Patients with locally advanced (stage III) breast cancer (LABC) are characterized by a significantly worse prognosis compared to patients with primarily operable breast cancer. While neoadjuvant chemotherapy has been the first choice in this situation for several decades, recent evidence suggests that some patients may experience an extraordinary effect from neoadjuvant endocrine treatments involving aromatase inhibitors as monotherapy or in modern drug combinations.Selected LABC patients admitted for treatment will be offered combination therapy including letrozole and ribociclib. The overall goal of the project is to improve understanding of tumor responses and resistance in patients suffering from ER-positive/HER-2 negative locally advanced breast cancer, focusing on the role of the immune system including the gut microbiome.

开始日期2022-12-01

申办/合作机构

Akershus Universitetssykehus HF

[+2]

NCT03283384 / Active, not recruiting临床2期IIT

Tailoring NEOadjuvant Therapy in Hormone Receptor Positive, HER2 Negative, Luminal Breast Cancer.

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

[+1]

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）

2023-09-01·Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners

Toxic hepatitis in metastatic breast cancer patient using ribociclib and denosumab.

Article

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

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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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L01XE	-

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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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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03248427 (CORALLEEN, Pubmed \| Lancet Oncol) 人工标引	临床2期	PIK3CA突变/HR阳性/HER2阴性乳腺癌新辅助 HR positive \| HER2-negative	106	Ribociclib plus letrozole	鹽網膚糧糧鹽顧糧鹽膚(顧廠醖憲鑰鏇觸構蓋餘) = 積壓壓鑰鹹鏇選選憲齋網淵廠範淵獵構鑰壓網 (餘窪淵範鏇製簾鹽鏇夢, 32.5 ~ 61.7)	积极	2020-01-01
				doxorubicin+cyclophosphamide+paclitaxel	鹽網膚糧糧鹽顧糧鹽膚(顧廠醖憲鑰鏇觸構蓋餘) = 醖範壓鏇廠壓窪觸鹹積網淵廠範淵獵構鑰壓網 (餘窪淵範鏇製簾鹽鏇夢, 32.9 ~ 61.5)