BENITIONSClinical Trial Intelligence

Carboplatin and Paclitaxel With or Without Atezolizumab Before Surgery in Treating Patients With Newly Diagnosed, Stage II-III Triple-Negative Breast Cancer

2상 진행 중(모집 완료) NCT02883062

대상 질환Invasive Breast Carcinoma, Stage II Breast Cancer AJCC v6 and v7, Stage III Breast Cancer AJCC v7, Triple-Negative Breast Carcinoma
임상 단계2상
스폰서National Cancer Institute (NCI)
상태진행 중(모집 완료)
참여자 수67 명
중재(약물)Atezolizumab, Biospecimen Collection, Carboplatin, Lumpectomy, Mastectomy
시작일2017년 8월 2일
완료일2019년 12월 18일
결과 공개일2024년 6월 18일

요약

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
Arm B (Atezolizumab, Carboplatin, Paclitaxel, Breast Surgery)17.5 percentage of TIL
Arm A (Carboplatin, Paclitaxel, Mastectomy, Lumpectomy)18.3 percentage of TIL
Arm B (Atezolizumab, Carboplatin, Paclitaxel, Breast Surgery)21.7 percentage of TIL
p-value0.36

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
Arm B (Atezolizumab, Carboplatin, Paclitaxel, Breast Surgery)25 Participants
p-value0.018

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