Clinical trials: HER2/Neu Positive
Breast Neoplasms
Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer
Primary objective: Compare disease-free survival in women with human epidermal growth factor receptor 2 (HER2)-neu-expressing node-positive or high-risk node-negative operable breast cancer treated with adjuvant doxorubicin…
- Trial name
- NCT00021255
- Testing
- Doxorubicin, Cyclophosphamide, Docetaxel
- Where
- 42 sites in United States, Argentina and 40 more
- Volunteers
- 3,222 people
- Sponsor
- Sanofi
Breast Cancer, Estrogen Receptor-positive Breast Cancer
Biology Guided Therapy for Breast Cancer for ER Positive
There are several approved and guideline-recommended treatments for metastatic, estrogen receptor-positive breast cancer that has progressed on an aromatase inhibitor and a CDK4/6 inhibitor.
- Conditions
- Breast Cancer, Estrogen Receptor-positive Breast Cancer, HER2-negative Breast Cancer
- Trial name
- SPOCK (NCT04965688)
- Testing
- Biopsy-Guided Therapy Selection
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Inova Health Care Services
HER2 Positive Early or Locally Advanced Breast Cancer
A Study to Compare the Effect of SB3 and Herceptin® in Women With HER2 Positive Breast Cancer
A Phase III Randomised, Double-Blind, Parallel Group, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity between SB3 (proposed trastuzumab biosimilar) and Herceptin® in Women with Newly…
- Trial name
- NCT02149524
- Testing
- Herceptin (trastuzuamb), SB3 (proposed trastuzumab biosimilar)
- Where
- Czechia
- Volunteers
- 875 people
- Sponsor
- Samsung Bioepis Co., Ltd.
Breast Cancer
Study Of SU011248 In Combination With Docetaxel And Trastuzumab In Patients With Advanced Breast Cancer HER-2 Positive
This is an exploratory trial evaluating the tolerability and preliminary anti-tumor activity of SU011248 combined with docetaxel and trastuzumab in patients with locally recurrent or metastatic breast cancer over-expressing…
- Trial name
- NCT00372424
- Testing
- Herceptin, Sunitinib, Taxotere
- Where
- 7 sites in Belgium, Italy
- Volunteers
- 26 people
- Sponsor
- Pfizer
Breast Cancer
Letrozole Plus Ribociclib or Placebo as Neo-adjuvant Therapy in ER-positive, HER2-negative Early Breast Cancer
The purpose of this study is to determine if ribociclib in combination with letrozole for 24 weeks as neoadjuvant endocrine therapy increases the proportion of women with Pre-operative Endocrine Prognostic Index (PEPI) score of 0…
- Trial name
- FELINE (NCT02712723)
- Testing
- Letrozole, Ribociclib
- Where
- 13 sites in United States
- Volunteers
- 121 people
- Sponsor
- Qamar Khan
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, Gastric Cancer
Anti-HER2 Bispecific Antibody Zanidatamab (ZW25) Activity in Combination With Chemotherapy With/Without Tislelizumab
The purpose of the study is to assess the safety, tolerability and preliminary antitumor activity of zanidatamab in combination with docetaxel in participants with human epidermal growth factor receptor 2 (HER2)-positive breast…
- Conditions
- Breast Cancer, Gastric Cancer, Gastroesophageal Junction Cancer
- Trial name
- NCT04276493
- Testing
- Zanidatamab, Docetaxel, Tislelizumab
- Where
- 21 sites in China, South Korea and 1 more
- Volunteers
- 71 people
- Sponsor
- BeiGene
Neoplasms, Breast
Study In Women And Men With Metastatic Breast Cancer That Have Overexpression Of ErbB2
This was a randomized, double-blind, placebo-controlled, multicenter, Phase III study to evaluate and compare the efficacy and safety of Lapatinib + Paclitaxel versus Placebo + Paclitaxel in men and women with ErbB2 amplified…
- Trial name
- NCT00281658
- Testing
- Lapatinib (GW572016) oral tablets, Paclitaxel infusion
- Where
- 54 sites in Brazil, China and 6 more
- Volunteers
- 444 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer, Colorectal Cancer
A Study of Poziotinib in Patients With Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Activating Mutations in Advanced Malignancies
This is a Phase 2, open-label, multicenter study whose principal objectives are to evaluate the efficacy and safety/tolerability of poziotinib in five cohorts of 30 previously-treated patients each.
- Conditions
- Breast Cancer, Colorectal Cancer, Solid Tumor, Glioblastome Multiforme
- Trial name
- NCT04172597
- Testing
- Poziotinib Hydrochloride, Loperamide
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
Estrogen Receptor Negative, Estrogen Receptor Positive
MK2206 in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer
This phase II trial is studies how well Akt inhibitor MK2206 works in treating patients with stage I-III breast cancer that can be removed by surgery.
- Conditions
- Estrogen Receptor Negative, Estrogen Receptor Positive, HER2/Neu Negative, HER2/Neu Positive
- Trial name
- NCT01319539
- Testing
- Akt Inhibitor MK2206, Therapeutic Conventional Surgery, Pharmacological Study
- Where
- 3 sites in United States
- Volunteers
- 12 people
- Sponsor
- National Cancer Institute (NCI)
Breast Cancer
Paclitaxel, Trastuzumab, and Pertuzumab in the Treatment of Metastatic HER2-Positive Breast Cancer
The purpose of this study is to see if a combination of drugs can help to treat this type of cancer. One drug is a chemotherapy agent called paclitaxel (Taxol®). Paclitaxel will be given every week through the vein.
- Trial name
- NCT01276041
- Testing
- pertuzumab in combination with trastuzumab and paclitaxel
- Where
- 6 sites in United States
- Volunteers
- 70 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
HR+/HER2- Locally Advanced, Metastatic Breast Cancer
UK Ibrance Patient Program (IPP) Study
What are the real-world treatment patterns, patients' characteristics, clinical outcomes and healthcare resource utilisation associated with palbociclib treatment in the 3 years following initiation in United Kingdom patients…
- Trial name
- ROIS (NCT03921866)
- Testing
- Palbociclib
- Where
- 8 sites in United Kingdom
- Volunteers
- 191 people
- Sponsor
- Pfizer
Breast Carcinoma Metastatic in the Bone, Circulating Tumor Cell Count
Denosumab in Treating Patients With ER and/or PR Positive, HER2 Negative Metastatic Breast Cancer With Bone Metastases and Detectable Circulating Tumor Cells
The purpose of this study is to look at the amount of cancer cells in the blood of participants who are being treated with denosumab.
- Conditions
- Breast Carcinoma Metastatic in the Bone, Circulating Tumor Cell Count, Estrogen Receptor Positive, HER2/Neu Negative
- Trial name
- NCT03070002
- Testing
- Denosumab, Laboratory Biomarker Analysis
- Where
- 2 sites in United States
- Volunteers
- 1 people
- Sponsor
- Northwestern University
Breast Cancer
A Study of HR+/HER2- Metastatic Breast Cancer Patients Treated With Palbociclib Together With an Aromatase Inhibitor From 2017 to 2023 in Denmark.
The purpose of this study is to describe the effect of the medicine palbociclib when given together with an aromatase inhibitor for treatment of breast cancer.
- Trial name
- NCT06307457
- Testing
- Palbociclib in combination with AI
- Where
- Denmark
- Volunteers
- 604 people
- Sponsor
- Pfizer
HER2-positive Newly Diagnosed, Primary Breast Cancer
NeoPHOEBE: Neoadjuvant Trastuzumab + BKM120 in Combination With Weekly Paclitaxel in HER2-positive Primary Breast Cancer
This randomized, parallel cohort, two stage, double-blind, placebo-controlled study evaluated the oral PI3K inhibitor BKM120 in combination with trastuzumab and paclitaxel in HER2-positive, PIK3CA wild-type and PIK3CA mutant…
- Trial name
- NeoPHOEBE (NCT01816594)
- Testing
- BKM120, Trastuzumab, Paclitaxel
- Where
- 7 sites in Australia, Austria and 2 more
- Volunteers
- 50 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Breast Cancer
Pilot Decentralized Clinical Trial in Men and Pre and Post-menopausal Women With Breast Cancer and a Specific Mutation (PIK3CA) Treated With Alpelisib in Combination With Fulvestrant
The study was designed to identify and register practical observations and experiences in connection with planning and implementing decentralized, patient-centered clinical trials at a geographic distance with virtual elements.
- Trial name
- TELEPIK (NCT04862143)
- Testing
- Alpelisib, Fulvestrant, Goserelin
- Where
- Sweden
- Volunteers
- 2 people
- Sponsor
- Novartis Pharmaceuticals
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
A Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Participants With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer
This study will evaluate the efficacy of ipatasertib + paclitaxel versus placebo + paclitaxel in participants with histologically confirmed, locally advanced or metastatic triple-negative breast cancer (TNBC) and in participants…
- Trial name
- IPATunity130 (NCT03337724)
- Testing
- Ipatasertib, Paclitaxel
- Where
- 176 sites in United States, Argentina and 28 more
- Volunteers
- 579 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
Safety and Efficacy of Trastuzumab as Part of Breast Cancer Treatment Regimen
This is a prospective, Phase IV, multi-center, single arm, open-label, interventional study to evaluate the safety of trastuzumab for the treatment of human epidermal growth factor receptor 2 protein (HER2)-positive node positive…
- Trial name
- NCT02419742
- Testing
- Carboplatin, Cyclophosphamide, Docetaxel
- Where
- 6 sites in India
- Volunteers
- 110 people
- Sponsor
- Hoffmann-La Roche
Estrogen Receptor Positive, HER2/Neu Negative
FLT PET in Measuring Treatment Response in Patients With Newly Diagnosed Estrogen Receptor-Positive, HER2-Negative Stage I-III Breast Cancer
This clinical trial studies fluorine F 18 fluorothymidine (FLT) positron emission tomography (PET) in measuring treatment response in patients with newly diagnosed estrogen receptor (ER)-positive, human epidermal growth factor…
- Conditions
- Estrogen Receptor Positive, HER2/Neu Negative, Male Breast Carcinoma, Stage IA Breast Cancer
- Trial name
- NCT01928186
- Testing
- Fluorothymidine F-18, Positron Emission Tomography, Laboratory Biomarker Analysis
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- University of Washington