Clinical trials: Non Metastatic HER2 Positive Breast Cancer
Breast Cancer
Tesetaxel Plus Reduced Dose of Capecitabine in Patients With HER2 Negative, HR Positive, LA/MBC
CONTESSA 2 is a multinational, multicenter, Phase 2 study of tesetaxel in patients with HER2 negative, HR positive, locally advanced or metastatic breast cancer (LA/MBC) not previously treated with a taxane.
- Trial name
- CONTESSA 2 (NCT03858972)
- Testing
- Tesetaxel, Capecitabine
- Where
- 25 sites in United States, Australia and 4 more
- Volunteers
- 152 people
- Sponsor
- Odonate Therapeutics, Inc.
Breast Neoplasms, Breast Cancer
PROVIDENCE - Prospective Non-interventional Study (NIS) to Examine Patient-reported Outcomes and Real-world Clinical Data in Patients With HER2-positive, HER2-low or HER2-ultralow Unresectable or Metastatic Breast Cancer Treated With Trastuzumab Deruxtecan
This is a prospective non-interventional, multicenter study observing patient reported outcomes as well as real-world efficacy and safety of trastuzumab deruxtecan (T-DXd) in patients with documented Human epidermal growth factor…
- Conditions
- Breast Neoplasms, Breast Cancer, Neoplasm Metastasis
- Trial name
- PROVIDENCE (NCT05573893)
- Where
- 109 sites in Germany
- Volunteers
- 800 people
- Sponsor
- AstraZeneca
Breast Cancer
Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver…
- Trial name
- NCT00054587
- Testing
- Trastuzumab, Cyclophosphamide, docetaxel
- Where
- 29 sites in France
- Volunteers
- 3,010 people
- Sponsor
- UNICANCER
Breast Cancer
Safety and Efficacy Comparison of Docetaxel and Ixabepilone in Non Metastatic Poor Prognosis Breast Cancer
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
- Trial name
- TavIx (NCT00630032)
- Testing
- cyclophosphamide, Docetaxel, epirubicin hydrochloride
- Where
- 86 sites in United States, Belgium and 1 more
- Volunteers
- 762 people
- Sponsor
- UNICANCER
HER2-positive Breast Cancer, HER2 Gene Mutation
Study of A166 in Patients With Relapsed/Refractory Cancers Expressing HER2 Antigen or Having Amplified HER2 Gene
Open-label, Phase I-II, first-in-human (FIH) study for A166 monotherapy in HER2-expressing or amplified patients who progressed on or did not respond to available standard therapies.
- Conditions
- HER2-positive Breast Cancer, HER2 Gene Mutation, HER-2 Gene Amplification, HER2 Positive Gastric Cancer
- Trial name
- NCT03602079
- Testing
- A166
- Where
- 10 sites in United States
- Volunteers
- 49 people
- Sponsor
- Klus Pharma Inc.
Metastatic Breast Cancer
Τreatment Standards and Outcomes of Patients With ER/PR Positive, HER2-negative Metastatic Breast Cancer
To capture the treatment patterns and clinical characteristics of patients with ER/PR positive, HER2-negative MBC in Greece
- Trial name
- MBC (NCT04247035)
- Where
- Greece
- Volunteers
- 300 people
- Sponsor
- Hellenic Society of Medical Oncology
Breast Cancer
T-DM1 and Non-pegylated Liposomal Doxorubicin in Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer
The primary goal is to determine the maximum tolerated dose (MTD) of the combination of T-DM1 and non-pegylated liposomal doxorubicin in metastatic breast cancer (mBC) patients previously treated with taxanes and…
- Trial name
- THELMA (NCT02562378)
- Testing
- Trastuzumab and non-pegylated liposomal doxorubicin
- Where
- 4 sites in France, Spain
- Volunteers
- 15 people
- Sponsor
- MedSIR
Metastatic Breast Cancer
Phase III Palbociclib With Endocrine Therapy vs. Capecitabine in HR+/HER2- MBC With Resistance to Aromatase Inhibitors
This is an international (4 countries) randomized phase III study with 2 cohorts, patients will be randomized 1:1 to endocrine therapy (cohort 1: exemestane 25 mg daily, cohort 2: fulvestrant 500mg days 1 and 15 cycle 1 and then…
- Trial name
- PEARL (NCT02028507)
- Testing
- Palbociclib, Capecitabine, Exemestane
- Where
- 37 sites in Austria, Hungary and 2 more
- Volunteers
- 693 people
- Sponsor
- Spanish Breast Cancer Research Group
Metastatic Urothelial Carcinoma, Breast Cancer
Imaging Study in Metastatic UC, HR+ and HER2- Breast Cancer, TNBC, and NSCLC
This imaging study aims to assess the feasibility, biodistribution, and dosimetry of the imaging agent in subjects with metastatic UC, HR+ and HER2- breast cancer, TNBC, or NSCLC.
- Conditions
- Metastatic Urothelial Carcinoma, Breast Cancer, TNBC - Triple-Negative Breast Cancer, Hormone Receptor Positive HER-2 Negative Breast Cancer
- Trial name
- NCT07671092
- Testing
- RYZ211/212
- Where
- 6 sites in Australia, New Zealand and 1 more
- Volunteers
- 40 people
- Sponsor
- RayzeBio, Inc.
Advanced Breast Cancer, Metastatic Breast Cancer
Study of NUV-422 in Combination With Fulvestrant in Patients With HR+HER2- aBC
NUV-422-03 is a randomized, non-comparative Phase 1/2 dose escalation and expansion study designed to evaluate the safety and efficacy of NUV-422 in combination with fulvestrant relative to NUV-422 monotherapy and fulvestrant…
- Conditions
- Advanced Breast Cancer, Metastatic Breast Cancer, Breast Cancer, Breast Carcinoma
- Trial name
- NCT05191004
- Testing
- NUV-422, Fulvestrant
- Where
- 5 sites in United States
- Sponsor
- Nuvation Bio Inc.
Locally Advanced or Metastatic Malignant Solid Tumors
A Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)
The primary purpose of this study is to determine the antitumor activity of enfortumab vedotin as measured by confirmed objective response rate (ORR) per RECIST v1.1.
- Trial name
- NCT04225117
- Testing
- enfortumab vedotin, pembrolizumab
- Where
- 39 sites in United States, Canada and 1 more
- Volunteers
- 329 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Immunotherapy, Chemotherapy
Clinical Study of Chemotherapy and Immunotherapy Combined With Lactobacillus Johnsonii in Patients With Multiple Irresectable Solid Tumors
This study plans to enroll 156 patients aged 18-75, who will be randomly divided into two groups to evaluate the clinical efficacy and safety of chemotherapy and immune therapy combined with Lactobacillus johnsonii in patients…
- Trial name
- NCT07191405
- Testing
- oral Lactobacillus johnsonii (1×10¹¹ CFU, twice daily)
- Volunteers
- 156 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Solid Tumor, Adult, Metastatic Breast Cancer
Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors
First in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-10203, a PI3Kα:RAS breaker, alone and in combination with other anti-cancer agents in patients with advanced solid tumors.
- Conditions
- Solid Tumor, Adult, Metastatic Breast Cancer, Advanced Breast Cancer, HER2 Mutation-Related Tumors
- Trial name
- NCT06625775
- Testing
- BBO-10203, Trastuzumab, Fulvestrant
- Where
- 44 sites in United States, Australia and 4 more
- Volunteers
- 392 people
- Sponsor
- TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
Breast Cancer, Metastatic Breast Cancer
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
The purpose of this study is to determine whether lucitanib is safe and effective in the treatment of patients with FGF aberrant metastatic breast cancer, as well as in the treatment of patients with biomarker negative (FGF…
- Conditions
- Breast Cancer, Metastatic Breast Cancer, MBC, HER2 Positive
- Trial name
- NCT02202746
- Testing
- Lucitanib
- Where
- 33 sites in United States
- Volunteers
- 178 people
- Sponsor
- Clovis Oncology, Inc.
Adult Solid Neoplasm, Extensive Stage Lung Small Cell Carcinoma
RO4929097 and Whole-Brain Radiation Therapy or Stereotactic Radiosurgery in Treating Patients With Brain Metastases From Breast Cancer
This randomized phase I/II trial studies the side effects and the best dose of RO4929097 (gamma-secretase/Notch signalling pathway inhibitor RO4929097) when given together with whole-brain radiation therapy or stereotactic…
- Conditions
- Adult Solid Neoplasm, Extensive Stage Lung Small Cell Carcinoma, HER2/Neu Negative, HER2/Neu Positive
- Trial name
- NCT01217411
- Testing
- Cognitive Assessment, Gamma-Secretase Inhibitor RO4929097, Laboratory Biomarker Analysis
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- National Cancer Institute (NCI)
Breast Cancer
Study With Atezolizumab in Combination With Trastuzumab and Vinorelbine in HER2-positive Advanced/Metastatic Breast Cancer
Immune checkpoint inhibitors given in monotherapy in advanced breast cancer have shown modest benefit in first-line, but very limited efficacy in later lines. Thus, combination therapies are needed.
- Trial name
- ATREZZO (NCT04759248)
- Testing
- Atezolizumab + Trastuzumab + Vinorelbine
- Where
- 15 sites in Spain
- Volunteers
- 55 people
- Sponsor
- SOLTI Breast Cancer Research Group
Esophageal Neoplasms, Gastric Neoplasms Malignant
[68Ga]Ga-ABY-025 PET for Quantification of HER2-status in Solid Tumors
The goal of this phase II clinical trial is to improve the selection of patients with solid tumors who would benefit from effective treatment with HER2 targeted drugs.
- Conditions
- Esophageal Neoplasms, Gastric Neoplasms Malignant, Breast Cancer, HER2-positive Gastric Cancer
- Trial name
- NCT05619016
- Testing
- [68Ga]Ga-ABY-025 PET, Biopsy and analysis of HER2 expression
- Where
- Sweden
- Volunteers
- 72 people
- Sponsor
- Karolinska University Hospital