Clinical trials: HER2/Neu Positive
Breast Cancer, Metastasis
Abemaciclib in Combination With Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer
This is an open label multicenter, Phase IB/II Study of Abemaciclib in Combination with Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer
- Trial name
- NCT05095207
- Testing
- Abemaciclib, Bicalutamide
- Where
- 3 sites in United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Icahn School of Medicine at Mount Sinai
Neoplasm, Breast, Congenital, Familial and Genetic Disorders
SEQUence of Endocrine Therapy in Advanced Luminal Breast Cancer (SEQUEL-Breast)
The study is a nationwide, multicenter single-arm phase 2 study. The current phase 2 study investigates the efficacy of the combination of fulvestrant and alpelisib directly after progression on fulvestrant (either in first or…
- Trial name
- SEQUEL-Breast (NCT05392608)
- Testing
- Alpelisib 150 MG Oral Tablet [Piqray], Fulvestrant
- Where
- 25 sites in Netherlands
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- Borstkanker Onderzoek Groep
Urology
Efficacy and Safety of Two Bladder-preserving Treatment Durations With Disitamab Vedotin Plus Toripalimab Combination in Her2-expressing Muscle-invasive Bladder Cancer: A Phase II, Open-Label, Randomized Clinical Trial
This study aims to evaluate the efficacy of disitamab vedotin combined with toripalimab as a bladder-preserving treatment combination in patients with HER2 positive locally advanced MIBC, including one year bladder-intact DFS…
- Trial name
- NCT07151560
- Testing
- 6 cycle RC48 and JS001, 12 cycle RC48 and JS001
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Renmin Hospital of Wuhan University
Trastuzumab Cardiotoxicity, HER2-Positive Breast Cancer Survivors
Assessment for Long-Term Cardiovascular Impairment Associated With Trastuzumab Cardiotoxicity in HER2-Positive Breast Cancer Survivors
This is for participants with a history of HER2-positive breast cancer and were treated with chemotherapy that increases the risk of abnormal heart function.
- Trial name
- NCT02615054
- Testing
- 2D Echocardiogram, Cardiopulmonary exercise testing and post-CPET cardiac function
- Where
- United States
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Memorial Sloan Kettering Cancer Center
Breast Cancer
A Randomised, Open-label, Multicentre Phase III Clinical Study to Evaluate the Efficacy and Safety of JS105 Combined With Dalpiciclib and Fulvestrant Compared With Dalpiciclib and Fulvestrant in Patients With PIK3CA-mutated, HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer.
This study is a randomised, open-label, multicentre phase III clinical study evaluating the efficacy and safety of JS105 combined with Dalpiciclib and Fulvestrant compared with Dalpiciclib and Fulvestrant in patients with…
- Trial name
- NCT07207070
- Testing
- JS105, Dalpiciclib, Fulvestrant 50 Mg/mL Intramuscular Solution
- Where
- 2 sites in China
- Volunteers
- 312 people, healthy volunteers welcome
- Sponsor
- Risen (Suzhou) Pharma Tech Co., Ltd.
HER2-positive Breast Cancer and Gastric Cancer
Clinical Study of 68Ga Labeled HER2 Affibody Analogues
The purpose of this study is to assess the dosimetric properties of the positron emission tomography (PET) imaging probe 68Ga labeled HER2 Affibody analogues and preliminarily evaluate its diagnosis value in patients with breast…
- Trial name
- NCT05411432
- Testing
- 68Ga labeled HER2 Affibody
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Xijing Hospital
Breast Cancer, Adjuvant Therapy
Compare Continuation of Original Targeted Therapy With Trastuzumab Combined With Pyrotinib and Capecitabine as Postoperative Adjuvant Therapy in Non-pCR Patients With HER2 Positive Early Breast Cancer
To evaluate the efficacy of continuation targeted therapy compared with trastuzumab combined with Pyrotinib and capecitabine in postoperative adjuvant therapy of HER-2 positive early breast cancer patients with residual tumor…
- Trial name
- NCT05292742
- Testing
- Pyrotinib+Trastuzumab+Capecitabine, Trastuzumab+Pertuzumab/Trastuzumab
- Where
- China
- Volunteers
- 206 people, healthy volunteers welcome
- Sponsor
- Fujian Medical University Union Hospital
Breast Cancer
A Pharmacokinetic Study Comparing EG1206A and Perjeta (Pertzumab) in Healthy Male Volunteers
This trial is a single-center, single-dose, double-blind, parallel-group, randomized, 3-arm PK trial in healthy male volunteers comparing a biosimilar pertuzumab (EG1206A) to a single intravenous (i.v.) infusion to both European…
- Trial name
- NCT05471648
- Testing
- 420 mg EG1206A EirGenix Pertuzumab in 14 mL Injection, Perjeta (EU origin) 420 mg in 14 mL Injection, Perjeta (US origin) 420 mg in 14 mL Injection
- Where
- Germany
- Volunteers
- 135 people, healthy volunteers welcome
- Sponsor
- EirGenix, Inc.
Breast Cancer
Gut Microbiome Components Predict Response to Neoadjuvant Therapy in HER2-positive Breast Cancer Patients : A Prospective Study
In this study the characteristics and alterations of the gut microbiome during neoadjuvant therapy for HER2-positive breast cancer patients are studied, as well as the relation between the gut microbiome and probability of pCR.
- Trial name
- NCT05444647
- Testing
- stool and blood collection
- Where
- China
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
HER2-positive Metastatic Breast Cancer, Ovarian Cancer
Feasibility of a New Technology for Isolating Circulating Tumour Cells
This is a prospective interventional single-site research with a collection of biological samples. The primary objective of the trial is to assess the ability of the "new technology" to isolating circulating tumor cells (CTC) in…
- Conditions
- HER2-positive Metastatic Breast Cancer, Ovarian Cancer, Hormone-resistant Prostate Cancer, Circulating Tumor Cell
- Trial name
- CTC-SMMiL-E (NCT03979339)
- Testing
- Blood sample collection
- Where
- France
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Centre Oscar Lambret
Healthy Subjects
A Study to Assess the Pharmacokinetics of Camizestrant (AZD9833) When Administered Alone and in Combination With Itraconazole
This study will be conducted in healthy post-menopausal female subjects to assess the pharmacokinetics (PK) of Camizestrant (AZD9833) when administered alone and in combination with Itraconazole.
- Trial name
- NCT05551897
- Testing
- Camizestrant, Itraconazole
- Where
- United Kingdom
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Triple Negative Breast Cancer, HER2-positive Breast Cancer
Exosome as the Prognostic and Predictive Biomarker in EBC Patients
This study is the experimental study for serial ctDNA and exosome evaluation in EBC patients
- Trial name
- NCT05955521
- Testing
- exosome and ctDNA evaluation
- Where
- South Korea
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Samsung Medical Center
Healthy
A Comparing Study Between ALT02(Trastuzumab Biosimilar) and Herceptin® in Healthy Subjects
The purpose of this study is to compare ALT02 (Trastuzumab biosimilar) and Herceptin® (US-licensed Trastuzumab and EU-licensed Trastuzumab) in healthy male subjects about the pharmacokinetics, safety, tolerability and…
- Trial name
- NCT03242239
- Testing
- ALT02, EU-licensed Herceptin, US-licensed Herceptin
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- Alteogen, Inc.
Triple Negative Breast Cancer, HER2-positive Breast Cancer
Programmed Death-Ligand1 Expression in Her-2 Positive and Triple Negative Breast Cancer
Patients with Her-2 positive and triple negative breast cancer who received neoadjuvant chemotherapy will be included in the study.
- Trial name
- NCT05169853
- Where
- Egypt
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Ain Shams University
TNBC - Triple-Negative Breast Cancer
Targeting Metastatic Breast Cancers by Alkaline Glucosodiene Molecules Via a Metabolic Pathway Phase I Clinical Trial
The diverse group of breast tumors known as triple-negative breast cancer (TNBC) which is lethally and deadly type of breast cancer and insensitive to endocrine therapy and HER2-targeted therapy because it lacks the expression of…
- Trial name
- NCT05957939
- Testing
- Alkaline Glucosodiene Molecules
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Ministry of Health, Saudi Arabia
Advanced HER2 Negative Breast Carcinoma, HRD+Breast Cancer
Fluzoparib in Combination With Chidamide or Camrelizumab for HRD Positive HER2 Negative Advanced Breast Cancer
This study is planned to include 40 patients with HER2-negative advanced breast cancer to receive fluzoparib combined with chidamide or fluzoparib combined with camrelizumab to observe and evaluate the efficacy and safety of…
- Trial name
- NCT05085626
- Testing
- fluzoparib+chidamide, fluzoparib+camrelizumab
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
HER2-positive Breast Cancer
Neoadjuvant Study of Pyrotinib and Trastuzumab Plus Chemotherapy in Patients With HER2 Positive Breast Cancer
This is a prospective, open-label,multicenter Phase II study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus chemotherapy as neoadjuvant treatment in HER2 positive early stage or locally…
- Trial name
- NCT03847818
- Testing
- Pyrotinib+Trastuzumab+Docetaxel+Carboplatin
- Volunteers
- 268 people, healthy volunteers welcome
- Sponsor
- Shandong University
Breast Cancer Female
Conformal Ablative Radiotherapy in Older Women (CARMEN) With Breast Cancer Undergoing Non-Operative Management
This phase II study evaluates SABR as non-operative treatment for women aged 65+ with ER-positive, HER2-negative breast cancer ≤5 cm and no lymph node involvement.
- Trial name
- CARMEN (NCT07242118)
- Testing
- SABR
- Where
- 2 sites in United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- University of Kansas Medical Center
Muscle-invasive Bladder Urothelial Carcinoma
A Phase II Study of Toripalimab Plus RC48-ADC With Radiotherapy for Bladder Preservation in HER2-Positive Muscle-Invasive Bladder Cancer
This is a prospective, open-label, single-center, single-arm clinical study. Plans to enroll 45 MIBC patients with clinical stage T2-T4aN0M0 and HER2-positive (IHC 1+/2+/3+) status.
- Trial name
- NCT07279597
- Testing
- RC48-ADC + Toripalimab
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Tongji Hospital
HER2 Positive Breast Carcinoma, Stage IIIA Breast Cancer
Cu64-DOTA-trastuzumab PET and Markers Predicting Response to Neoadjuvant Trastuzumab + Pertuzum in HER2+ Breast Cancer
This phase II trial studies how well copper Cu64-DOTA-trastuzumab positron emission tomography (PET) works in predicting response to treatment with trastuzumab and pertuzumab before surgery in patients with human epidermal growth…
- Conditions
- HER2 Positive Breast Carcinoma, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer
- Trial name
- NCT02827877
- Testing
- Copper Cu 64-DOTA-Trastuzumab, Laboratory Biomarker Analysis, Pertuzumab
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- City of Hope Medical Center