: | Breast Cancer Cancer |
ChemIDplus related topics: | Doxorubicin Doxorubicin hydrochloride Cyclophosphamide Paclitaxel Tamoxifen Tamoxifen citrate Citric acid Sodium Citrate |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Neoadjuvant Intratumoral Injection of Dendritic Cells in Breast Cancer Translation of Biotechnology Into the Clinic |
Estimated Enrollment: | 30 |
Study Start Date: | May 2006 |
Show Detailed Description |
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed invasive breast cancer meeting the following criteria:
HER2/neu-negative tumor by IHC
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Florida | |||||
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Recruiting | ||||
Tampa, Florida, United States, 33612-9497 | |||||
Contact: Clinical Trials Office - H. Lee Moffitt Cancer Center and Rese 800-456-7121 canceranswers@moffitt.org | |||||
United States, Nebraska | |||||
UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Recruiting | ||||
Omaha, Nebraska, United States, 68198-6805 | |||||
Contact: Clinical Trials Office - UNMC Eppley Cancer Center at the Univ 800-999-5465 |
University of Nebraska |
National Cancer Institute (NCI) |
Principal Investigator: | Elizabeth C. Reed, MD | University of Nebraska |
Principal Investigator: | Kenneth H. Cowan, MD, PhD | University of Nebraska |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000553127, UNMC-07206 |
First Received: | July 10, 2007 |
Last Updated: | September 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00499083 |
Health Authority: | Unspecified |
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