The aim of this prospective, randomized, multicenter, open-label, phase II study is to test if chemotherapy can be replaced by the combination of ribociclib plus letrozole as a neo-adjuvant therapy for patients with non-metastatic primary luminal breast cancer.

开始日期2019-06-15

申办/合作机构

Novartis AG

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100 项与来曲唑/琥珀酸瑞博西尼相关的临床结果

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100 项与来曲唑/琥珀酸瑞博西尼相关的转化医学

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100 项与来曲唑/琥珀酸瑞博西尼相关的专利（医药）

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项与来曲唑/琥珀酸瑞博西尼相关的文献（医药）

2024-12-31·Future Science OA

Gastric metastasis and peritoneal carcinosis revealing primary breast cancer: an unusual presentation

Article

作者: Zaimi, Yosra ; Mouelhi, Leila ; Safta, Amine Ben ; Ayadi, Shema ; Aloui, Raoudha ; Samaali, Imen ; Hammami, Mehdi ; Blel, Ahlem ; Monastiri, Souhir ; Kammoun, Mehdi

Breast cancer is the most frequent cancer among women. Gastrointestinal tract metastases are uncommon and might be misidentified as primary carcinoma. A noteworthy case-study involved 53-year-old-woman complaining from epigastric pain, ascites and overall health decline. Initial investigations were inconclusive, prompting laparoscopic peritoneal biopsies which revealed independent cell proliferation. Subsequently, a second look upper digestive endoscopy showed multiple gastric ulcerations suggestive of gastric carcinoma. Histologic examination confirmed independent cell proliferation with estrogen receptors expression, a characteristic feature of breast carcinoma. Further investigations led to bilateral invasive lobular breast carcinoma diagnosis. Epirubicin cycophosphamide was prescribed after progression under letrozole ribocilib therapy. This case aims to raise awareness among clinicians about the importance of ruling out breast cancer in patients with peritoneal carcinosis and paying attention to digestive symptoms in breast cancer patients with careful gastric endoscopic examination to avoid misdiagnosis.

2023-09-01·Journal of Oncology Pharmacy Practice

Toxic hepatitis in metastatic breast cancer patient using ribociclib and denosumab

Article

作者: Uçar, Gökhan ; Bayram, Doğan ; Aktürk Esen, Selin ; Köş, Fahriye Tuğba

Introduction Hepatotoxicity is observed due to cyclin-dependent kinase (CDK4/6) inhibitors used to treat hormone receptor-positive metastatic breast cancer. However, it should not be ignored that denosumab may be hepatotoxic, although it is rare. Case Report A 73-year-old female patient with breast cancer with axillary lymph node, adrenal gland and bone metastases was started on ribociclib letrozole and denosumab treatment. Ribociclib treatment was discontinued due to grade 4 hepatotoxicity during treatment, but liver function tests did not decrease. After discontinuation of denosumab treatment, alanine aminotransferase and aspartate aminotransferase values regressed to baseline values. Management and Outcome Despite the discontinuation of ribociclib treatment, other causes of liver toxicity were investigated due to persistence of hepatic transaminases and elevation. Autoimmune hepatitis markers were negative. Hepatobiliary USG did not reveal any pathological findings except hepatosteatosis. Liver biopsy was performed to determine the etiology. Pathology result was compatible with acute hepatocellular damage (in favor of toxic hepatitis). A decrease in liver values was detected after discontinuation of denosumab treatment. Discussion Although cases with improvement in liver enzymes have been reported after discontinuation of ribociclib, no improvement in hepatotoxicity was observed in our case. Since the liver biopsy was toxic hepatitis, it was thought that other drugs used by the patient might cause this toxicity, and a significant decrease was observed in liver values after discontinuation of denosumab. Denosumab-induced liver toxicity is very rare, and there are only a limited number of cases in the literature.

100 项与来曲唑/琥珀酸瑞博西尼相关的药物交易

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适应症	国家/地区	公司	日期
HR阳性/HER2阴性乳腺癌	美国	Novartis Pharmaceuticals Corp.	2017-05-04

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适应症	最高研发状态	国家/地区	公司	日期
HR阳性/HER2阴性乳腺癌	临床3期	美国	Sarah Cannon Research Institute LLC	2017-05-30
HR阳性/HER2阴性乳腺癌	临床3期	美国	Texas Oncology PA	2017-05-30

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


OncoDynamics project (EHA2019)	N/A	转移性乳腺癌	7	Ribociclib plus letrozole	簾獵憲鹽憲衊廠顧糧積(膚廠廠壓糧觸壓鑰遞願) = 4 patients (57,1%) had a sustained rise of the mean corpuscular volume (MCV > 97 fL) 膚淵夢憲獵遞繭餘憲積 (齋觸膚鏇鹽築觸顧鬱壓 )	-	2019-05-16