Paclitaxel, Cyclophosphamide & Doxorubicin, Autologous Dendritic Cells & Surgery in Stage II/III Breast Cancer (Women)

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00499083

Run by

University of Nebraska

People needed

17

Starts

2006-05-01

Expected to finish

2010-01-28

Last updated by the study team

2023-09-29

Who can join

Age: 19 and older, up to 120. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed invasive breast cancer meeting the following criteria:
• Primary tumor ≥ 3 cm by mammography, ultrasound, or palpation AND/OR palpable axillary lymph nodes > 1 cm
• Survivin- and/or carcinoembryonic antigen-positive by IHC
• Tumor must be localized by exam or ultrasound to allow tumor injection
• No stage IV or metastatic disease
• HER2/neu-negative tumor by IHC
• o If 2+ or in the indeterminate range, further testing of HER2/neu overexpression by fluorescent in situ hybridization (FISH) is required
• Hormone receptor status known
• Female
• Pre-, peri-, or postmenopausal
• ECOG performance status 0-1
• Fertile patients must use effective contraception during and for up to 6 months following completion of study therapy
• ANC ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Alkaline phosphatase ≤ 1.5 times upper limit of normal (ULN)
• Total bilirubin ≤ 1.5 times ULN
• AST and ALT ≤ 1.5 times ULN
• Creatinine < 1.5 times ULN

You may not qualify if…

• No prior chemotherapy or radiotherapy
• No active serious infections
• No prior malignancy except adequately treated basal cell or squamous cell skin cancer, noninvasive carcinoma, or other cancer from which the patient has been disease free for 5 years
• No comorbidity or condition that would interfere with study assessments and procedures or preclude study participation
• Not pregnant or nursing/negative pregnancy test

Where it is running

• H. Lee Moffitt Cancer Center and Research Institute, University of South Florida — Tampa, Florida, United States
• Eppley Cancer Center, University of Nebraska Medical Center — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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