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

第2相 実施中(募集終了) NCT02883062

対象疾患Invasive Breast Carcinoma, Stage II Breast Cancer AJCC v6 and v7, Stage III Breast Cancer AJCC v7, Triple-Negative Breast Carcinoma
第2相
スポンサーNational Cancer Institute (NCI)
ステータス実施中(募集終了)
参加者数67 名
介入(薬剤)Atezolizumab, Biospecimen Collection, Carboplatin, Lumpectomy, Mastectomy
開始日2017年8月2日
完了日2019年12月18日
結果公開日2024年6月18日

概要

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
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

BENITIONS で見る ClinicalTrials.gov の原文を見る

同じ疾患の他の治験

すべての治験

このページは ClinicalTrials.gov の公開データをまとめたものです。医学的助言ではなく、投資助言でもありません。必ず専門医にご相談ください。