MCC-DM1

别名: N2'-[3-[[1-[[4-(氨基羰基)环己基]甲基]-2,5-二氧代-3-吡咯烷基]硫代]-1-氧代丙基]-N2'-脱乙酰基-美登素
目录号: V53075 纯度: ≥98%
MCC-DM1 是一种生物活性分子-接头缀合物,用于 ADC 合成,类似于用于合成 Anti-CD22-MCC-DM1。
MCC-DM1 CAS号: 1100692-14-5
产品类别: Drug-Linker Conjugates for ADC
产品仅用于科学研究,不针对患者销售
规格 价格
1mg
5mg
10mg
Other Sizes
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产品描述
MCC-DM1 是一种生物活性分子-接头缀合物,用于 ADC 合成,类似于用于合成 Anti-CD22-MCC-DM1。
生物活性&实验参考方法
毒性/毒理 (Toxicokinetics/TK)
妊娠期和哺乳期影响
◉ 哺乳期用药概述
目前尚无曲妥珠单抗-美坦新在哺乳期临床应用的信息。由于曲妥珠单抗是一种分子量为 145,531 Da 的大分子蛋白质,其在乳汁中的含量可能非常低。此外,曲妥珠单抗很可能在婴儿的胃肠道中部分被破坏,因此婴儿的吸收量可能极少。然而,美坦新 (DM1) 是一种小分子微管抑制剂,可能会分泌到乳汁中。制造商建议在接受曲妥珠单抗德鲁西特康治疗期间以及末次给药后7个月内停止母乳喂养。
◉ 对母乳喂养婴儿的影响
截至修订日期,未找到相关的已发表信息。
◉ 对泌乳和母乳的影响
截至修订日期,未找到相关的已发表信息。
◉ 哺乳期用药概述
目前尚无关于ado-曲妥珠单抗在哺乳期临床应用的信息。由于曲妥珠单抗是一种分子量为145,531 Da的大分子蛋白质,其在乳汁中的含量可能非常低。此外,它很可能在婴儿的胃肠道中部分被破坏,婴儿的吸收量可能极少。然而,ado-曲妥珠单抗恩坦辛也含有DM1,这是一种小分子毒素,可能会进入乳汁并被婴儿吸收。由于母乳喂养的婴儿可能出现严重不良反应,生产商建议在接受ado-trastuzumab emtansine治疗期间及治疗结束后7个月内避免母乳喂养。
◉ 对母乳喂养婴儿的影响
截至修订日期,未找到相关的已发表信息。
◉ 对哺乳和母乳的影响
截至修订日期,未找到相关的已发表信息。
参考文献

[1]. Antibody-DM1 conjugates as cancer therapeutics. Cancer Lett. 2011 Aug 28;307(2):113-8.

[2]. LC-MS/MS method for the simultaneous determination of Lys-MCC-DM1, MCC-DM1 and DM1 as potential intracellular catabolites of the antibody-drug conjugate trastuzumab emtansine (T-DM1). J Pharm Biomed Anal. 2017 Apr 15;137:170-177.

其他信息
一种免疫毒素,由人源化单克隆抗HER2抗体曲妥珠单抗与抗微管药物美坦新诺DM1共价连接而成,用于治疗既往接受过曲妥珠单抗和紫杉烷类药物(单独或联合)治疗的转移性乳腺癌患者。
另见:曲妥珠单抗-美坦新(注释已移至)。
药物适应症
早期乳腺癌(EBC)Kadcyla作为单药,适用于接受过新辅助紫杉烷类药物和HER2靶向治疗后,乳腺和/或淋巴结中仍有残留浸润性病灶的HER2阳性早期乳腺癌成年患者的辅助治疗。 Kadcyla作为单药治疗,适用于既往接受过曲妥珠单抗和紫杉烷类药物(单独或联合)治疗的HER2阳性、不可切除的局部晚期或转移性乳腺癌成人患者。患者应符合以下任一条件:既往接受过局部晚期或转移性疾病的治疗,或在辅助治疗期间或完成辅助治疗后六个月内出现疾病复发。
*注: 文献方法仅供参考, InvivoChem并未独立验证这些方法的准确性
化学信息 & 存储运输条件
分子式
C47H64CLN5O13S
分子量
974.55
精确质量
973.39
CAS号
1100692-14-5
PubChem CID
166596981
外观&性状
White to off-white solid powder
LogP
2
tPSA
262
氢键供体(HBD)数目
3
氢键受体(HBA)数目
14
可旋转键数目(RBC)
13
重原子数目
67
分子复杂度/Complexity
1950
定义原子立体中心数目
8
SMILES
C[C@]12[C@]([H])(CC(N(C3=C(C(OC)=CC(CC(C)=CC=C[C@@]([H])(OC)[C@@]4(NC(=O)O[C@@]([H])(C4)[C@@H](C)[C@@H]1O2)O)=C3)Cl)C)=O)OC(=O)[C@H](C)N(C)C(=O)CCSC1CC(=O)N(CC2CCC(C(=O)N)CC2)C1=O |t:16,18,&1:1,2,20,24,29,32,34,44|
InChi Key
WPWQMVXPTHKASL-KLVLVJRKSA-N
InChi Code
InChI=1S/C47H64ClN5O13S/c1-25-10-9-11-35(63-8)47(61)23-33(64-45(60)50-47)26(2)41-46(4,66-41)36(22-38(55)52(6)31-19-29(18-25)20-32(62-7)40(31)48)65-44(59)27(3)51(5)37(54)16-17-67-34-21-39(56)53(43(34)58)24-28-12-14-30(15-13-28)42(49)57/h9-11,19-20,26-28,30,33-36,41,61H,12-18,21-24H2,1-8H3,(H2,49,57)(H,50,60)/b11-9-,25-10-/t26-,27+,28?,30?,33+,34?,35-,36+,41+,46+,47+/m1/s1
化学名
[(1S,2R,3S,5S,6S,16Z,18Z,20R,21S)-11-chloro-21-hydroxy-12,20-dimethoxy-2,5,9,16-tetramethyl-8,23-dioxo-4,24-dioxa-9,22-diazatetracyclo[19.3.1.110,14.03,5]hexacosa-10,12,14(26),16,18-pentaen-6-yl] (2S)-2-[3-[1-[(4-carbamoylcyclohexyl)methyl]-2,5-dioxopyrrolidin-3-yl]sulfanylpropanoyl-methylamino]propanoate
HS Tariff Code
2934.99.9001
存储方式

Powder      -20°C    3 years

                     4°C     2 years

In solvent   -80°C    6 months

                  -20°C    1 month

注意: 请将本产品存放在密封且受保护的环境中(例如氮气保护),避免吸湿/受潮和光照。
运输条件
Room temperature (This product is stable at ambient temperature for a few days during ordinary shipping and time spent in Customs)
溶解度数据
溶解度 (体外实验)
DMSO : 190 mg/mL (194.96 mM)
溶解度 (体内实验)
配方 1 中的溶解度: ≥ 4.75 mg/mL (4.87 mM) (饱和度未知) in 10% DMSO + 40% PEG300 + 5% Tween80 + 45% Saline (这些助溶剂从左到右依次添加,逐一添加), 澄清溶液。
例如,若需制备1 mL的工作液,可将100 μL 47.5 mg/mL澄清的DMSO储备液加入到400 μL PEG300中,混匀;再向上述溶液中加入50 μL Tween-80,混匀;然后加入450 μL生理盐水定容至1 mL。
*生理盐水的制备:将 0.9 g 氯化钠溶解在 100 mL ddH₂O中,得到澄清溶液。

配方 2 中的溶解度: ≥ 4.75 mg/mL (4.87 mM) (饱和度未知) in 10% DMSO + 90% (20% SBE-β-CD in Saline) (这些助溶剂从左到右依次添加,逐一添加), 澄清溶液。
例如,若需制备1 mL的工作液,可将 100 μL 47.5mg/mL澄清的DMSO储备液加入到900μL 20%SBE-β-CD生理盐水中,混匀。
*20% SBE-β-CD 生理盐水溶液的制备(4°C,1 周):将 2 g SBE-β-CD 溶解于 10 mL 生理盐水中,得到澄清溶液。

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配方 3 中的溶解度: ≥ 4.75 mg/mL (4.87 mM) (饱和度未知) in 10% DMSO + 90% Corn Oil (这些助溶剂从左到右依次添加,逐一添加), 澄清溶液。
例如,若需制备1 mL的工作液,可将 100 μL 47.5 mg/mL 澄清 DMSO 储备液加入到 900 μL 玉米油中并混合均匀。


请根据您的实验动物和给药方式选择适当的溶解配方/方案:
1、请先配制澄清的储备液(如:用DMSO配置50 或 100 mg/mL母液(储备液));
2、取适量母液,按从左到右的顺序依次添加助溶剂,澄清后再加入下一助溶剂。以 下列配方为例说明 (注意此配方只用于说明,并不一定代表此产品 的实际溶解配方):
10% DMSO → 40% PEG300 → 5% Tween-80 → 45% ddH2O (或 saline);
假设最终工作液的体积为 1 mL, 浓度为5 mg/mL: 取 100 μL 50 mg/mL 的澄清 DMSO 储备液加到 400 μL PEG300 中,混合均匀/澄清;向上述体系中加入50 μL Tween-80,混合均匀/澄清;然后继续加入450 μL ddH2O (或 saline)定容至 1 mL;

3、溶剂前显示的百分比是指该溶剂在最终溶液/工作液中的体积所占比例;
4、 如产品在配制过程中出现沉淀/析出,可通过加热(≤50℃)或超声的方式助溶;
5、为保证最佳实验结果,工作液请现配现用!
6、如不确定怎么将母液配置成体内动物实验的工作液,请查看说明书或联系我们;
7、 以上所有助溶剂都可在 Invivochem.cn网站购买。
制备储备液 1 mg 5 mg 10 mg
1 mM 1.0261 mL 5.1306 mL 10.2611 mL
5 mM 0.2052 mL 1.0261 mL 2.0522 mL
10 mM 0.1026 mL 0.5131 mL 1.0261 mL

1、根据实验需要选择合适的溶剂配制储备液 (母液):对于大多数产品,InvivoChem推荐用DMSO配置母液 (比如:5、10、20mM或者10、20、50 mg/mL浓度),个别水溶性高的产品可直接溶于水。产品在DMSO 、水或其他溶剂中的具体溶解度详见上”溶解度 (体外)”部分;

2、如果您找不到您想要的溶解度信息,或者很难将产品溶解在溶液中,请联系我们;

3、建议使用下列计算器进行相关计算(摩尔浓度计算器、稀释计算器、分子量计算器、重组计算器等);

4、母液配好之后,将其分装到常规用量,并储存在-20°C或-80°C,尽量减少反复冻融循环。

计算器

摩尔浓度计算器可计算特定溶液所需的质量、体积/浓度,具体如下:

  • 计算制备已知体积和浓度的溶液所需的化合物的质量
  • 计算将已知质量的化合物溶解到所需浓度所需的溶液体积
  • 计算特定体积中已知质量的化合物产生的溶液的浓度
使用摩尔浓度计算器计算摩尔浓度的示例如下所示:
假如化合物的分子量为350.26 g/mol,在5mL DMSO中制备10mM储备液所需的化合物的质量是多少?
  • 在分子量(MW)框中输入350.26
  • 在“浓度”框中输入10,然后选择正确的单位(mM)
  • 在“体积”框中输入5,然后选择正确的单位(mL)
  • 单击“计算”按钮
  • 答案17.513 mg出现在“质量”框中。以类似的方式,您可以计算体积和浓度。

稀释计算器可计算如何稀释已知浓度的储备液。例如,可以输入C1、C2和V2来计算V1,具体如下:

制备25毫升25μM溶液需要多少体积的10 mM储备溶液?
使用方程式C1V1=C2V2,其中C1=10mM,C2=25μM,V2=25 ml,V1未知:
  • 在C1框中输入10,然后选择正确的单位(mM)
  • 在C2框中输入25,然后选择正确的单位(μM)
  • 在V2框中输入25,然后选择正确的单位(mL)
  • 单击“计算”按钮
  • 答案62.5μL(0.1 ml)出现在V1框中
g/mol

分子量计算器可计算化合物的分子量 (摩尔质量)和元素组成,具体如下:

注:化学分子式大小写敏感:C12H18N3O4  c12h18n3o4
计算化合物摩尔质量(分子量)的说明:
  • 要计算化合物的分子量 (摩尔质量),请输入化学/分子式,然后单击“计算”按钮。
分子质量、分子量、摩尔质量和摩尔量的定义:
  • 分子质量(或分子量)是一种物质的一个分子的质量,用统一的原子质量单位(u)表示。(1u等于碳-12中一个原子质量的1/12)
  • 摩尔质量(摩尔重量)是一摩尔物质的质量,以g/mol表示。
/

配液计算器可计算将特定质量的产品配成特定浓度所需的溶剂体积 (配液体积)

  • 输入试剂的质量、所需的配液浓度以及正确的单位
  • 单击“计算”按钮
  • 答案显示在体积框中
动物体内实验配方计算器(澄清溶液)
第一步:请输入基本实验信息(考虑到实验过程中的损耗,建议多配一只动物的药量)
第二步:请输入动物体内配方组成(配方适用于不溶/难溶于水的化合物),不同的产品和批次配方组成不同,如对配方有疑问,可先联系我们提供正确的体内实验配方。此外,请注意这只是一个配方计算器,而不是特定产品的确切配方。
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计算结果:

工作液浓度 mg/mL;

DMSO母液配制方法 mg 药物溶于 μL DMSO溶液(母液浓度 mg/mL)。如该浓度超过该批次药物DMSO溶解度,请首先与我们联系。

体内配方配制方法μL DMSO母液,加入 μL PEG300,混匀澄清后加入μL Tween 80,混匀澄清后加入 μL ddH2O,混匀澄清。

(1) 请确保溶液澄清之后,再加入下一种溶剂 (助溶剂) 。可利用涡旋、超声或水浴加热等方法助溶;
            (2) 一定要按顺序加入溶剂 (助溶剂) 。

临床试验信息
Assessing the Efficacy and Safety of Anti-HER2 Therapy in Nigerian Women With HER2+ Breast Cancer Before and After Surgery
CTID: NCT06348134
Phase: Phase 2    Status: Not yet recruiting
Date: 2024-11-29
Testing the Use of Ado-Trastuzumab Emtansine Compared to the Usual Treatment (Chemotherapy With Docetaxel Plus Trastuzumab) for Recurrent, Metastatic, or Unresectable HER2-Positive Salivary Gland Cancer
CTID: NCT05408845
Phase: Phase 2    Status: Recruiting
Date: 2024-11-27
Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study
CTID: NCT04589845
Phase: Phase 2    Status: Recruiting
Date: 2024-11-22
A Study of Trastuzumab Emtansine in Combination with Atezolizumab or Placebo As a Treatment for Participants with Human Epidermal Growth Factor 2 (HER2)-Positive and Programmed Death-ligand 1 (PD-L1)-Positive Locally Advanced (LABC) or Metastatic Breast Cancer (MBC)
CTID: NCT04740918
Phase: Phase 3    Status: Terminated
Date: 2024-11-19
Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib in Combination With Trastuzumab Deruxtecan or With Trastuzumab Emtansine and to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread
CTID: NCT06324357
Phase: Phase 1/Phase 2    Status: Recruiting
Date: 2024-11-18
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Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)
CTID: NCT02465060
Phase: Phase 2    Status: Active, not recruiting
Date: 2024-11-18


A Study to Evaluate the Safety and Effectiveness of Trastuzumab Emtansine (T-DM1) as Therapy in Chinese Participants With HER2 Positive Advanced Breast Cancer
CTID: NCT05945927
Phase:    Status: Recruiting
Date: 2024-11-18
KPMNG Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II
CTID: NCT05525858
Phase:    Status: Recruiting
Date: 2024-11-12
Testing Ado-Trastuzumab Emtansine as a Potential Targeted Treatment in Cancers With HER2 Genetic Changes (MATCH-Subprotocol Q)
CTID: NCT04439110
Phase: Phase 2    Status: Active, not recruiting
Date: 2024-11-07
A Study To Evaluate the Efficacy and Safety Of Atezolizumab or Placebo in Combination With Neoadjuvant Doxorubicin + Cyclophosphamide Followed By Paclitaxel + Trastuzumab + Pertuzumab In Early Her2-Positive Breast Cancer
CTID: NCT03726879
Phase: Phase 3    Status: Completed
Date: 2024-11-05
A Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy
CTID: NCT04873362
Phase: Phase 3    Status: Recruiting
Date: 2024-11-05
ELVN-002 in HER2 Mutant Non-Small Cell Lung Cancer
CTID: NCT05650879
Phase: Phase 1    Status: Recruiting
Date: 2024-10-29
A Study to Investigate Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab and/or TransCon TLR7/8 Agonist or Other Anticancer Therapies in Adult Participants With Locally Advanced or Metastatic Solid Tumor Malignancies
CTID: NCT05081609
Phase: Phase 1/Phase 2    Status: Recruiting
Date: 2024-10-15
A Safety Extension Study of Trastuzumab Emtansine in Participants Previously Treated With Trastuzumab Emtansine Alone or in Combination With Other Anti-Cancer Therapy in One of the Parent Studies
CTID: NCT00781612
Phase: Phase 2    Status: Active, not recruiting
Date: 2024-10-08
Feasibility of Chemotherapy De-escalation in Early-Stage HER2 Positive Breast Cancer
CTID: NCT04419181
Phase: Phase 2    Status: Suspended
Date: 2024-10-08
A Study to Evaluate Patient Preference for Home Administration of Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Administration in Participants With Early or Locally Advanced/Inflammatory HER2-Positive Breast Cancer
CTID: NCT05415215
Phase: Phase 3    Status: Active, not recruiting
Date: 2024-10-08
Phase Ib Dose-escalation Trial of Taselisib (GDC-0032) in Combination With Anti-HER2 Therapies in Participants With Advanced HER2+ Breast Cancer
CTID: NCT02390427
Phase: Phase 1    Status: Completed
Date: 2024-10-02
T-DM1 vs Paclitaxel/Trastuzumab for Breast (ATEMPT Trial)
CTID: NCT01853748
Phase: Phase 2    Status: Active, not recruiting
Date: 2024-09-25
A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors
CTID: NCT04931342
Phase: Phase 2    Status: Active, not recruiting
Date: 2024-09-19
A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE)
CTID: NCT01772472
Phase: Phase 3    Status: Completed
Date: 2024-09-19
De-escalation Adjuvant Chemo in HER2+/ER-/node-neg Early BC Patients Who Achieved PCR After Neoadjuvant Chemo & Dual HER2 Blockade
CTID: NCT04675827
Phase: Phase 2    Status: Suspended
Date: 2024-09-19
HER2 Molecular Imaging with 89Zr-trastuzumab PET/CT As a Predictive Biomarker for Antibody-drug Conjugate Sequencing in Patients with Advanced HER2-positive Breast Cancer
CTID: NCT06595563
Phase: Phase 2    Status: Not yet recruiting
Date: 2024-09-19
A Phase II Study of Tucatinib and Ado-trastuzumab Emtansine (T-DM1) in Patients with HER2-positive Metastatic Solid Tumors and Metastases to Brain (TUCATEMEB)
CTID: NCT05673928
Phase: Phase 2    Status: Recruiting
Date: 2024-09-19
T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive Breast Cancer, the CompassHER2 RD Trial
CTID: NCT04457596
Phase: Phase 3    Status: Recruiting
Date: 2024-08-02
A Study of Targeted Agents for Patients With Recurrent or Persistent Endometrial Cancer
CTID: NCT04486352
Phase: Phase 1/Phase 2    Status: Recruiting
Date: 2024-07-03
Secondary BRain Metastases Prevention After Isolated Intracranial Progression on Trastuzumab/Pertuzumab or T-DM1 in Patients With aDvanced Human Epidermal Growth Factor Receptor 2+ brEast Cancer With the Addition of Tucatinib
CTID: NCT05323955
Phase: Phase 2    Status: Recruiting
Date: 2024-06-06
DP303c Versus Trastuzumab Emtansine in in Patients With HER2-positive Advanced Breast Cancer
CTID: NCT06313086
Phase: Phase 3    Status: Recruiting
Date: 2024-05-10
CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy
CTID: NCT04266249
Phase: Phase 2    Status: Recruiting
Date: 2024-04-18
Trastuzumab Emtansine (T-DM1) in HER2-positive Breast Cancer Patients With Progressive Disease After TKIs or HP Therapy
CTID: NCT06125834
Phase: Phase 2    Status: Recruiting
Date: 2024-04-16
Safety of Continuing HER-2 Directed Therapy in Overt Left Ventricular Dysfunction
CTID: NCT04680442
Phase: Phase 2    Status: Recruiting
Date: 2024-03-15
Stereotactic Radiation Therapy for HE2-positive Oligometastatic Breast Cancer
CTID: NCT06299852
Phase: N/A    Status: Recruiting
Date: 2024-03-08
A Study Evaluating Targeted Therapies in Participants Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response
CTID: NCT04632992
Phase: Phase 2    Status: Completed
Date: 2024-03-07
A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Participants With Metastatic Breast Cancer (MARIANNE)
CTID: NCT01120184
Phase: Phase 3    Status: Completed
Date: 2024-03-04
Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial
CTID: NCT03878524
Phase: Phase 1    Status: Terminated
Date: 2024-03-04
SMMART Adaptive Clinical Treatment (ACT) Trial
CTID: NCT05238831
PhaseEarly Phase 1    Status: Withdrawn
Date: 2024-01-23
TPIV100 and Sargramostim for the Treatment of HER2 Positive, Stage II-III Breast Cancer in Patients With Residual Disease After Chemotherapy and Surgery
CTID: NCT04197687
Phase: Phase 2    Status: Recruiting
Date: 2023-12-18
Deciphering Antitumour Response and Resistance With INtratumour Heterogeneity
CTID: NCT02314481
Phase: Phase 2    Status: Active, not recruiting
Date: 2023-12-04
A Phase III, Active-Controlled Study of SHR-A1811 Versus Trastuzumab Emtansine (T-DM1) in HER2-Positive Primary Breast Cancer Participants With Residual Invasive Disease Following Neoadjuvant Therapy
CTID: NCT06126640
Phase: Phase 3    Status: Not yet recruiting
Date: 2023-11-13
The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy
CTID: NCT04591431
Phase: Phase 2    Status: Active, not recruiting
Date: 2023-10-03
Efficacy and Safety of Trastuzumab Emtansine in Chinese Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Locally Advanced or Metastatic Breast Cancer
CTID: NCT03084939
Phase: Phase 3    Status: Completed
Date: 2023-05-06
Copanlisib in Combination With T-DM1 in Pretreated Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer
CTID: NCT04042051
Phase: Phase 1    Status: Terminated
Date: 2023-04-06
A Study of MRG002 in the Treatment of Patients With HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer
CTID: NCT04924699
Phase: Phase 2/Phase 3    Status: Recruiting
Date: 2023-03-17
Observational Study of Effectiveness and Safety of Trastuzumab Emtansine (T-DM1) in HER2-positive Breast Cancer Patients With Residual Invasive Disease Following Neoadjuvant Chemotherapy and Anti-HER2 Target Therapy
CTID: NCT05754502
Phase:    Status: Recruiting
Date: 2023-03-03
T-DM1 and Osimertinib Combination Treatment to Target HER2 Bypass Track Resistance in EGFR Mutation Positive NSCLC
CTID: NCT03784599
Phase: Phase 2    Status: Terminated
Date: 2022-11-10
ProTarget - A Danish Nationwide Clinical Trial on Targeted Cancer Treatment Based on Genomic Profiling
CTID: NCT04341181
Phase: Phase 2    Status: Recruiting
Date: 2022-10-26
Phase II Clinical Study of T-DM1 and Pyrotinib Maleate in Patients With HER2-positive Metastatic Breast Cancer Who Had Progressed on TKI Therapy
CTID: NCT05560308
Phase: N/A    Status: Not yet recruiting
Date: 2022-10-03
A Study of Trastuzumab Emtansine (Kadcyla) Plus Pertuzumab (Perjeta) Following Anthracyclines in Comparison With Trastuzumab (Herceptin) Plus Pertuzumab and a Taxane Following Anthracyclines as Adjuvant Therapy in Participants With Operable HER2-Positive Primary Breast Cancer
CTID: NCT01966471
Phase: Phase 3    Status: Completed
Date: 2022-06-14
T-DM1 With or Without Abemaciclib for the Treatment of HER2-Positive Metastatic Breast Cancer
CTID: NCT04351230
Phase: Phase 2    Status: Withdrawn
Date: 2022-05-26
A Study of Trastuzumab Emtansine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer Who Have Received Prior Anti-HER2 And Chemotherapy-based Treatment
CTID: NCT01702571
Phase: Phase 3    Status: Completed
Date: 2022-04-04
A Stud
A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF ADJUVANT ATEZOLIZUMAB OR PLACEBO AND TRASTUZUMAB EMTANSINE FOR HER2-POSITIVE BREAST CANCER AT HIGH RISK OF RECURRENCE FOLLOWING PREOPERATIVE THERAPY.
CTID: null
Phase: Phase 3    Status: Trial now transitioned, Ongoing
Date: 2021-03-01
A RANDOMIZED, MULTICENTER, DOUBLEBLIND, PLACEBO-CONTROLLED PHASE III STUDY OF THE EFFICACY AND SAFETY OF TRASTUZUMAB EMTANSINE IN COMBINATION WITH ATEZOLIZUMAB OR PLACEBO IN PATIENTS WITH HER2-POSITIVE AND PD-L1-POSITIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER WHO HAVE RECEIVED PRIOR TRASTUZUMAB- (+/- PERTUZUMAB) AND TAXANE-BASED THERAPY (KATE3).
CTID: null
Phase: Phase 3    Status: Prematurely Ended, Completed
Date: 2021-01-27
A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in Subjects with High-Risk HER2-Positive Primary Breast Cancer Who Have Residual Invasive Disease in Breast or Axillary Lymph Nodes Following Neoadjuvant Therapy
CTID: null
Phase: Phase 3    Status: Trial now transitioned, Ongoing
Date: 2021-01-21
A PHASE Ib/II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF VENETOCLAX IN COMBINATION WITH TRASTUZUMAB EMTANSINE IN PATIENTS WITH PREVIOUSLY TREATED HER2-POSITIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER
CTID: null
Phase: Phase 1, Phase 2    Status: Prematurely Ended
Date: 2020-07-24
The ROME trial from histology to target: the road to personalize target therapy and immunotherapy
CTID: null
Phase: Phase 2    Status: Ongoing
Date: 2020-07-08
ProTarget
CTID: null
Phase: Phase 2    Status: Trial now transitioned
Date: 2020-04-28
A phase II trial of an individualized treatment strategy for patients with metastatic non-clear cell renal carcinoma
CTID: null
Phase: Phase 2    Status: Trial now transitioned
Date: 2019-11-20
EXPLORING OPTIMAL SEQUENCE TREATMENT IN HER2+ PERTUZUMAB PRE- TREATED ADVANCED BREAST CANCER PATIENTS. THE STEP TRIAL.
CTID: null
Phase: Phase 2    Status: Ongoing
Date: 2019-09-30
Atezolizumab, Pertuzumab and Trastuzumab with chemotherapy as neoadjuvant treatment of HER2 positive early high-risk and locally advanced breast cancer.
CTID: null
Phase: Phase 3    Status: Ongoing
Date: 2019-03-11
PREDIX II HER2. Improving pre-operative systemic therapy for human epidermal growth factor receptor 2 (HER2) amplified breast cancer
CTID: null
Phase: Phase 2    Status: Prematurely Ended
Date: 2019-03-06
A Phase 3, multicenter, randomized, open-label, active-controlled study of trastuzumab deruxtecan (DS-8201a), an anti-HER2-antibody drug
CTID: null
Phase: Phase 3    Status: Trial now transitioned, GB - no longer in EU/EEA, Ongoing
Date: 2019-02-06
A phase III, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of Atezolizumab or placebo in combination with neoadjuvant doxorubicin + cyclophosphamide followed by paclitaxel + trastuzumab + pertuzumab in early HER2-positive breast cancer
CTID: null
Phase: Phase 3    Status: Temporarily Halted, Completed
Date: 2018-11-27
Multicentre, non-randomised, open-label, single agent phase II study to determine the clinical benefit of trastuzumab emtansine (T-DM1) in HER2-positive metastatic breast cancer patients with brain metastasis
CTID: null
Phase: Phase 2    Status: Prematurely Ended
Date: 2018-01-26
A RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE II STUDY OF THE EFFICACY AND SAFETY OF TRASTUZUMAB EMTANSINE IN COMBINATION WITH ATEZOLIZUMAB OR ATEZOLIZUMAB-PLACEBO IN PATIENTS WITH HER2-POSITIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER WHO HAVE RECEIVED PRIOR TRASTUZUMAB AND TAXANE BASED THERAPY.
CTID: null
Phase: Phase 2    Status: Completed, Prematurely Ended
Date: 2016-10-21
PHASE II, EXPLORATORY, MULTICENTER, NON RANDOMIZED, SINGLE AGENT COHORT STUDY TO DETERMINE BEST TUMOR RESPONSE WITH TRASTUZUMAB EMTANSINE IN HER2 OVEREXPRESSING SOLID TUMORS.
CTID: null
Phase: Phase 2    Status: Completed
Date: 2016-09-22
Molecular-biological tumor profiling for drug treatment selection in patients with advanced and refractory carcinoma
CTID: null
Phase: Phase 2    Status: Completed
Date: 2015-05-04
A PHASE II, MULTICENTER, SINGLE-ARM STUDY OF TRASTUZUMAB EMTANSINE IN PATIENTS WITH HER2 IHC-POSITIVE, LOCALLY ADVANCED OR METASTATIC NON−SMALL CELL LUNG CANCER WHO HAVE RECEIVED AT LEAST ONE PRIOR CHEMOTHERAPY REGIMEN
CTID: null
Phase: Phase 2    Status: Completed
Date: 2014-12-01
PREDIX HER2 - Neoadjuvant response-guided treatment of HER2 positive breast cancer. Part of a platform of translational phase II trials based on molecular subtypes
CTID: null
Phase: Phase 2    Status: Trial now transitioned
Date: 2014-11-12
A Phase II, Randomized Study of T DM1 versus T DM1 plus short induction with docetaxel in first line treatment for locally advanced or metastatic HER2+ breast cancer.
CTID: null
Phase: Phase 2    Status: Ongoing
Date: 2014-10-20
A RANDOMIZED, MULTICENTER, OPEN-LABEL, TWO-ARM, PHASE III NEOADJUVANT STUDY EVALUATING TRASTUZUMAB EMTANSINE PLUS PERTUZUMAB COMPARED WITH CHEMOTHERAPY PLUS TRASTUZUMAB AND PERTUZUMAB FOR PATIENTS WITH HER2-POSITIVE BREAST CANCER.
CTID: null
Phase: Phase 3    Status: Completed
Date: 2014-08-11
A RANDOMIZED, MULTICENTER, OPEN-LABEL, PHASE III TRIAL COMPARING TRASTUZUMAB PLUS PERTUZUMAB PLUS A TAXANE FOLLOWING ANTHRACYCLINES VERSUS TRASTUZUMAB EMTANSINE PLUS PERTUZUMAB FOLLOWING ANTHRACYCLINES AS ADJUVANT THERAPY IN PATIENTS WITH OPERABLE HER2 POSITIVE PRIMARY BREAST CANCER.
CTID: null
Phase: Phase 3    Status: Temporarily Halted, GB - no longer in EU/EEA, Prematurely Ended, Completed
Date: 2014-01-13
Pertuzumab + trastuzumab (PH) versus PH plus metronomic chemotherapy (PHM) in the elderly HER2+ metastatic breast cancer population who may continue on T-DM1 alone following disease progression while on PH / PHM: an open-label multicenter randomized phase II selection trial of the EORTC Elderly Task Force and Breast Cancer Group
CTID: null
Phase: Phase 2    Status: GB - no longer in EU/EEA, Completed
Date: 2013-06-11
A RANDOMIZED, MULTICENTER, OPEN LABEL PHASE III STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TRASTUZUMAB EMTANSINE VERSUS TRASTUZUMAB AS ADJUVANT THERAPY FOR PATIENTS WITH HER2-POSITIVE PRIMARY BREAST CANCER WHO HAVE RESIDUAL TUMOR PRESENT PATHOLOGICALLY IN THE BREAST OR AXILLARY LYMPH NODES FOLLOWING PREOPERATIVE THERAPY.
CTID: null
Phase: Phase 3    Status: Ongoing, GB - no longer in EU/EEA, Prematurely Ended, Completed
Date: 2013-04-09
A randomized phase II trial of pertuzumab in combination with trastuzumab with or without chemotherapy, both followed by T-DM1 in case of progression, in patients with HER2-positive metastatic breast cancer
CTID: null
Phase: Phase 2    Status: Completed
Date: 2013-02-04
A randomized, multicenter, adaptive phase II/III study to evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) versus taxane (docetaxel or paclitaxel) in patients with previously treated locally advanced or metastatic HER2-positive gastric cancer, including adenocarcinoma of the gastroesophageal junction.
CTID: null
Phase: Phase 2, Phase 3    Status: Completed
Date: 2012-11-23
A two-cohort, open-label, multicenter, study of trastuzumab emtansine (T-DM1) in HER2-positive locally advanced or metastatic breast cancer patients who have received prior anti-HER2 and chemotherapy-based treatment
CTID: null
Phase: Phase 3    Status: Completed
Date: 2012-11-22
Phase I followed by phase II study of the combination of trastuzumab emtansine (T-DM1) and capecitabine in HER2-positive metastatic breast cancer and HER2-positive locally advanced or metastatic gastric cancer patients
CTID: null
Phase: Phase 1, Phase 2    Status: Completed
Date: 2012-08-22
Adjuvant Dynamic marker-Adjusted Personalized Therapy trial optimizing risk assessment and therapy response prediction in early breast cancer
CTID: null
Phase: Phase 2, Phase 3    Status: Ongoing
Date: 2012-03-29
A phase II prospective imaging study evaluating the utility of pre-treatment zirconium-89 labelled trastuzumab PET/CT and an early FDG-PET/CT response to identify patients with advanced HER-2 positive breast cancer unlikely to benefit from a novel anti-HER2 therapy: T-DM1
CTID: null
Phase: Phase 2    Status: Completed
Date: 2012-03-05
A Phase III randomized, multicenter, two-arm, open-label trial to evaluate the efficacy of trastuzumab emtansine compared with treatment of physician’s choice in patients with HER2-positive metastatic breast cancer who have received at least two prior regimens of HER2-directed therapy.
CTID: null
Phase: Phase 3    Status: Completed
Date: 2011-12-02
An open-label, multicenter extension study of trastuzumab emtansine administered as a single agent or in combination with other anti-cancer therapies in patients previously enrolled in a Genentech and /or F. Hoffmann-La Roche Ltd. - sponsored trastuzumab emtansine study.
CTID: null
Phase: Phase 2    Status: Trial now transitioned, Completed
Date: 2011-04-29
“ESTUDIO FASE II MULTINACIONAL, MULTICÉNTRICO,PARA EVALUAR LA SEGURIDAD CLÍNICA Y VIABILIDAD DE LA ADMINISTRACIÓN DE T-DM1 DE FORMA SECUENCIAL CON UN RÉGIMEN DE QUIMIOTERAPIA BASADO EN ANTRACICLINAS, PARA EL TRATAMIENTO ADYUVANTE O NEOADYUVANTE DE PACIENTES CON CÁNCER DE MAMA HER2 POSITIVO PRECOZ”
CTID: null
Phase: Phase 2    Status: Completed
Date: 2010-10-18
A randomized, 3 arm, multicentre, phase III study to evaluate the efficacy and the safety of T-DM1 combined with pertuzumab or T-DM1 combined with pertuzumab-placebo (blinded for pertuzumab), versus the combination of trastuzumab plus taxane, as first line treatment in HER2- positive progressive or recurrent locally advanced or metastatic breast cancer (MBC).
CTID: null
Phase: Phase 3    Status: Completed
Date: 2010-04-22
An open-label, multi-center study of the safety and tolerability of the combination of Trastuzumab-MCC-DM1 (T-DM1) with docetaxel, and potentially pertuzumab, for treatment for patients with advanced breast cancer.
CTID: null
Phase: Phase 1, Phase 2    Status: Completed
Date: 2009-08-24
A Phase Ib/II, open-label study of the safety, tolerability, and efficacy of trastuzumab-MCC-DM1 in combination with pertuzumab administered intravenously to patients with HER2-positive locally advanced or metastatic breast cancer who have progressed while receiving prior therapy
CTID: null
Phase: Phase 1, Phase 2    Status: Completed
Date: 2009-04-27
A randomized, multicenter, phase III open-label study of the efficacy and safety of trastuzumab-MCC-DM1 vs. capecitabine + lapatinib in patients with HER2-positive locally advanced or metastatic breast cancer who have received prior trastuzumab-based therapy.
CTID: null
Phase: Phase 3    Status: Completed
Date: 2009-03-18
A randomized, multicenter, Phase II study of the efficacy and safety of trastuzumab-MCC-DM1 vs. trastuzumab (Herceptin®) and docetaxel (Taxotere®) in patients with metastatic HER2-positive breast cancer who have not received prior chemotherapy for metastatic disease
CTID: null
Phase: Phase 2    Status: Completed
Date: 2009-03-02

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