Clinical trial · Interventional
Paclitaxel, Cyclophosphamide & Doxorubicin, Autologous Dendritic Cells & Surgery in Stage II/III Breast Cancer (Women)
Neoadjuvant Intratumoral Injection of Dendritic Cells in Breast Cancer Translation of Biotechnology Into the Clinic
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (17)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| aromatase inhibition therapy | Drug | — | UNRESOLVED |
| biopsy | Procedure | — | UNRESOLVED |
| conventional surgery | Procedure | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| gene expression analysis | Genetic | — | UNRESOLVED |
| immunoenzyme technique | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vaccine
- description
- Patients with HER-2/neu negative tumors will receive IT DCs one week after the first three of four cycles of dose dense T therapy and then four cycles of dose dense AC therapy will be given (i.e. T-AC).
- interventionNames
- Biological: therapeutic autologous dendritic cells
- Drug: aromatase inhibition therapy
- Drug: cyclophosphamide
- Drug: doxorubicin hydrochloride
- Drug: paclitaxel
- Drug: tamoxifen citrate
- Genetic: gene expression analysis
- Genetic: protein expression analysis
- Genetic: reverse transcriptase-polymerase chain reaction
- Other: immunoenzyme technique
- Other: immunohistochemistry staining method
- Other: laboratory biomarker analysis
- Procedure: adjuvant therapy
- Procedure: biopsy
- Procedure: conventional surgery
- Procedure: neoadjuvant therapy
- Radiation: radiation therapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDHong WX, Sagiv-Barfi I, Czerwinski DK, Sallets A, Levy R. Neoadjuvant Intratumoral Immunotherapy with TLR9 Activation and Anti-OX40 Antibody Eradicates Metastatic Cancer. Cancer Res. 2022 Apr 1;82(7):1396-1408. doi: 10.1158/0008-5472.CAN-21-1382. PMID 35135810