Clinical trials: HER-2 Positive Malignant Carcinoma of Breast
Resectable HER2-positive Breast Cancer
A Phase III Study of KN026 in Combination With HB1801 as Adjuvant Therapy for Resectable HER2-Positive Breast Cancer
This is a randomized, controlled, open-label, multicenter, Phase Ⅲ clinical study designed to compare the efficacy and safety of KN026 combined with HB1801 and chemotherapy versus trastuzumab combined with pertuzumab and…
- Trial name
- NCT07441460
- Testing
- KN026, HB1801, Trastuzumab
- Where
- China
- Volunteers
- 1,800 people
- Sponsor
- Shanghai JMT-Bio Inc.
HER2-positive Breast Cancer
Tumor Markers for Efficacy of Dual-Target Therapy in HER2+ Breast Cancer
This is a prospective, randomized study to compare the efficacy of TP (Taxane plus Carboplatin) chemotherapy combined with dual-HER2 blockade (trastuzumab and pertuzumab) versus TP chemotherapy plus single-HER2 blockade…
- Trial name
- NCT07115095
- Testing
- TP Chemotherapy + Trastuzumab + Pertuzumab, TP Chemotherapy + Trastuzumab
- Where
- China
- Volunteers
- 98 people
- Sponsor
- Nanlin Li
HER-2 Positive Breast Cancer
A Study of Liposomal Doxorubicin+Docetaxel+Trastuzumab+Metformin in Operable and Locally Advanced HER2 Positive Breast Cancer
It is a multicenter, open-label, two stage phase II trial, to assess activity, safety and potential early predictors of response in neoadjuvant setting.
- Trial name
- met-HEReMYTA (NCT02488564)
- Testing
- Liposomal doxorubicin, Docetaxel, Trastuzumab
- Where
- 9 sites in Italy
- Volunteers
- 49 people
- Sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Breast Cancer
HER2-positive Breast Cancer Project Initiated by Investigators
This study will assess the objective response rate (ORR), safety, progression-free survival (PFS) , overall survival (OS), 6-month survival rate, 12-month survival rate, 18-month survival rate, 24-month survival rate, disease…
- Trial name
- NCT05346328
- Testing
- Injection of A166
- Volunteers
- 48 people
- Sponsor
- Fudan University
Metastatic Breast Cancer, Advanced Breast Cancer
Margetuximab Plus Tucatinib and Capecitabine in HER2-positive Metastatic Breast Cancer
This is a multicenter, open-label, single-arm, phase II clinical trial to evaluate the efficacy and safety of margetuximab in combination with tucatinib and capecitabine in patients with human epidermal growth factor receptor 2…
- Conditions
- Metastatic Breast Cancer, Advanced Breast Cancer, HER2-positive Breast Cancer
- Trial name
- MARGARET (NCT05227131)
- Testing
- Margetuximab, Tucatinib, Capecitabine
- Sponsor
- MedSIR
HER2-positive Breast Cancer, Early Breast Cancer (EBC)
SHR-A1811 Versus Trastuzumab Plus Pertuzumab in ctDNA-Positive HER2-Positive Early Breast Cancer After Pathologic Complete Response
This investigator-initiated, single-center, randomized, open-label, phase II trial will evaluate the efficacy and safety of intensified adjuvant SHR-A1811 compared with trastuzumab plus pertuzumab in women with initially stage…
- Trial name
- NCT07856303
- Testing
- SHR-A1811, Trastuzumab, Pertuzumab
- Where
- China
- Volunteers
- 358 people
- Sponsor
- Fudan University
Breast Cancers
Neoadjuvant Oral Paclitaxel Plus Subcutaneous Pertuzumab/Trastuzumab in Patients With HER2-positive Breast Cancer
The goal of this clinical trial is to evaluate the efficacy and safety of oral paclitaxel plus fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in the neoadjuvant treatment of HER2+ breast cancer…
- Trial name
- OPTIMAL-BC (NCT07095023)
- Testing
- Paclitaxel oral solution plus Subcutaneous Pertuzumab/Trastuzumab
- Where
- 9 sites in China
- Volunteers
- 112 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Breast Cancer
Short-course Trastuzumab, Pertuzumab with Taxanes in the Adjuvant Treatment of Early HER2-positive Breast Cancer
The investigators plan to carry out a phase II, open-label, single-arm clinical study of short-course trastuzumab, pertuzumab combined with taxanes in the adjuvant treatment of early HER2-positive breast cancer, to explore…
- Trial name
- NCT05891561
- Testing
- Pertuzumab
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Shanghai Jiao Tong University School of Medicine
Hormone Receptor Positive Breast Cancer, HER-2 Positive Breast Cancer
A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer
The purpose of this study is to evaluate the effectiveness of abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus physicians choice standard of care chemotherapy in women with hormone receptor…
- Trial name
- monarcHER (NCT02675231)
- Testing
- Abemaciclib, Trastuzumab, Fulvestrant
- Where
- 93 sites in United States, Argentina and 12 more
- Volunteers
- 237 people
- Sponsor
- Eli Lilly and Company
Unresectable Breast Cancer, Metastatic Breast Cancer
HER-TEMPO - Real World Treatment-related Outcomes on T-DXd in Canada
Trastuzumab deruxtecan (T-DXd) has been studied in multiple global prospective DESTINY-Breast trials and has a marketing authorization from Health Canada for patients with HER2-positive metastatic breast cancer (mBC) and HER2-low…
- Conditions
- Unresectable Breast Cancer, Metastatic Breast Cancer, HER2-low Expressing Breast Cancer, HER2-positive Breast Cancer
- Trial name
- HER-TEMPO (NCT06386263)
- Testing
- Trastuzumab deruxtecan
- Where
- Canada
- Volunteers
- 22 people
- Sponsor
- AstraZeneca
Early Breast Cancer
A Real-World Study on the Impact of Different Adjuvant Treatment Regimens on Prognosis in Non-pCR Patients With HER2-Positive Breast Cancer After Neoadjuvant Therapy
This study is a multicenter, retrospective, real-world cohort study. It retrospectively collected data from HER2-positive breast cancer patients who received neoadjuvant therapy with trastuzumab-containing chemotherapy regimens…
- Trial name
- NCT07540520
- Volunteers
- 2,000 people
- Sponsor
- Hebei Medical University Fourth Hospital
HER2-positive Breast Cancer, Recurrent Breast Cancer
Pertuzumab, Trastuzumab, and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With HER2-Positive Advanced Breast Cancer
This phase II trial studies how well pertuzumab, trastuzumab, and paclitaxel albumin-stabilized nanoparticle formulation work in treating patients with human epidermal growth factor receptor (HER) 2-positive stage II-IV breast…
- Conditions
- HER2-positive Breast Cancer, Recurrent Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer
- Trial name
- NCT01730833
- Testing
- pertuzumab, trastuzumab, paclitaxel albumin-stabilized nanoparticle formulation
- Where
- 3 sites in United States
- Volunteers
- 63 people
- Sponsor
- City of Hope Medical Center
Breast Cancer, Brain Metastases
Lapatinib in Combination With Radiation Therapy in Patients With Brain Metastases From HER2-Positive Breast Cancer
The purpose of this research study is to determine the safety of combining lapatinib plus radiation in patients with breast cancer that has spread to the brain.
- Trial name
- NCT00470847
- Testing
- Lapatinib, Whole Brain Radiation, Herceptin
- Where
- 3 sites in United States
- Volunteers
- 35 people
- Sponsor
- Nancy Lin, MD
HER2 Positive Breast Carcinoma, Stage IV Breast Cancer AJCC v6 and v7
Neratinib in Treating Older Patients With Stage IV HER2-Positive Breast Cancer
This phase II trial studies the side effects of and how well neratinib works in treating older patients with stage IV HER2-positive breast cancer.
- Trial name
- NCT02673398
- Testing
- Comprehensive Geriatric Assessment, Laboratory Biomarker Analysis, Neratinib
- Where
- 7 sites in United States
- Volunteers
- 25 people
- Sponsor
- City of Hope Medical Center
Breast Cancer Metastatic, Locally Advanced Breast Cancer (LABC)
A Study to Assess CLBR001+ABBV-461 in Subjects With Locally Advanced or Metastatic Breast Cancer
The goal of this clinical trial is to evaluate CLBR001 and ABBV-461 as a treatment for patients with locally advanced or metastatic breast cancer.
- Conditions
- Breast Cancer Metastatic, Locally Advanced Breast Cancer (LABC), Malignant Neoplasm of Breast, Triple Negative Breast Cancer (TNBC)
- Trial name
- NCT06878248
- Testing
- Two Component Product CLBR001 + ABBV-461
- Where
- 5 sites in United States
- Volunteers
- 10 people
- Sponsor
- Calibr, a division of Scripps Research
HER2-positive Breast Cancer
Monitoring Early Response to Targeted Therapy in Stage IV HER2+ Breast Cancer Patients With Advanced PET/MR Imaging
The purpose of the study is to see if a new group of imaging tests can help identify response to stage IV HER2+ breast cancer before treatment.
- Trial name
- NCT04273555
- Testing
- [18F]-FDG
- Where
- United States
- Sponsor
- University of Alabama at Birmingham
HER2-positive Breast Cancer, Diarrhea Caused by Drug
Probiotics for Prevention of Neratinib-Induced Diarrhea in Breast Cancer Patients
This study aims to evaluate the efficacy and safety of probiotics for the prevention of diarrhea in patients with breast cancer receiving the tyrosine kinase inhibitor (TKI) Neratinib.
- Conditions
- HER2-positive Breast Cancer, Diarrhea Caused by Drug, Neratinib
- Trial name
- NCT06892093
- Testing
- Probiotics, Loperamide
- Where
- China
- Volunteers
- 308 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
HER2-Positive Breast Carcinoma, Hormone Receptor-Positive Breast Carcinoma
Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab With or Without Estrogen Deprivation in Treating Patients With Hormone Receptor-Positive, HER2-Positive Operable or Locally Advanced Breast Cancer
This randomized phase III trial studies docetaxel, carboplatin, trastuzumab, and pertuzumab with estrogen deprivation to see how they work compared to docetaxel, carboplatin, trastuzumab, and pertuzumab without estrogen…
- Conditions
- HER2-Positive Breast Carcinoma, Hormone Receptor-Positive Breast Carcinoma, Stage IB Breast Cancer AJCC v7, Stage IIA Breast Cancer AJCC v6 and v7
- Trial name
- NCT02003209
- Testing
- Aromatase Inhibition Therapy, Carboplatin, Cytology Specimen Collection Procedure
- Where
- 732 sites in United States, Puerto Rico
- Volunteers
- 315 people
- Sponsor
- National Cancer Institute (NCI)
Metastatic Breast Cancer
T-DM1 With Abraxane and Lapatinib for Metastatic HER2 Positive Breast Cancer
This open-label, single-center Phase Ib study will assess the safety and tolerability of combining trastuzumab emtansine (T-DM1) with Lapatinib and Abraxane in patients with metastatic HER2-positive breast cancer.
- Trial name
- STELA (NCT02073916)
- Testing
- T-DM1, Lapatinib, Abraxane
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Jenny C. Chang, MD
HER-2 Positive Breast Cancer
PETRA: PErtuzumab and Trastuzumab Biosimilars Real Life Association for the First Line Treatment of HER2-positive Metastatic Breast Cancer, an Observational Prospective Multicenter Study
Currently there are five trastuzumab biosimilars approved by EMA (Ogivri® Mylan , Herzuma® Biogaran, Ontruzant® MSD, Trazimera® Pfizer, and Kanjinti® Amgen) for the treatment of HER2-positive breast cancer.
- Trial name
- PETRA (NCT04644406)
- Testing
- Efficacy of the Pertuzumab-Trastuzumab combination
- Where
- 6 sites in France
- Volunteers
- 200 people
- Sponsor
- Hospices Civils de Lyon