Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Biliary Tract Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Biliary Tract Diseases

Gastrointestinal Diseases

Biliary Tract Cancer

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Trastuzumab

Oxaliplatin

Leucovorin

Fluorouracil

Herzuma (Trastuzumab-pkrb) 4mg/kg after 6mg/kg loading D1 5FU 400mg/m2 bolus+2400mg/m2 infusion for 46 hrs D1 Leucovorin 200mg/m2 D1 Oxaliplatin 85mg/m2 D1 every 2 weeks

HERZUMA+mFOLFOX

Choong-kun Lee

Trastuzumab is approved for the treatment of HER2-positive breast cancer and gastric cancer. The recent study showed that HER2 overexpression or amplification is noted about 5-15% of total biliary tract cancer patients and have shown efficacy in small basket trials. The aim of this study is to evaluate the efficacy and safety of trastuzumab in the combination of mFOLFOX for gemcitabine+cisplatin refractory biliary tract cancer patients.

This phase II study is designed to see whether trastuzumab-pkrb+FOLFOX is active as 2nd or 3rd line treatment for HER2-positive biliary tract cancer patients.

Trastuzumab-pkrb Combined With Modified FOLFOX-6 in Biliary Tract Cancer Patients Progressed on First Line Therapy

A Phase II Trial of Trastuzumab-pkrb Combined With Modified FOLFOX-6 in Biliary Tract Cancer Patients Progressed on First Line Therapy

rate of patients with complete remission (CR) or partial remission (PR) based on RESIST1.1.

PFS is defined as time interval from cycle 1 day 1 to tumor progression/death/last follow-up

DCR is rate of patients with CR, PR, or SD per RECIST 1.1.

OS is defined as time interval from cycle 1 day 1 to tumor death/last follow-up.

Incidence of treatment related adverse events (TRAE) will be assessed using NCI CTCAE v5.0 and tabulated and reported.

Yonsei University

Carcinoma

Carcinoma, Ductal

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

D1 Nanoxel 75 mg/m2 + D5W 100mL MIV over 1hr D1 Herzuma 8mg/kg (loading dose) + N/S 250mL miv over 90mins 6mg/kg (maintenance) + N/S 250mL MIV over 30mins (since 2 cycle) repeated every 3 weeks

nanoxel

herzuma

Myung-Ju Ahn, PhD

1. Study outline This is a multicenter, single-arm, phase II trial to evaluate the efficacy and safety of nanoxel plus herzuma combination chemotherapy in patients with metastatic salivary ductal cancer. Approximately 41 patients will be enrolled. Treatment will be continued until disease progression or unacceptable toxicities. Response evaluation will be performed every 2 cycles.
2. Dosing \& Treatment schedule D1 Nanoxel 75 mg/m2 + D5W 100mL MIV over 1hr D1 Herzuma 8mg/kg (loading dose) + N/S 250mL miv over 90mins 6mg/kg (maintenance) + N/S 250mL MIV over 30mins (since 2 cycle) repeated every 3 weeks (In case of discontinuation of nanoxel without progression, single agent herzuma can be administered until progression)

Combination of Nanoxel and Herzuma in Salivary Duct Carcinoma

Combination of Nanoxel and Herzuma as First-line Chemotherapy in Patients With Metastatic Salivary Duct Carcinoma : Open Label Single Arm Multicenter Phase II Study

Samsung Medical Center

Professor

Symptoms and General Pathology

Stomach Neoplasms

Neoplasm Metastasis

Stomach Diseases

Stomach Cancer

Capecitabine

Cisplatin

Antimetabolites

Antineoplastic Agents, Immunological

* Trastuzumab (Herzuma) 8mg/kg loading over 90min (1st cycle)
* Trastuzumab (Herzuma) 6mg/kg maintenance over 30min (2nd cycle\~ ) every 3 weeks
* Capecitabine 1000mg/m2 p.o. bid D1-D14 every 3 weeks
* Cisplatin 60\~100mg/m2 i.v. D1 every 3 weeks

* Trastuzumab (Herzuma) 8mg/kg loading over 90min (1st cycle)
* Trastuzumab (Herzuma) 6mg/kg maintenance over 30min (2nd cycle\~ ) every 3 weeks

- Capecitabine 1000mg/m2 p.o. bid D1-D14 every 3 weeks

- Cisplatin 60\~100mg/m2 i.v. D1 every 3 weeks

Sung Yong Oh, MD

Enhee Choi, RN

Stomach cancer is the fifth largest cancer in the world. Despite many combinations of studies, metastatic stomach cancer shows a median survival period of 10 to 12 months.

According to a report in Korea in 2010, 17 % of cancer patients had over-expression of human epidemiology growth factor receptor 2 (HER-2). And Using of Trastuzumab reported better results.Herzuma® is the Trastuzumab biosimilar (Biosimilar) cloned antibody.

In this study, the investigators want to prospectively analyze the effects and side effects of Herzuma® in gastric or gastroesophageal adenocarcinoma.

Stomach cancer is the fifth largest cancer in the world, with an estimated 723,000 patients each year, and cancer-related deaths being the third leading cause. In contrast to the decline in the West, the Far East Asia, including South Korea, showed a high prevalence of cancer. In 2014, 29,854 new cases of cancer were reported in Korea. This is the second most important cancer in terms of incidence and the third in cancer related mortality.

The 5 year survival rate has increased to 74 % due to increased early detection of stomach cancer, but in the case of metastatic stomach cancer, the rate of gastric cancer is about one-third of the total number of stomach cancer cases, resulting in poor outcomes. Treatment is 5-fluorouracil, Oxaliplatin, Irinotecan, Epirubicin , Docetaxel, etc. based on platinum or non-platinum. Despite many combinations of studies, metastatic stomach cancer shows a median survival period of 10 to 12 months..

According to a report in Korea in 2010, 17 % of cancer patients had over-expression of human epidemiology growth factor receptor-2(HER-2). And Using of Trastuzumab reported better results in progression free survival (18.6 months vs. 17.1 months) and total overall survival (13.8 months vs. 11.1 months) (hazard ratio 0.74 ; 95 % confidential interval(CI) 0.60-0.91 ; p=0.0046) Trastuzumab was first used for HER-2 and breast cancer, and in three weeks of treatment, it is recommended to perform an induction phase of 8 mg/kg of 90 min and then a maintenance phase of 6mg/kg of 30min to 60min infusion. However, clinical research and data analysis are required because of concerns of toxic expression due to short-term injection. The phase I study of the maintenance 30 minutes toxicity was performed in breast cancer, and there was little difference from 60 minutes of injection in a 250ml or 100ml solution or new toxic event.

Herzuma® is the Trastuzumab biosimilar (Biosimilar) cloned antibody. In the phase I pharmacodynamics study, same the results with trastuzumab were reported. Biosimilar use was approved based on the results of a phase III clinical study on breast cancer. A double-blind, random assignment test was conducted on 549 HER-2 positive breast cancer patients comparing the validity and stability of Trastuzumab. The primary goal was to achieve a postoperative pathologic complete remission in 46.8 % of Herzuma® compared to 50.4% of trastuzumab. In addition, the secondary goal of "overall response rate " and "pharmacodynamics" showed the same results as the Trastuzumab control group.

Biosimilar Herzuma® licensed through breast cancer study also can be used in HER-2 overexpressed stomach cancer. However, there has not been a study on the effects and side effects of the drug.

So in this study, the investigators want to prospectively analyze the effects and side effects of Herzuma® in gastric or gastroesophageal adenocarcinoma.

* Herzuma 8mg/kg loading over 90min (1st cycle)
* Herzuma 6mg/kg maintenance over 30min (2nd cycle\~ ) every 3 weeks
* Capecitabine 1000mg/m2 p.o. bid D1-D14 every 3 weeks
* Cisplatin 60\~100mg/m2 i.v. D1 every 3 weeks

Herzuma-capecitabine/Cisplatin for Gastric Cancer

Safety and Efficacy Evaluation of Capecitabine, Cisplatin, and Herzuma Combination Chemotherapy for the First Line Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Patients.

complete response+partial response by RECIST

Celltrion

Sung Yong Oh

Pricipal Investigator

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Herzuma + Treatment of Physician's Choice

Herzuma

In Hae Park, MD

Trastuzumab combined with chemotherapy has been approved as the first line therapy in HER2+ metastatic breast cancer. When patients experienced progression beyond trastuzumab containing therapy, T-DM1 is considered as the second line therapy followed by trastuzumab plus any other chemotherapeutic agents or lapatinib plus capecitabine.

A biosimilar drug is a biological product that is highly similar to a licensed biological product, with no clinically meaningful differences in terms of safety, purity, or potency. Several trastuzumab biosimilar products have been approved after efficacy and safety studies which were usually as the first line setting with taxane combined.

Even though trastuzumab biosimilar drugs demonstrated similarity of equivalence with trastuzumab in these studies, the efficacy of their second use beyond progression with other chemotherapeutic agents has not been tested yet. In addition, the investigators don't have any data regarding possible cross reactivity between trastuzumab and trastuzumab biosimilar drugs.

In this study, the investigators plan multicenter phase II clinical trial to test the efficacy, safety and immunogenicity of trastuzumab biosimilar, Herzuma® in combination with TPC in patients with HER2+ metastatic breast cancer who progressed after 2 or more HER-2 directed chemotherapy.

Efficacy and Safety of Trastuzumab Biosimilar (Herzuma®) Plus Treatment of Physician's Choice (TPC) in Patients With HER-2 Positive Metastatic Breast Cancer

Open Label, Multicenter, Prospective Phase II Study to Investigate the Efficacy and Safety of Trastuzumab Biosimilar (Herzuma®) Plus Treatment of Physician's Choice (TPC) in Patients With HER-2 Positive Metastatic Breast Cancer Who Progressed After 2 or More HER-2 Directed Chemotherapy

defined as the time from study entry until the first observation of existing disease progression according to the above schedule or death due to any cause.

National Cancer Center, Korea

Senior Scientist

8mg/kg IVF loading dose at first cycle -\> 6mg/kg IVF at 2,3,4th cycle of each 21 day cycle

Jun Jeong

Joon Jeong, M.D.,Ph.D.

M.D.

In this study, we prospectively analyzed molecular subtyping through the PAM 50 test in HER2-negative (IHC1+ or 2+ (FISH/SISH-)) breast cancer patients. A phase 2 single arm study was designed to determine whether the addition of HER2-targeted treatment with treatment increases the pathologic remission rate.

Phase II Trial of Anti-HER2 Treatment in HER2-enriched Early Breast Cancer Identified by PAM50 (HER2E-PAM, PAMILIA Study)

TPathologic Complete Response (pCR) rate, assessed as no evidence of invasive disease in excised surgical specimens of breast and/or axilla(ypT0/isYpN0), in participants who received at least 1 cycle of herzuma and taxane in HER2-enriched subtype breast cancer

Gangnam Severance Hospital

Gedatolisib

Protein Kinase Inhibitors

Enzyme Inhibitors

* Trastuzumab biosimilar: Intravenously administered on Day 1 of every 21 day cycle at a dose of 6mg/kg (loading dose 8mg/kg at 1C)
* Gedatolisib: Intravenously administered on Day 1, 8 and 15 of every 21 day cycle at a dose of 180mg

Trastuzumab biosimilars(Herzuma), Gedatolisib

Kyong Hwa Park, MD, PhD

Jung Yoon Choi, MD

Yeon Hee Park, MD, PhD

Phase II Pilot Study of Trastuzumab Biosimilar (Herzuma®) plus Gedatolisib in Patients with HER-2 Positive Metastatic Breast Cancer Who Progressed after 2 or more HER-2 directed Chemotherapy

All the patients will be included in the final analysis, with a total of 15 patients to be enrolled.

Treatment will occur until disease progression, unacceptable toxicity or patient withdrawal.

Tumor measurement and evaluation are going to be performed at every 6 weeks for the first 3 months, then at every 9 weeks till progression, and then follow-up evaluation at every 12 weeks thereafter end of study.

Phase II Study of Herzuma® Plus Gedatolisib in Patients With HER-2 Positive Metastatic Breast Cancer

Phase II Study of Trastuzumab Biosimilar (Herzuma®) Plus Gedatolisib in Patients With HER-2 Positive Metastatic Breast Cancer Who Progressed After 2 or More HER-2 Directed Chemotherapy

the percentage of patients experiencing confirmed complete response (CR) and partial response (PR) assessed by RECIST criteria v.1.1

the time from study entry until the first observation of disease progression according to the above schedule or death due to any cause

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Trastuzumab-pkrb Combined With Modified FOLFOX-6 in Biliary Tract Cancer Patients Progressed on First Line Therapy	NCT04722133	HER2 Positive A...	HERZUMA+mFOLFOX	19 Years -	Yonsei University
Combination of Nanoxel and Herzuma in Salivary Duct Carcinoma	NCT03614364	Salivary Duct C...	nanoxel herzuma	20 Years -	Samsung Medical Center
Trastuzumab-pkrb Combined With Modified FOLFOX-6 in Biliary Tract Cancer Patients Progressed on First Line Therapy	NCT04722133	HER2 Positive A...	HERZUMA+mFOLFOX	19 Years -	Yonsei University
Herzuma-capecitabine/Cisplatin for Gastric Cancer	NCT03588533	HER-2 Positive ... Metastatic Canc...	Trastuzumab Capecitabine Cisplatin	20 Years -	Dong-A University Hospital
Efficacy and Safety of Trastuzumab Biosimilar (Herzuma®) Plus Treatment of Physician's Choice (TPC) in Patients With HER-2 Positive Metastatic Breast Cancer	NCT03755141	HER2-positive B... Metastatic Brea...	Herzuma	19 Years -	National Cancer Center, Korea
Efficacy and Safety of Trastuzumab Biosimilar (Herzuma®) Plus Treatment of Physician's Choice (TPC) in Patients With HER-2 Positive Metastatic Breast Cancer	NCT03755141	HER2-positive B... Metastatic Brea...	Herzuma	19 Years -	National Cancer Center, Korea
Phase II Trial of Anti-HER2 Treatment in HER2-enriched Early Breast Cancer Identified by PAM50 (HER2E-PAM, PAMILIA Study)	NCT04817540	HER2 Enriched S...	Herzuma	19 Years -	Gangnam Severance Hospital
Phase II Study of Herzuma® Plus Gedatolisib in Patients With HER-2 Positive Metastatic Breast Cancer	NCT03698383	HER2-positive B... Metastatic Brea...	Trastuzumab bio...	19 Years -	Korean Cancer Study Group
Herzuma-capecitabine/Cisplatin for Gastric Cancer	NCT03588533	HER-2 Positive ... Metastatic Canc...	Trastuzumab Capecitabine Cisplatin	20 Years -	Dong-A University Hospital
Phase II Trial of Anti-HER2 Treatment in HER2-enriched Early Breast Cancer Identified by PAM50 (HER2E-PAM, PAMILIA Study)	NCT04817540	HER2 Enriched S...	Herzuma	19 Years -	Gangnam Severance Hospital
Phase II Trial of Anti-HER2 Treatment in HER2-enriched Early Breast Cancer Identified by PAM50 (HER2E-PAM, PAMILIA Study)	NCT04817540	HER2 Enriched S...	Herzuma	19 Years -	Gangnam Severance Hospital

Spots Global Cancer Trial Database for herzuma

Every month we try and update this database with for herzuma cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for herzuma

Every month we try and update this database with for herzuma cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for herzuma cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.