Clinical trials: HER2 + Breast Cancer
HER2-positive Breast Cancer, Male Breast Cancer
Ex Vivo-Expanded HER2-Specific T Cells and Cyclophosphamide After Vaccine Therapy in Treating Patients With HER2-Positive Stage IV Breast Cancer
RATIONALE : Laboratory-treated T cells may stimulate the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor…
- Conditions
- HER2-positive Breast Cancer, Male Breast Cancer, Stage IV Breast Cancer
- Trial name
- NCT01219907
- Testing
- HER-2/neu peptide vaccine, cyclophosphamide, ex vivo-expanded HER2-specific T cells
- Where
- United States
- Sponsor
- University of Washington
Breast Cancer
Study of PIK3CA Mutations and Effectiveness and Tolerability Outcomes of Alpelisib in Real-world
SPEAR is a non-interventional / observational, prospective, multicenter study planned to be conducted across ~ 30 sites in India, among HR-positive and HER2-negative ABC/MBC patients.
- Trial name
- SPEAR (NCT05022342)
- Testing
- alpelisib plus fulvestrant
- Where
- 28 sites in India
- Volunteers
- 595 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Breast Cancer
Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor
The purpose of this study is to learn if certain drug combinations are effective treatments for patients with advanced ER+/HER2- who have previously been treated with palbociclib, ribociclib, or abemaciclib.
- Trial name
- GERTRUDE (NCT05933395)
- Testing
- Fulvestrant, Neratinib, Alpelisib
- Where
- United States
- Volunteers
- 135 people
- Sponsor
- Dartmouth-Hitchcock Medical Center
Breast Cancer
Elacestrant in Patients With ER+ HER2- ESR1-mutated Locally Advanced or Metastatic Breast Cancer
The objective of this non-interventional study (NIS) is to evaluate prevalence of ESR1 mutation after endocrine therapy in the palliative setting, quality of life, tolerability, and safety and to describe treatment detail and…
- Trial name
- ELENI (NCT07563595)
- Testing
- Elacestrant, Standard of care (Investigator Choice)
- Where
- 3 sites in Germany
- Volunteers
- 500 people
- Sponsor
- iOMEDICO AG
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic HER2-Negative Breast Carcinoma
Tka Assay for CDK4/6i
This clinical trial assesses whether using a test developed by DiviTum can identify optimal levels of CDK 4/6 inhibitor medications in the blood and whether assessing medical compliance and drug-drug interactions can optimize…
- Trial name
- NCT06572800
- Testing
- DiviTum-TKa
- Where
- 18 sites in United States
- Volunteers
- 34 people
- Sponsor
- Yale University
HR+/HER2- Breast Cancer, Metastatic Disease
Abemaciclib for the Treatment of Luminal Metastatic breAst caNcer in the Real-life Clinical pracTice in Russia.
The ATLANT study is prospective, multicentre, non-interventional, observational study. Patients with HR+/HER2-negative metastatic breast cancer received abemaciclib as monotherapy or in combination with endocrine therapy.
- Conditions
- HR+/HER2- Breast Cancer, Metastatic Disease, Аdvanced Disease
- Trial name
- ATLANT (NCT05789771)
- Testing
- Abemaciclib
- Where
- Russia
- Volunteers
- 136 people
- Sponsor
- Blokhin's Russian Cancer Research Center
Breast Cancer With Low to Intermediate HER2 Expression, Breast Cancer (Triple Negative Breast Cancer (TNBC))
Use of Magtrace Bracketing for Excision of Lesion and Sentinel Lymph Node Localization in Breast Conserving Surgery for Breast Cancer
Breast cancer is the commonest cancer affecting women worldwide. Early breast cancer is treated surgically with wide local excision of tumor with axillary staging operations like sentinel node biopsy.
- Conditions
- Breast Cancer With Low to Intermediate HER2 Expression, Breast Cancer (Triple Negative Breast Cancer (TNBC)), Breast Cancer (Triple Negative Type), Breast Cancer - Infiltrating Ductal Carcinoma
- Trial name
- MagBracket (NCT07844473)
- Testing
- Super paramagnetic iron oxide bracketing injection
- Where
- Saudi Arabia
- Volunteers
- 35 people
- Sponsor
- King Faisal Specialist Hospital & Research Center
Breast Neoplasms
A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer
The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2…
- Trial name
- EMBER-4 (NCT05514054)
- Testing
- Imlunestrant, Tamoxifen, Anastrozole
- Where
- 672 sites in United States, Argentina and 29 more
- Volunteers
- 8,000 people
- Sponsor
- Eli Lilly and Company
Breast Cancer
An Observational Study of the Mean Duration of Trastuzumab (Herceptin) Treatment in Participants With Early or Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer
This single arm observational study will assess the duration and safety of treatment with trastuzumab in routine clinical practice in participants with early or metastatic HER2-positive breast cancer.
- Trial name
- HERODOT (NCT01187381)
- Testing
- Trastuzumab
- Where
- Romania
- Volunteers
- 250 people
- Sponsor
- Hoffmann-La Roche
Locally Advanced or Unresectable Metastatic Breast Cancer, Stage IV Breast Cancer
Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy
The goal of this clinical study is to see if sacituzumab govitecan-hziy (SG) can improve life spans of people with HR+/HER2- metastatic breast cancer and their tumor does not grow or spread when compared to currently available…
- Trial name
- ASCENT-07 (NCT05840211)
- Testing
- Sacituzumab Govitecan-hziy, Paclitaxel, Nab-paclitaxel
- Where
- 288 sites in United States, Argentina and 26 more
- Volunteers
- 654 people
- Sponsor
- Gilead Sciences
Breast Neoplasms
Study to Identify the Impact of Denosumab on the Immune System in Patients With HER2 Negative Breast Cancer
The aim of this prospective, randomized, multicenter, open-label, explorative phase II study is to identify the impact of (neo)adjuvant denosumab on the systemic immunity and local immunologic microenvironment in postmenopausal…
- Trial name
- PERIDENO (NCT03532087)
- Testing
- Denosumab 120 mg, Denosumab 60 mg
- Where
- 8 sites in Netherlands
- Sponsor
- Borstkanker Onderzoek Groep
Breast Cancer
Combination Study of BMS-754807 and Herceptin® in Patients With Advanced or Metastatic Her-2-positive Breast Cancer
This is a Phase I/II study to evaluate the safety profile, tolerability, pharmacokinetics and pharmacodynamics following daily oral doses of 50 to 200 mg of BMS-754807 in combination with trastuzumab (Herceptin®) in subjects with…
- Trial name
- NCT00788333
- Testing
- BMS-754807, trastuzumab (Herceptin®)
- Where
- 9 sites in Australia, Belgium and 3 more
- Volunteers
- 40 people
- Sponsor
- Bristol-Myers Squibb
Breast Cancer
Paclitaxel Plus Pembrolizumab vs. Paclitaxel Weekly in ER+ Luminal B Metastatic Breast Cancer
PELICAN is a randomised phase II trial that aims to evaluate the efficacy and safety of paclitaxel plus pembrolizumab relative to paclitaxel alone, in patients with locally advanced or metastatic ER-positive, HER2-negative…
- Trial name
- PELICAN (NCT03841747)
- Testing
- Pembrolizumab, Paclitaxel
- Sponsor
- Queen Mary University of London
Breast Cancer, Adherence, Medication
Adherence and Safety of Ribociclib Plus Aromatase Inhibitors in Patients With Early Stage, HR+ and HER2- Breast Cancer
Breast cancer is the most common malignancy in women, with HR+/HER2- early breast cancer accounting for approximately 70% of cases.
- Trial name
- riboADHERE (NCT07630948)
- Testing
- Adherence package consisting of additional education and adherence reminders
- Where
- Slovenia
- Volunteers
- 90 people
- Sponsor
- Institute of Oncology Ljubljana
Breast Cancer
Capecitabine 7/7 Schedule With Neratinib in Patients With Metastatic HER2-Positive Breast Cancer
This is a phase l/II study. The purpose of this study is to test the safety of the study drug neratinib in combination with a standard chemotherapy drug called capecitabine at different doses to find out what effects, if any, it…
- Trial name
- NCT03377387
- Testing
- Capecitabine, Neratinib, EORTC QLQ - BR23, EQ-5D-5L, EORTC QLQ-C30
- Where
- 10 sites in United States
- Volunteers
- 34 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Breast Cancer
Study Evaluating DNA Double-strand Breaks (DSBs) REpair Factors (POLQ, Shieldin Complex and 53BP1) Expression as Biomarker of PARP Inhibitor Resistance in Patients With Deleterious Germline Mutation in BRCA 1/2 and HER2-negative, Metastatic or Locally Advanced Breast Cancer.
The purpose of this study is to assess whether expression of not only POLQ/Polθ, but also Shieldin complex and/or 53BP1 are correlated with primary and/or acquired resistance to PARPi (Poly(ADP-Ribose) Polymerases inhibitors) in…
- Trial name
- REPARP (NCT05378204)
- Testing
- Main study:, Sub-study:
- Where
- 25 sites in France
- Volunteers
- 120 people
- Sponsor
- Institut Claudius Regaud
Breast Cancer, Metastatic Breast Cancer
89Zr-DFO*-Trastuzumab PET in Patients With Gastric or Breast Cancer - a Pilot Study
The goal of this clinical trial is to test a new PET tracer in patients with HER2-positive breast or gastric cancer. This tracer is made of radioactively labeled trastuzumab, and can show where HER2 is present in the body using a…
- Conditions
- Breast Cancer, Metastatic Breast Cancer, HER2-positive Breast Cancer, Gastric Cancer
- Trial name
- HER Image (NCT05955833)
- Testing
- 89Zr-DFO*-trastuzumab PET scan
- Where
- Netherlands
- Volunteers
- 6 people
- Sponsor
- Amsterdam UMC, location VUmc
Breast Neoplasms
Study Of SU011248 Versus Chemotherapy For Patients With Previously Treated Triple Receptor Negative Breast Cancer
The purpose of this study is to compare progression free survival for SU011248 [sutent (sunitinib malate)] versus standard of care therapy in patients with previously treated, advanced, triple receptor negative (ER, PR, HER2)…
- Trial name
- NCT00246571
- Testing
- SU011248, Chemotherapy
- Where
- 113 sites in United States, Bulgaria and 10 more
- Volunteers
- 217 people
- Sponsor
- Pfizer
Metastatic Breast Cancer
ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer Study
The purpose of this study is to evaluate the efficacy and safety of elacestrant over the course of 6 months in patients with estrogen receptor positive (ER+)/human epidermal growth factor receptor-2 negative (HER2-)…
- Trial name
- ELCIN (NCT05596409)
- Testing
- Elacestrant
- Where
- 22 sites in United States, Brazil and 4 more
- Volunteers
- 61 people
- Sponsor
- Stemline Therapeutics, Inc.
Breast Cancer
Laboratory-Treated T Cells After Second-Line Chemotherapy in Treating Patients With HER2/Neu-Negative Metastatic 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
- NCT01022138
- Testing
- HER2Bi-armed activated T cells, Cyclophosphamide, Laboratory biomarker analysis
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- Barbara Ann Karmanos Cancer Institute
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