Phase 2
N=17
Paclitaxel, Cyclophosphamide & Doxorubicin, Autologous Dendritic Cells & Surgery in Stage II/III Breast Cancer (Women)
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00499083 ↗Enrolled (actual)
17
Serious AEs
33.3%
Results posted
Jul 2018
Primary outcome: Primary: Number of Patients With Pathological Complete Response — 2 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- therapeutic autologous dendritic cells (Biological); aromatase inhibition therapy (Drug); cyclophosphamide (Drug); doxorubicin hydrochloride (Drug); paclitaxel (Drug); tamoxifen citrate (Drug); gene expression analysis (Genetic); protein expression analysis (Genetic); reverse transcriptase-polymerase chain reaction (Genetic); immunoenzyme technique (Other); immunohistochemistry staining method (Other); laboratory biomarker analysis (Other); adjuvant therapy (Procedure); biopsy (Procedure); conventional surgery (Procedure); neoadjuvant therapy (Procedure); radiation therapy (Radiation)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- Female
- Sponsor
- University of Nebraska
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Pathological Complete Response |
2 | — |
| SECONDARY Inflammatory Cell Infiltration |
— | — |
| SECONDARY Antibody-dependent Cell-mediated Cytotoxicity |
— | — |
| SECONDARY Influence of Tumor COX-2 and VEGF Expression on Dendritic Cell-mediated Tumor-specific Immunity |
— | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00499083). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.