Clinical trials: HER2-Positive Breast Cancer
Breast Cancer
AryoTrust® (Trastuzumab) Safety Study
This study was a phase IV, observational, multicenter, single-arm, open-label, post-marketing surveillance study for the assessment of AryoTrust safety in Iranian HER2-positive breast cancer patients undergoing adjuvant…
- Trial name
- NCT06021379
- Testing
- Trastuzumab
- Where
- 15 sites in Iran
- Volunteers
- 597 people
- Sponsor
- AryoGen Pharmed Co.
Breast Cancer
Docetaxel, Carboplatin, and Trastuzumab and/or Lapatinib in Treating Women With Stage I, Stage II, or Stage III Breast Cancer That Can Be Removed by Surgery
RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
- Trial name
- NCT00769470
- Testing
- trastuzumab, carboplatin, docetaxel
- Where
- 15 sites in United States
- Volunteers
- 18 people
- Sponsor
- Translational Oncology Research International
Metastatic Breast Cancer, HER2 Positive Breast Carcinoma
Niraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer
The human epidermal growth factor receptor 2 (HER2) regulates cell growth and survival. Approximately 15-20% of all breast cancers are HER2-positive, which are an aggressive and fast-growing subtype of breast cancer.
- Trial name
- NCT03368729
- Testing
- Niraparib, Trastuzumab
- Where
- 7 sites in United States
- Volunteers
- 46 people
- Sponsor
- University of Alabama at Birmingham
Brain Metastases, HER2-positive Breast Cancer
Tucatinib, Trastuzumab, and Capecitabine With SRS for Brain Metastases From HER-2 Positive Breast Cancer
This research study will evaluate how well brain metastases associated with HER-2 positive breast cancer can be controlled using a type of radiation known as stereotactic radiosurgery (SRS) when combined with three therapeutic…
- Trial name
- NCT05553522
- Testing
- Combined use of SRS with Tucatinib, Trastuzumab, and Capecitabine
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Baptist Health South Florida
HER2-positive Breast Cancer, Breast Adenocarcinoma
Incidence and Severity of Diarrhea in Patients With HER2 Positive Breast Cancer Treated With Trastuzumab and Neratinib
This phase II trial studies the incidence and severity of diarrhea in patients with stage II-IIIC HER2 Positive breast cancer treated with trastuzumab and neratinib.
- Conditions
- HER2-positive Breast Cancer, Breast Adenocarcinoma, Stage II Breast Cancer AJCC v6 and v7, Stage IIA Breast Cancer AJCC v6 and v7
- Trial name
- NCT03094052
- Testing
- Neratinib, Trastuzumab, Loperamide
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- University of California, San Francisco
Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer
A Phase Ib Dose Escalation Study of the Combination of LEE011 With Letrozole and Dose Expansion of LEE011 With Hormonal Therapy for the Treatment of Pre-(With Goserelin) and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer
The purpose of the Phase Ib is to: 1. determine the recommended dose of LEE011 in combination with a standard dose of letrozole as well as to provide additional safety and anti-tumor activity data in Asian non-Japanese patients…
- Trial name
- NCT02333370
- Testing
- LEE011, Letrozole, Tamoxifen
- Where
- 15 sites in Hong Kong, Japan and 1 more
- Volunteers
- 88 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer, Brain Metastases
TOPAZ: Tucatinib in COmbination With Pembrolizumab And TrastuZumab in Patients With HER2-Positive Breast Cancer Brain Metastases
This is a single arm, open label trial to assess the safety and efficacy of tucatinib in combination with pembrolizumab and trastuzumab for the treatment of HER2+ breast cancer brain metastases (BCBM).
- Conditions
- Breast Cancer, Brain Metastases, HER2-positive Breast Cancer, CNS Disease
- Trial name
- TOPAZ (NCT04512261)
- Testing
- Tucatinib, Pembrolizumab, Trastuzumab
- Where
- United States
- Sponsor
- Reva Basho
HER-2 Positive Breast Cancer, Metastatic Malignant Neoplasm to Brain
Study of the Combination of KD019 and Trastuzumab in Subjects With HER2-Positive Metastatic Breast Cancer
Evaluate the safety and tolerability and determine the maximum tolerated dose (MTD) of the combination of tesevatinib and trastuzumab in subjects with HER2-positive metastatic breast cancer
- Trial name
- NCT02154529
- Testing
- Tesevatinib, Trastuzumab
- Where
- 6 sites in United States
- Volunteers
- 17 people
- Sponsor
- Kadmon Corporation, LLC
Metastatic HER2+ Advanced Breast Cancer
Real World-clinical Outcomes of Tucatinib, Trastuzumab, and Capecitabine Following Trastuzumab Deruxtecan (T-DXd) for the Treatment of HER2-positive Metastatic Breast Cancer.
A retrospective study of de-identified (to preserve patient privacy) patient information from the Flatiron Health Database to describe 3L and 4L real-world (rw) outcomes (e.g.
- Trial name
- NCT06961331
- Testing
- Tucatinib, Trastuzumab, Capecitabine
- Where
- United States
- Volunteers
- 86 people
- Sponsor
- Pfizer
ER-Positive HER2-Negative Breast Cancer
A Phase IIIb Study to Evaluate Camizestrant Plus Ribociclib in ER-positive, HER2-negative Advanced Breast Cancer
The purpose of this study is to investigate the efficacy, safety, and tolerability of camizestrant in combination with ribociclib in patients with ER+ HER2- BC who have not received any other systemic treatment for advanced…
- Trial name
- SERAFA-1 (NCT07647328)
- Testing
- Camizestrant, Ribociclib
- Where
- 89 sites in United States, France and 7 more
- Volunteers
- 150 people
- Sponsor
- AstraZeneca
Advanced Breast Cancer, Hormone-receptor-positive Breast Cancer
Study of SHR-A1921 Combined Adebrelimab in HR-positive, HER2-negative Advanced Breast Cancer
Our study is aimed to evaluate the efficacy and safety of novel ADC named SHR-A1921 combined with Adebrelimab in endocrine therapy-failed HR (Hormone Receptor)-positive, HER2-negative advanced breast cancer.
- Conditions
- Advanced Breast Cancer, Hormone-receptor-positive Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
- Trial name
- NCT06470672
- Testing
- SHR-A1921, Adebrelimab
- Where
- China
- Volunteers
- 32 people
- Sponsor
- Fudan University
Male Breast Carcinoma, Stage IIA Breast Cancer AJCC v6 and v7
Paclitaxel and Trastuzumab With or Without Lapatinib in Treating Patients With Stage II or Stage III Breast Cancer That Can Be Removed by Surgery
This randomized phase III trial studies paclitaxel and trastuzumab with or without lapatinib to see how well they work in treating patients with stage II or stage III breast cancer that can be removed by surgery.
- Conditions
- Male Breast Carcinoma, Stage IIA Breast Cancer AJCC v6 and v7, Stage IIB Breast Cancer AJCC v6 and v7, Stage IIIA Breast Cancer AJCC v7
- Trial name
- NCT00770809
- Testing
- Laboratory Biomarker Analysis, Lapatinib Ditosylate, Paclitaxel
- Where
- 318 sites in United States, Puerto Rico
- Volunteers
- 305 people
- Sponsor
- National Cancer Institute (NCI)
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.
Advanced Breast Cancer
A Clinical Trial of TQB3909 Tablets in Patients With Breast Cancer
TQB3909 is an inhibitor targeting B-cell lymphoma (BCL)-2 protein. By binding to BCL-2 protein, TQB3909 releases Pro apoptotic proteins such as BCL-2-Anatagonist/Killer 1(BAK), BCL-2 associated X (BAX) protein and BCL-2…
- Trial name
- NCT05775575
- Testing
- TQB3909 tablets
- Where
- China
- Volunteers
- 65 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Breast Cancer
Pet Imaging as a Biomarker in Hormone Refractory postmenopausaL Women
This is a prospective, single arm trial in which patients with locally advanced or metastatic endocrine receptor positive and HER2 negative breast cancer refractory to non-steroidal aromatase inhibitors (NSAI) will receive…
- Trial name
- PEARL (NCT02028364)
- Testing
- Everolimus, Exemestane
- Where
- 5 sites in Belgium
- Volunteers
- 55 people
- Sponsor
- Jules Bordet Institute
Advanced Breast Cancer
First-Line Ribociclib Plus Endocrine Therapy Versus Chemotherapy With or Without Subsequent Endocrine Therapy in Patients With Rapidly Progressive HR-Positive/HER2-Negative Advanced Breast Cancer
This phase II study focuses on women with rapidly progressive hormone receptor-positive and HER2-negative advanced breast cancer, including patients with symptomatic visceral metastases, rapidly increasing tumor burden, impending…
- Trial name
- NCT06375707
- Testing
- Ribociclib
- Where
- China
- Volunteers
- 74 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Breast Cancer
Axillary Nodal Burden in HER2+ and TNBC
This study aimed to evaluated rates of pathologic axillary nodal metastasis in patients with with early-stage HER2-positive BC or TNBC who had clinically node-negative status on preoperative ultrasonography and underwent upfront…
- Trial name
- NCT07211451
- Testing
- Breast conserving surgery with axillary surgery
- Where
- South Korea
- Volunteers
- 1,571 people
- Sponsor
- Gangnam Severance Hospital
Breast Cancer
APRiCOT-B: Study to Evaluate Apricoxib in Combination With Lapatinib and Capecitabine in the Treatment of HER2/Neu+ Breast Cancer (TP2001-202)
This study will compare the anti-tumor efficacy of apricoxib and lapatinib/capecitabine with placebo and lapatinib/capecitabine as measured by time to disease progression and evaluate urinary PGE-M measurements or baseline COX-2…
- Trial name
- APRiCOT-B (NCT00657137)
- Testing
- apricoxib + lapatinib + capecitabine
- Where
- 44 sites in United States
- Volunteers
- 12 people
- Sponsor
- Tragara Pharmaceuticals, Inc.
Breast Neoplasm Female, Therapeutics
Clinical Value of Next Generation Sequencing in Endocrine Therapy for Advanced Hormone Receptor Positive/HER-2 Negative Breast Cancer
To determine the landscape of gene mutation before and after endocrine therapy, to search for molecular markers of endocrine therapy efficacy, and to explore the clinical value of using NGS detection of ctDNA to guide precise…
- Conditions
- Breast Neoplasm Female, Therapeutics, Mutation
- Trial name
- NCT03786575
- Testing
- Next Generation Sequencing (NGS) detection
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Peking Union Medical College
Breast Cancer
Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)
This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib and palbociclib plus endocrine therapy for the treatment of patients with locally advanced or metastatic HR+/HER2…
- Trial name
- NCT06757634
- Testing
- Arm A: Gedatolisib + Palbociclib + Fulvestrant, Arm B: Ribociclib + Fulvestrant, Arm C: Gedatolisib + Palbociclib + Letrozole
- Where
- 239 sites in United States, Argentina and 23 more
- Volunteers
- 1,180 people
- Sponsor
- Celcuity Inc