更新于：2024-11-18

Tamoxifen Citrate

枸橼酸他莫昔芬

更新于：2024-11-18

概要

概要

基本信息

药物类型

小分子化药

别名

(Z)-2-(4-(1,2-Diphenyl-1-butenyl)phenoxy)-N,N-dimethylethanamine、(Z)-2-(para-(1,2-Diphenyl-1-butenyl)phenoxy)-N,N-dimethylamine、1-p-beta-Dimethylaminoethoxyphenyl-trans-1,2-diphenylbut-1-ene

+ [17]

靶点

作用机制

ERs拮抗剂(雌激素受体家族拮抗剂)

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

Mayne Pharma, Inc.AstraZeneca KK

苏州第壹制药有限公司

非在研机构

AstraZeneca PLCAstraZeneca Pharmaceuticals LP

最高研发阶段批准上市

首次获批日期

美国 (1977-12-30),

乳腺癌

最高研发阶段(中国)批准上市

特殊审评孤儿药 (欧盟)

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结构

分子式C32H37NO8

InChIKeyFQZYTYWMLGAPFJ-OQKDUQJOSA-N

CAS号54965-24-1

关联

392

项与枸橼酸他莫昔芬相关的临床试验

NCT06630325 / Not yet recruiting临床2期IIT

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART): Adaptive Clinical Treatment (ACT)

This phase II trial tests the how well a precision medicine approach (serial measurements of molecular and architectural response to therapy [SMMART])-adaptive clinical treatment [ACT]) works in treating patients with sarcoma, prostate, breast, ovarian or pancreatic cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). SMMART testing uses genetic and protein tests to learn how cancer changes and to understand what drugs may work against a person's cancer or why drugs stop working. These test results are reviewed by a group of physicians and scientists during a SMMART tumor board who then recommend precision therapy.

开始日期2025-01-01

申办/合作机构

OHSU Knight Cancer Institute

[+3]

NCT06434064 / Not yet recruiting临床2期IIT

A Pilot, Single-Arm, Phase II Trial of Tamoxifen Plus Pegylated Liposomal Doxorubicin in Patients With Metastatic Triple Negative Breast Cancer

This phase II trial tests how well tamoxifen and pegylated liposomal doxorubicin works in treating patients with triple negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or that has spread to nearby tissue or lymph nodes (locally advanced) and is unable to be operated on (inoperable). Tamoxifen works by blocking the effects of estrogen in the breast. This may help stop the growth of tumor cells that need estrogen to grow. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Liposomal doxorubicin is a form of the anticancer drug doxorubicin that is contained inside very tiny, fat-like particles. Liposomal doxorubicin may have fewer side effects and work better than other forms of the drug. Giving tamoxifen and pegylated liposomal doxorubicin together may work better in treating patients with metastatic or inoperable, locally advanced triple negative breast cancer than giving either of these drugs alone.

开始日期2024-11-30

申办/合作机构

Roswell Park Comprehensive Cancer Center

NCT06671912 / Not yet recruiting临床3期IIT

LoTam: a Randomized, Phase III Clinical Trial of Low-Dose Tamoxifen for Selected Patients with Molecular Low-Risk Early-Stage Breast Cancer

This phase III trial compares the effect of low dose tamoxifen to usual hormonal therapy, including aromatase inhibitors, in treating post-menopausal women with hormone positive, HER2 negative early stage breast cancer. Tamoxifen is in a class of medications known as antiestrogens. It blocks the activity of estrogen (a female hormone) in the breast. This may stop the growth of some breast tumors that need estrogen to grow. Aromatase inhibitors, such as anastrozole, letrozole, and exemestane, prevent the formation of estradiol, a female hormone, by interfering with an aromatase enzyme. Aromatase inhibitors are used as a type of hormone therapy to treat postmenopausal women with hormone-dependent breast cancer. Giving low dose tamoxifen may be more effective compared to usual hormone therapy in treating post-menopausal women with hormone-positive, HER2 negative early stage breast cancer.

开始日期2024-11-15

申办/合作机构

Alliance for Clinical Trials in Oncology

[+1]

100 项与枸橼酸他莫昔芬相关的临床结果

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100 项与枸橼酸他莫昔芬相关的转化医学

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100 项与枸橼酸他莫昔芬相关的专利（医药）

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19,841

项与枸橼酸他莫昔芬相关的文献（医药）

2024-12-31·The Journal of dermatological treatment

The impact of hormones in autoimmune cutaneous diseases

Review

作者: Lopes Almeida Gomes, Lais ; Werth, Adrienne J ; Thomas, Preethi ; Werth, Victoria P

INTRODUCTION:

Dermatomyositis, systemic and cutaneous lupus erythematosus have a significantly higher prevalence in women than men, emphasizing the relevance of exploring the relationship between sex hormones and autoimmune skin diseases. This review analyzes the interplay between sex hormones and these two skin diseases.

MATERIALS AND METHODS:

We performed an extensive literature search using the PubMed database from July to August 2023. Search terms included 'contraceptives', 'pregnancy', 'hormone replacement', 'tamoxifen', and 'aromatase inhibitors'.

RESULTS AND DISCUSSION:

This comprehensive literature review shows that there remains considerable debate regarding the use of hormonal contraceptives and hormonal replacement therapy in individuals with autoimmune skin conditions. Nonetheless, it is well established that their use is contraindicated in patients with antiphospholipid syndrome or when antiphospholipid antibodies are positive. Individuals experiencing disease flares and uncontrolled symptoms should also avoid these interventions. Pregnancy planning should be timed to coincide with well-managed disease states to minimize obstetric and neonatal complications. Hormonal breast cancer treatment requires close skin monitoring.

CONCLUSION:

Pregnancy, menopause, contraceptive use, hormone replacement therapy, and breast cancer treatment drugs result in substantial shifts in hormone levels. Additionally, hormone levels are altered by aromatase inhibitors and anti-estrogen medications. These fluctuations can modulate mechanisms influencing autoimmune skin abnormalities.

2024-12-01·Molecular biology reports

The effect of human umbilical cord mesenchymal stem cells conditioned medium combined with tamoxifen drug on BRCA1 and BRCA2 expression in breast cancer mouse models

Article

作者: Delashoub, Masoud ; Aval, Sedigheh Fekri ; Panahandeh, Ahmad Reza

BACKGROUND:

A growing number of studies has indicated that the expression of Breast Cancer Susceptibility Genes 1 (BRCA1) and BRCA2 contribute to the resistance to DNA-damaging chemotherapies. Tamoxifen induces tumor cell death by suppressing estrogen receptor (ER) signaling and inducing DNA damage, and BRCA1 upregulation causes Tamoxifen chemoresistance in breast cancer cells. Consequently, this research study aimed to investigate the possible therapeutic effect of Human Umbilical Cord Mesenchymal Stem Cells Conditioned Medium (UCMSCs-CM) on sensitizing breast cancer cells to Tamoxifen by regulating BRCA1 and BRCA2 expression in vivo.

METHODS:

Forty female mice, 4-8 weeks old, with weight of 150 g, were used for this study. Mouse 4T1 breast tumor models were established and then treated with UCMSCs-CM and Tamoxifen alone or in combination. After 10 days, the tumor masses were collected and the expression levels of BRCA1 and BRCA2 were evaluated using qRT-PCR assay.

RESULTS:

The results obtained from qRT-PCR assay illustrated that UCMSCs-CM, either alone or in combination with Tamoxifen, significantly downregulated the mRNA expression levels of BRCA1 in breast cancer mouse models. However, both UCMSCs-CM and Tamoxifen indicated no statistically significant impact on BRCA2 mRNA expression compared to controls.

CONCLUSION:

Our findings evidenced that UCMSCs-CM could be considered as a potential therapeutic option to modulate Tamoxifen chemosensitivity by regulating BRCA1 in breast cancer.

2024-11-01·BMJ supportive & palliative care3区 · 医学

Cognitive complaints during breast cancer endocrine therapy: aromatase inhibitors versus tamoxifen

3区 · 医学

Article

作者: Abdallah, Ichrak Ben ; Laabidi, Soumaya ; Boussen, Hamouda ; Rachdi, Haifa ; Mejri, Nesrine ; Berrazega, Yosra

Objective:

Previous data hypothesise that women receiving aromatase inhibitors (AIs) exhibit worse cognitive functioning than patients on tamoxifen (TAM) since their oestrogen levels are lower. We aimed to compare cognitive complaints in both groups.

Methods:

From September 2020 to January 2021, we conducted a cross-sectional study on patients with stage I–III breast cancer undergoing adjuvant endocrine therapy for at least 6 months. Cognitive complaints were assessed using the Functional Assessment of Cancer Therapy–Cognitive V.3 questionnaire with higher scores indicating better outcomes.

Results:

We included 108 female patients, 60 on AI and 48 on TAM. Mean age at diagnosis was 52 (44 in the TAM group vs 58 in the AI group, p<0.001). Assessment of ‘perceived cognitive impairment-20 subscale’ did not identify a significant difference between the two groups (mean score: patients on AI=63/80 vs patients on TAM=58/80, p=0.198). Patients on TAM scored significantly worse than patients on AI (p<0.001) on the concentration complaints, while for the verbal domain, memory, multitasking, speed and functional interference, no significant difference between the two groups was observed. The difference in concentration complaints was maintained after adjustment to age, educational level, physical activity, prior exposure to chemotherapy, and living alone or with others. Finally, a favourable impact of regular physical activity on concentration scores was observed in both groups (p<0.001).

Conclusion:

Despite age difference, patients on AI did not demonstrate worse complaints than patients on TAM. Patients on TAM exhibited significantly increased concentration complaints. Oncologists should carefully screen their patients for mental fog and educate them on the importance of regular exercise.

164

项与枸橼酸他莫昔芬相关的新闻（医药）

2024-11-05

·ioncology

SABCS 2024丨乳腺癌领域年终盛典将至，重磅研究汇总！

点击蓝字，关注我们编者按：第47届圣安东尼奥乳腺癌研讨会（SABCS）将于当地时间2024年12月10日至13日在美国得克萨斯州圣安东尼奥举行。日前，官网已公布摘要题目，肿瘤瞭望特将Late-Breaking Oral Presentations、General Session、Rapid Fire、Poster Spotlight Sessions等环节口头报告内容进行整理，敬请关注！ Late-Breaking Oral Presentations 时间：12月10日6:00 – 7:00 pm 地点：Stars at Night 1-2 主持人：Rita Nanda, University of Chicago Medicine, Chicago, Illinois LB1-01: Long-term effects of the omission of immediate surgery in operable breast cancer, or reduction of surgical extent: patient-level meta-analysis of the four randomised trials among 2,514 women. 可手术乳腺癌中省略即刻手术或缩小手术范围的长期影响：基于2514名女性的四项随机试验患者层面的荟萃分析讲者：Robert Hills, University of Oxford, Oxford, United Kingdom LB1-02: MARGOT/TBCRC052: A randomized phase II trial comparing neoadjuvant paclitaxel/margetuximab/pertuzumab (TMP) vs paclitaxel/trastuzumab/pertuzumab (THP) in patients (pts) with stage II-III HER2+ breast cancer. MARGOT/TBCRC052：一项随机II期临床试验，比较II-III期HER2阳性乳腺癌患者中新辅助治疗帕妥珠单抗/马吉妥昔单抗/紫杉醇（TMP）vs帕妥珠单抗/曲妥珠单抗/紫杉醇（THP）的疗效讲者：Adrienne Waks, Dana-Farber Cancer Institute, Boston, Massachusetts LB1-03: Primary results of the randomised Phase III trial comparing first-line ET plus palbociclib vs standard mono-chemotherapy in women with high risk HER2-/HR+ metastatic breast cancer and indication for chemotherapy - PADMA study. PADMA研究：比较高危HR+/HER2-转移性乳腺癌女性患者一线ET联合哌柏西利vs标准单药化疗的随机III期试验的主要结果讲者：Sibylle Loibl, German Cooperative Group, Neu-Isenburg, Germany LB1-04: Efficacy and safety of trastuzumab deruxtecan (T-DXd) vs physician’s choice of chemotherapy (TPC) by pace of disease progression on prior endocrine-based therapy: additional analysis from DESTINY-Breast06. 基于既往内分泌治疗的疾病进展速度，比较德曲妥珠单抗（T-DXd） vs医生选择的化疗（TPC）的疗效与安全性：来自DESTINY-Breast06的额外分析讲者：Aditya Bardia, UCLA David Geffen School of Medicine, Los Angeles, California LB1-05: ROSC (Neo)adjuvant nab-PAC weekly vs sb-PAC q2w, followed by EC q2w, in genomically or clinically high-risk HR+/HER- early breast cancer according to ET-response: final survival results from the WSG ADAPT-HR+/HER2- chemotherapy-trial. 在遗传或临床高危HR+/HER2-早期乳腺癌中，根据ET反应（新）辅助nab-PAC周疗 vs 每2周1次sb-PAC，随后每2周1次EC：WSG ADAPT-HR+/HER2-化疗试验最终生存结果讲者：Sherko Kuemmel, German Medical Institute, Limassol, Germany LB1-06: Primary results of SOLTI VALENTINE: neoadjuvant randomized phase II trial of HER3-DXd alone or in combination with letrozole for high-risk hormone receptor positive (HR+)/HER2-negative (neg) early breast cancer (EBC). SOLTI VALENTINE研究的主要结果：针对高风险HR+/HER2-早期乳腺癌（EBC），比较单独使用HER3-DXd或联合使用来曲唑新辅助治疗的随机II期试验讲者：Mafalda Oliveira, Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain LB1-07: Exploratory Biomarker Analysis of the Phase 3 KEYNOTE-522 Study of Neoadjuvant Pembrolizumab or Placebo Plus Chemotherapy Followed by Adjuvant Pembrolizumab or Placebo for Early-Stage TNBC. 3期KEYNOTE-522研究生物标志物探索性分析：对早期TNBC患者用帕博利珠单抗或安慰剂联合化疗进行新辅助治疗，随后用帕博利珠单抗或安慰剂进行辅助治疗讲者：Joyce O’Shaughnessy, Baylor-Sammons Cancer Center, Dallas, Texas General Session 1 时间：12月11日9:15 – 11:30 am 地点：Hall 1 GS1-01: Imlunestrant, an Oral Selective Estrogen Receptor Degrader (SERD), as Monotherapy and Combined with Abemaciclib, for Patients w/ ER+, HER2- Advanced Breast Cancer (ABC), Pretreated w/ Endocrine Therapy (ET): Results of the Phase 3 EMBER-3 trial. 口服选择性雌激素受体降解剂（SERD）Imlunestrant单药治疗及联合阿贝西利治疗既往接受内分泌治疗（ET）的雌激素受体阳性（ER+）、人表皮生长因子受体2阴性（HER2-）晚期乳腺癌（ABC）患者的疗效：III期EMBER-3研究结果讲者：Komal Jhaveri, Memorial Sloan Kettering Cancer Center, New York, New York GS1-03: Pyrotinib or placebo in combination with trastuzumab and docetaxel for untreated HER2-positive metastatic breast cancer (mBC): prespecified final analysis of progression-free survival (PFS) of the phase 3 PHILA trial. 吡咯替尼或安慰剂联合曲妥珠单抗和多西他赛用于未接受过治疗的HER2阳性转移性乳腺癌（mBC）：III期PHILA试验预设的无进展生存期（PFS）最终分析讲者：徐兵河（中国医学科学院肿瘤医院） GS1-04: HER2-Directed Antibody-Drug Conjugate SHR-A1811 in the Neoadjuvant Treatment of HER2-positive Early Breast Cancer: a Prospective, Randomized, Open-label, Phase 2 Trial. 靶向HER2的抗体-药物偶联物SHR-A1811用于HER2阳性早期乳腺癌的新辅助治疗：一项前瞻性、随机、开放标签的2期试验讲者：李俊杰（复旦大学附属肿瘤医院） GS1-06: PRO B – a superiority randomized controlled trial evaluating the effects of symptom monitoring in metastatic breast cancer patients. PRO B ——一项评估转移性乳腺癌患者症状监测效果的优效性随机对照试验讲者：Maria Margarete Karsten, Charité-Universitätsmedizin, Berlin GS1-08: Association between risk-reducing surgeries and survival in young BRCA carriers with breast cancer: results from an international cohort study. 年轻乳腺癌患者中BRCA携带者接受降低风险性手术与生存期之间的关联：一项国际队列研究结果讲者：Matteo Lambertini, University of Genova, Genova, Italy GS1-09: OlympiA- Phase 3, multicenter, randomized, placebo-controlled trial of adjuvant olaparib after (neo)adjuvant chemotherapy in patients w/ germline BRCA1/BRCA2 pathogenic variants & high risk HER2-negative primary breast cancer; longer term follow. OlympiA长期随访——一项针对携带胚系BRCA1/BRCA2致病性变异且高危HER2阴性原发性乳腺癌患者，在（新）辅助化疗后使用辅助奥拉帕利（olaparib）的III期、多中心、随机、安慰剂对照试验讲者：Judy Garber, Dana-Farber Cancer Institute, Boston, Massachusetts Rapid Fire 1 时间：12月11日12:00 – 12:50 pm 地点：Stars at Night 1-2 主持人：Moderator: Shom Goel, University of Melbourne Peter MacCallum Cancer Centre RF1-01: Effect of a weight loss intervention (WLI) on metabolic and inflammatory biomarkers in women with obesity and breast cancer: Results from the Breast Cancer Weight Loss (BWEL) Trial (Alliance). 减重干预（WLI）对肥胖合并乳腺癌女性的代谢和炎症生物标志物的影响：乳腺癌减重（BWEL）试验（Alliance）的结果讲者：Jennifer Ligibel, Dana-Farber Cancer Institute, Boston, Massachusetts RF1-02: Palbociclib plus letrozole versus weekly paclitaxel, both in combination w/ trastuzumab plus pertuzumab, as neoadjuvant treatment for patients w/ HR+/HER2+ early breast cancer: primary results from the randomized phase II TOUCH trial (IBCSG 55-17). 哌柏西利联合来曲唑对比周疗紫杉醇，两者均与曲妥珠单抗和帕妥珠单抗联用，作为HR+/HER2+早期乳腺癌患者的新辅助治疗：来自II期TOUCH随机试验（IBCSG 55-17）的主要结果讲者：Luca Malorni, USL Toscana Centro, Hospital of Prato, Prato, Italy RF1-03: Three-year event-free survival (EFS) of the multicenter phase II TRAIN-3 study evaluating image-guided optimization of neoadjuvant chemotherapy duration in stage II and III HER2-positive breast cancer (BOOG 2018-01). 多中心II期TRAIN-3研究评估了II期和III期HER2阳性乳腺癌（BOOG 2018-01）中基于影像引导的新辅助化疗持续时间优化的三年无事件生存率（EFS）讲者：Fleur Louis, Antoni van Leeuwenhoekziekenhuis, Amsterdam, Netherlands RF1-04: Long-Term Follow-up and updated analysis from S0221, Comparing Alternative Dose-Schedules of Adjuvant Anthracycline/Taxane Therapy in High-Risk Early Breast Cancer. S0221研究长期随访与更新分析：比较蒽环类/紫杉类辅助治疗高危早期乳腺癌的替代剂量方案讲者：Azka Ali, Rosalind Franklin University of Medicine and Science, North Chicago, Illinois RF1-05: DNA methylation patterns are similar in benign tissue from ipsilateral and contralateral breast while different from matched breast cancer, and healthy controls. 同侧与对侧乳房的良性组织中的DNA甲基化模式相似，但与配对的乳腺癌组织和健康对照组存在差异讲者：Saya Dennis, Northwestern University Feinberg School of Medicine, Chicago, Illinois RF1-06: Association of polygenic-based breast cancer risk prediction with patient management. 基于多基因的乳腺癌风险预测与患者管理的相关性讲者：Katie Johansen Taber, Myriad Genetics, San Francisco, California RF1-07: Multifactor analysis for pathologic complete response (pCR) in a chemotherapy-free regimen of durvalumab, trastuzumab, and pertuzumab (DTP Trial) in HER2-enriched early breast cancer. 在HER2过表达的早期乳腺癌中，不含化疗的度伐利尤单抗、曲妥珠单抗和帕妥珠单抗方案（DTP研究）的病理完全缓解（pCR）的多因素分析讲者：Bojana Stefanovska, UT Health Science Center, San Antonio, Texas General Session 2 时间：12月12日9:00–11:45 am 地点：Hall 1 GS2-01: Exclusive endocrine therapy or radiation therapy in women aged 70+ years with luminal-like early breast cancer (EUROPA): preplanned interim analysis of a randomized phase 3 trial. 随机3期EUROPA研究预先计划的期中分析：70岁以上luminal型早期乳腺癌女性患者单纯内分泌治疗或放疗的疗效讲者：Icro Meattini, University of Florence, Florence, Italy GS2-02: Impact of Tamoxifen Only after Breast Conservation Surgery for "Good Risk" Duct Carcinoma in Situ: Results from the NRG Oncology/RTOG 9804 and ECOG-ACRIN E5194 Trial “低风险”原位导管癌保乳术后仅采用他莫昔芬治疗的影响：NRG Oncology/RTOG 9804和ECOG-ACRIN E5194试验的结果讲者：Jean Wright, University of North Carolina School of Medicine, Chapel Hill, North Carolina GS2-03: Does postmastectomy radiotherapy in 'intermediate-risk' breast cancer impact overall survival? 10-year results of the BIG 2-04 MRC SUPREMO randomised trial: on behalf of the SUPREMO trial investigators. “中危”乳腺癌患者术后放疗是否影响总生存期？BIG 2-04 MRC SUPREMO随机试验10年结果：代表SUPREMO试验研究者讲者：Ian Kunkler, Edinburgh Cancer Centre, University of Edinburgh, Edinburgh, Scotland GS2-05: Early Oncologic Outcomes Following Active Monitoring or Surgery (+/- Radiation) for Low Risk DCIS: the Comparing an Operation to Monitoring, with or without Endocrine Therapy (COMET) Study (AFT-25). 低危导管原位癌（DCIS）患者主动监测或手术（±放疗）后的早期肿瘤学结局：比较手术与监测伴或不伴内分泌治疗（COMET）研究（AFT-25）讲者：Eun-Sil Hwang, Duke University School of Medicine, Durham, North Carolina GS2-06: Patient Reported Outcomes Following Active Monitoring or Surgery (+/- Radiation) for Low Risk DCIS in the Comparing an Operation to Monitoring, with or without Endocrine Therapy (COMET) Study (AFT-25). 低危导管原位癌（DCIS）患者主动监测或手术（±放疗）后的患者报告结局：比较手术与监测伴或不伴内分泌治疗（COMET）研究（AFT-25）讲者：Ann Partridge, Dana-Farber Cancer Institute, Boston, Massachusetts GS2-07: No axillary surgery versus axillary sentinel lymph node biopsy in patients with early invasive breast cancer and breast-conserving surgery: Final primary results of the Intergroup-Sentinel-Mamma (INSEMA) trial. 早期浸润性乳腺癌患者不接受腋窝手术vs接受保乳手术的腋窝前哨淋巴结活检比较：INSEMA（intergroup sentinel - mamma）试验的最终主要结果讲者：Toralf Reimer, Universitätsmedizin Rostock, Rostock, Germany GS2-09: Overweight, obesity and prognosis in 206,904 women in the Early Breast Cancer Trialists’ Collaborative Group (EBCTCG) database. 早期乳腺癌试验协作组（Early Breast Cancer trials’Collaborative Group，EBCTCG）数据库中206904名女性的超重、肥胖和预后情况讲者：Hongchao Pan, University of Oxford, Oxford, United Kingdom GS2-10: A long-term image-derived AI risk model for primary prevention of breast cancer. 用于乳腺癌一级预防的基于长期图像衍生的AI风险模型讲者：Mikael Eriksson, Karolinska Institutet, Solna, Sweden GS2-11: APOBEC3 mutagenesis induces resistance-promoting genomic alterations in breast cancer. APOBEC3突变诱导乳腺癌中促进耐药的基因组改变讲者：Avantika Gupta, Memorial Sloan Kettering Cancer Center, New York, New York Rapid Fire 2 时间：12月12日12:00 – 12:50 pm 地点：Hall 1 主持人：Carlos Arteaga, UT Southwestern, Dallas, Texas RF2-01: Factors Influencing Additional Nodal Disease and Pathologic Nodal Upstaging with Axillary Dissection in Patients with Residual Node-Positive Breast Cancer After Neoadjuvant Chemotherapy Enrolled on Alliance A011202 Clinical Trial. Alliance A011202临床试验纳入的新辅助化疗后残留淋巴结阳性乳腺癌患者中，腋窝清扫术对额外淋巴结病变和病理性淋巴结分期上调的影响因素讲者：Judy Boughey, Mayo Clinic, Rochester, Minnesota RF2-02: Axillary surgery after neoadjuvant systemic therapy (NST) for early-stage breast cancer – Treatment algorithms and prognostic impact of residual micrometastases in five neoadjuvant studies. 早期乳腺癌新辅助全身治疗（NST）后的腋窝手术——5项新辅助治疗研究中残留微转移的治疗路径和预后影响讲者：Johannes Holtschmidt, VP Medicine & Research GBG Forschungs GmbH RF2-03: Diagnostic performance of axillary ultrasound after neoadjuvant chemotherapy in initially node-positive breast cancer patients – results from the prospective AXSANA registry trial (NCT04373655). 初诊淋巴结阳性乳腺癌患者新辅助化疗后行腋窝超声的诊断效能——来自前瞻性AXSANA注册试验（NCT04373655）的结果讲者：Steffi Hartmann, University of Rostock, Rostock, Germany RF2-04: Ultrahypofractionated versus conventional fractionated sequential boost after whole-breast radiation therapy in breast cancer patients. One-year cosmetic outcomes of a randomized, controlled, phase 3 trial (ULTIMO). 乳腺癌患者全乳放疗后超大分割vs常规分割序贯加量疗效对比：一项随机、对照、3期试验（ULTIMO）1年美容效果讲者：Melanie Machiels, Universiteit Antwerpen, Antwerp, Belgium RF2-05: Validation of the association between TILs, ER status and benefit of radiotherapy in node positive, breast cancer patients: a DBCG study. DBCG研究：验证TILs、ER状态与淋巴结阳性乳腺癌患者放疗获益之间的关系讲者：Demet Özcan, Aarhus University Hospital, Aarhus, Denmark RF2-06: A Nationwide Double-Blind Phase III RCT Comparing Olanzapine and Prochlorperazine for Refractory Chemotherapy-Induced Nausea in NCORP Community Practices. 一项全国性、双盲、III期、随机对照试验（RCT），比较NCORP社区实践中奥氮平和丙氯拉嗪治疗化疗导致的难治性恶心讲者：Luke Peppone, University of Rochester Medical Center, Rochester, New York General Session 3 时间：12月13日9:00–11:45 am 地点：Hall 1 GS3-01: Circulating tumor DNA surveillance in ZEST, a randomized, phase 3, double-blind study of niraparib or placebo in patients w/ triple-negative breast cancer or HER2+ BRCA-mutated breast cancer with molecular residual disease after definitive therapy. ZEST是一项随机、3期、双盲研究，在尼拉帕利或安慰剂进行根治性治疗后有分子残留病变的三阴性乳腺癌或HER2+ BRCA突变乳腺癌患者中对循环肿瘤DNA进行监测。讲者：Nicholas Turner, Ralph Lauren Centre for Breast Cancer Research, London, United Kingdom GS3-03: Impact of Anthracyclines in High Genomic Risk Node-Negative HR+/HER2- Breast Cancer. 蒽环类药物对高基因组风险淋巴结阴性HR+/HER2-乳腺癌的影响讲者：Nan Chen, University of Chicago Medicine, Chicago, Illinois GS3-04: (Neo)adjuvant nab-PAC weekly vs sb-PAC q2w, followed by EC q2w, in genomically or clinically high-risk HR+/HER2- early breast cancer according to ET-response: final survival results from the WSG ADAPT-HR+/HER2- chemotherapy-trial. 在遗传或临床高危HR+/HER2-早期乳腺癌中，根据ET反应（新）辅助nab-PAC周疗 vs 每2周1次sb-PAC，随后每2周1次EC：WSG ADAPT-HR+/HER2-化疗试验最终生存结果讲者：Sherko Kuemmel, German Medical Institute, Berlin, Germany GS3-05: NSABP B-59/GBG-96-GeparDouze: A randomized double-blind phase III clinical trial of neoadjuvant chemotherapy with atezolizumab or placebo followed by adjuvant atezolizumab or placebo in patients with Stage II and III triple-negative breast cancer. NSABP B-59/GBG-96-GeparDouze：一项针对II期和III期三阴性乳腺癌患者的随机双盲III期临床试验，比较新辅助化疗联合阿替利珠单抗或安慰剂，随后辅助使用阿替利珠单抗或安慰剂的效果讲者：Charles Geyer, University of Pittsburgh, Pittsburgh, Pennsylvania GS3-06: Neoadjuvant camrelizumab plus chemotherapy (chemo) for early or locally advanced triple-negative breast cancer (TNBC): a randomized, double-blind, phase 3 trial. 卡瑞利珠单抗联合化疗（chemo）新辅助治疗早期或局部晚期三阴性乳腺癌（TNBC）：一项随机、双盲、3期试验讲者：邵志敏（复旦大学附属肿瘤医院） GS3-08: In situ detection of individual classical MHC-I gene products in breast cancer identifies gene- and subtype-specific biased antigen presentation loss. 在乳腺癌中原位检测单个经典MHC-I基因产物，可识别出基因和亚型特异性的特异性抗原呈递缺失讲者：Paula Gonzalez-Ericsson, Vanderbilt-Ingram Cancer Center, Nashville, Tennessee GS3-09: Multimodal integration of real world clinical and genomic data for the prediction of CDK4/6 inhibitors outcomes in patients with HR+/HER2- metastatic breast cancer. 真实世界临床和基因组数据的多模态整合用于预测CDK4/6抑制剂在HR+/HER2-转移性乳腺癌患者中的结局讲者：Enrico Moiso, Memorial Sloan Kettering Cancer Center, New York, New York GS3-10: Paired DNA and RNA analysis of CALGB 40603 (Alliance) reveals insights into the molecular and prognostic landscape of stage II-III triple-negative breast cancer. 配对的DNA和RNA分析CALGB 40603（Alliance）揭示了II-III期三阴性乳腺癌的分子和预后特征讲者：Brooke Felsheim, UNC School of Medicine, Chapel Hill, North Carolina Rapid Fire 3 时间：12月13日12:00 – 12:50 pm 地点：Hall 1 主持人：Peter Fasching, University Hospital Erlangen and Comprehensive Cancer Center Erlangen-EMN, Germany RF3-01: TBCRC 056: A phase II study of neoadjuvant niraparib with dostarlimab for patients with BRCA- or PALB2-mutated breast cancer: Results from the ER+/HER2- cohort. TBCRC 056研究ER+/HER2-队列的结果：一项尼拉帕利联合dostarlimab新辅助治疗BRCA突变或PALB2突变乳腺癌患者的II期研究讲者：Erica Mayer, Dana-Farber Cancer Institute, Boston, Massachusetts RF3-02: Efficacy of adjuvant avelumab by PD-L1, tumor infiltrating lymphocytes and residual cancer burden in high-risk triple negative breast cancer: secondary and exploratory endpoints of the phase III A-BRAVE trial. 基于PD-L1、肿瘤浸润淋巴细胞和残余肿瘤负荷对高危三阴性乳腺癌进行阿维鲁单抗辅助治疗的疗效：III期A-BRAVE研究的次要和探索性终点讲者：Maria Vittoria Dieci, University of Padua, Padua, Italy RF3-03: Nivolumab + Ipilimumab (NIVO+IPI) compared to capecitabine for triple-negative breast cancer patients with residual disease after neoadjuvant chemotherapy – Final results of BreastImmune-03, a multicenter randomized open-label phase II trial. 纳武利尤单抗+伊匹木单抗（NIVO+IPI）与卡培他滨在新辅助化疗后有残留病变的三阴性乳腺癌患者中的疗效比较——多中心随机开放标签II期试验BreastImmune-03的最终结果讲者：Olivier Trédan, Centre Lèon Bèrard, Lyon, France RF3-04: NRG-BR004: A Randomized, Double-blind, Phase III Trial of Taxane/Trastuzumab/Pertuzumab with Atezolizumab or Placebo in First-line HER2-positive Metastatic Breast Cancer. NRG-BR004：紫杉烷/曲妥珠单抗/帕妥珠单抗联合阿替利珠单抗或安慰剂一线治疗HER2阳性转移性乳腺癌的随机、双盲、III期试验讲者：Vicente Valero, MD Anderson Cancer Center, Houston, Texas RF3-05: A Phase 2 Study of Neoadjuvant HER2-targeted Therapy +/- Immunotherapy with Pembrolizumab (neoHIP). 新辅助HER2靶向治疗±帕博利珠单抗免疫治疗的2期研究（neoHIP）讲者：Heather McArthur, UT Southwestern Medical Center, Dallas, Texas RF3-06: Mepitel Film for the Reduction of Radiation Dermatitis in Post-mastectomy Radiation Therapy: Results from Alliance A221803: A Multicenter Phase III Randomized Clinical Trial Mepitel贴膜在减少乳腺癌术后放疗所致放射性皮炎中的应用：Alliance A221803多中心III期随机临床试验结果讲者：Kimberly Corbin, Mayo Clinic, Rochester, Minnesota RF3-07: ROSCO:Response to Optimal Selection of neoadjuvant Chemotherapy in Operable breast cancer: A randomised phase III, stratified biomarker trial of neoadjuvant 5-Fluorouracil, Epirubicin & Cyclophosphamide vs Docetaxel & Cyclophosphamide chemotherapy. ROSCO研究：随机III期、分层生物标志物试验，比较新辅助5-氟尿嘧啶、表柔比星与环磷酰胺vs多西他赛和环磷酰胺化疗方案，评估可手术乳腺癌新辅助化疗最优选择反应。讲者：Daniel Rea, University of Birmingham, Birmingham, United Kingdom Poster Spotlight Sessions ▌Concurrent Poster Spotlight Sessions 1, 3-5, 7 Session 1: New Insights into Immune Biomarkers（免疫生物标志物的新见解）时间：12月11日7:00 – 8:30 am 地点：Room 221ABC 主持人：David Rimm, Yale University Session 3: Highlights on Novel Therapeutics（新型治疗亮点）时间：12月11日7:00 – 8:30 am 地点：Stars at Night 1-2 主持人：Sara Tolaney, Dana-Farber Cancer Institute Session 4: Prediction of Chemotherapy Response（化疗疗效预测）时间：12月11日7:00 – 8:30 am 地点：Stars at Night 3-4 主持人：Sherene Loi, Peter Macallum Cancer Centre Session 5: The Heart of the Matter - Improving Adverse Effects（核心问题-改善不良反应）时间：12月11日7:00 – 8:30 am 地点：Hemisfair Ballroom 3 主持人：Anne Blaes, Masonic Cancer Center University of Minnesota Session 7: Targeting the ER and PI3K pathway: Novel drugs and combinations（靶向ER和PI3K通路：新型药物和组合）时间：12月11日7:00 – 8:30 am 地点：Hemisfair Ballroom 1-2 主持人：Shom Goel, Peter MacCallum Cancer Centre ▌Concurrent Poster Spotlight Sessions 2, 6, 8, 9 and 15 Session 2: Personalizing CDK 4/6 inhibitor therapy for patients with Metastatic Breast Cancer: Survival, QOL and biomarkers（转移性乳腺癌患者的个体化CDK 4/6抑制剂治疗：生存期、生活质量和生物标志物）时间：12月12日7:00 – 8:30 am 地点：Hemisfair Ballroom 1-2 主持人：Lisa Carey, Lineberger Comprehensive Cancer Center University of North Carolina Session 6: Locoregional Therapy（局部区域治疗）时间：12月12日7:00 – 8:30 am 地点：Room 221ABC 主持人：Mylin Torres, Winshop Cancer Institute of Emory University Session 8: Novel HER2 Therapeutics（新型HER2治疗）时间：12月12日7:00 – 8:30 am 地点：Stars at Night 1-2 主持人：Ian Krop, Yale School of Medicine Session 9: ctDNA uses for Minimal Residual Disease testing, tumor evolution, and novel technologies（ctDNA用于微小残留病检测、肿瘤进化和新技术）时间：12月12日7:00 – 8:30 am 地点：Stars at Night 3-4 主持人：Charles Perou, Lineberger Comprehensive Cancer Center University of North Carolina Session 15: Survivorship – Biomarker predictors and other survival-associated factors（生存-生物标志物预测和其他生存相关因素）时间：12月12日7:00 – 8:30 am 地点：Room 221ABC 主持人：Lindsay Peterson, Washington University Siteman Cancer Center, St. Louis, Missouri ▌Concurrent Poster Spotlight Sessions 10-14 Session 10: Addressing Racial Disparities in Breast Cancer Outcomes（探讨乳腺癌结局的种族差异）时间：12月13日7:00 – 8:30 am 地点：Hemisfair Ballroom 3 主持人：Yara Abdou, University of North Carolina School of Medicine Session 11: Imaging to Guide Breast Cancer Treatment – Molecular Imaging and AI（影像学指导乳腺癌治疗——分子影像学和人工智能）时间：12月13日7:00 – 8:30 am 地点：Hemisfair Ballroom 1-2 主持人：David Mankoff, Perelman School of Medicine University of Pennsylvania Session 12: Immunobiology Impact on Therapeutic Efficacy（免疫生物学对治疗效果的影响）时间：12月13日7:00 – 8:30 am 地点：Room 221ABC 主持人：Lajos Pusztai, Yale School of Medicine, New Haven, Connecticut Session 13: Molecular determinants of therapeutic response and resistance - Spotight on CDK 4/6i and ADCs （治疗反应和耐药的分子决定因素——聚焦CDK4/6i和ADCs）时间：12月13日7:00 – 8:30 am 地点：Stars at Night 1-2 主持人：Aditya Bardia, UCLA David Geffen School of Medicine, Los Angeles, California Session 14: Brain Metastasis（脑转移）时间：12月13日7:00–8:30 am 地点：Stars at Night 3-4 主持人：William Gradishar, Northwestern University Feinberg School of Medicine, Chicago, Illinois （来源：《肿瘤瞭望》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

临床结果临床2期抗体药物偶联物

2024-11-05

·奇点网

《细胞》子刊：肥胖致胰岛素抵抗的原因，竟然搞错了？科学家发现问题主要在大脑对营养过剩“反应过激”

*仅供医学专业人士阅读参考胰岛素抵抗这个词，想必大家已经不陌生了。胰岛素抵抗是糖尿病的先兆，这意味着细胞已经不能响应胰岛素发挥相关功能，无法正常下调血糖，在不断的恶性循环中导致糖尿病。传统观点认为，肥胖导致的胰岛素抵抗主要来自于胰岛素信号系统的损伤，但近期发表在《细胞·代谢》杂志上的一篇论文却指出，这事儿怪不了胰岛素不努力，而是我们的大脑反应太“过激”。罗格斯大学Christoph Buettner团队的研究结果发现，高脂饮食会过度激活交感神经系统（SNS），导致去甲肾上腺素（NE）等儿茶酚胺（CA）类神经递质大量释放，触发了脂肪组织分解，并导致后续的代谢障碍。当研究者减少了小鼠的SNS儿茶酚胺释放，小鼠即使吃着高脂的食物、猛猛长胖，却也不会出现胰岛素抵抗和脂肪肝等代谢障碍问题。论文题图肥胖是2型糖尿病的主要风险因素之一。相较正常体重个体，超重个体患糖尿病风险超过3倍，肥胖个体风险更是10倍以上。而糖尿病的发生更是非常隐匿的，在肥胖出现之前，就能够以胰岛素抵抗的形式悄悄潜伏，带来葡萄糖不耐、脂肪组织功能障碍、肝脂肪变性等问题。传统观点认为，这首先是靶组织中胰岛素信号传导出了问题，但这与实际情况却产生了一定的分歧。有研究结果发现，胰岛素信号受损并不能够完全解释胰岛素抵抗，在肥胖早期，细胞胰岛素信号通路还完好的阶段，胰岛素已经不能在肝脏和脂肪等靶组织中起效了。 Christoph Buettner一直都非常关注大脑调节代谢和其中胰岛素的作用，他想到了另外一条有关的通路，交感神经系统。交感神经系统通过去甲肾上腺素等儿茶酚胺类神经递质参与调控代谢，它还控制胰高血糖素释放与胰岛素打擂台。不过交感神经系统具体拿的什么剧本我们并不清楚。既往研究交感神经作用普遍依赖于切除模型，本次研究中则使用了一种新的模式小鼠（ TH△per），这种小鼠可以用他莫昔芬诱导条件敲除酪氨酸羟化酶，使外周组织的交感儿茶酚胺水平显著降低90%以上，但中枢水平维持不变，如此避免了旧模型的潜在问题。研究者给小鼠实行了短期增肥计划，鼠粮换成了富含脂肪的高脂饮食（HFD）。有趣的事情发生了， TH△per小鼠和对照的正常小鼠同样大吃大喝、同样长胖不少、空腹胰岛素水平相当，但 TH△per小鼠空腹血糖、葡萄糖耐受等指标并未像对照组小鼠一样恶化。 TH△per小鼠并未因短期高脂饮食导致胰岛素抵抗研究者分析发现，高脂饮食简直就是交感神经系统的“鸡血”，短期高脂饮食就能够迅速提升交感神经活动，导致去甲肾上腺素的大量释放，促进脂肪组织分解，血浆甘油三酯水平升高。持续高脂饮食喂养12周， TH△per小鼠仍旧就维持了胖但健康的状态，而对照组小鼠已经脂肪肝、胰岛素抵抗、炎症、甚至肝纤维化几毒俱全了。 HFD对照小鼠出现了明显的肝脂肪变性和炎症由此来看，交感神经在代谢中的作用还真够重要的，以交感神经作为靶点或许能够有一些效果非常出色的药物出现。不过既往的肾上腺素能阻滞剂大多并没有表现出什么对肥胖患有有益的效果，研究者猜想作用靶点可能还得再仔细研究研究。另外，高脂饮食到底是怎么让交感神经这么“过激”的，目前我们也没搞清楚。研究者准备从神经递质在其他疾病中的作用下手，寻找新的契机。参考资料： [1]https://www-cell-com.libproxy1.nus.edu.sg/cell-metabolism/abstract/S1550-4131(24)00376-0 [2]https://www-nature-com.libproxy1.nus.edu.sg/articles/d41586-024-03513-z 本文作者 | 代丝雨

AHA会议

2024-10-26

·ioncology

SIBCS 2024丨范蕾教授：乳腺癌辅助治疗的进展和争议

点击上方蓝字关注我们编者按：乳腺癌是全球女性最常见的恶性肿瘤之一，其治疗模式的不断进步为众多患者带来了新的希望。在2024年SIBCS大会上的“第四届3C高峰论坛——2025乳腺癌指南小红书修订前沿速写”环节，复旦大学附属肿瘤医院范蕾教授带来了“乳腺癌辅助治疗的进展和争议”的报告，从乳腺癌的三个主要分型出发，详细探讨了不同类型乳腺癌在辅助治疗方面的最新研究成果与存在的争议。本文特将讲课内容进行整理，以飨读者。范蕾教授根据乳腺癌的分子分型，从Luminal亚型乳腺癌、三阴性乳腺癌（TNBC）、HER2阳性乳腺癌三个亚型分别介绍了当前辅助治疗的进展和争议。 PART/1 Luminal亚型乳腺癌的辅助治疗进展及争议 Luminal亚型乳腺癌占所有乳腺癌的60%～70%，内分泌治疗为主要治疗手段。临床实践中，会根据患者的治疗风险进行分层，化疗的降阶梯治疗以及不同类型药物的引入（如CDK4/6抑制剂、PARP抑制剂），使得该亚型患者个体化治疗更加精准。范蕾教授介绍道，monarchE研究和NATALEE研究是评估CDK4/6抑制剂在Luminal亚型乳腺癌辅助治疗中疗效的两项重要研究，但这两项研究在试验设计及研究结果上存在一定差异。monarchE研究纳入的是早期高危HR+/HER2-乳腺癌患者，包括腋窝淋巴结转移≥4枚或1-3枚腋窝阳性淋巴结且伴有高危因素（如组织学分级3级、肿瘤直径≥5cm或Ki-67≥20%）的患者。monarchE研究3年iDFS绝对值差值为4.8%，随着随访时间的延长，5年iDFS绝对值差值扩大至7.6%。 NATALEE研究则纳入了更多N0（无淋巴结转移）的患者，包括IIA期：全部的N1的患者和部分合并高危因素的N0患者（G3或G2伴以下高危因素之一：Ki67≥20%、基因检测为高风险）；IIB期（N0/N1）和所有的III期患者。但研究结果显示，瑞波西利在N0患者中也显示出了一定的疗效。随着NATALEE研究4年随访数据的公布，其绝对获益在全部人群中达到了4.9%，N0人群的获益更是扩大到了5.1%。范蕾教授提到，尽管CDK4/6抑制剂在Luminal亚型乳腺癌患者辅助治疗中显示出了显著疗效，但其应用仍存在一些争议。 1、N0人群的治疗选择：NATALEE研究中仅入组了部分N0患者（约15%），而在真实世界中，Luminal亚型乳腺癌患者人群中N0患者占比高达60%～70%。因此，对于N0患者如何精准选择CDK4/6抑制剂治疗是一个重要问题。 2、内分泌治疗时长：随着CDK4/6抑制剂的加入，内分泌治疗的时长是否需要调整也是值得探讨的问题。对于相对风险偏低的患者，特别是N1人群，能否进一步缩短治疗时长？ 3、CDK4/6抑制剂耐药后的治疗选择：如何定义CDK4/6抑制剂的耐药人群和时间？耐药后应如何选择后续治疗方案？ 4、化疗降阶梯：对于绝经前中危患者，特别是21基因评分为16～25分的患者，化疗的获益程度仍存在争议。 PART/2 三阴性乳腺癌免疫治疗进展及争议三阴性乳腺癌（TNBC）因其独特的临床特征和免疫原性，一直都是临床研究的热点。近年来，免疫治疗在TNBC领域取得了显著进展。KEYNOTE-522研究总生存数据的公布，为我们展示了新辅助到辅助免疫治疗地位的确立和进一步的人群优化。但三阴性乳腺癌新辅助免疫治疗的多项临床研究中，患者临床获益和生存结果之间存在差异，仍需要具体分析免疫治疗的疗效。 KEYNOTE-522研究是一项评估新辅助帕博利珠单抗联合化疗序贯帕博利珠单抗单药辅助治疗早期TNBC的Ⅲ期研究。该研究于2024年ESMO大会上公布了中位随访5年的总生存数据，结果显示，新辅助免疫治疗显著提高了患者的无事件生存期（EFS）和总生存期（OS）。特别是对于非病理学完全缓解（non-pCR）的人群，OS获益更为显著。范蕾教授总结道，免疫治疗具有长生存获益的持久应答特点，其给患者带来的不是暴风骤雨式的疗效，而是绵绵细雨式的持续生存改善。因此，对于TNBC患者的免疫治疗，建议应将总生存纳入到统计学设计当中。未来免疫治疗的探索方向包括： 1、免疫药物使用时机：新辅助免疫治疗效果要优于晚期和早期辅助治疗，这是目前的共识。因此，把握好使用时机才能让患者有最大获益。 2、免疫药物的配伍：对于pCR人群，是否需要配伍其他新型药物，是未来探索的一个重要方向。 3、患者选择：挑选肿瘤负荷更高的患者进行免疫治疗，可能会带来更好的疗效。范蕾教授表示，复旦大学附属肿瘤医院目前正在进行的COSMOS研究，入组了Ⅱ期～Ⅲ期的TNBC患者，探索免疫联合抗血管生成药物的治疗疗效，以期能在早期高危患者人群中带来新的治疗选择，期待更多数据结果的公布。 PART/3 HER2阳性乳腺癌的治疗进展 HER2阳性乳腺癌的治疗进展相对较少，但2024年也有两项研究为这一亚型患者的治疗提供了新的启示。 WSG-TP-II研究是一项探索HR阳性/HER2阳性乳腺癌降阶梯治疗的Ⅱ期研究。研究结果显示，无论是内分泌联合双靶还是化疗联合双靶，在4个周期（12周）的治疗后，患者都取得了非常优异的5年生存结果。这一结果提示我们，在逐步进行辅助强化治疗的时代，降阶治疗仍然具有非常重要的意义。期待COMPASS-HER2-pCR/RD、PHERGAIN-II等研究继续为我们提供更多降阶梯治疗的研究数据。 HERA研究对绝经前HR阳性/HER2阳性的三阳性乳腺癌患者进行了卵巢功能抑制（OFS）联合治疗的分析。在这项研究中，共分析了965例患者，其中501例患者（51.9%）只接受他莫昔芬治疗，464例患者（48.1%）接受含OFS的内分泌治疗（他莫昔芬[n=269，27.9%]或依西美坦[n=195，20.2%]）。结果显示，OFS+内分泌治疗优于单药内分泌治疗，同时OFS联合芳香化酶抑制剂（AI）疗效也优于OFS联合他莫昔芬（TAM）。这一结果再次提示我们，HR阳性/HER2阳性乳腺癌患者的内分泌治疗依然非常重要。范蕾教授提到，HER2阳性乳腺癌患者治疗领域仍存在一些争议，如三阳性乳腺癌患者的降阶梯治疗、内分泌治疗选择等；随着ADC药物在乳腺癌患者中的逐步应用，期待其能否改变当前早期乳腺癌患者的治疗格局。 PART/4 争议与展望尽管乳腺癌的辅助治疗取得了显著的进展，但仍存在一些争议和未解决的问题。例如，在Luminal亚型乳腺癌中，如何精准选择N0患者进行CDK4/6抑制剂治疗、内分泌治疗时长的调整、CDK4/6抑制剂耐药后的治疗选择等问题仍需进一步探讨。在三阴性乳腺癌中，免疫治疗的最佳时机、患者选择以及治疗方案的优化等问题也亟待解决。在HER2阳性乳腺癌治疗领域，三阳性乳腺癌患者的降阶梯治疗、内分泌治疗选择、ADC药物的应用等都是值得我们探索的。未来，随着新型药物的不断涌现和临床研究的不断深入，我们期待能够为乳腺癌患者提供更加精准和有效的个体化治疗方案。同时，我们需要更加深入地探索乳腺癌的发病机制和生物学特性为患者提供更加精准和有效的治疗方案。范蕾教授复旦大学附属肿瘤医院乳腺外科副主任医师，硕导复旦大学肿瘤学博士，硕士生导师中国抗癌协会乳腺癌专业委员会青委委员中华医学会肿瘤学分会乳腺学组青委委员上海女医师协会乳腺专业委员会副主委上海市医学会肿瘤靶分子分会青委副主委中国抗癌协会国际医疗交流分会委员上海市抗癌协会乳腺癌专委会青委委员上海市医学会心身医学专委会委员上海女医师协会科普委员会委员哈佛大学医学院麻省总医院肿瘤中心Fellow 主持及参与国家级及上海市级基金多项 SCI收录论文30余篇，第一及通讯作者文章20余篇，收录于《柳叶刀肿瘤》《JAMA Oncol》等（来源：《肿瘤瞭望》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

临床结果临床成功临床2期临床3期

100 项与枸橼酸他莫昔芬相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00966	枸橼酸他莫昔芬	L02BA01	DB00675

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
ER阳性乳腺癌	美国	Mayne Pharma, Inc.	2018-09-25
非浸润性导管内癌	美国	Mayne Pharma, Inc.	2005-10-29
乳腺癌	美国	AstraZeneca Pharmaceuticals LP	1977-12-30

未上市

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适应症	最高研发状态	国家/地区	公司	日期
男子乳腺发育	临床3期	意大利	AstraZeneca PLC	2003-12-01
前列腺癌	临床3期	意大利	AstraZeneca PLC	2003-12-01
HR阳性乳腺癌	临床3期	奥地利	AstraZeneca PLC	1996-01-01
早期乳腺癌	临床3期	-	AstraZeneca PLC	1990-12-01
膀胱癌	临床2期	美国	AstraZeneca PLC	2007-01-01
膀胱癌	临床2期	意大利	AstraZeneca PLC	2007-01-01
痴呆	临床2期	美国	AstraZeneca PLC	2007-01-01
痴呆	临床2期	意大利	AstraZeneca PLC	2007-01-01
尿路上皮癌	临床2期	美国	AstraZeneca PLC	2007-01-01
尿路上皮癌	临床2期	意大利	AstraZeneca PLC	2007-01-01

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临床结果

适应症

分期

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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


NCT01124695 (ECOG-ACRIN E3108, Pubmed \| Breast Cancer Res Treat) 人工标引	临床2期	转移性乳腺癌 CYP2D6	85	tamoxifen (CYP2D6 poor metabolizer)	鏇齋餘積憲積壓齋積築(網襯鬱糧齋獵獵衊網鏇) = 醖窪繭簾齋糧鹹糧鹹齋繭願壓範衊鏇廠積鏇襯 (願廠網製鏇鏇鬱廠壓鏇 )	不佳	2024-10-21
				tamoxifen (CYP2D6 intermediate and normal metabolizer)	鏇齋餘積憲積壓齋積築(網襯鬱糧齋獵獵衊網鏇) = 觸鑰窪鬱顧淵鹽蓋齋顧繭願壓範衊鏇廠積鏇襯 (願廠網製鏇鏇鬱廠壓鏇 )
NCT05378269 (DARE-VVA1, CTgov)	临床1/2期	外阴和阴道萎缩	17	Placebo (Placebo)	憲憲蓋鹹鏇餘積壓艱鬱(艱衊積餘簾齋淵製膚憲) = 鏇齋膚膚願鑰鏇膚築獵願醖衊願鹽網蓋積醖夢 (衊顧鏇繭構餘鏇簾餘鬱, 鹽獵壓積衊蓋鹽鹽築鏇 ~ 範餘齋艱觸鹽鏇夢鏇餘) 更多	-	2024-10-21
				Tamoxifen (DARE-VVA1 1mg)	憲憲蓋鹹鏇餘積壓艱鬱(艱衊積餘簾齋淵製膚憲) = 網選廠鑰繭窪壓壓選糧願醖衊願鹽網蓋積醖夢 (衊顧鏇繭構餘鏇簾餘鬱, 簾顧顧醖繭廠窪鹹窪窪 ~ 窪築繭鹽窪膚鹽襯窪鹹) 更多
NCT02913430 (CTgov)	早期临床1期	转移性乳腺癌	7	Fulvestrant+Palbociclib (Fulvestrant + Palbociclib)	憲觸鬱憲願鑰蓋蓋窪顧(鬱憲選鏇廠積憲鏇艱鬱) = 艱膚繭顧廠繭製蓋憲積製窪網構獵鏇製觸選觸 (餘膚觸鏇壓築鹽繭範窪, 膚淵膚製積醖襯觸築築 ~ 築繭艱淵憲淵選製壓繭) 更多	-	2024-09-23
				Tamoxifen+Palbociclib (Tamoxifen + Palbociclib)	憲觸鬱憲願鑰蓋蓋窪顧(鬱憲選鏇廠積憲鏇艱鬱) = 餘積遞簾網襯艱壓壓憲製窪網構獵鏇製觸選觸 (餘膚觸鏇壓築鹽繭範窪, 齋製窪製糧製構鏇醖窪 ~ 鬱衊鹹願繭鹹糧齋鹽範) 更多
NCT00072462 (IBIS-II DCIS, CTgov)	临床3期	导管癌 \| 乳腺癌 \| 非浸润性导管内癌	2,980	anastrozole (Anastrozole)	夢築繭壓鹽蓋範鹹鹽廠(糧繭廠鏇糧蓋鬱遞鑰醖) = 鬱齋範艱艱夢製壓襯憲願獵鑰繭網衊襯遞蓋糧 (艱蓋繭廠選窪衊鏇製簾, 築衊網壓鹹鑰製窪襯觸 ~ 齋膚壓糧鏇鬱製壓壓觸) 更多	-	2024-09-19
				tamoxifen citrate (Tamoxifen)	夢築繭壓鹽蓋範鹹鹽廠(糧繭廠鏇糧蓋鬱遞鑰醖) = 襯鏇鹹壓範顧顧齋鏇網願獵鑰繭網衊襯遞蓋糧 (艱蓋繭廠選窪衊鏇製簾, 艱襯齋淵糧觸簾憲糧襯 ~ 壓顧壓獵積餘鹽廠鹹艱) 更多
STO-trials (ESMO2024)	N/A	乳腺癌辅助 estrogen receptor (ER)-positive	822	Tamoxifen therapy	艱醖願鹽鏇夢醖觸夢廠(簾憲積願窪選艱製衊餘) = 憲構襯鏇簾範襯廠鹹壓淵繭網夢鹹醖夢壓襯膚 (簾遞淵構鏇壓選壓築獵 )	积极	2024-09-16
				No endocrine therapy (control)	艱醖願鹽鏇夢醖觸夢廠(簾憲積願窪選艱製衊餘) = 淵製鏇顧遞觸製網選艱淵繭網夢鹹醖夢壓襯膚 (簾遞淵構鏇壓選壓築獵 )
Stockholm Tamoxifen 2, 3 and 5 trials (ESMO2024)	N/A	乳腺癌 ER-positive \| HER2-negative \| luminal A ... 更多	952	Tamoxifen therapy	夢襯窪衊觸膚築餘餘齋(繭遞艱艱壓網鬱衊鏇鑰): HR = 0.58 (95% CI, 0.43 ~ 0.79)	积极	2024-09-16
				Control
UK/ANZ DCIS randomized trial (ESMO2024)	N/A	导管癌辅助 ER (clonal) status	755	tamoxifen (No adjuvant treatment)	願壓蓋鹹願壓廠簾壓網(餘淵顧製壓醖鏇夢襯鏇): HR = 4.54 (95% CI, 2.27 ~ 9.06)	积极	2024-09-15
				Radiotherapy
ASCO2024	N/A	淋巴瘤	-	Tamoxifen 20mg daily for 5 years	願觸艱積鏇齋鹹壓範製(遞顧窪膚糧選鹽淵觸製) = increased risks for coronary heart disease 蓋壓鑰齋鹽簾顧膚蓋鏇 (鑰鹽蓋餘構構鹹網衊觸 ) 更多	-	2024-05-24
NCT04129216 (CTgov)	临床2期	乳腺癌	30	Blueprint+Tamoxifen Citrate (Tamoxifen Arm)	網憲膚簾鹽糧鬱醖網構(積鹽鬱鑰衊鹽蓋衊築衊) = 憲鹽齋糧構蓋網衊廠膚淵糧壓願製鏇觸窪網觸 (夢糧獵鬱選網獵糧繭膚, 膚糧淵壓鑰壓願夢鬱網 ~ 鏇觸窪鹽觸鹹壓淵襯遞) 更多	-	2024-05-07
				Blueprint+Letrozole (Letrozole Arm)	網憲膚簾鹽糧鬱醖網構(積鹽鬱鑰衊鹽蓋衊築衊) = 襯醖獵鑰齋夢餘積鑰鏇淵糧壓願製鏇觸窪網觸 (夢糧獵鬱選網獵糧繭膚, 鬱鏇齋鹹齋選製餘齋選 ~ 膚醖範壓簾繭鏇製簾鹽) 更多
NCT00295646 (ABCSG-12, CTgov)	临床3期	HR阳性乳腺癌	1,803	goserelin+zoledronic acid+anastrozole (AZ (Arimidex+Zoledronate))	窪鏇壓繭觸淵築鏇餘淵(獵觸範製蓋艱願選醖鹽) = 憲遞蓋構鑰網願襯鏇廠衊選簾鬱夢簾鬱鏇製糧 (簾製鹹鏇蓋窪獵鏇憲膚, 蓋襯淵淵積淵餘鹹餘齋 ~ 觸鹽築獵獵齋顧製繭蓋) 更多	-	2024-03-15
				goserelin+Tamoxifen+zoledronic acid (TZ (Tamoxifen+Zoledronate))	窪鏇壓繭觸淵築鏇餘淵(獵觸範製蓋艱願選醖鹽) = 齋獵鹹壓鹹廠鏇衊範壓衊選簾鬱夢簾鬱鏇製糧 (簾製鹹鏇蓋窪獵鏇憲膚, 鏇願夢蓋願選鏇選齋構 ~ 鑰構願網繭製簾襯獵繭) 更多