Laboratory-Treated T Cells After Chemotherapy in Treating Women With Stage II or Stage III Breast Cancer Undergoing Surgery

2014-07-23 21:08:44 | BioPortfolio


RATIONALE: Treating a patient's T cells in the laboratory may help the T cells kill more tumor cells when they are put back in the body. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy followed by laboratory-treated T cells before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II clinical trial is studying how well giving laboratory-treated T cells after chemotherapy works in treating women with stage II or stage III breast cancer undergoing surgery.



- To determine, in a phase II clinical trial of women with stage II-III triple-negative breast cancer, if a regimen of neoadjuvant chemotherapy followed by HER2Bi-armed activated T cells (ATCs) improves the pathologic complete response (pCR) rate at the time of surgery.

- To investigate the association between pCR and clinical responses (disease-free survival and overall survival).

- To determine if HER2Bi-armed ATCs administered after neoadjuvant chemotherapy will modulate the cytotoxicity of lymphocytes in the blood and tumor-infiltrating lymphocytes.

- To determine if there is an association between systemic and tumor site anti-tumor responses.

- To determine if HER2Bi-armed ATCs administration after neoadjuvant chemotherapy decreases the frequency and colony-forming ability of the putative breast cancer stem cells in the tumor tissue at the time of surgery compared to that obtained in the tumor biopsy after chemotherapy.

- To investigate the association between the observed changes in numbers and proportion of CD44^hi/CD24^lo, CD133, aldehyde dehydrogenase activity (ALDH1)-positive cells and the pCR.

OUTLINE: This is a multicenter study.

- Neoadjuvant chemotherapy: Patients receive doxorubicin hydrochloride and cyclophosphamide every 2 weeks for 4 doses. Patients then receive paclitaxel once a week for 12 doses.

- Neoadjuvant immunotherapy: Beginning 3-6 days after the last dose of chemotherapy, patients receive autologous HER2Bi-armed activated T cells (ATCs) IV over 30-60 minutes once a week for 4 weeks.

- Surgery: Approximately 2 weeks after the last dose of HER2Bi-armed ATCs, patients undergo standard surgery.

Tissue and blood samples are collected periodically for correlative immune function tests.

After completion of study treatment, patients are followed up every 8 weeks for 48 weeks and then every 3 months thereafter.

Study Design

Masking: Open Label, Primary Purpose: Treatment


Breast Cancer


HER2Bi-armed activated T cells, cyclophosphamide, doxorubicin hydrochloride, paclitaxel, laboratory biomarker analysis, neoadjuvant therapy, therapeutic conventional surgery


Not yet recruiting


National Cancer Institute (NCI)

Results (where available)

View Results


Published on BioPortfolio: 2014-07-23T21:08:44-0400

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