Carboplatin and Paclitaxel With or Without Atezolizumab Before Surgery in Treating Patients With Newly Diagnosed, Stage II-III Triple-Negative Breast Cancer
2期
进行中（已停止招募）
NCT02883062
| 适应症 | Invasive Breast Carcinoma, Stage II Breast Cancer AJCC v6 and v7, Stage III Breast Cancer AJCC v7, Triple-Negative Breast Carcinoma |
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| 分期 | 2期 |
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| 申办方 | National Cancer Institute (NCI) |
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| 状态 | 进行中（已停止招募） |
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| 受试者人数 | 67 人 |
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| 干预（药物） | Atezolizumab, Biospecimen Collection, Carboplatin, Lumpectomy, Mastectomy |
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| 开始日期 | 2017年8月2日 |
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| 完成日期 | 2019年12月18日 |
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| 结果公布日 | 2024年6月18日 |
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摘要
This phase II trial studies how well carboplatin and paclitaxel with or without atezolizumab before surgery works in treating patients with newly diagnosed, stage II-III triple negative breast cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving carboplatin and paclitaxel with or without atezolizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Change in Tumor Infiltrating Lymphocyte (TIL) Percentage
Baseline and between days 18-22 following completion of cycle 1 (each cycle is 3 weeks) · percentage of TIL
| Arm A (Carboplatin, Paclitaxel, Mastectomy, Lumpectomy) | 16.7 percentage of TIL |
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| Arm B (Atezolizumab, Carboplatin, Paclitaxel, Breast Surgery) | 17.5 percentage of TIL |
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| Arm A (Carboplatin, Paclitaxel, Mastectomy, Lumpectomy) | 18.3 percentage of TIL |
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| Arm B (Atezolizumab, Carboplatin, Paclitaxel, Breast Surgery) | 21.7 percentage of TIL |
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Pathologic Complete Response (pCR) Rate
At the time of surgery (3-6 weeks after last dose of neoadjuvant chemotherapy, neoadjuvant chemotherapy will be up to 12 weeks in length) · Participants
| Arm A (Carboplatin, Paclitaxel, Mastectomy, Lumpectomy) | 3 Participants |
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| Arm B (Atezolizumab, Carboplatin, Paclitaxel, Breast Surgery) | 25 Participants |
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本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。