Clinical trials: HER2 Positive Metastatic Breast Cancer
Breast Cancer
Imaging With 111 Indium (111In)-Pertuzumab (PmAb) to Predict Response to Trastuzumab (TmAb) in Human Epidermal Growth Factor-2 (HER2) Positive Metastatic Breast Cancer (MBC) or Locally Advanced Breast Cancer (LABC)
The general objective of the study is to improve the care of women with Human Epidermal Growth Factor Receptor-2 (HER2) positive metastatic or locally advanced breast cancer by using a radio-labelled biomarker with whole body…
- Trial name
- PETRA (NCT01805908)
- Testing
- 111In-Pertuzumab + SPECT-CT
- Where
- 2 sites in Canada
- Volunteers
- 3 people
- Sponsor
- Ontario Clinical Oncology Group (OCOG)
Breast Cancer
A Pharmacokinetic Study Comparing EG1206A and Perjeta (Pertzumab) in Healthy Male Volunteers
This trial is a single-center, single-dose, double-blind, parallel-group, randomized, 3-arm PK trial in healthy male volunteers comparing a biosimilar pertuzumab (EG1206A) to a single intravenous (i.v.) infusion to both European…
- Trial name
- NCT05471648
- Testing
- 420 mg EG1206A EirGenix Pertuzumab in 14 mL Injection, Perjeta (EU origin) 420 mg in 14 mL Injection, Perjeta (US origin) 420 mg in 14 mL Injection
- Where
- Germany
- Volunteers
- 135 people, healthy volunteers welcome
- Sponsor
- EirGenix, Inc.
Breast Cancer
Treatment of HER2-Positive Metastatic Breast Cancer With Herceptin and Bevacizumab (Antibodies Against HER2 and VEGF)
The purpose of this study is to evaluate the safety and effectiveness of combined treatment with trastuzumab (Herceptin) and bevacizumab (anti-VEGF antibody) in patients with HER2-positive metastatic breast cancer.
- Trial name
- NCT00095706
- Testing
- Bevacizumab (drug), Herceptin (drug)
- Where
- 18 sites in United States
- Volunteers
- 50 people
- Sponsor
- Translational Oncology Research International
Breast Cancer, Metastatic Breast Cancer
89Zr-DFO*-Trastuzumab PET in Patients With Gastric or Breast Cancer - a Pilot Study
The goal of this clinical trial is to test a new PET tracer in patients with HER2-positive breast or gastric cancer. This tracer is made of radioactively labeled trastuzumab, and can show where HER2 is present in the body using a…
- Conditions
- Breast Cancer, Metastatic Breast Cancer, HER2-positive Breast Cancer, Gastric Cancer
- Trial name
- HER Image (NCT05955833)
- Testing
- 89Zr-DFO*-trastuzumab PET scan
- Where
- Netherlands
- Volunteers
- 6 people
- Sponsor
- Amsterdam UMC, location VUmc
Advanced Metastatic Breast Cancer
Study for Women and Men With Hormone-receptor Positive Locally Advanced or Metastatic Breast Cancer
This was a national, multi-center, open-label, phase IIIb trial to determine the efficacy and safety of treatment with ribociclib (LEE011) plus letrozole in patients with HR+, HER2-negative advanced (recurrent or metastatic)…
- Trial name
- NCT03096847
- Testing
- ribociclib, letrozole, goserelin
- Where
- 84 sites in Germany
- Volunteers
- 502 people
- Sponsor
- Novartis Pharmaceuticals
HER2-positive, Unresectable, Locally Advanced or Metastatic Breast Cancer, SKB264
SKB264 Plus Inetetamab in HER2-Positive Metastatic Breast Cancer Patients Progressing After T-DXd Treatment
This is a prospective, single-arm, single-center, Phase II clinical study designed to assess the preliminary efficacy and safety of SKB264 Plus Inetetamab plus inetetamab for the treatment of HER2-positive, unresectable, locally…
- Conditions
- HER2-positive, Unresectable, Locally Advanced or Metastatic Breast Cancer, SKB264, Inetetamab
- Trial name
- SHINE-HER (NCT07182721)
- Testing
- SKB264 Plus Inetetamab
- Where
- China
- Volunteers
- 48 people
- Sponsor
- Fudan University
HR Positive/HER2 Negative Advanced or Metastatic Breast Cancer
A Phase III Clinical Trial of NTQ1062 in Combination With Fulvestrant for the Treatment of Advanced or Metastatic HR+/HER2- Breast Cancer
NTQ1062-301 is a randomized, double-blind, placebo-controlled Phase III clinical trial to evaluate the efficacy and safety of the small-molecule AKT inhibitor NTQ1062 combined with fulvestrant versus placebo combined with…
- Trial name
- NCT07393321
- Testing
- NTQ1062+Fulvestrant
- Volunteers
- 210 people
- Sponsor
- Nanjing Chia-tai Tianqing Pharmaceutical
Breast Cancer
Capecitabine 7/7 Schedule With Neratinib in Patients With Metastatic HER2-Positive Breast Cancer
This is a phase l/II study. The purpose of this study is to test the safety of the study drug neratinib in combination with a standard chemotherapy drug called capecitabine at different doses to find out what effects, if any, it…
- Trial name
- NCT03377387
- Testing
- Capecitabine, Neratinib, EORTC QLQ - BR23, EQ-5D-5L, EORTC QLQ-C30
- Where
- 10 sites in United States
- Volunteers
- 34 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Breast Cancer
Lenvatinib+Letrozole Versus Fulvestrant in Metastatic ER+/HER2- Breast Cancer, Post Progression on Al + CDK4/6 Inhibitor
Based on the results of the phase Ib/II study, the investigators hypothesize that combining a RET inhibitor lenvatinib with endocrine therapy letrozole improves objective response and progression-free survival compared to…
- Trial name
- NCT05181033
- Testing
- Lenvatinib + Letrozole, Fulvestrant
- Where
- Singapore
- Volunteers
- 120 people
- Sponsor
- National University Hospital, Singapore
HER2-positive, Metastatic Breast Cancer
ARX788 in HER2-positive Breast Cancer Patients With Brain Metastases
A Phase 2 Study of ARX788 in HER2-positive, Metastatic Breast Cancer Patients whose Disease is resistant or refractory to Tyrosine kinase inhibitors (TKI).
- Trial name
- NCT05018702
- Testing
- ARX788
- Where
- China
- Volunteers
- 32 people
- Sponsor
- Fudan University
Metastatic Breast Cancer
A Phase II Study of SSGJ-612 Plus a HER2-Targeted ADC in HR-Positive, HER2-Low or HER2-Ultralow Expression Metastatic Breast Cancer
This study is a phase II clinical trial of SSGJ-612 combined with a human epidermal growth factor receptor 2 (HER2)-targeted antibody-drug conjugate (ADC) in patients with hormone receptor (HR)-positive, HER2-low or HER2-ultralow…
- Trial name
- NCT07757230
- Testing
- SSGJ-612 (HER2-targeted antibody), HER2-targeted ADC
- Where
- China
- Volunteers
- 87 people
- Sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
HER2/Neu Negative, No Evidence of Disease
Vaccine Therapy in Preventing Cancer Recurrence in Patients With Non-Metastatic, Node Positive, HER2 Negative Breast Cancer That is in Remission
This phase I trial studies the side effects and best dose of a vaccine therapy in preventing cancer from coming back in patients with non-metastatic, node positive, human epidermal growth factor receptor (HER)2 negative breast…
- Conditions
- HER2/Neu Negative, No Evidence of Disease, One or More Positive Axillary Nodes, Stage IB Breast Cancer
- Trial name
- WOKVAC (NCT02780401)
- Testing
- Laboratory Biomarker Analysis, pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine, Sargramostim
- Where
- 2 sites in United States
- Volunteers
- 32 people
- Sponsor
- University of Washington
Breast Cancer, Metastatic Breast Cancer
Prospective Study to Evaluate the Clinical Utility of ctDNA Tumor Fraction (TF) for Detection of ESR1 Mutations in HR+/HER2- Metastatic Breast Cancer (MBC)
This is a prospective, single center, single-arm interventional study to evaluate the clinical utility of protocol-mandated diagnostic testing algorithm incorporating liquid biopsy and reflex tissue biopsy NGS for detection of…
- Conditions
- Breast Cancer, Metastatic Breast Cancer, HR+/HER- Metastatic Breast Cancer
- Trial name
- NCT07910565
- Testing
- FoundationOne® Liquid CDx (F1LCDx), Reflex tissue biopsy
- Where
- United States
- Volunteers
- 155 people
- Sponsor
- Yale University
Metastatic Breast Cancer
A Study of Pertuzumab With High-Dose Trastuzumab for the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer (MBC) With Central Nervous System (CNS) Progression Post-Radiotherapy
This study will examine the safety and efficacy of pertuzumab in combination with high-dose trastuzumab in adult participants with HER2-positive MBC with CNS metastases and disease progression in the brain following radiotherapy.
- Trial name
- NCT02536339
- Testing
- Pertuzumab, Trastuzumab
- Where
- 16 sites in United States
- Volunteers
- 40 people
- Sponsor
- Genentech, Inc.
Breast Cancer
Capecitabine or Endocrinotherapy as a Maintenance Therapy Regimen at Least 2nd Line in Hormone Receptor Positive and HER2 Negative Metastatic Breast Cancer
A single-site study about the efficacy of sequential monotherapy: Capecitabine vs. endocrine therapy, in metastatic breast cancer patients with HR-positive \& HER2-negative after capecitabine-base chemotherapy.
- Trial name
- NCT03204734
- Testing
- Capecitabine, endocrine therapy
- Where
- China
- Volunteers
- 132 people
- Sponsor
- Zhejiang Cancer Hospital
HR Positive HER2 Negative Advanced Breast Cancer
Iribrine Plus Tucidinostat in the Treatment of HR+/HER2 Advanced Breast Cancer After CDK4/6 Inhibitor Failure
To explore the safety and efficacy of Eribulin plus Tucidinostat amine in patients with HR+/ HER2-advanced metastatic breast cancer
- Trial name
- NCT05335473
- Testing
- Eribulin and Tucidinostat
- Where
- China
- Volunteers
- 34 people
- Sponsor
- Henan Cancer Hospital
Locally Advanced or Metastatic Breast Cancer
A Study to Evaluate the Efficacy and Safety of Giredestrant in Combination With Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf) Versus Phesgo in Participants With Locally Advanced or Metastatic Breast Cancer (heredERA Breast Cancer)
This Phase III, randomized, two-arm, open-label, multicenter study will evaluate the efficacy and safety of giredestrant plus Phesgo compared with Phesgo after induction therapy with Phesgo plus taxane in participants with human…
- Trial name
- NCT05296798
- Testing
- Phesgo, Giredestrant, Docetaxel
- Where
- 198 sites in United States, Argentina and 27 more
- Volunteers
- 922 people
- Sponsor
- Hoffmann-La Roche
Estrogen Receptor Negative, Estrogen Receptor Positive
Lapatinib Ditosylate and Akt Inhibitor MK2206 in Treating Women With Metastatic Breast Cancer
This phase I trial studies the side effects and the best dose of lapatinib ditosylate and Akt inhibitor MK2206 in treating women with metastatic breast cancer.
- Conditions
- Estrogen Receptor Negative, Estrogen Receptor Positive, HER2/Neu Positive, Progesterone Receptor Negative
- Trial name
- NCT01281163
- Testing
- Akt Inhibitor MK2206, Laboratory Biomarker Analysis, Lapatinib Ditosylate
- Where
- 5 sites in United States
- Volunteers
- 4 people
- Sponsor
- National Cancer Institute (NCI)
Breast Cancer, Breast Cancer Female
DATO-BASE: DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs
The purpose of this study is to test the safety and effectiveness of the study drug datopotamab deruxtecan in participants with metastatic breast cancer that has spread to the brain.
- Conditions
- Breast Cancer, Breast Cancer Female, Metastatic Triple-Negative Breast Carcinoma, ER Positive Breast Cancer
- Trial name
- NCT06176261
- Testing
- Datopotamab Deruxtecan
- Where
- 3 sites in United States
- Volunteers
- 58 people
- Sponsor
- Nancy Lin, MD
Breast Neoplasms, Breast Diseases
A Study of RC48-ADC Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer With or Without Liver Metastases
This is a randomized, open, parallel-controlled, multicenter, phase II/III, seamless design clinical trial to compare the efficacy and safety of RC48-ADC with capecitabine + lapatinib in locally advanced or metastatic human…
- Conditions
- Breast Neoplasms, Breast Diseases, Capecitabine, HER2-positive Breast Cancer
- Trial name
- NCT03500380
- Testing
- RC48-ADC, Lapatinib, Capecitabine
- Where
- 67 sites in China
- Volunteers
- 301 people
- Sponsor
- RemeGen Co., Ltd.