Paclitaxel, Cyclophosphamide, and Doxorubicin Followed by Autologous Dendritic Cells and Surgery With or Without Radiation Therapy and/or Hormone Therapy in Treating Women With Stage II or Stage III Breast Cancer

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Nebraska
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Aromatase Inhibitors; Cyclophosphamide; Doxorubicin; Hormones; Liposomal doxorubicin; Paclitaxel; Tamoxifen

Criteria

DISEASE CHARACTERISTICS:

• 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

• 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

PATIENT CHARACTERISTICS:

• Female

• Pre-, peri-, or postmenopausal

• ECOG performance status 0-1

• Not pregnant or nursing

• Negative pregnancy test

• 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

• 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

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy or radiotherapy