Clinical trials: HER2/Neu Positive
HER2/Neu Positive, Stage IA Breast Cancer
Combination Chemotherapy and Paclitaxel Plus Trastuzumab in Treating Women With Palpable Breast Cancer That Can Be Removed by Surgery
This randomized phase III trial is studying giving fluorouracil together with epirubicin and cyclophosphamide followed by paclitaxel and trastuzumab to see how well it works compared with giving paclitaxel together with…
- Conditions
- HER2/Neu Positive, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer
- Trial name
- NCT00513292
- Testing
- Cyclophosphamide, Epirubicin Hydrochloride, Laboratory Biomarker Analysis
- Where
- 115 sites in United States, Puerto Rico
- Volunteers
- 280 people
- Sponsor
- National Cancer Institute (NCI)
Breast Neoplasms
A Safety and Tolerability Study of Assisted and Self-Administered Subcutaneous (SC) Herceptin (Trastuzumab) as Adjuvant Therapy in Early Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer
This multicenter, two-cohort, non-randomized, open-label study will evaluate the safety and tolerability of assisted and self-administered SC Herceptin as adjuvant therapy in participants with early HER2-positive breast cancer…
- Trial name
- SafeHER (NCT01566721)
- Testing
- Herceptin
- Where
- 437 sites in Albania, Algeria and 57 more
- Volunteers
- 2,577 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
XeNA Study - A Study of Xeloda (Capecitabine) in Patients With Invasive Breast Cancer
This single arm study stratified patients into two treatment cohorts based on HER2-neu overexpression/amplification. Each cohort will be independently powered for the primary endpoint.
- Trial name
- NCT00127933
- Testing
- capecitabine [Xeloda], Taxotere, Herceptin (HER2-neu positive patients only)
- Where
- 38 sites in United States
- Volunteers
- 157 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
A Study of Trastuzumab Emtansine in Comparison With Treatment of Physician's Choice in Participants With HER2-positive Breast Cancer Who Have Received at Least Two Prior Regimens of HER2-directed Therapy
This randomized, multicenter, 2-arm, open-label study (TH3RESA) will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) in comparison with treatment of the physician's choice in participants with metastatic or…
- Trial name
- TH3RESA (NCT01419197)
- Testing
- Trastuzumab emtansine, Treatment of physician's choice
- Where
- 184 sites in United States, Australia and 20 more
- Volunteers
- 602 people
- Sponsor
- Hoffmann-La Roche
Cancer
Continued HER2 Suppression With Lapatinib Plus Trastuzumab Versus Trastuzumab Alone
This was a randomized, open-label, multi-center Phase III study evaluating the efficacy and safety of lapatinib in combination with trastuzumab versus trastuzumab alone as continued HER2 suppression therapy in women with…
- Trial name
- NCT00968968
- Testing
- Lapatinib, Trastuzumab
- Where
- 116 sites in United States, Canada
- Volunteers
- 37 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Palbociclib In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR+, HER2- Advanced Breast Cancer
A study of palbociclib in combination with letrozole as treatment of post-menopausal women with hormone receptor-positive, her2-negative advanced breast cancer for whom letrozole therapy is deemed appropriate.
- Trial name
- NCT02679755
- Testing
- Palbociclib, Letrozole
- Where
- 34 sites in Australia, India
- Volunteers
- 252 people
- Sponsor
- Pfizer
HER2-positive Breast Cancer, Breast Cancer
Neoadjuvant Her2-targeted Therapy and Immunotherapy With Pembrolizumab [IIT2018-04-MCARTHUR-NEOHP]
A phase 2 open-label, randomized, multi-center trial to evaluate the efficacy and safety of neoadjuvant trastuzumab, pertuzumab and weekly paclitaxel (THP) as compared to neoadjuvant trastuzumab, pertuzumab, pembrolizumab and…
- Trial name
- NCT03747120
- Testing
- Paclitaxel, Trastuzumab, Pertuzumab
- Where
- 5 sites in United States
- Volunteers
- 138 people
- Sponsor
- University of Texas Southwestern Medical Center
Breast Cancer
A Study of Limited Heart Monitoring During Non-anthracycline Trastuzumab-based Therapy in Breast Cancer Patients
The purpose of this study is to test whether patients with breast cancer who are being treated with non-anthracycline trastuzumab therapy can safely be monitored for heart related side effects less often than usual.
- Trial name
- NCT03983382
- Testing
- Left Ventricular Ejection Fraction
- Where
- 8 sites in United States
- Volunteers
- 190 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Breast Neoplasms, Breast Cancer
Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer
This study will look at the efficacy and safety of trastuzumab deruxtecan (T-DXd) in a neoadjuvant setting, in high-risk, HER2-positive early non-metastatic breast cancer.
- Conditions
- Breast Neoplasms, Breast Cancer, HER2-positive Early Breast Cancer
- Trial name
- NCT05113251
- Testing
- Trastuzumab Deruxtecan, Paclitaxel, Trastuzumab
- Where
- 145 sites in United States, Brazil and 16 more
- Volunteers
- 927 people
- Sponsor
- AstraZeneca
Breast Cancer
A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE)
This 2-arm, randomized, open-label study will evaluate the efficacy and safety of trastuzumab emtansine versus trastuzumab as adjuvant therapy in patients with HER2-positive breast cancer who have residual tumor present in the…
- Trial name
- NCT01772472
- Testing
- trastuzumab, trastuzumab emtansine
- Where
- 268 sites in United States, Argentina and 26 more
- Volunteers
- 1,486 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer, Breast Carcinoma
A Study to Describe the Breast Cancer Patient Population, Treatment, and Results in Indian Patients Receiving Combinations of the Medicines Called Palbociclib for Advanced Breast Cancer
The purpose of this clinical study is to describe the patient population, breast cancer treatment, and breast cancer treatment results of adult female patients who have received palbociclib combination treatments for advanced or…
- Conditions
- Breast Cancer, Breast Carcinoma, Breast Neoplasms, Breast Tumors
- Trial name
- NCT05584644
- Testing
- Palbociclib plus hormonal treatment - first line treatment, Palbociclib plus hormonal treatment - second line treatment
- Where
- 6 sites in India
- Volunteers
- 150 people
- Sponsor
- Pfizer
Breast Cancer
A Study to Compare Subcutaneous (SC) Versus Intravenous (IV) Administration of Herceptin (Trastuzumab) in Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer
In this open-label multicenter trial, participants with operable or locally advanced breast cancer will be randomized to pre-operative treatment with 8 cycles of chemotherapy (4 cycles of docetaxel followed by 4 cycles of…
- Trial name
- NCT00950300
- Testing
- 5-Fluorouracil, Cyclophosphamide, Docetaxel
- Where
- 106 sites in Argentina, Brazil and 24 more
- Volunteers
- 596 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
Real-world Treatment Patterns of Endocrine Based Therapy Among Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor-2-negative (HR+/HER2-) Advanced Breast Cancer: An Analysis of Administrative Claims Data in Japan
This is a retrospective observational study focusing on patients diagnosed with advanced breast cancer(ABC) in Japan using de-identified claim data from Medical Data Vision (MDV) database.
- Trial name
- NCT05153187
- Where
- Japan
- Volunteers
- 1,170 people
- Sponsor
- Pfizer
Triple-negative Breast Cancer, Non-squamous Non-small-cell Lung Cancer
A Study of Zilovertamab Vedotin (MK-2140/VLS-101) in Participants With Solid Tumors (MK-2140-002)
This is a study evaluating the efficacy, safety, and pharmacokinetics of zilovertamab vedotin in participants with metastatic solid tumors including previously treated cancers of triple-negative breast cancer (TNBC), non-TNBC…
- Conditions
- Triple-negative Breast Cancer, Non-squamous Non-small-cell Lung Cancer, NSCLC, Estrogen-receptor-positive Breast Cancer
- Trial name
- NCT04504916
- Testing
- Zilovertamab vedotin
- Where
- 14 sites in United States, Canada
- Volunteers
- 102 people
- Sponsor
- VelosBio Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Metastatic Breast Cancer
A Study of Abemaciclib (LY2835219) in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer
The reason for this study is to compare the efficacy of abemaciclib, in combination with fulvestrant, to that of physician's choice of chemotherapy in women with hormone receptor-positive (HR+), human epidermal growth factor…
- Trial name
- NCT04031885
- Testing
- Abemaciclib, Fulvestrant, Standard Chemotherapy
- Where
- 61 sites in United States, Puerto Rico
- Volunteers
- 4 people
- Sponsor
- Eli Lilly and Company
Breast Cancer
Study of Poziotinib in Participants With HER2-Positive Metastatic Breast Cancer
The purpose of this study is to establish the dose regimen and evaluate the preliminary efficacy and the safety/tolerability of poziotinib in participants with human epidermal growth factor receptor 2 (HER2)-positive metastatic…
- Trial name
- NCT02659514
- Testing
- Poziotinib
- Where
- 35 sites in United States
- Volunteers
- 67 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
Advanced Breast Cancer
Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer.
The main aim of this study was to evaluate the efficacy and safety of adding ribociclib to fulvestrant in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer.
- Trial name
- MONALEESA-3 (NCT02422615)
- Testing
- Ribociclib, Fulvestrant
- Where
- 174 sites in United States, Australia and 28 more
- Volunteers
- 726 people
- Sponsor
- Novartis Pharmaceuticals
Node Positive HER2 Negative Breast Cancer
Aspirin in Preventing Recurrence of Cancer in Patients With HER2 Negative Stage II-III Breast Cancer After Chemotherapy, Surgery, and/or Radiation Therapy
This randomized phase III trial studies how well aspirin works in preventing the cancer from coming back (recurrence) in patients with human epidermal growth factor receptor 2 (HER2) negative breast cancer after chemotherapy…
- Trial name
- NCT02927249
- Testing
- Aspirin
- Where
- 1,452 sites in United States, Canada and 2 more
- Volunteers
- 3,021 people
- Sponsor
- Alliance for Clinical Trials in Oncology
Metastases, Brain
Lapatinib Plus Capecitabine Versus Trastuzumab Plus Capecitabine in ErbB2 (HER2) Positive Metastatic Breast Cancer
This open label study was designed to evaluate Lapatinib effect on incidence of brain metastases in ErbB2 (HER2) positive metastatic breast cancer patients exposed to prior taxanes or anthracyclines.
- Trial name
- NCT00820222
- Testing
- capecitabine, lapatinib, trastuzumab
- Where
- 164 sites in United States, Belgium and 12 more
- Volunteers
- 540 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Neratinib +/- Fulvestrant in HER2+, ER+ Metastatic Breast Cancer
This research study is studying a drug called Neratinib with and without Fulvestrant as possible treatments for HER2-positive breast cancer . The interventions involved in this study are: Neratinib and Fulvestrant Neratinib alone
- Trial name
- NCT03289039
- Testing
- Neratinib, Fulvestrant
- Where
- 6 sites in United States
- Volunteers
- 21 people
- Sponsor
- Dana-Farber Cancer Institute