Clinical trials: Her2 Positive Metastatic Breast Cancer
Expanded Access Use of Tucatinib for HER2+ Metastatic Breast Cancer
Physicians interested in requesting a single patient IND should contact Seattle Genetics' Medical Information (medinfo@seagen.com).
- Trial name
- NCT03424473
- Testing
- Tucatinib
- Sponsor
- Seagen Inc.
Neoplasms, Breast
A Study to Examine the Effects of Esomeprazole on the Pharmacokinetics of Orally Administered Lapatinib in Subjects With Metastatic ErbB2 Positive Breast Cancer
This study will characterize the effect of elevated gastric pH mediated by the proton-pump inhibitor, esomeprazole, on the relative bioavailability of lapatinib in subjects with metastatic ErbB2 positive breast cancer.
- Trial name
- NCT00849329
- Testing
- lapatinib, lapatinib plus esomeprazole
- Where
- 4 sites in United States, South Korea and 1 more
- Volunteers
- 12 people
- Sponsor
- GlaxoSmithKline
Human Epithelial Receptor (HER)-2 Positive Breast Cancer
A Safety and Efficacy Study of BCD-022 With Paclitaxel Compared to Herceptin With Paclitaxel in HER2+ Metastatic Breast Cancer Patients
BCD-022-02 is a double-blind randomized clinical trial comparing efficacy of BCD-022 (INN: trastuzumab) and paclitaxel to Herceptin and paclitaxel in HER2-positive metastatic breast cancer with pharmacokinetics substudy.
- Trial name
- NCT01764022
- Testing
- Trastuzumab, Paclitaxel
- Where
- 36 sites in Belarus, India and 2 more
- Volunteers
- 225 people
- Sponsor
- Biocad
Breast Cancer
89Zr-trastuzumab PET for Imaging the Effect of HSP90 Inhibition
HSP90 inhibition is a potentially new targeted drug modality in the treatment of HER2 positive, trastuzumab refractory breast cancer.
- Trial name
- AUY922 (NCT01081600)
- Testing
- Imaging with 89Zr-trastuzumab PET
- Where
- Netherlands
- Volunteers
- 7 people
- Sponsor
- University Medical Center Groningen
Breast Cancer
TREATMENT AND MONITORING PATTERNS AND CLINICAL OUTCOMES IN PATIENTS RECEIVING PALBOCICLIB COMBINATION TREATMENT (WITH AI OR FULVESTRANT) FOR HR+/HER2- A/MBC IN A COMMUNITY ONCOLOGY SETTING.
This is a retrospective, observational study that will document the treatment and monitoring patterns and clinical outcomes of patients diagnosed with HR+/HER2- a/mBC who received Palbociclib combination therapy with aromatase…
- Trial name
- NCT04498481
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Pfizer
Breast Cancer, HER2-positive Breast Cancer
Pyrotinib, Trastuzumab And Abraxane in HER2-positive MBC With Brain Metastasis
The purpose of this study is to assess the efficacy and safety of pyrotinib combined with trastuzumab and abraxane in HER2-positive MBC with brain metastasis.
- Trial name
- NCT04639271
- Testing
- Pyrotinib Plus And, Trastuzumab, Abraxane
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Shandong Cancer Hospital and Institute
Advanced Breast Cancer
A Study of XZP-3287 in Combination With Letrozole/Anastrozole in Patients With Advanced Breast Cancer
This is a Phase III clinical trial designed to evaluate the efficacy and safety of XZP-3287 in combination with Letrozole/Anastrozole versus placebo in combination with Letrozole/Anastrozole in patients with HR-positive and…
- Trial name
- NCT05257395
- Testing
- XZP-3287+ Letrozole/Anastrozole
- Where
- China
- Volunteers
- 397 people
- Sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.
Metastatic Breast Cancer, HER2-positive Breast Cancer
A Study of Surgery and Radiotherapy in People With Breast Cancer
The researchers are doing this study to see if the combination of surgery, locoregional radiation therapy, SBRT (stereotactic body radiation therapy), and the usual approach is more effective in treating oligometastatic…
- Trial name
- NCT07053085
- Testing
- Lumpectomy or mastectomy, Radiotherapy, Trastuzumab, Pertuzumab, Paclitaxel, or a combination of these drugs
- Where
- 7 sites in United States
- Volunteers
- 178 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Breast Cancer
Pharmacokinetics and Pharmacogenomics of Ribociclib in Race-based Cohorts
The aim is to determine the pharmacological and biochemical association between ribociclib exposure and CYP3A variants in African American/Blacks and Non-Hispanic White patients.
- Trial name
- LEANORA (NCT04657679)
- Testing
- Ribociclib
- Where
- 3 sites in United States
- Volunteers
- 21 people
- Sponsor
- Georgetown University
HER2/Neu Positive, Invasive Breast Carcinoma
Entinostat, Lapatinib Ditosylate and Trastuzumab in Treating Patients With Locally Recurrent or Distant Relapsed Metastatic Breast Cancer Previously Treated With Trastuzumab Only
This phase I trial studies the side effects and best dose of entinostat when given together with lapatinib ditosylate and trastuzumab in treating patients with breast cancer that has spread from the original (primary) tumor to…
- Conditions
- HER2/Neu Positive, Invasive Breast Carcinoma, Recurrent Breast Carcinoma, Stage IV Breast Cancer AJCC v6 and v7
- Trial name
- NCT01434303
- Testing
- Entinostat, Laboratory Biomarker Analysis, Lapatinib Ditosylate
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- National Cancer Institute (NCI)
Metastatic Breast Cancer
PalbocIclib in PreMenopausal Women With ER Positive/HER-2 Negative MetAstatic Breast Cancer
This is an open label, randomized, multicenter, international phase II study for premenopausal patients with hormone receptor positive, HER2 negative metastatic or locally advanced breast cancer.
- Trial name
- FATIMA (NCT02917005)
- Testing
- Palbociclib, Exemestane, Goserelin
- Where
- South Africa
- Volunteers
- 160 people
- Sponsor
- Hamdy A. Azim
Breast Cancer
Study of Gemcitabine and Herceptin Versus Xeloda and Herceptin in HER-2 (+) Metastatic Breast Cancer Patients
The optimal treatment for pretreated patients with metastatic breast cancer has not been established. Gemcitabine and capecitabine are two active agents in this setting.
- Trial name
- NCT00440622
- Testing
- Gemcitabine, Herceptin, Capecitabine (Xeloda)
- Where
- 9 sites in Greece
- Volunteers
- 90 people
- Sponsor
- Hellenic Oncology Research Group
Breast Neoplasm
Clinical Benefit of the Treatment With Trastuzumab in Combination With Lapatinib in Metastatic Breast Cancer HER2 Positive Patients Who Has Been Previously Treated With Trastuzumab and/or Lapatinib
A retrospective, observational, not EPA, multicenter study to evaluate the Clinical Benefit of Trastuzumab in Combination With Lapatinib in Metastatic Breast Cancer HER2 Positive Patients Who Has Been Previously Treated With…
- Trial name
- TRASTYVERE (NCT02056080)
- Where
- 11 sites in Spain
- Volunteers
- 111 people
- Sponsor
- MedSIR
HER2 Positive Breast Cancer
A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer
This study is being done to see if tucatinib works better than placebo when given with other drugs to treat participants with HER2-positive breast cancer.
- Trial name
- HER2CLIMB-05 (NCT05132582)
- Testing
- Tucatinib, Trastuzumab, Pertuzumab
- Where
- 307 sites in United States, Australia and 21 more
- Volunteers
- 654 people
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
HER2-negative Breast Cancer, Hormone-receptor-positive Breast Cancer
DiviTum®TKa: A Biomarker Assay for Efficacy in HR+ Breast Cancer Patients
This study is being done to determine if there is a pattern associated with response to endocrine therapy alone and in combination with CDK4/6 inhibitor used for hormone receptor positive HER2 negative breast cancer.
- Conditions
- HER2-negative Breast Cancer, Hormone-receptor-positive Breast Cancer, Metastatic Breast Cancer, Anatomic Stage II Breast Cancer AJCC v8
- Trial name
- NCT06388122
- Testing
- Biospecimen Collection
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Mayo Clinic
Breast Cancer (Locally Advanced or Metastatic), HER2-positive Breast Cancer
Dual-Target CAR-NK Cells for Advanced Breast Cancer (HER2+ and TNBC)
This study tests the safety and preliminary anti-tumor activity of an investigational dual-target chimeric antigen receptor natural killer (CAR-NK) cell therapy in adults with advanced breast cancer.
- Conditions
- Breast Cancer (Locally Advanced or Metastatic), HER2-positive Breast Cancer, Triple-Negative Breast Cancer (TNBC)
- Trial name
- DUAL-NK-BC (NCT07486089)
- Testing
- Dual-target CAR-NK cells (EB-DT-CAR-NK), Lymphodepleting chemotherapy, Supportive care
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Beijing Biotech
Neoplasms, Breast
Evaluation of Biomarkers Associated With Response to Subsequent Therapies in Subjects With HER2-Positive Metastatic Breast Cancer
This was a multicenter, open-label, Phase II study in subjects with Human epidermal growth factor receptor (HER2)-positive metastatic breast cancer who received at least 2 prior lines of anti-HER2-targeted therapies of which at…
- Trial name
- NCT02213042
- Testing
- Lapatinib, Trastuzumab, Aromatase Inhibitors (AIs)
- Where
- 51 sites in United States, Argentina and 10 more
- Volunteers
- 42 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
FIH Study of RGT-419B Alone and With Endocrine Therapy in HR-Positive, HER2-Negative Advanced/Metastatic Breast Cancer
This is a phase I, First-in-Human (FIH), open-label study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, and preliminary efficacy of RGT-419B administered orally as monotherapy OR in combination with Hormonal…
- Trial name
- NCT05304962
- Testing
- RGT-419B, RGT-419B in combination with hormonal therapy
- Where
- 8 sites in United States
- Volunteers
- 64 people
- Sponsor
- Regor Pharmaceuticals Inc.
Neoplasms, Breast
Neo ALTTO (Neoadjuvant Lapatinib and/or Trastuzumab Treatment Optimisation) Study
This is a randomised, open label multicenter Phase III study comparing the efficacy of neoadjuvant lapatinib plus paclitaxel, versus trastuzumab plus paclitaxel, versus concomitant lapatinib and trastuzumab plus paclitaxel given…
- Trial name
- Neo ALTTO (NCT00553358)
- Testing
- Lapatinib, Trastuzumab, Paclitaxel
- Where
- 121 sites in Argentina, Belgium and 22 more
- Volunteers
- 455 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
THOR Study: A Study of Continued Herceptin (Trastuzumab) in Combination With Second Line Chemotherapy in Patients With HER2 Positive Metastatic Breast Cancer.
This 2 arm study will compare the efficacy and safety of continuation or discontinuation of Herceptin treatment in combination with 2nd line chemotherapy, in patients with HER2 positive metastatic breast cancer whose condition…
- Trial name
- NCT00448279
- Testing
- trastuzumab, Chemotherapy
- Where
- 35 sites in Italy
- Volunteers
- 58 people
- Sponsor
- Hoffmann-La Roche