Clinical trials: HER-2 Positive Malignant Carcinoma of Breast
- Condition HER-2 Positive Malignant Carcinoma of Breast
- Funder type Industry (pharma, biotech, devices)
Breast Cancer
A Study of Herceptin (Trastuzumab) in Combination With Xeloda (Capecitabine) in Patients With Metastatic or Recurrent HER2-positive Breast Cancer After First-Line or (Neo)Adjuvant Therapy.
This single arm. open-label study will assess the efficacy and safety of Herceptin (trastuzumab) in combination with Xeloda (capecitabine) in patients with metastatic or recurrent HER2-positive breast cancer, refractory to or…
- Trial name
- NCT01290718
- Testing
- capecitabine [Xeloda], trastuzumab [Herceptin]
- Where
- 6 sites in Taiwan
- Volunteers
- 4 people
- Sponsor
- Hoffmann-La Roche
Advanced HER2-positive Breast Cancer
Combination of AUY922 With Trastuzumab in HER2+ Advanced Breast Cancer Patients Previously Treated With Trastuzumab
The phase Ib part of the trial will assess the MTD of AUY922 in combination with Trastuzumab in patients with Trastuzumab-refractory locally advanced or metastatic HER2+.
- Trial name
- NCT01271920
- Testing
- AUY922, Trastuzumab
- Where
- 16 sites in United States, France and 6 more
- Volunteers
- 45 people
- Sponsor
- Novartis Pharmaceuticals
HER2-positive Breast Cancer, Metastatic Breast Cancer
SMP-656 for HER2-Positive Advanced Breast Cancer
The goal of this clinical trial is to learn if single-agent SMP-656 works to treat patients with HER2-positive locally advanced or metastatic breast cancer who have progressed after prior HER2-targeted topoisomerase inhibitor…
- Conditions
- HER2-positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer (LABC)
- Trial name
- NCT07726342
- Testing
- SMP-656 Injection
- Where
- 15 sites in China
- Volunteers
- 60 people
- Sponsor
- Chengdu SciMount Pharmatech Co., Ltd.
Metastatic Breast Cancer
A Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus the Combination of Trastuzumab Plus Docetaxel in Patients With HER2-positive Breast Cancer
This is a Phase III, randomized, multicenter, multinational, two-arm, open-label clinical trial to investigate a first-line treatment of participants with human epidermal growth factor receptor-2 (HER2)-positive metastatic breast…
- Trial name
- NCT02144012
- Testing
- Trastuzumab, Trastuzumab Emtansine, Docetaxel
- Where
- 8 sites in Malaysia, South Korea and 2 more
- Volunteers
- 49 people
- Sponsor
- Hoffmann-La Roche
Breast Neoplasms, Cancer of the Breast
A Trial for HER2 Positive Breast Cancer Patients With Metastatic Disease
This phase II trial that includes Gemcitabine 1,250mg/m2 to be administered over approximately 30 minutes on days 1 and 8, every 21 days and Trastuzumab 8 mg/kg IV to be administered over 90 minutes on day 1 of the first cycle…
- Conditions
- Breast Neoplasms, Cancer of the Breast, Breast Cancer
- Trial name
- NCT00191373
- Testing
- Gemcitabine, Trastuzumab
- Where
- 13 sites in United States
- Volunteers
- 66 people
- Sponsor
- Eli Lilly and Company
HER2-positive Breast Cancer
Clinical Study of Recombinant Anti-HER2 Humanized Monoclonal Antibody for Injection
A randomized, multicenter, Phase I/IIa clinical study to evaluate the tolerability, safety, efficacy, pharmacokinetics and immunogenicity after single/multiple administration of recombinant anti-HER2 humanized monoclonal antibody…
- Trial name
- NCT04170595
- Testing
- GB221,2 mg/kg, GB221,6 mg/kg, Herceptin,6 mg/kg
- Where
- China
- Volunteers
- 132 people
- Sponsor
- Genor Biopharma Co., Ltd.
Breast Cancer
An Observational Study of the Safety of Herceptin Given Subcutaneously in Patients With Early HER2-positive Breast Cancer
This non-interventional prospective study will assess the safety of Herceptin SC (subcutaneous administration) as used in routine clinical practice.
- Trial name
- NCT02286362
- Where
- 97 sites in France
- Volunteers
- 510 people
- Sponsor
- Hoffmann-La Roche
HER2-positive Metastatic Breast Cancer
Study of KN026 in Combination With Palbociclib and Fulvestrant in Patients With Advanced Breast Cancer
This is an open-label, multicenter, dose-escalation and parallel-group expansion Phase II clinical trial to evaluate the efficacy, safety and tolerability of KN026 in combination with palbociclib and fulvestrant in women or male…
- Trial name
- NCT04778982
- Testing
- KN026 combined with Palbociclib and Fulvestrant
- Where
- China
- Volunteers
- 4 people
- Sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
HER2-positive Breast Cancer
A Study of A166 Versus Trastuzumab Emtansine (T-DM1) in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane Therapy
Evaluation of the efficacy of A166 versus trastuzumab emtansine (T-DM1) in Patients with HER2-Positive unresectable or metastatic breast cancer previously treated with trastuzumab and taxane therapy
- Trial name
- A166 (NCT06968585)
- Testing
- A166, T-DM1
- Where
- China
- Volunteers
- 365 people
- Sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Breast Cancer, Gastric Cancer
Safety Study of MGAH22 in HER2-positive Carcinomas
The purpose of this study is to determine if MGAH22 is safe when given by intravenous (IV) infusion to patients with HER2-positive cancer.
- Trial name
- NCT01148849
- Testing
- margetuximab
- Where
- 3 sites in United States, South Korea
- Volunteers
- 66 people
- Sponsor
- MacroGenics
Metastatic Breast Cancer, HER2+ Breast Cancer
Phase 1b/2 Study of BKM120 Plus Trastuzumab in Patients With HER2-positive Breast Cancer
This study will assess the safety and efficacy of BKM120 in combination with trastuzumab in patients with relapsing HER2 overexpressing breast cancer who have previously failed trastuzumab.
- Trial name
- NCT01132664
- Testing
- BKM120, Trastuzumab, Capecitabine
- Where
- 21 sites in United States, Belgium and 4 more
- Volunteers
- 72 people
- Sponsor
- Novartis Pharmaceuticals
HER2-positive Advanced Solid Tumor
A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1303/BNT323 in subjects with advanced solid tumors that express HER2.
- Trial name
- NCT05150691
- Testing
- DB-1303/BNT323, Pertuzumab Injection, Ritonavir
- Where
- 102 sites in United States, Australia and 4 more
- Volunteers
- 796 people
- Sponsor
- DualityBio Inc.
Metastatic Breast Cancer
A Study of Trastuzumab Emtansine, Paclitaxel, and Pertuzumab in Patients With HER2-Positive, Locally Advanced or Metastatic Breast Cancer
This Phase Ib-IIa, multi-institutional, open-label, dose-escalation study is designed to evaluate the safety, tolerability, pharmacokinetics and feasibility of trastuzumab emtansine (T-DM1) administered by intravenous (IV)…
- Trial name
- NCT00951665
- Testing
- paclitaxel, pertuzumab [Perjeta], trastuzumab emtansine [Kadcyla]
- Where
- 5 sites in United States
- Volunteers
- 107 people
- Sponsor
- Genentech, Inc.
Breast Cancer
Eribulin With Trastuzumab as First-line Therapy for Locally Recurrent or Metastatic HER2 Positive Breast Cancer
This is a multicenter phase 2 study designed to evaluate the safety and efficacy of eribulin mesylate in combination with trastuzumab as first line treatment in female subjects with locally recurrent or metastatic human epidermal…
- Trial name
- NCT01269346
- Testing
- Eribulin Mesylate
- Where
- 26 sites in United States
- Volunteers
- 52 people
- Sponsor
- Eisai Inc.
Advanced Breast Cancer, HER2-positive Breast Cancer
A Study to Compare Pertuzumab + Trastuzumab + Vinorelbine vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-positive Metastatic Breast Cancer
This is a randomized, open-label, two-arm, phase III trial in Germany to investigate whether vinorelbine-based triple combination presents a less toxic treatment option than docetaxel-based triple combination in patients with…
- Trial name
- ATTILA (NCT03811418)
- Testing
- Trastuzumab, Pertuzumab, Vinorelbine
- Where
- Germany
- Sponsor
- iOMEDICO AG
HER2-positive Breast Cancer
Comparing Efficacy and Safety Between Pertuzumab® and Perjeta® in Neoadjuvant Treatment of HER2+ Breast Cancer
This study was a phase III, multicenter, triple-blind, equivalency clinical trial to determine the therapeutic efficacy and safety between Pertuzumab® (CinnaGen Co.) compared to originator pertuzumab in HER2-positive early breast…
- Trial name
- NCT04957212
- Testing
- Trastuzumab, Pertuzumab, Carboplatin
- Where
- 44 sites in Iran
- Volunteers
- 214 people
- Sponsor
- Cinnagen
HER2-positive Breast Cancer
A Study of BL-M07D1 Versus T-DM1 in the Adjuvant Treatment of HER2-positive Breast Cancer With Residual Invasive Cancer After Neoadjuvant Therapy
This trial is a registered phase III, randomized, open-label, multicenter study designed to evaluate the efficacy and safety of BL-M07D1 in the adjuvant treatment of HER2-positive breast cancer with residual invasive cancer after…
- Trial name
- NCT06830889
- Testing
- BL-M07D1, T-DM1
- Where
- 2 sites in China
- Volunteers
- 1,450 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
Breast Cancer, Breast Neoplasms
A Study to Evaluate the Efficacy and Safety of HLX11 vs. EU-Perjeta® in the Neoadjuvant Therapy of HER2-Positive and HR-Negative Early-stage or Locally Advanced Breast Cancer
This is a phase III, double-blind, randomized, parallel-controlled, multicenter equivalence study to compare the efficacy and safety of pertuzumab biosimilar HLX11 vs.
- Conditions
- Breast Cancer, Breast Neoplasms, HER2-positive Breast Cancer
- Trial name
- NCT05346224
- Testing
- HLX11, EU-Perjeta®
- Where
- 79 sites in China, Hungary and 2 more
- Volunteers
- 900 people
- Sponsor
- Shanghai Henlius Biotech
Breast Cancer, Metastatic
ASPEN-09-03: A Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Metastatic HER2-Positive Breast Cancer
The Substudy Protocol ASPEN-09-03 is a Phase 2, single-arm, multicenter study evaluating the efficacy, safety, and tolerability of evorpacept in combination with trastuzumab and chemotherapy in participants with HER2-positive…
- Trial name
- ASPEN-09-03 (NCT07007559)
- Testing
- Evorpacept (ALX148), Trastuzumab, Paclitaxel
- Where
- 60 sites in United States, Canada and 6 more
- Volunteers
- 120 people
- Sponsor
- ALX Oncology Inc.
Breast Cancer
DV in Combination With Pertuzumab With or Without Toripalimab Neoadjuvant Therapy With HER2-positive Breast Cancer
The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin in combination with Pertuzumab with or without Toripalimab neoadjuvant therapy in patients with HER2-positive breast cancer.
- Trial name
- NCT06178159
- Testing
- Disitamab Vedotin Injection, Pertuzumab Injection, Toripalimab
- Where
- China
- Volunteers
- 40 people
- Sponsor
- RemeGen Co., Ltd.