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Life sciences · Phase 2 Trial
ClinicalTrials.gov · September 29, 2026
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Phase 2 Trial.
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Registry record from ClinicalTrials.gov (NCT02883062). This is a study registration, not published results. Lead sponsor: National Cancer Institute (NCI). Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 67 participants (ACTUAL). Conditions: Invasive Breast Carcinoma, Stage II Breast Cancer AJCC v6 and v7, Stage III Breast Cancer AJCC v7, Triple-Negative Breast Carcinoma. Interventions: DRUG: Atezolizumab; PROCEDURE: Biospecimen Collection; DRUG: Carboplatin; PROCEDURE: Lumpectomy; PROCEDURE: Mastectomy; DRUG: Paclitaxel. Primary outcome measures: Change in Tumor Infiltrating Lymphocyte (TIL) Percentage , Baseline and between days 18-22 following completion of cycle 1 (each cycle is 3 weeks); 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). Brief 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.