Clinical trials: HER2-Positive Breast Cancer
Breast Neoplasms
Study of Radium-223 Dichloride Versus Placebo and Hormonal Treatment as Background Therapy in Subjects With Bone Predominant HER2 (Human Epidermal Growth Factor Receptor 2) Negative Hormone Receptor Positive Metastatic Breast Cancer
The objective of this study was to assess efficacy and safety of radium-223 dichloride in subjects with human epidermal growth factor receptor 2 negative (HER2 negative) hormone receptor positive breast cancer with bone…
- Trial name
- NCT02258464
- Testing
- Radium-223 dichloride (Xofigo, BAY88-8223), Background hormonal therapy
- Where
- 71 sites in United States, Austria and 18 more
- Volunteers
- 99 people
- Sponsor
- Bayer
Estrogen Receptor Negative, Estrogen Receptor Positive
Pembrolizumab and Carboplatin in Treating Patients With Circulating Tumor Cells Positive Metastatic Breast Cancer
The purpose of the study is to evaluate the impact on progression-free survival (PFS) with the combination carboplatin - pembrolizumab in patients with CTC (circulating tumor cells) positive, HER2 negative metastatic breast…
- Conditions
- Estrogen Receptor Negative, Estrogen Receptor Positive, HER2/Neu Negative, Progesterone Receptor Negative
- Trial name
- NCT03213041
- Testing
- Carboplatin, Laboratory Biomarker Analysis, Pembrolizumab
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Northwestern University
Breast Cancer
Chemotherapy and Lapatinib or Trastuzumab in Treating Women With HER2/Neu-Positive Metastatic Breast Cancer
This was a multi-center, multinational, randomized, open-label, Phase III study comparing combination taxane-based chemotherapy plus lapatinib to combination taxane-based chemotherapy plus trastuzumab in women with documented…
- Trial name
- NCT00667251
- Testing
- trastuzumab, docetaxel, lapatinib ditosylate
- Where
- 257 sites in United States, Argentina and 19 more
- Volunteers
- 652 people
- Sponsor
- Novartis Pharmaceuticals
Breast Neoplasms
A Long-term Follow-up Study for Cardiac Safety in the Patients With HER2 (+) Breast Cancer Who Have Completed the SB3-G31-BC
A Long-term Follow-up Study for Cardiac Safety in the Patients with HER2 Positive Early or Locally Advanced Breast Cancer Who Have Completed the SB3-G31-BC
- Trial name
- NCT02771795
- Testing
- Herceptin (trastuzumab), SB3 (proposed trastuzumab biosimilar)
- Where
- 40 sites in Bulgaria, Czechia and 5 more
- Volunteers
- 538 people
- Sponsor
- Samsung Bioepis Co., Ltd.
Early Breast Cancer
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Giredestrant Plus Palbociclib Compared With Anastrozole Plus Palbociclib for Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Untreated Early Breast Cancer (coopERA Breast Cancer)
This is a randomized, multicenter, open-label, two-arm, Phase II study to evaluate the efficacy, safety, and pharmacokinetics of giredestrant versus anastrozole (in the window-of-opportunity phase) and giredestrant plus…
- Trial name
- NCT04436744
- Testing
- Giredestrant, Anastrozole, Palbociclib
- Where
- 65 sites in United States, Australia and 9 more
- Volunteers
- 221 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
Study in Participants With Early-Stage or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2-Positive Breast Cancer to Evaluate Treatment With Trastuzumab Plus (+) Pertuzumab + Docetaxel Compared With Trastuzumab + Placebo + Docetaxel
This is an Asia-Pacific regional, randomized, double-blind, multicenter trial designed to evaluate treatment with trastuzumab + pertuzumab + docetaxel compared with trastuzumab + placebo + docetaxel in chemotherapy-naïve…
- Trial name
- PEONY (NCT02586025)
- Testing
- FEC Chemotherapy, Surgery, Docetaxel
- Where
- 23 sites in China, South Korea and 2 more
- Volunteers
- 329 people
- Sponsor
- Hoffmann-La Roche
Breast Adenocarcinoma, Estrogen Receptor- Negative Breast Cancer
Neoadjuvant Pembrolizumab + Decitabine Followed by Std Neoadj Chemo for Locally Advanced HER2- Breast Ca
This study is a 2-cohort, open-label, multicenter, phase 2 study of a short course of immunotherapy consisting of sequential decitabine followed by pembrolizumab administered prior to a standard neoadjuvant chemotherapy regimen…
- Conditions
- Breast Adenocarcinoma, Estrogen Receptor- Negative Breast Cancer, Estrogen Receptor-positive Breast Cancer, HER2/Neu Negative
- Trial name
- NCT02957968
- Testing
- Doxorubicin, Cyclophosphamide, Paclitaxel
- Where
- 4 sites in United States
- Volunteers
- 46 people
- Sponsor
- Virginia Commonwealth University
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma
Testing the Addition of Copanlisib to Usual Treatment (Fulvestrant and Abemaciclib) in Metastatic Breast Cancer
This phase I trial studies the effects (good and bad) of adding copanlisib to the usual therapy of fulvestrant and abemaciclib in treating patients with hormone receptor positive and HER2 negative breast cancer that has spread…
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic HER2-Negative Breast Carcinoma, Metastatic Hormone Receptor-Positive Breast Carcinoma
- Trial name
- NCT03939897
- Testing
- Abemaciclib, Biopsy Procedure, Biospecimen Collection
- Where
- 14 sites in United States
- Volunteers
- 24 people
- Sponsor
- National Cancer Institute (NCI)
Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, Hormone Receptor (HR)-Positive Breast Cancer
Palbociclib With Everolimus + Exemestane In BC
This research study is studying a combination of targeted therapy and hormonal therapy as a possible treatment for breast cancer that has spread to other places in the body and is hormone receptor positive (HR+) and…
- Trial name
- NCT02871791
- Testing
- Palbociclib, Everolimus, Exemestane
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- Dana-Farber Cancer Institute
Breast Cancer
RW Treatment Patterns and Outcomes in Postmenopausal HR+/HER2- mBC Patients Treated With Palbociclib Plus Letrozole as Initial Endocrine Therapy at Community Oncology Practices in the U.S.
This is a retrospective, observational study that will document treatment patterns and clinical outcomes of postmenopausal patients diagnosed with HR+/HER2- mBC who received Palbociclib plus Letrozole as initial endocrine-based…
- Trial name
- NCT04460898
- Where
- United States
- Volunteers
- 195 people
- Sponsor
- Pfizer
HER2 Positive Breast Carcinoma, Recurrent Breast Carcinoma
4-1BB Agonist Monoclonal Antibody PF-05082566 With Trastuzumab Emtansine or Trastuzumab in Treating Patients With Advanced HER2-Positive Breast Cancer
This trial studies the best dose and side effects of utomilumab (4-1BB agonist monoclonal antibody PF-05082566) with trastuzumab emtansine or trastuzumab in treating patients with HER2-positive breast cancer that has spread to…
- Conditions
- HER2 Positive Breast Carcinoma, Recurrent Breast Carcinoma, Stage III Breast Cancer, Stage IIIA Breast Cancer
- Trial name
- NCT03364348
- Testing
- Utomilumab, Trastuzumab, Ado-Trastuzumab Emtansine
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- George W. Sledge Jr.
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
Advanced or Metastatic Breast Cancer
Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer
This study will evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy in human epidermal growth factor receptor (HER)2-low, hormone receptor (HR) positive breast…
- Trial name
- DB-06 (NCT04494425)
- Testing
- Trastuzumab deruxtecan, Capecitabine, Paclitaxel
- Where
- 293 sites in United States, Argentina and 26 more
- Volunteers
- 866 people
- Sponsor
- AstraZeneca
Breast Cancer
A Study of Herceptin (Trastuzumab)and Biomarkers in Patients With HER2-Positive Metastatic Breast Cancer
This single arm study will evaluate alterations in molecular marker expression in HER2-positive targeted therapy, and will evaluate the effect of continued treatment with Herceptin and Xeloda beyond progression following initial…
- Trial name
- NCT00885755
- Testing
- Standard taxane therapy, capecitabine [Xeloda], trastuzumab [Herceptin]
- Where
- 13 sites in Australia, Spain and 2 more
- Volunteers
- 33 people
- Sponsor
- Hoffmann-La Roche