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乳がん患者を対象としたサシツズマブ チルモテカン(Sac-TMT、MK-2870)の臨床試験(MK-2870-032)

基本情報

NCT ID
NCT06966700
ステータス
募集中
試験のフェーズ
第3相
試験タイプ
介入
目標被験者数
2,400
治験依頼者名
Merck Sharp & Dohme LLC

概要

Researchers are looking for new ways to treat types of breast cancer that are both: * High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment * Early-stage, which means the cancer is in the breast or the lymph nodes around the breast The 2 types of breast cancer in this study are triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer. These cancers have zero or a low amount of a protein called HER2 and other proteins that attach to the hormones estrogen or progesterone. Sacituzumab tirumotecan (also known as sac-TMT or MK-2870), the study medicine, is a type of targeted therapy. A targeted therapy is a treatment that works to control how specific types of cancer cells grow and spread. The main goals of this study are to learn if people who receive sac-TMT, pembrolizumab, and chemotherapy: * Have fewer cancer cells found in the tumors and lymph nodes removed during surgery compared to those who receive only pembrolizumab and chemotherapy * Live longer without the cancer growing, spreading, or coming back compared to people who receive only pembrolizumab with chemotherapy

対象疾患

乳がんトリプルネガティブ乳がんHR低陽性/HER2陰性乳がん

介入

Olaparib(DRUG)
Sacituzumab tirumotecan(BIOLOGICAL)
Pembrolizumab(BIOLOGICAL)
Rescue Medication(DRUG)
Carboplatin(DRUG)
Paclitaxel(DRUG)
Doxorubicin(DRUG)
Epirubicin(DRUG)
Cyclophosphamide(DRUG)
Capecitabine(DRUG)

依頼者(Sponsor)

MSD株式会社(INDUSTRY)

実施施設 (30)

独立行政法人国立病院機構大阪医療センター

Osaka, Japan(RECRUITING)

Kyoto University Hospital ( Site 2313)

Kyoto, Japan(RECRUITING)

Kanagawa Cancer Center ( Site 2308)

Yokohama, Kanagawa, Japan(RECRUITING)

くまもと森都総合病院

Kumamoto, Japan(RECRUITING)

国家公務員共済組合連合会 虎の門病院

Minato, Tokyo, Japan(RECRUITING)

Mie University Hospital ( Site 2312)

Tsu, Mie-ken, Japan(RECRUITING)

関西医科大学附属病院

Hirakata, Osaka, Japan(RECRUITING)

Kanazawa Medical University Hospital ( Site 2321)

Kahoku-gun, Ishikawa-ken, Japan(RECRUITING)

近畿大学病院

Sakai, Osaka, Japan(RECRUITING)

Naha Nishi Clinic ( Site 2320)

Naha, Okinawa, Japan(RECRUITING)

国立大学法人 三重大学医学部附属病院

Tsu, Mie-ken, Japan(RECRUITING)

地方独立行政法人広島市立病院機構 広島市立広島市民病院

Hiroshima, Japan(RECRUITING)

地方独立行政法人 大阪府立病院機構 大阪国際がんセンター

Suita, Osaka, Japan(RECRUITING)

Nakagami Hospital ( Site 2323)

Okinawa, Japan(RECRUITING)

京都大学医学部附属病院

Kyoto, Japan(RECRUITING)

Fukushima Medical University Hospital ( Site 2301)

Fukushima, Japan(RECRUITING)

Kansai Medical University Hospital ( Site 2317)

Hirakata, Osaka, Japan(RECRUITING)

公立大学法人 福島県立医科大学附属病院

Fukushima, Japan(RECRUITING)

秋田大学医学部附属病院

Akita, Japan(RECRUITING)

神奈川県立がんセンター

Yokohama, Kanagawa, Japan(RECRUITING)

独立行政法人国立病院機構北海道がんセンター

Sapporo, Hokkaido, Japan(RECRUITING)

National Cancer Center Hospital ( Site 2305)

Chūō, Tokyo, Japan(RECRUITING)

国立研究開発法人国立がん研究センター中央病院

Chūō, Tokyo, Japan(RECRUITING)

地方独立行政法人 静岡市立静岡病院

Sunto-gun, Shizuoka, Japan(RECRUITING)

千葉県がんセンター

Chiba, Japan(RECRUITING)

静岡県立静岡がんセンター

Sunto-gun, Shizuoka, Japan(RECRUITING)

社会医療法人 敬愛会 中頭病院

Okinawa, Japan(RECRUITING)

大阪大学医学部附属病院

Suita, Osaka, Japan(RECRUITING)

昭和医科大学病院

Shinagawa, Tokyo, Japan(RECRUITING)

名古屋市立大学病院

Nagoya, Aichi-ken, Japan(RECRUITING)