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

Plain-language summary

This study evaluates chemotherapy (Paclitaxel, Cyclophosphamide, Doxorubicin), a dendritic cell vaccine made from the patient's own immune cells, and surgery together in women with Stage II/III breast cancer. It included patients with HER2-negative tumors 3 cm or larger. It was a Phase 2 study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Completed

Sponsor

University of Nebraska

Intervention

therapeutic autologous dendritic cells, aromatase inhibition therapy, cyclophosphamide, doxorubicin hydrochloride, paclitaxel, tamoxifen citrate, gene expression analysis, protein expression analysis, reverse transcriptase-polymerase chain reaction, immunoenzyme technique, immunohistochemistry staining method, laboratory biomarker analysis, adjuvant therapy, biopsy, conventional surgery, neoadjuvant therapy, radiation therapy

Start date

5/1/2006

Estimated completion

1/28/2010

Countries

United States

Related genes

Locations

• Tampa, United States
• Omaha, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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