| 1 |
NCT03321045 |
Recruiting |
PET Imaging With 89Zr-Trastuzumab for Prediction of HER2 Targeted Therapy Effectiveness |
|
- Drug: [89Zr]-Df-Trastuzumab
- Diagnostic Test: PET/MRI Imaging
|
Interventional |
Early Phase 1 |
- University of Alabama at Birmingham
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Investigate the use of [89Zr]-Df-Trastuzumab as a HER2 imaging agent
|
10 |
Female |
18 Years and older (Adult, Senior) |
NCT03321045 |
IRB-170220004 |
|
November 21, 2017 |
January 2022 |
January 2022 |
October 25, 2017 |
January 23, 2018 |
|
- The Kirklin Clinic
Birmingham, Alabama, United States
|
| 2 |
NCT02120911 |
Completed |
Feasibility Study of Chemoradiation, TRAstuzumab and Pertuzumab in Resectable HER2+ Esophageal Carcinoma |
|
- Drug: Pertuzumab, trastuzumab
|
Interventional |
Phase 1
Phase 2 |
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Roche Pharma AG
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- % of patients completing trastuzumab and pertuzumab treatment.
- Toxicity of pertuzumab and trastuzumab alone and in combination with chemoradiation
- Number of post-operative complications
- (and 3 more...)
|
40 |
All |
18 Years and older (Adult, Senior) |
NCT02120911 |
AMCMEDONC 2013-377
2013-004111-42 |
TRAP |
January 2014 |
February 2017 |
February 2017 |
April 23, 2014 |
May 31, 2017 |
|
- Academic Medical Center, Medical Oncology
Amsterdam, Netherlands
|
| 3 |
NCT02725541 |
Withdrawn |
Trial of Neoadjuvant Trastuzumab Emtansine in Patients With HER2-Equivocal Breast Cancer |
|
- Drug: Trastuzumab emtansine
|
Interventional |
Phase 2 |
- Jenny C. Chang, MD
- Genentech, Inc.
- The Methodist Hospital System
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Objective response rate
- Radiological response
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
|
0 |
Female |
18 Years and older (Adult, Senior) |
NCT02725541 |
Pro00013875 |
NATURE |
March 2016 |
April 2019 |
May 2019 |
April 1, 2016 |
September 14, 2016 |
|
- Houston Methodist Hospital
Houston, Texas, United States
|
| 4 |
NCT02658461 |
Completed
Has Results |
An Observational Time and Motion Study of Trastuzumab Subcutaneous (SC) and Intravenous (IV) Formulations in Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Early Breast Cancer (EBC) |
|
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Monetary Cost of Health Care Resources Used Per Episode of Care in Administration of Trastuzumab Single-Use Injection Device
- Monetary Cost of Health Care Resources Used Per Episode of Care in Administration of Trastuzumab SC Injection
- Monetary Cost of Health Care Resources Used Per Episode of Care in Preparation and Administration of Trastuzumab IV Infusion
- (and 14 more...)
|
36 |
Female |
18 Years and older (Adult, Senior) |
NCT02658461 |
ML29123
2010-024099-25 |
|
February 2012 |
February 2013 |
February 2013 |
January 18, 2016 |
April 29, 2016 |
March 25, 2016 |
- Brighton, United Kingdom
- Cardiff, United Kingdom
- Maidstone, United Kingdom
- Nottingham, United Kingdom
|
| 5 |
NCT01325207 |
Active, not recruiting |
Intrathecal Trastuzumab for Leptomeningeal Metastases in HER2+ Breast Cancer |
|
|
Interventional |
Phase 1
Phase 2 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Determine the safety and maximum tolerated dose of IT trastuzumab.
- Determine response to IT trastuzumab: radiological, cytological and clinical.
- Define the CSF PK of IT trastuzumab.
|
34 |
All |
18 Years and older (Adult, Senior) |
NCT01325207 |
NU 10C03
STU00040150 |
|
April 2011 |
March 2018 |
March 2019 |
March 29, 2011 |
December 21, 2017 |
|
- University of California San Francisco (UCSF)
San Francisco, California, United States - Northwestern University
Chicago, Illinois, United States - Tufts Medical Center
Boston, Massachusetts, United States - (and 5 more...)
|
| 6 |
NCT01894711 |
Completed |
Real World Efficiency of Trastuzumab in Early Breast Cancer |
|
|
Observational |
|
- Maastricht University Medical Center
|
Other |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
- Effectiveness of the use of trastuzumab in patients with human epidermal growth factor receptor 2 (HER2) positive tumor
- Number of patients treated with trastuzumab who develop (cardio)toxicity?
|
2684 |
All |
Child, Adult, Senior |
NCT01894711 |
MEC 09-4-075 |
|
May 2010 |
November 2012 |
May 2013 |
July 10, 2013 |
July 10, 2013 |
|
- Maastricht University Medical Centre
Maastricht, Limburg, Netherlands
|
| 7 |
NCT03153163 |
Active, not recruiting |
Study of the Pharmacokinetics and Safety of Trastuzumab Emtansine in Chinese Participants With Locally Advanced Inoperable or Metastatic HER2+ Breast Cancer |
|
- Drug: Trastuzumab Emtansine
|
Interventional |
Phase 1 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Area Under the Concentration-Time Curve [AUC] of Trastuzumab Emtansine, Total Trastuzumab, N2'-Deacetyl-N2'-(3-Mercapto-1-Oxopropyl)-Maytansine (DM1), Non-reducible Thioether Linkage (MCC)-DM1 and Lys-MCC-DM1
- Maximum Serum Concentration (Cmax) Immediately After Dosing of Trastuzumab Emtansine, Total Trastuzumab, N2'-Deacetyl-N2'-(3-Mercapto-1-Oxopropyl)-Maytansine (DM1), Non-reducible Thioether Linkage (MCC)-DM1 and Lys-MCC-DM1
- Minimum (Trough) Concentration (Cmin) of Trastuzumab Emtansine, Total Trastuzumab, N2'-Deacetyl-N2'-(3-Mercapto-1-Oxopropyl)-Maytansine (DM1), Non-reducible Thioether Linkage (MCC)-DM1 and Lys-MCC-DM1
- (and 4 more...)
|
11 |
All |
18 Years and older (Adult, Senior) |
NCT03153163 |
BP29920 |
|
June 20, 2017 |
February 27, 2018 |
September 19, 2019 |
May 15, 2017 |
February 13, 2018 |
|
- Fudan University Shanghai Cancer Center; Medical Oncology
Shanghai, China
|
| 8 |
NCT01081600 |
Completed |
89Zr-trastuzumab PET for Imaging the Effect of HSP90 Inhibition |
|
- Other: Imaging with 89Zr-trastuzumab PET
|
Observational |
|
- University Medical Center Groningen
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- To show the effect of the HSP90 inhibitor AUY922 on HER2 expression by means of 89Zr-trastuzumab PET scanning.
|
7 |
All |
18 Years and older (Adult, Senior) |
NCT01081600 |
27112008 version 1
2008-005751-26 |
AUY922 |
February 2010 |
February 2012 |
February 2012 |
March 5, 2010 |
May 14, 2013 |
|
- University Medical Center Groningen
Groningen, Netherlands
|
| 9 |
NCT02805829 |
Not yet recruiting |
Combination Trastuzumab With Expanded Natural Killer Cells for Treating HER2-positive Gastric Cancer |
|
- Drug: Trastuzumab + NK cells
|
Interventional |
Phase 1
Phase 2 |
- Xuzhou Medical University
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
- Number of Participants with tumor recurrence metastasis as a Measure of effectiveness
|
20 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT02805829 |
XYFY2016-KL014-01 |
|
January 2017 |
January 2020 |
January 2020 |
June 20, 2016 |
June 22, 2016 |
|
- Xuzhou medical university
Xuzhou, Jiangsu, China
|
| 10 |
NCT01816594 |
Completed |
NeoPHOEBE: Neoadjuvant Trastuzumab + BKM120 in Combination With Weekly Paclitaxel in HER2-positive Primary Breast Cancer |
- HER2-positive, Newly Diagnosed, Primary Breast Cancer, Neoadjuvant Therapy, Trastuzumab
|
- Drug: BKM120
- Drug: Trastuzumab
- Drug: Paclitaxel
- Drug: Placebo
|
Interventional |
Phase 2 |
- Novartis Pharmaceuticals
- Breast International Group
- German Breast Group (GBG)
- (and 2 more...)
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Pathological complete response (pCR) rate
- Overall objective clinical response rate at the end of the biologic window and prior to surgery
- Efficacy by other pCR definitions
- (and 4 more...)
|
50 |
Female |
18 Years and older (Adult, Senior) |
NCT01816594 |
CBKM120F2203 |
NeoPHOEBE |
September 2013 |
February 2015 |
February 2015 |
March 22, 2013 |
September 23, 2015 |
|
- Novartis Investigative Site
Concord NSW, New South Wales, Australia - Novartis Investigative Site
Parkville, Victoria, Australia - Novartis Investigative Site
Salzburg, Austria - (and 16 more...)
|
| 11 |
NCT02066532 |
Recruiting |
Ruxolitinib in Combination With Trastuzumab in Metastatic HER2 Positive Breast Cancer |
- Metastatic Breast Cancer
- Breast Carcinoma
- HER-2 Positive Breast Cancer
|
- Drug: Ruxolitinib
- Drug: Trastuzumab
|
Interventional |
Phase 1
Phase 2 |
- Kevin Kalinsky
- Incyte Corporation
- National Cancer Institute (NCI)
- Columbia University
|
Other / Industry / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum Tolerated dose of Ruxolitinib in combination with Trastuzumab (Phase I)
- Objective response rate
- Number of participants with adverse events
- Prevalence of progression free survival (PFS) rate (Phase II)
|
40 |
All |
18 Years and older (Adult, Senior) |
NCT02066532 |
AAAM1906
5U01CA168426 |
|
June 2014 |
June 2018 |
December 2018 |
February 19, 2014 |
February 13, 2018 |
|
- Mount Sinai Medical Center
New York, New York, United States - Columbia University Medical Center
New York, New York, United States - New York Hospital-Weill Cornell Medical Center
New York, New York, United States - Montefiore Medical Center
New York, New York, United States
|
| 12 |
NCT01373710 |
Active, not recruiting |
Intrathecal Trastuzumab Administration in Metastatic Breast Cancer Patients Developing Carcinomatous Meningitis |
- Metastatic Breast Cancer
- Carcinomatous Meningitis
|
|
Interventional |
Phase 1
Phase 2 |
- Institut Curie
- Hoffmann-La Roche
- Centre Leon Berard
- (and 7 more...)
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Phase I : To determine the Trastuzumab maximum tolerated dose (MTD) when weekly administrated by intrathecal or intraventricular route.
- Phase I : Recommended dose (RD will be used in Phase II)
- Phase I&II : Toxicity during treatment
- (and 8 more...)
|
34 |
All |
18 Years and older (Adult, Senior) |
NCT01373710 |
09/501/M
2009-017218-63 |
HIT |
May 19, 2011 |
May 2018 |
May 2019 |
June 15, 2011 |
November 6, 2017 |
|
- François Baclesse Center
Caen, Calvados, France - Rene Huguenin Hospital
Saint-Cloud, Haut De Seine, France - Institut Curie - Claudius Regaud Hospital
Paris, Ile De France, France - (and 7 more...)
|
| 13 |
NCT01420146 |
Completed
Has Results |
Pilot Imaging Study With 89Zr-Trastuzumab in HER2-positive Metastatic Breast Cancer Patients |
- Breast Neoplasms
- Secondary
- HER2 Positive Carcinoma of Breast
|
|
Interventional |
Phase 1 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Test the Diagnostic Accuracy of the HER2 Imaging Using the Labelled Monoclonal Antibody Trastuzumab by Correlating the HER2 PET/CT Imaging With the FDG-PET/CT and Molecular Characterization of Tumor Samples With Discordant Image Findings
- Time Activity Curve
- HER2 Extracellular Domain
|
20 |
All |
18 Years and older (Adult, Senior) |
NCT01420146 |
IJBMNZrT003 |
IJBMNZrT003 |
August 2011 |
September 2015 |
September 2015 |
August 19, 2011 |
April 18, 2017 |
April 18, 2017 |
- Jules Bordet Institut
Brussels, Belgium
|
| 14 |
NCT02774421 |
Recruiting |
Pilot Study of the Effect of Trastuzumab and GM-CSF on Children With Recurrent Ependymoma |
- Posterior Fossa Ependymoma (PFEPN)
|
- Drug: Trastuzumab after SubQ GM-CSF
- Drug: Trastuzumab in combination with SubQ GM-CSF
|
Interventional |
Phase 1 |
- University of Colorado, Denver
- Children's Hospital Colorado
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Stratum 1: Detection of trastuzumab in tumor following IT administration
- Stratum 2: Determine the Maximum Tolerated Dose (MTD) for IT trastuzumab in combination with fixed doses of subQ GM-CSF
|
33 |
All |
12 Months to 21 Years (Child, Adult) |
NCT02774421 |
14-1076 |
|
December 2016 |
November 2021 |
March 2022 |
May 17, 2016 |
December 15, 2017 |
|
- Children's Hospital Colorado
Aurora, Colorado, United States
|
| 15 |
NCT01875367 |
Active, not recruiting |
A Phase III Clinical Trial to Evaluate Patient´s Preference of Subcutaneous Trastuzumab (SC) Versus Intravenous (IV) Administration in Patients With HER2 Positive Advanced Breast Cancer (ABC). |
|
- Drug: Trastuzumab subcutaneous inyection vial
- Device: Trastuzumab subcutaneous device administration
|
Interventional |
Phase 3 |
- Spanish Breast Cancer Research Group
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of treatment preference
- Percentage of subcutaneous treatment (Vial v.s. device administration)preference
- Medical staff satisfaction
- (and 3 more...)
|
160 |
Female |
18 Years and older (Adult, Senior) |
NCT01875367 |
GEICAM/2012-07 |
ChangHER-SC |
September 2013 |
July 2018 |
July 2018 |
June 11, 2013 |
February 12, 2018 |
|
- Hospital General Universitario de Granollers
Granollers, Barcelona, Spain - Hospital de Mataró
Mataró, Barcelona, Spain - Hospital Sant Joan Despí Moises Broggi
Sant Joan Despí, Barcelona, Spain - (and 24 more...)
|
| 16 |
NCT02059876 |
Unknown † |
Dose-dense (Biweekly) Carboplatin Plus Paclitaxel With or Without Trastuzumab as Neoadjuvant Treatment for Breast Cancer |
|
- Drug: carboplatin and paclitaxel and or without trastuzumab
|
Interventional |
Phase 2 |
- Guangdong General Hospital
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- pathologic complete response
|
60 |
Female |
18 Years and older (Adult, Senior) |
NCT02059876 |
20120608 |
|
November 2013 |
December 2014 |
December 2014 |
February 11, 2014 |
February 12, 2014 |
|
- Guangdong General Hospital
Guangzhou, Guangdong, China
|
| 17 |
NCT01196052 |
Completed
Has Results |
A Study of Trastuzumab Emtansine (T-DM1) Sequentially With Anthracycline-based Chemotherapy, as Adjuvant or Neoadjuvant Therapy for Patients With Early Stage Herceptin (HER)2-positive Breast Cancer |
|
- Drug: Trastuzumab emtansine
|
Interventional |
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Participants With a Cardiac Event Within 12 Weeks After the Start of Trastuzumab Emtansine Treatment
- Adverse Events, LVEF Function, and Deaths
- Percentage of Participants Who Experienced at Least 1 Adverse Event During Concurrent Radiotherapy With Trastuzumab Emtansine Treatment
- (and 5 more...)
|
153 |
All |
18 Years and older (Adult, Senior) |
NCT01196052 |
BO22857
TDM4874g |
|
October 2010 |
June 2013 |
June 2013 |
September 8, 2010 |
October 6, 2014 |
June 26, 2014 |
- Fort Myers, Florida, United States
- Lafayette, Indiana, United States
- Scarborough, Maine, United States
- (and 41 more...)
|
| 18 |
NCT01785420 |
Recruiting |
Pre Operative Trastuzumab in Operable Breast Cancer |
- Carcinoma Breast Stage I
- HER2 Positive Breast Cancer
|
- Drug: Trastuzumab
- Drug: Placebo
|
Interventional |
Phase 3 |
- Dr Rajendra A. Badwe
- Tata Memorial Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Disease Free Survival
- Overall survival
- Circulating Tumour Cells in Peripheral Blood
- 4.1.3. Evaluation of the paraffin blocks for pTEN loss6-8 and p95ErbB2 truncated form of HER2
|
1100 |
Female |
18 Years to 80 Years (Adult, Senior) |
NCT01785420 |
TMH Project-982 |
|
May 2013 |
February 2018 |
February 2021 |
February 7, 2013 |
January 17, 2018 |
|
- Tata Memorial Centre
Mumbai, India
|
| 19 |
NCT01939275 |
Active, not recruiting |
64Cu DOTA-Trastuzumab PET/CT in Studying Patients With Gastric Cancer |
- Adenocarcinoma of the Gastroesophageal Junction
- Diffuse Adenocarcinoma of the Stomach
- Intestinal Adenocarcinoma of the Stomach
- (and 10 more...)
|
- Radiation: copper Cu 64-DOTA-trastuzumab
- Device: positron emission tomography
- Other: laboratory biomarker analysis
- Procedure: Computed Tomography
|
Interventional |
Not Applicable |
- City of Hope Medical Center
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Tumor uptake of copper Cu 64-DOTA trastuzumab
- Percent of patients whose tumors image with Cu-PET/CT
|
22 |
All |
18 Years and older (Adult, Senior) |
NCT01939275 |
13229
NCI-2013-01721 |
|
September 25, 2014 |
July 2018 |
July 2018 |
September 11, 2013 |
December 13, 2017 |
|
- City of Hope Medical Center
Duarte, California, United States
|
| 20 |
NCT03367676 |
Not yet recruiting |
12 weekS Adjuvant dOcetaxel Plus trastuzumaB in Patients With Small, Node-negative, HER2-positive Breast cancER (SOBER) |
|
- Drug: Trastuzumab
- Drug: Docetaxel
|
Interventional |
Phase 2 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Disease-free Survival
- Breast Cancer Specific Survival
- Overall Survival
- (and 2 more...)
|
112 |
Female |
18 Years and older (Adult, Senior) |
NCT03367676 |
RJBC1712 |
SOBER |
December 29, 2017 |
January 1, 2021 |
June 1, 2021 |
December 11, 2017 |
December 11, 2017 |
|
- Ruijin Hospital
Shanghai, Shanghai, China
|
| 21 |
NCT01187381 |
Terminated
Has Results |
An Observational Study of the Mean Duration of Trastuzumab (Herceptin) Treatment in Participants With Early or Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer |
|
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Treatment Duration With Trastuzumab in the Routine Clinical Practice
- Percentage of Participants Who Discontinued Trastuzumab Therapy According to Reasons for Discontinuation
- Percentage of Participants Who Received Previous Neoadjuvant Therapy
- (and 4 more...)
|
250 |
Female |
18 Years and older (Adult, Senior) |
NCT01187381 |
ML25235 |
HERODOT |
April 14, 2010 |
October 15, 2015 |
October 15, 2015 |
August 24, 2010 |
October 20, 2017 |
October 20, 2017 |
- Cluj Clinical County Hospital; Oncology Dept
Cluj-Napoca, Romania
|
| 22 |
NCT00824733 |
Terminated
Has Results |
Agatolimod and Trastuzumab in Treating Patients With Locally Advanced or Metastatic Breast Cancer |
|
- Drug: Trastuzumab
- Drug: PF03512676
- Other: Correlative Studies
|
Interventional |
Phase 2 |
- Bhuvaneswari Ramaswamy
- Pfizer
- Ohio State University Comprehensive Cancer Center
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- PF-03512676 Augments Antibody Mediated Cytoxicity (ADCC)Against Trastuzumab-coated Target Cells in Metastatic HER2 Overexpressing Breast Cancer.
- Progression-free Survival for Patients With Metastatic Breast Cancer That Are Receiving Trastuzumab Plus PF-03512676
- Combination of PF-03512676 and Trastuzumab Induces MIP-1 (Macrophage Inflammatory Protein 1), MCP-1 (Monocyte Chemoattract Protein 1) and RANTES.
|
6 |
All |
18 Years and older (Adult, Senior) |
NCT00824733 |
OSU-08153
NCI-2011-03157 |
|
February 2009 |
February 2013 |
April 2014 |
January 19, 2009 |
January 14, 2016 |
January 14, 2016 |
- The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
|
| 23 |
NCT01265927 |
Completed |
A Study Inhibiting Telomerase to Reverse Trastuzumab Resistance in HER2+ Breast Cancer |
|
- Drug: GRN163L in combination with trastuzumab
|
Interventional |
Phase 1 |
- Indiana University
- Breast Cancer Research Foundation
- Geron Corporation
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Determine the dose-limiting toxicity of GRN163L in combination with trastuzumab in patients with refractory HER2+ metastatic disease
- Measure the concentration of trastuzumab and GRN163L from blood samples immediately before and after infusion on day 1, weekly during cycle 1, and immediately prior to cycle 2
- Tumor biopsy and bone marrow aspirate assayed for telomerase activity prior to treatment and immediately prior to planned cycle 2
- (and 3 more...)
|
10 |
All |
18 Years and older (Adult, Senior) |
NCT01265927 |
IUCRO-0314
1010-05 |
|
January 2011 |
August 2012 |
October 2015 |
December 23, 2010 |
October 27, 2015 |
|
- Indiana University Simon Cancer Center
Indianapolis, Indiana, United States
|
| 24 |
NCT02030561 |
Recruiting |
NK Cell Infusions With Trastuzumab for Patients With HER2+ Breast and Gastric Cancer |
- Breast Cancer
- Gastric Cancer
|
- Drug: Trastuzumab + NK cells
|
Interventional |
Phase 1
Phase 2 |
- National University Hospital, Singapore
- National University, Singapore
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Participants with Serious and Non-Serious Adverse Events
- Duration of Tumor Response Measure
- Time-to-Event Outcome Measure
|
29 |
All |
21 Years to 99 Years (Adult, Senior) |
NCT02030561 |
MC01/21/13
2013/00566 |
|
January 2014 |
August 2017 |
August 2018 |
January 8, 2014 |
June 22, 2016 |
|
- National University Hospital
Singapore, Singapore - National University Hospital
Singapore, Singapore
|
| 25 |
NCT01170143 |
Unknown † |
Efficacy and Safety Study of Trastuzumab, Paclitaxel and Carboplatin on HER2+ Preoperative Breast Cancer |
|
- Drug: Trastuzumab QW, Trastuzumab Q3W
|
Interventional |
Phase 2 |
- Fudan University
- Hoffmann-La Roche
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Primary Endpoint is efficacy. To compare the efficacy in terms of the pathological complete response rate (pCR) to preoperative administration of qw or q3w Paclitaxel, Carboplatin and Trastuzumab (PCH).
|
60 |
Female |
18 Years to 70 Years (Adult, Senior) |
NCT01170143 |
ML22700 |
PCH |
August 2009 |
December 2015 |
December 2015 |
July 27, 2010 |
July 27, 2010 |
|
- Cancer Hospital Affiliated to Fudan University
Shanghai, Shanghai, China
|
| 26 |
NCT01810393 |
Active, not recruiting |
A Study to Assess Preference for Subcutaneous Trastuzumab Treatment in Participants With Human Epidermal Growth Factor Receptor (HER)2-Positive Metastatic Breast Cancer Responding to First-Line Intravenous Trastuzumab for at Least 3 Years |
|
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Participants With Preference for Either SC or IV Route of Administration According to Participant Preference Questionnaire (PPQ) Score
- Percentage of Participants With Adverse Events
- Percentage of Health Care Professionals With Preference for Either SC or IV Administration According to Health Care Professional Questionnaire (HCPQ) Score
|
114 |
All |
18 Years and older (Adult, Senior) |
NCT01810393 |
ML28589
2012-003442-32 |
|
June 11, 2013 |
August 10, 2019 |
August 10, 2019 |
March 13, 2013 |
April 6, 2018 |
|
- Clinique Du Docteur Calabet; Cromg
Agen, France - Clinique De L Europe; Radiotherapie Chimiotherapie
Amiens, France - ICO Paul Papin; Oncologie Medicale.
Angers, France - (and 67 more...)
|
| 27 |
NCT02598427 |
Terminated |
Intrathecal Pertuzumab and Trastuzumab in Patients With New Untreated Asymptomatic or Low Symptomatic Brain Metastasis in HER2 Positive Breast Cancer |
- HER2 Positive Untreated Metastatic Breast Cancer
- Asymptomatic or Low Symptomatic Brain Metastasis in Breast Cancer
|
- Drug: Pertuzumab
- Drug: Trastuzumab
|
Interventional |
Phase 1 |
- Kimberly Blackwell
- Duke University
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety as measured by adverse events
- Maximum tolerated dose as measure by dose limiting toxicity
- Response rate as measured by brain MRI
- Changes in cell-free circulating tumor DNA (ctDNA) in response to treatment
|
1 |
All |
18 Years and older (Adult, Senior) |
NCT02598427 |
Pro00061309 |
|
May 1, 2017 |
February 22, 2018 |
February 22, 2018 |
November 5, 2015 |
February 28, 2018 |
|
- Duke University Medical Center
Durham, North Carolina, United States
|
| 28 |
NCT00605397 |
Completed |
PET Imaging With Cu-64 Labeled Trastuzumab in HER2+ Metastatic Breast Cancer |
|
- Radiation: PET Imaging With Cu-64 Labeled Trastuzumab
|
Interventional |
Phase 1 |
- Memorial Sloan Kettering Cancer Center
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- test safety & feas of (PET) imaging w radiolabeled 64Cu-trastuzumab to determine dosimetry & biodistribution of trastuzumab, using a radiotracer dilution technique w copper-64 labeled trastuzumab
- to determine reproducibility of the measurement of the Standardized Uptake Value (SUV) in normal organs and tumors in a sub-cohort of 8 patients who will undergo two injections of the tracer.
- to determine the pharmacokinetic profile of the 64Cu-trastuzumab radiotracer.
|
11 |
Female |
18 Years and older (Adult, Senior) |
NCT00605397 |
06-134 |
Cu-64 HER2+ |
January 2007 |
December 2013 |
December 2013 |
January 31, 2008 |
December 28, 2015 |
|
- Memorial Sloan Kettering Cancer Center
New York, New York, United States
|
| 29 |
NCT02238509 |
Recruiting |
Safety and QoL of Trastuzumab With Lapatinib or Chemiotherapy in MBC and HER2+ Patients Refractory to Anti HER2 Therapies |
|
- Drug: Lapatinib
- Drug: Trastuzumab
|
Interventional |
Phase 2 |
- Consorzio Oncotech
- Clinical Research Technology S.r.l.
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Clinical Benefit Rate
- Progression free survival
- Overall Survival
- (and 2 more...)
|
154 |
Female |
18 Years and older (Adult, Senior) |
NCT02238509 |
GIM12-TYPHER
2013-005044-29 |
|
November 2014 |
October 2017 |
October 2017 |
September 12, 2014 |
June 15, 2016 |
|
- A.O.U. Ospedali Riuniti Umberto I
Ancona, Italy - Centro di Riferimento Oncologico
Aviano, Italy - Policlinico S. Orsola Malpighi
Bologna, Italy - (and 33 more...)
|
| 30 |
NCT03425656 |
Recruiting |
Comparing Efficacy and Safety of AryoGen Pharmed Biosimilar Trastuzumab (AryoTrust®) Versus Herceptin® in Breast Cancer |
- Malignant Neoplasm of Breast
|
- Drug: Trastuzumab plus docetaxel (for 4 21-day cycles) after four 14-day cycles of Doxorubicin plus cyclophosphamide
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- pathologic Complete Response
- clinical Complete Response
- clinical Partial Response
- (and 5 more...)
|
108 |
Female |
18 Years to 65 Years (Adult) |
NCT03425656 |
TRA.ARY.RS.94 (III) |
|
July 9, 2016 |
October 30, 2018 |
October 30, 2018 |
February 7, 2018 |
February 7, 2018 |
|
- Imam Khomeini hospital
Tehran, Iran, Islamic Republic of
|
| 31 |
NCT00509769 |
Completed
Has Results |
A Study of Trastuzumab Emtansine (Trastuzumab-MCC-DM1) Administered Intravenously to Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer |
|
- Drug: Trastuzumab emtansine [Kadcyla]
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Objective Response Assessed by the Independent Review Facility Using Response Evaluation Criteria in Solid Tumors (RECIST)
- Duration of Objective Response (OR) Assessed by the Independent Review Facility Using Response Evaluation Criteria in Solid Tumors (RECIST)
- Progression-free Survival (PFS) Assessed by the Independent Review Facility Using Response Evaluation Criteria in Solid Tumors (RECIST)
- (and 3 more...)
|
112 |
All |
Child, Adult, Senior |
NCT00509769 |
TDM4258g |
|
July 2007 |
January 2009 |
June 2009 |
July 31, 2007 |
April 2, 2013 |
April 2, 2013 |
- Little Rock Hem Onc Assoc
Little Rock, Arkansas, United States - Rocky Mountain Cancer Center
Denver, Colorado, United States - Washington Cancer Institute
Washington, District of Columbia, United States - (and 37 more...)
|
| 32 |
NCT01384253 |
Completed |
Safety Study of ²¹²Pb-TCMC-Trastuzumab Radio Immunotherapy |
- Breast Neoplasms
- Peritoneal Neoplasms
- Ovarian Neoplasms
- (and 2 more...)
|
- Other: ²¹²Pb-TCMC-Trastuzumab
- Biological: trastuzumab
|
Interventional |
Phase 1 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety and tolerability: To measure the number of participants who experience adverse events after intraperitoneal (IP) administration of ²¹²Pb-TCMC-Trastuzumab.
- Immunogenicity: To characterize the human immune response against ²¹²Pb-TCMC-Trastuzumab given via IP infusion.
- Anti-tumor effects: To monitor for anti-tumor effects as assessed by physical examination, radiographic imaging, and tumor marker studies.
- Pharmacokinetics: To determine the plasma pharmacokinetics and assess the extent of exit of radioactivity from the peritoneal cavity by γ-camera imaging.
|
18 |
All |
19 Years and older (Adult, Senior) |
NCT01384253 |
AREVAMED01 |
|
July 2011 |
October 2015 |
July 2016 |
June 29, 2011 |
September 30, 2016 |
|
- University Of Alabama at Birmingham
Birmingham, Alabama, United States - UCSD Moores Cancer Center
San Diego, California, United States
|
| 33 |
NCT00679211 |
Completed
Has Results |
A Study of Trastuzumab-Mcc-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer |
|
- Drug: Trastuzumab emtansine [Kadcyla]
|
Interventional |
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Participants With an Objective Response as Assessed Through Independent Radiologic Review
- Duration of Objective Response as Assessed Through Independent Radiologic Review
- Progression-free Survival as Assessed Through Independent Radiologic Review
- (and 5 more...)
|
110 |
All |
18 Years and older (Adult, Senior) |
NCT00679211 |
TDM4374g |
|
August 2008 |
September 2009 |
April 2011 |
May 16, 2008 |
March 31, 2017 |
April 23, 2013 |
|
| 34 |
NCT03368729 |
Not yet recruiting |
Niraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer |
- Metastatic Breast Cancer
- HER2 Positive Breast Carcinoma
|
- Drug: Niraparib
- Drug: Trastuzumab
|
Interventional |
Phase 1
Phase 2 |
- University of Alabama at Birmingham
- Translational Breast Cancer Research Consortium
- Tesaro, Inc.
- (and 2 more...)
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Sequential Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Phase 1: Dose-limiting toxicity (DLT)
- Phase 2: Objective Response Rate
- Number of adverse events
- (and 2 more...)
|
40 |
Female |
18 Years and older (Adult, Senior) |
NCT03368729 |
F2017000 (UAB 17112) |
|
June 1, 2018 |
June 1, 2020 |
June 1, 2021 |
December 11, 2017 |
January 29, 2018 |
|
- University of Alabama at Birmingham
Birmingham, Alabama, United States
|
| 35 |
NCT02649686 |
Active, not recruiting |
Durvalumab in Patients With HER-2 Positive Metastatic Breast Cancer Receiving Trastuzumab |
|
- Drug: Durvalumab
- Drug: Trastuzumab
|
Interventional |
Phase 1 |
- Canadian Cancer Trials Group
- AstraZeneca
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Confirm the recommended phase II dose of durvalumab given to patients with advanced/recurrent HER-2 positive metastatic breast cancer (MBC) who are receiving treatment with trastuzumab
- Number of participants with treatment related adverse events as assessed by CTCAE V 4.0
- Measure response rate of durvalumab measured by RECIST 1.1/Immune Response Criteria) in patients receiving trastuzumab
- (and 2 more...)
|
15 |
All |
18 Years and older (Adult, Senior) |
NCT02649686 |
I229 |
|
April 21, 2016 |
September 25, 2017 |
June 2018 |
January 7, 2016 |
February 14, 2018 |
|
- BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, Canada - Ottawa Hospital Research Institute
Ottawa, Ontario, Canada - University Health Network
Toronto, Ontario, Canada
|
| 36 |
NCT01340430 |
Active, not recruiting |
Neoadjuvant 5-fluorouracil, Epirubicin and Cyclophosphamide (FEC) Followed by Weekly Paclitaxel and Trastuzumab in Her2 Positive Breast Cancer |
- HER-2 Positive Breast Cancer
|
|
Interventional |
Phase 2 |
- Lucia Del Mastro,MD
- IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- pathologic complete response
- safety and tolerability
- cardiotoxicity
- (and 4 more...)
|
43 |
Female |
18 Years and older (Adult, Senior) |
NCT01340430 |
NEOHER-021
2010-021600-24 |
|
March 2011 |
December 2015 |
May 2025 |
April 22, 2011 |
November 1, 2016 |
|
- Istituto Nazionale per La Ricerca sul Cancro (IST)
Genoa, Ge, Italy - Ospedale S. Maria della Misericordia - Oncologia Medica
Perugia, PG, Italy - Fondazione del Piemonte per l'Oncologia - IRCC di Candiolo
Candiolo, TO, Italy - (and 3 more...)
|
| 37 |
NCT02040935 |
Active, not recruiting |
A Study of SC Administration of Trastuzumab (Herceptin) by SID at Home in HER2-Positive EBC Participants |
|
|
Interventional |
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
- Pharmacokinetics: Trough Concentrations (Ctrough) of Trastuzumab
- Health Survey Short Form-36 (SF-36) Score
- (and 2 more...)
|
128 |
All |
18 Years and older (Adult, Senior) |
NCT02040935 |
ML28878
2013-000829-31 |
HOMERUS |
February 21, 2014 |
July 6, 2018 |
July 6, 2018 |
January 20, 2014 |
February 26, 2018 |
|
- Medisch Centrum Alkmaar
Alkmaar, Netherlands - Meander Medisch Centrum; Locatie Lichtenberg
Amersfoort, Netherlands - Amphia ziekenhuis, locatie langendijk
Breda, Netherlands - (and 14 more...)
|
| 38 |
NCT02536339 |
Active, not recruiting |
Pertuzumab With High-Dose Trastuzumab in Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer (MBC) With Central Nervous System (CNS) Progression Post-Radiotherapy |
|
- Drug: Pertuzumab
- Drug: Trastuzumab
|
Interventional |
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Participants With Objective Response (OR) in the CNS Assessed per Response Assessment in Neuro-Oncology-Brain Metastases (RANO-BM) Criteria
- Percentage of Participants With Drop in Left Ventricular Ejection Fraction (LVEF) of at Least 10 Points From Baseline and to Below 50 Percent (%)
- Duration of Response (DOR) in the CNS
- (and 8 more...)
|
40 |
All |
18 Years and older (Adult, Senior) |
NCT02536339 |
ML29366 |
|
December 16, 2015 |
May 29, 2020 |
May 29, 2020 |
August 31, 2015 |
April 12, 2018 |
|
- Arizona Cancer Center
Tucson, Arizona, United States - City of Hope National Medical Center
Duarte, California, United States - Stanford Cancer Institute
Stanford, California, United States - (and 16 more...)
|
| 39 |
NCT00637325 |
Unknown † |
Trastuzumab Optimization Trial in Breast Cancer |
- Metastatic or Locally Advanced Breast Cancer
|
|
Interventional |
Phase 3 |
- Regione Lombardia
- Mario Negri Institute for Pharmacological Research
- Istituto Clinico Humanitas
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- progression free survival for maintenance study and overall survival for 2nd line study
- overall survival for the maintenance study and progression free survival for the 2nd line study
|
500 |
Female |
18 Years to 70 Years (Adult, Senior) |
NCT00637325 |
TOP |
TOP |
November 2007 |
May 2009 |
April 2011 |
March 17, 2008 |
March 17, 2008 |
|
- Ospedale E. Profili
Fabriano, Ancona, Italy - Azienda Ospedaliera Treviglio- Caravaggio
Treviglio, Bergamo, Italy - Policlinico Universitario
Monserrato, Cagliari, Italy - (and 22 more...)
|
| 40 |
NCT02999672 |
Active, not recruiting |
A Study to Determine Best Tumor Response With Trastuzumab Emtansine in Human Epidermal Growth Factor Receptor 2 (HER2) Overexpressing Solid Tumors |
- Bladder Cancer
- Pancreas Cancer
- Cholangiocellular Carcinoma
|
- Drug: Trastuzumab Emtansine
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Participants With Best Overall Response of Complete Response (CR) or Partial Response (PR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1)
- Progression-Free Survival (PFS) Assessed by Investigator Using RECIST V1.1
- Overall Survival (OS)
- (and 3 more...)
|
20 |
All |
18 Years and older (Adult, Senior) |
NCT02999672 |
MO29694
2015-001377-40 |
KAMELEON |
December 23, 2016 |
March 31, 2018 |
March 31, 2018 |
December 21, 2016 |
March 20, 2018 |
|
- IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
Meldola, Emilia-Romagna, Italy - Irccs Ospedale San Raffaele;Oncologia Medica
Milano, Lombardia, Italy - Irccs Istituto Europeo Di Oncologia (IEO); Cure Mediche
Milano, Lombardia, Italy - (and 13 more...)
|
| 41 |
NCT01912963 |
Active, not recruiting |
Phase II Study of Eribulin Mesylate, Trastuzumab, and Pertuzumab in Women With Metastatic, Unresectable Locally Advanced, or Locally Recurrent HER2-Positive Breast Cancer |
- HER-2 Positive Breast Cancer
|
- Drug: Pertuzumab, Trastuzumab and Eribulin
|
Interventional |
Phase 2 |
- Dana-Farber Cancer Institute
- Eisai Inc.
- Genentech, Inc.
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety and tolerability of the combination regimen
- Efficacy of treatment regimen
- Clinical benefit rate (CBR)
- (and 2 more...)
|
32 |
All |
18 Years and older (Adult, Senior) |
NCT01912963 |
13-163 |
|
August 2013 |
May 2017 |
March 2020 |
July 31, 2013 |
September 20, 2017 |
|
- Massachusetts General Hospital
Boston, Massachusetts, United States - Dana-Farber Cancer Institute
Boston, Massachusetts, United States
|
| 42 |
NCT02598310 |
Recruiting |
Neoadjuvant Nab-PTX and Trastuzumab for ER Negative and HER2 Positive Breast Cancer |
- Breast Cancer
- Estrogen Receptor Negative Neoplasm
- HER-2 Positive Breast Cancer
|
- Drug: nab-paclitaxel
- Drug: Trastuzumab
|
Interventional |
Phase 2 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Pathological complete response rate
- Disease free survival
- Objective response rate
- (and 3 more...)
|
30 |
Female |
20 Years to 70 Years (Adult, Senior) |
NCT02598310 |
OMC BC-04 |
|
November 2015 |
November 2020 |
November 2025 |
November 5, 2015 |
April 5, 2018 |
|
- Osaka Medical College
Takatsuki, Osaka, Japan
|
| 43 |
NCT02625441 |
Recruiting |
Adjuvant Trastuzumab, Pertuzumab Plus Docetaxel in the Treatment of Early HER2-positive Breast Cancer |
|
- Drug: Pertuzumab
- Drug: Trastuzumab
|
Interventional |
Phase 3 |
- Helsinki University Central Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Invasive disease-free survival
- Overall survival
- Distant disease-free survival
- (and 3 more...)
|
1366 |
Female |
18 Years and older (Adult, Senior) |
NCT02625441 |
FBCG-01-2015
2015-002323-25 |
BOLD-1 |
December 2015 |
December 2022 |
June 2023 |
December 9, 2015 |
August 10, 2017 |
|
- Helsinki University Central Hospital
Helsinki, Finland
|
| 44 |
NCT03501979 |
Not yet recruiting
New |
Tucatinib, Trastuzumab, and Capecitabine for the Treatment of HER2+ LMD |
- Metastatic Breast Cancer
- Leptomeningeal Disease
|
- Drug: Tucatinib
- Drug: Trastuzumab
- Drug: Capecitabine
|
Interventional |
Phase 2 |
- University of Alabama at Birmingham
- Cascadian Therapeutics Inc.
- Translational Breast Cancer Research Consortium
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall survival
- Number of adverse events
- Progression free survival
- (and 6 more...)
|
30 |
All |
18 Years and older (Adult, Senior) |
NCT03501979 |
UAB 1794 |
|
July 2018 |
July 2022 |
July 2023 |
April 18, 2018 |
April 18, 2018 |
|
- University of Alabama at Birmingham
Birmingham, Alabama, United States - University of Texas MD Anderson Cancer Center
Houston, Texas, United States
|
| 45 |
NCT00126607 |
Terminated |
Trastuzumab in Treating Patients With Metastatic or Recurrent Salivary Gland Cancer |
- High-grade Salivary Gland Mucoepidermoid Carcinoma
- Recurrent Salivary Gland Cancer
- Salivary Gland Acinic Cell Tumor
- (and 5 more...)
|
- Biological: trastuzumab
- Other: laboratory biomarker analysis
|
Interventional |
Phase 2 |
- National Cancer Institute (NCI)
|
NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Response (confirmed and unconfirmed, complete and partial response) in patients treated with trastuzumab
- Progression-free survival
- Overall survival
|
35 |
All |
18 Years and older (Adult, Senior) |
NCT00126607 |
NCI-2012-03172
S0431
U10CA032102
CDR0000437831 |
|
July 2005 |
May 2007 |
|
August 4, 2005 |
February 28, 2013 |
|
- Southwest Oncology Group
San Antonio, Texas, United States
|
| 46 |
NCT01402401 |
Terminated |
Phase II of AUY922 in Second-line Gastric Cancer in Combination With Trastuzumab in HER2 Positive Patients |
|
- Drug: AUY922 + Trastuzumab
|
Interventional |
Phase 2 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- efficacy of AUY922 in combination with trastuzumab as assessed by RECIST
|
21 |
All |
18 Years and older (Adult, Senior) |
NCT01402401 |
CAUY922A2205
2011-002570-23 |
|
November 2011 |
June 2013 |
June 2013 |
July 26, 2011 |
February 24, 2014 |
|
- University of California at Los Angeles UCLA LeConte Location
Los Angeles, California, United States - Clinical Research Alliance
Lake Success, New York, United States - University of Texas/MD Anderson Cancer Center UT SC
Houston, Texas, United States - (and 12 more...)
|
| 47 |
NCT01702571 |
Active, not recruiting |
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 |
|
- Drug: Trastuzumab Emtansine
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Participants with Adverse Events
- Progression-Free Survival According to Response Evaluation for Solid Tumors (RECIST) Version (v) 1.1 As Per Investigator Assessment
- Overall Survival According to RECIST v 1.1 As Per Investigator Assessment
- (and 4 more...)
|
2003 |
All |
18 Years and older (Adult, Senior) |
NCT01702571 |
MO28231
2012-001628-37 |
|
November 27, 2012 |
October 21, 2016 |
September 30, 2019 |
October 8, 2012 |
September 11, 2017 |
|
- CEMIC
Buenos Aires, Argentina - Centro Oncologico Riojano Integral (CORI)
La Rioja, Argentina - Hospital Privado De Comunidad; General Practice
Mar Del Plata, Argentina - (and 303 more...)
|
| 48 |
NCT01557764 |
Withdrawn |
Lapatinib With Trastuzumab in Treating Patients With HER2-Negative/HER2 Mutant Metastatic Breast Cancer |
|
- Drug: lapatinib ditosylate
- Biological: trastuzumab
|
Interventional |
Phase 2 |
- Washington University School of Medicine
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall clinical benefit rate (CBR; CD + PR + SD) of lapatinib and trastuzumab in patients with breast cancer that carry HER2 mutations
- PFS of patients treated with lapatinib and trastuzumab
- Correlation of HER2 mutation with histology subtype (invasive lobular vs. invasive ductal cancer)
- (and 4 more...)
|
0 |
All |
18 Years and older (Adult, Senior) |
NCT01557764 |
201206025 |
|
September 2012 |
March 2016 |
March 2016 |
March 19, 2012 |
July 4, 2013 |
|
|
| 49 |
NCT02569489 |
Withdrawn |
Dose Escalation Study of HBI-8000 in Combination With Paclitaxel and Trastuzumab in Women With Advanced or Metastatic HER2+ Breast Cancer |
|
- Drug: HBI-8000
- Drug: Trastuzumab
- Drug: Paclitaxel
|
Interventional |
Phase 1 |
- HUYA Bioscience International
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- MTD of HBI-8000 twice weekly in combination with weekly paclitaxel and trastuzumab in women with HER2+ breast cancer
|
0 |
Female |
18 Years and older (Adult, Senior) |
NCT02569489 |
HBI-8000-106 |
|
December 2015 |
December 2015 |
|
October 6, 2015 |
June 10, 2016 |
|
|
| 50 |
NCT00317720 |
Completed
Has Results |
Trastuzumab and RAD001 in Patients With Human Epidermal Growth Receptor 2 (HER-2) Overexpressing Breast Cancer |
- Breast Cancer
- Neoplasm Metastasis
|
- Drug: Trastuzumab
- Drug: RAD001
|
Interventional |
Phase 1
Phase 2 |
- M.D. Anderson Cancer Center
- Novartis
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Optimal Dose of RAD001 in Combination With Trastuzumab (Phase I)
- Clinical Benefit Response Rate (CBR)
|
40 |
All |
18 Years and older (Adult, Senior) |
NCT00317720 |
2005-0471 |
|
April 2006 |
February 2013 |
February 2013 |
April 25, 2006 |
June 26, 2014 |
June 12, 2014 |
- UT MD Anderson Cancer Center
Houston, Texas, United States
|
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