A Phase II Study of Anti-CD3 x Anti-HER2/Neu (Her2Bi) Armed Activated T Cells (ATC) After Neoadjuvant Chemotherapy in Women With HER2/Neu (0-2+), Hormone Receptor (HR) Negative Stage II-III Breast Cancers
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Progression-free Survival
研究概览
简要总结
RATIONALE: Neoadjuvant chemotherapy for women with stage II-III Her negative breast cancer followed by Her2Bi armed activated T cells (ATCs) may significantly improve the pathologic complete response (pCR) rate at the time of surgery. Arming ex vivo expanded T cells in the laboratory may help the T cells kill more tumor cells when they are put back in the body. Giving combination neoadjuvant 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 neoadjuvant chemotherapy works in treating women with stage II or stage III breast cancer undergoing surgery.
详细描述
PRIMARY OBJECTIVES:
I. To estimate progression-free survival (PFS) in women with stage II-III triple-negative breast cancer without a complete pathologic response (cPR) who receive a regimen of neoadjuvant chemotherapy (chemoT), surgery, and/or irradiation followed by 8 infusions of ~10-15 x 10^9 Her2Bi-armed activated T cells (ATC) (aATC) given twice per week for 4 weeks in combination with IL-2 (aldesleukin) (300,000 IU/m^2/day) and GM-CSF (sargramostim) (250 μg/m^2/twice per week) beginning 3 days before the 1st infusion and ending 1 week after the last infusion (defined as immunotherapy).
II. To estimate the change from baseline (pre immunotherapy [IT]) to post-IT in specific cytotoxicity and interferon gamma (IFN-γ) enzyme-linked immunosorbent spots (Elispots) of lymphocytes in the blood directed at breast cancer cells.
III. To investigate if pathologic response and the changes in numbers and proportion of infiltrating cells and cancer stem cells in the tumor at the time of surgery are associated with progressive disease.
OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
HER2Bi-armed activated T cells + Neoadjuvant Chemotherapy
HER2Bi-armed activated T cells - Total of 4 of the T cell infusions IV over a period of 1 month
Cyclophosphamide, doxorubicin hydrochloride, paclitaxel -As prescribed by physician, standard of care.
干预措施: HER2Bi-armed activated T cells (Biological)
HER2Bi-armed activated T cells + Neoadjuvant Chemotherapy
HER2Bi-armed activated T cells - Total of 4 of the T cell infusions IV over a period of 1 month
Cyclophosphamide, doxorubicin hydrochloride, paclitaxel -As prescribed by physician, standard of care.
干预措施: cyclophosphamide (Drug)
HER2Bi-armed activated T cells + Neoadjuvant Chemotherapy
HER2Bi-armed activated T cells - Total of 4 of the T cell infusions IV over a period of 1 month
Cyclophosphamide, doxorubicin hydrochloride, paclitaxel -As prescribed by physician, standard of care.
干预措施: doxorubicin hydrochloride (Drug)
HER2Bi-armed activated T cells + Neoadjuvant Chemotherapy
HER2Bi-armed activated T cells - Total of 4 of the T cell infusions IV over a period of 1 month
Cyclophosphamide, doxorubicin hydrochloride, paclitaxel -As prescribed by physician, standard of care.
干预措施: paclitaxel (Drug)
HER2Bi-armed activated T cells + Neoadjuvant Chemotherapy
HER2Bi-armed activated T cells - Total of 4 of the T cell infusions IV over a period of 1 month
Cyclophosphamide, doxorubicin hydrochloride, paclitaxel -As prescribed by physician, standard of care.
干预措施: laboratory biomarker analysis (Other)
HER2Bi-armed activated T cells + Neoadjuvant Chemotherapy
HER2Bi-armed activated T cells - Total of 4 of the T cell infusions IV over a period of 1 month
Cyclophosphamide, doxorubicin hydrochloride, paclitaxel -As prescribed by physician, standard of care.
干预措施: neoadjuvant therapy (Procedure)
HER2Bi-armed activated T cells + Neoadjuvant Chemotherapy
HER2Bi-armed activated T cells - Total of 4 of the T cell infusions IV over a period of 1 month
Cyclophosphamide, doxorubicin hydrochloride, paclitaxel -As prescribed by physician, standard of care.
干预措施: therapeutic conventional surgery (Procedure)
结局指标
主要结局
Progression-free Survival
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 years..
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesion
次要结局
- Overall Deaths(From date of randomization until date of death from any cause or end of study, whichever came first, assessed up to 7 years)
研究者
Abhinav Deol
Investigator
Barbara Ann Karmanos Cancer Institute