Carboplatin and Paclitaxel With or Without Atezolizumab Before Surgery in Treating Patients With Newly Diagnosed, Stage II-III Triple-Negative Breast Cancer
Phase 2
Active, not recruiting
NCT02883062
| Condition | 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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| Phase | Phase 2 |
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| Sponsor | National Cancer Institute (NCI) |
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| Status | Active, not recruiting |
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| Enrollment | 67 participants |
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| Interventions | Atezolizumab, Biospecimen Collection, Carboplatin, Lumpectomy, Mastectomy |
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| Start date | Aug 2, 2017 |
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| Completion date | Dec 18, 2019 |
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| Results posted | Jun 18, 2024 |
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Summary
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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Open in BENITIONS
View on ClinicalTrials.gov
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