Clinical trials: HER2/Neu Positive
Breast Cancer
A Dose-Finding Study of Subcutaneous Herceptin (Trastuzumab) in Healthy Male Volunteers and Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Females
This two-part study is designed to select the subcutaneous (SC) dose of Herceptin that results in comparable exposure to intravenous (IV) Herceptin in healthy male participants and in HER2-positive female participants.
- Trial name
- NCT00800436
- Testing
- Herceptin
- Where
- 3 sites in Australia, New Zealand
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Breast Cancer Female
Pyrotinib Combined With Trastuzumab and Chemotherapy Neoadjuvant Therapy for HER2-positive Breast Cancer
This study is a prospective, single-center, observational clinical study, The objection was to observe the treatment of pyrotinib combined with trastuzumab and neoadjuvant chemotherapy Efficacy of Stage II-III breast cancer and…
- Trial name
- NCT06035679
- Testing
- Pyrotinib and Trastuzumab
- Where
- China
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Youzhi Zhu
HER2-positive Breast Cancer, HER2 Low
ISPY-P1.01:Evaluating the Safety of Weekly Paclitaxel With Trastuzumab Duocarmazine (SYD985) in Patients With Metastatic Cancer
This is an open-label, single-arm, multi-site phase I/Ib trial with SYD985, an antibody-drug conjugate (ADC) targeting HER2 on the cell membrane, combined with paclitaxel.
- Conditions
- HER2-positive Breast Cancer, HER2 Low, SYD-985, SYD985
- Trial name
- NCT04602117
- Testing
- Vic-trastuzumab duocarmazine (SYD985) + paclitaxel
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- QuantumLeap Healthcare Collaborative
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
HER2-positive Breast Cancer
PIK3CA in HER2+ BC and pCR Trial
The goal of the study is to evaluate the impact of somatic PI3KCA mutations on pCR in HER2-positive early breast cancer in real life. The main question it aims to answer iS.
- Trial name
- NCT05750693
- Testing
- PIK3CA analysis
- Where
- Italy
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
HER2-positive Breast Cancer
Trastuzumab Combined With Pyrrolidine and Chemotherapy for Locally HER2 Positive Breast Cancer
This study is a one-arm, open, phase II clinical study, and the study subjects are locally advanced and inflammatoryPatients with sexual or early HER2-positive breast cancer entered the trial period after signing informed…
- Trial name
- NCT04481932
- Testing
- Trastuzumab combined with Pyrotinib and chemotherapy
- Where
- China
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Peking University
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
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
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
Real-world Study of Pyrotinib in Neoadjuvant Therapy for HER2-positive Breast Cancer
Pyrotinib is currently being investigated in both registration studies and investigator-initiated studies in the neoadjuvant and adjuvant setting for HER2-positive breast cancer, all of which are RCTs, but randomized clinical…
- Trial name
- NCT05561686
- Testing
- Pyrotinib
- Where
- China
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Hunan Cancer Hospital
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
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.
HER2-Positive Breast Carcinoma
Impact of Aromatase Inhibitor Therapy on Glucose Homeostasis and Diabetes Risk
This study assesses the effect of hormone directed treatment for breast cancer on glucose metabolism.
- Trial name
- NCT06557057
- Testing
- Non-Interventional Study
- Where
- United States
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
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
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
ER-positive, HER2-negative Breast Cancer
A Study to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]AZD9833
The Sponsor is developing the test medicine, AZD9833 for the potential treatment of estrogen receptor (ER)-positive breast cancer.
- Trial name
- NCT05364255
- Testing
- [14C]AZD9833 Oral Solution, 75 mg
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Breast Cancer
Study of Cipatinib in Patients With HER2 Positive or Uncertain Advanced Breast Cancer
Cipatinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is designed to evaluate the safety and tolerability of cipatinib in patients with HER2 positive or uncertain advanced breast…
- Trial name
- NCT01301911
- Testing
- Cipatinib
- Where
- China
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Metastatic Breast Cancer
Study to Determine the Utility of FES-PET and FDG-PET in the Prediction of Response to Hormone Therapy in Women With Estrogen Positive Metastatic Breast Cancer
This study of hormone positive (estrogen receptor [ER]), metastatic invasive ductal breast cancer looks at functional scanning using positron emission tomography (PET) and patient response to hormone therapy.
- Trial name
- NCT00358098
- Where
- Canada
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- AHS Cancer Control Alberta
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
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.