Clinical trials: HER-2 Positive Breast Cancer
HER2 Positive Breast Cancers
A Study of Tucatinib (ONT-380) Combined With Ado-trastuzumab Emtansine (T-DM1) in Patients With HER2+ Breast Cancer
The purpose of this study is to determine the maximal tolerated dose (MTD) or recommended dose (RD) and to assess the safety and tolerability of tucatinib (ONT-380) combined with ado-trastuzumab emtansine (T-DM1) in patients with…
- Trial name
- NCT01983501
- Testing
- Tucatinib (ONT-380), T-DM1
- Where
- 11 sites in United States, Canada
- Volunteers
- 57 people
- Sponsor
- Seagen Inc.
Breast Cancer
Phase IIIb Study to Evaluate the Safety and Tolerability of Herceptin SC With Perjeta and Docetaxel in Patients With HER2-positive Advanced Breast Cancer
This is an open-label, single-arm, multicenter, Phase IIIb study to evaluate the safety and tolerability of Herceptin SC in combination with Perjeta IV plus docetaxel in female patients with HER2-positive metastatic or locally…
- Trial name
- NCT02402712
- Testing
- Docetaxel, pertuzumab [Perjeta], trastuzumab [Herceptin]
- Where
- 112 sites in Belgium, Bulgaria and 10 more
- Volunteers
- 418 people
- Sponsor
- Hoffmann-La Roche
Metastatic Breast Cancer in the Liver
Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in Patients w/ Metastatic Breast Cancer w/Liver Dominant Disease
The goal of this clinical trial is to learn if using a liver-directed therapy with high dose chemotherapy followed by approved cancer treatment to treat patients with breast cancer that has spread to the liver is safe and…
- Trial name
- DELUMA (NCT06875128)
- Testing
- Melphalan/HDS followed by Physician's choice of SOC (eribulin, vinorelbine, or capecitabine), Physician's choice of SOC (eribulin, vinorelbine, or capecitabine)
- Where
- 8 sites in United States, Italy and 2 more
- Volunteers
- 90 people
- Sponsor
- Delcath Systems Inc.
HER2-positive Breast Cancer
Safety, Effectiveness and Quality of Life of Trastuzumab Deruxtecan in Patients with HER2+ Breast Cancer
Collection of data in real life conditions on satefy, effectiveness and quality of life of trastuzumab deruxtecan in patients with metastatic or unresectable HER2-positive breast cancer.
- Trial name
- NCT05149014
- Where
- France
- Volunteers
- 306 people
- Sponsor
- Daiichi Sankyo France
Breast Cancer
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-0587 as a Monotherapy and in Combination With Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer
This is a first-in-human, Phase Ia/Ib, dose-escalation and expansion study evaluating the safety, pharmacokinetics, and activity of GDC-0587 (cyclin-dependent kinase-4 [CDK4] inhibitor) as a monotherapy and in combination with…
- Trial name
- NCT07214662
- Testing
- GDC-0587, Giredestrant, Omeprazole
- Where
- 4 sites in United States, Taiwan
- Volunteers
- 3 people
- Sponsor
- Genentech, Inc.
Breast Cancer
A Trial Using ARV-471 or Anastrozole in Post-Menopausal Women With Breast Cancer Prior to Surgery
This trial is a Phase 2 neoadjuvant study evaluating ARV-471 or anastrozole in post-menopausal women with estrogen receptor positive/ human epidermal growth factor receptor 2 (ER+/HER2)- localized breast cancer.
- Trial name
- NCT05549505
- Testing
- ARV-471, Anastrozole, Surgical resection of breast tumor
- Where
- 49 sites in United States, Georgia and 2 more
- Volunteers
- 152 people
- Sponsor
- Arvinas Inc.
HER2-positive Breast Cancer, HER2-positive Gastric Cancer
PRS-343 in HER2-Positive Solid Tumors
A multi center, open-label, Phase 1 dose escalation study with expansion cohort is designed to determine the MTD, RP2D and dosing schedule of PRS-343 in patients with HER2+ advanced or metastatic solid tumors.
- Conditions
- HER2-positive Breast Cancer, HER2-positive Gastric Cancer, HER2-positive Bladder Cancer, HER2-positive Solid Tumor
- Trial name
- NCT03330561
- Testing
- PRS-343
- Where
- 10 sites in United States
- Volunteers
- 85 people
- Sponsor
- Pieris Pharmaceuticals, Inc.
HER2-positive Breast Cancer
Real-world Outcomes of Patients With HER2+ Metastatic Breast Cancer After Treatment With Trastuzumab Deruxtecan
This study will explore treatment patterns and clinical outcomes using the US-based Flatiron Health database to describe patients with HER2+ mBC who were previously treated with T-DXd to better characterize this population and…
- Trial name
- NCT06833268
- Testing
- No drug
- Where
- United States
- Volunteers
- 228 people
- Sponsor
- Daiichi Sankyo
Breast Cancer
A Phase 1 Study of Oral OP-1250 in Combination With Palbociclib in HR+/HER2- Breast Cancer Patients
This is an open-label, Phase 1b dose escalation and expansion study to determine the maximum tolerated dose (MTD) of OP-1250 in combination with palbociclib (Ibrance®️, Pfizer Inc.).
- Trial name
- NCT05266105
- Testing
- Palazestrant, Palbociclib
- Where
- 8 sites in Australia
- Volunteers
- 60 people
- Sponsor
- Olema Pharmaceuticals, Inc.
Breast Cancer
Study Evaluating Hemay022 in Combination With Endocrine Therapy In Subjects With ER Positive and HER2 Positive Advanced Breast Cancer
The purpose of this study is to evaluate the safety and tolerability of Hemay022 combined with endocrine therapy in the treatment of ER and HER2-positive metastatic or advanced breast cancer, and to establish OTR (best tolerated…
- Trial name
- NCT03308201
- Testing
- Hemay022+exemestane, Hemay022+letrozole, Hemay022+ fulvestrant
- Where
- China
- Volunteers
- 55 people
- Sponsor
- Tianjin Hemay Pharmaceutical Co., Ltd
Metastatic Breast Cancer
A Study of Trastuzumab Emtansine (Trastuzumab-MCC-DM1) Administered Intravenously to Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer
This was a multi-institutional, open-label, single-arm, Phase II study of trastuzumab emtansine (T-DM1) administered by intravenous (IV) infusion to patients with human epidermal growth factor receptor 2 (HER2)-positive…
- Trial name
- NCT00509769
- Testing
- Trastuzumab emtansine [Kadcyla]
- Where
- 40 sites in United States
- Volunteers
- 112 people
- Sponsor
- Genentech, Inc.
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.
Breast Neoplasms
Study of H3B-6545 in Japanese Women With Estrogen Receptor (ER)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer
The purpose of study is to determine tolerability and safety profile of H3B-6545 in Japanese women with ER-positive, HER2-negative breast cancer, and also to confirm the dose applicability to Japanese.
- Trial name
- NCT04568902
- Testing
- H3B-6545, Antihistamine
- Where
- 2 sites in Japan
- Volunteers
- 33 people
- Sponsor
- Eisai Co., Ltd.
Breast Cancer
Trastuzumab Deruxtecan (T-DXd) in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastatic Breast Cancer
This study will evaluate the safety and efficacy of trastuzumab deruxtecan (T-DXd) in participants with human epidermal growth factor receptor 2 (HER2)-low or HER2 immunohistochemistry (IHC) 0 (who are both hormone receptor…
- Trial name
- NCT05950945
- Testing
- Trastuzumab Deruxtecan
- Where
- 88 sites in United States, Australia and 8 more
- Volunteers
- 250 people
- Sponsor
- Daiichi Sankyo
Breast Neoplasms
A Long-term Follow-up Study for Cardiac Safety in the Patients With HER2 (+) Breast Cancer Who Have Completed the SB3-G31-BC
A Long-term Follow-up Study for Cardiac Safety in the Patients with HER2 Positive Early or Locally Advanced Breast Cancer Who Have Completed the SB3-G31-BC
- Trial name
- NCT02771795
- Testing
- Herceptin (trastuzumab), SB3 (proposed trastuzumab biosimilar)
- Where
- 40 sites in Bulgaria, Czechia and 5 more
- Volunteers
- 538 people
- Sponsor
- Samsung Bioepis Co., Ltd.
Advanced Solid Tumors, HER2-positive Breast Cancer
A Phase 1 Trial of ZN-A-1041 Enteric Capsules or Combination in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Solid Tumors
This will be a Phase 1, multicenter, open-label trial to evaluate the safety, tolerability, PK and efficacy of ZN-A-1041 as a monotherapy or in combination in participants with HER2-positive advanced solid tumors with or without…
- Trial name
- NCT05593094
- Testing
- ZN-A-1041, ZN-A-1041 + T-DM1 3.6 mg/kg iv. for Phase 1b, ZN-A-1041 + T-Dxd 5.4 mg/kg iv. for Phase 1b
- Where
- 36 sites in United States, Australia and 5 more
- Volunteers
- 210 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
A Study of Patients With HER2-Positive Metastatic Breast Cancer
This is a prospective observational cohort study designed to describe effectiveness and safety (treatment outcomes and clinically significant cardiac adverse events, respectively) in patients with HER2-positive metastatic breast…
- Trial name
- NCT00105456
- Volunteers
- 1,000 people
- Sponsor
- Genentech, Inc.
HER2-Positive Early Breast Cancer
A Study to Evaluate Patient Preference and Satisfaction of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Participants With HER2-Positive Early Breast Cancer
This is a Phase II, randomized, multicentre, multinational, open-label, cross-over study in adult patients who have completed neoadjuvant chemotherapy with neoadjuvant pertuzumab and trastuzumab and have undergone surgical…
- Trial name
- PHranceSCa (NCT03674112)
- Testing
- Pertuzumab and Trastuzumab Fixed-Dose Combination for Subcutaneous Administration (PH FDC SC), Pertuzumab IV, Trastuzumab IV
- Where
- 40 sites in United States, Argentina and 15 more
- Volunteers
- 160 people
- Sponsor
- Hoffmann-La Roche
HER2-positive Recurrent or Metastatic Breast Cancer
A Study of JSKN003 Versus Trastuzumab in Combination With Pertuzumab and Docetaxel as First-Line Treatment for HER2-Positive Recurrent or Metastatic Breast Cancer
This study is a randomized, controlled, open-label, multicenter, phase II superiority clinical trial. The planned study population consists of participants with HER2-positive recurrent or metastatic breast cancer who have not…
- Trial name
- NCT07545044
- Testing
- JSKN003, Trastuzumab, Pertuzumab
- Volunteers
- 60 people
- Sponsor
- Shanghai JMT-Bio Inc.
Breast Neoplasms
Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer
Primary objective: Compare disease-free survival in women with human epidermal growth factor receptor 2 (HER2)-neu-expressing node-positive or high-risk node-negative operable breast cancer treated with adjuvant doxorubicin…
- Trial name
- NCT00021255
- Testing
- Doxorubicin, Cyclophosphamide, Docetaxel
- Where
- 42 sites in United States, Argentina and 40 more
- Volunteers
- 3,222 people
- Sponsor
- Sanofi