Clinical trials: HER2-Positive Breast Cancer
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.
Small Cell Lung Cancer, Ovarian Cancer
PF-07104091 as a Single Agent and in Combination Therapy
To assess the safety and tolerability of increasing doses of PF-07104091 and to estimate the Maximum Tolerated Dose (MTD) and/or select the Recommended Phase 2 dose (RP2D) for PF-07104091 as a single agent in participants with…
- Conditions
- Small Cell Lung Cancer, Ovarian Cancer, Breast Cancer
- Trial name
- NCT04553133
- Testing
- PF-07104091 monotherapy dose escalation, PF-07104091 + palbociclib + fulvestrant, PF-07104091 + palbociclib + letrozole
- Where
- 22 sites in United States, Argentina and 2 more
- Volunteers
- 157 people
- Sponsor
- Pfizer
Breast Cancer
Study to Evaluate Safety and Dosimetry of [18F]GEH121224 in Patients With Locally Advanced or Metastatic Breast Cancer
The study described in this protocol is a Phase 1, single center clinical trial to evaluate the safety and potential of [18F]GEH121224 as a PET radiotracer for the diagnostic imaging of HER2 positive breast cancer lesions.
- Trial name
- NCT05634954
- Testing
- GEH121224 (18F) Injection, Dynamic and Static - PET/CT Scan, Static - PET/CT Scan
- Where
- United States
- Sponsor
- GE Healthcare
HER2-positive Recurrent / Metastatic Breast Cancer
Effect of Montmorillonite Power or Loperamide on the Pharmacokinetics of Pyrotinib in Healthy Subjects
The study will assess the effect of anti-diarrhea drug Montmorillonite Power or Loperamide on the single dose pharmacokinetic parameters of pyrotinib in healthy Chinese subjects.
- Trial name
- NCT05252546
- Testing
- pyrotinib tablet, Montmorillonite Power, Loperamide
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Non Small Cell Lung Cancer, Breast Cancer
A Study of Abemaciclib (LY2835219) in Participants With Non-Small Cell Lung Cancer or Breast Cancer
The main purpose of this study is to evaluate the safety and efficacy of abemaciclib in combination with pembrolizumab in participants with advanced non-small cell lung cancer (NSCLC) or hormone receptor positive (HR+), human…
- Trial name
- NCT02779751
- Testing
- Abemaciclib, Pembrolizumab, Anastrozole
- Where
- 24 sites in United States, Belgium and 5 more
- Volunteers
- 100 people
- Sponsor
- Eli Lilly and Company
Early Breast Cancer
A Pharmacodynamics Pre-surgical Study of LEE011 in Early Breast Cancer Patients (MONALEESA-1)
This is a multi-center, open-label Phase II randomized pre-surgical pharmacodynamics study.
- Trial name
- MONALEESA-1 (NCT01919229)
- Testing
- LEE011 (ribociclib), letrozole
- Where
- 7 sites in United States, Singapore and 1 more
- Volunteers
- 14 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Breast Cancer
A Phase Ib Study of GB491 Plus Letrozole in Patients With Advanced Breast Cancer
GB491-005 is a multicenter, open-label, phase Ib Clinical Trial study to evaluate the safety, pharmacokinetic (PK), pharmacodynamic (PD) activity, and preliminary anti-tumor activity of GB491 in combination with Letrozole in…
- Trial name
- NCT05337657
- Testing
- GB491+Letrozole
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Genor Biopharma Co., Ltd.
Breast Cancer
A Safety and Immunology Study of a Modified Vaccinia Vaccine for HER-2(+) Metastatic Breast Cancer
The current trial, BNIT-BR-002, will evaluate the safety and biological activity of a fixed dose of MVA-BN®-HER2, with and without Herceptin, following 1st- or 2nd-line chemotherapy in patients with Her-2-positive metastatic…
- Trial name
- NCT00485277
- Testing
- MVA-BN-HER2
- Where
- 2 sites in United States
- Volunteers
- 9 people
- Sponsor
- Bavarian Nordic
HR-positive,HER2-negative in Advanced Breast Cancer
TQB3616 Capsules Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer in Clinical Trail
This is a Phase III, a randomized, double-blind, parallel , multi-center trail to evaluate the efficacy and safety of TQB3616 capsules plus fulvestrant compared to placebo plus fulvestrant in participants with estrogen…
- Trial name
- NCT05375461
- Testing
- TQB3616 capsules, Fluvestrin injection
- Where
- 2 sites in China
- Volunteers
- 293 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Breast Cancer
A European Registry Study to Prospectively Observe Treatment Patterns and Outcomes in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Unresectable Locally Advanced (LA) or Metastatic Breast Cancer (mBC) (SAMANTHA)
This disease registry is a prospective, multicenter non-interventional study designed to observe anti-cancer treatment regimens and clinical outcomes in participants with HER2-positive unresectable LA/mBC.
- Trial name
- NCT02913456
- Where
- 54 sites in Austria, Bulgaria and 3 more
- Volunteers
- 629 people
- Sponsor
- Hoffmann-La Roche
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.
HER2-positive Breast Cancer, HER-2 Protein Overexpression
Study of ORM-5029 in Subjects With HER2-Expressing Advanced Solid Tumors
This is a Phase 1 first-in-human study of ORM-5029 in participants with HER2-expressing advanced solid tumors. The study consists of two parts: a Part 1 Dose Escalation and Part 2 Dose Expansion.
- Conditions
- HER2-positive Breast Cancer, HER-2 Protein Overexpression, HER-2 Gene Amplification, HER2 Gene Mutation
- Trial name
- NCT05511844
- Testing
- ORM-5029
- Where
- 11 sites in United States
- Volunteers
- 25 people
- Sponsor
- Orum Therapeutics USA, Inc.
Breast Cancer With Low to Intermediate HER2 Expression
Efficacy and Safety Study of NeuVax™ (Nelipepimut-S or E75) Vaccine to Prevent Breast Cancer Recurrence
Purpose of this trial: 1. To assess the efficacy and safety of NeuVax™ administered with adjuvant Leukine® (sargramostim, GM-CSF). 2. To evaluate and compare the disease free survival (DFS) in the vaccinated and control subjects.
- Trial name
- PRESENT (NCT01479244)
- Testing
- NeuVax™ vaccine, Leukine® (sargramostim, GM-CSF) and water for injection
- Where
- 197 sites in United States, Bulgaria and 11 more
- Volunteers
- 758 people
- Sponsor
- Galena Biopharma, Inc.
Breast Cancer
HER2(Human Epidermal Growth Factor Receptor 2) -Positive Metastatic Breast Cancer in Russia
Planned study population consists of approximately 1,000 adult patients with HER2-positive mBC receiving anti-HER2 therapy in about 50 oncological centers (in each center it is expected to recruit about 20 patients) in different…
- Trial name
- NCT05905939
- Where
- 29 sites in Russia
- Volunteers
- 774 people
- Sponsor
- AstraZeneca
Breast Neoplasms
An Observational Study Evaluating the Productivity and Health-Related Quality of Life of People With HER2 Positive Breast Cancer
The purpose of this study is to compare productivity (in terms of work or daily activity) and generic and disease-specific health-related quality of life of participants with HER2 positive early breast cancer currently receiving…
- Trial name
- NCT03099200
- Testing
- No Intervention
- Where
- 14 sites in United Kingdom
- Volunteers
- 300 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer (Advanced/Metastatic), HER2-positive Breast Cancer
Dual-Target CAR-NK Cells for Advanced Breast Cancer HER2+ TNBC
This study tests the safety and preliminary anti-tumor activity of an investigational dual-target chimeric antigen receptor natural killer (CAR-NK) cell therapy in adults with advanced breast cancer.
- Conditions
- Breast Cancer (Advanced/Metastatic), HER2-positive Breast Cancer, Triple-negative Breast Cancer
- Trial name
- NCT07510802
- Testing
- Dual-target CAR-NK cells, Lymphodepleting, Supportive care
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Beijing Biotech
Cancer
Continued HER2 Suppression With Lapatinib Plus Trastuzumab Versus Trastuzumab Alone
This was a randomized, open-label, multi-center Phase III study evaluating the efficacy and safety of lapatinib in combination with trastuzumab versus trastuzumab alone as continued HER2 suppression therapy in women with…
- Trial name
- NCT00968968
- Testing
- Lapatinib, Trastuzumab
- Where
- 116 sites in United States, Canada
- Volunteers
- 37 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
A Study to Understand the Use of Palbociclib in Canadian Patients With Breast Cancer That Has Spread to Other Organs
The purpose of this real-world study is to understand the use of palbociclib as first treatment for Hormone receptor positive (HR+) and Human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer in Canada…
- Trial name
- NCT06003114
- Testing
- Palbociclib
- Where
- Canada
- Volunteers
- 472 people
- Sponsor
- Pfizer
Breast Cancer
Palbociclib In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR+, HER2- Advanced Breast Cancer
A study of palbociclib in combination with letrozole as treatment of post-menopausal women with hormone receptor-positive, her2-negative advanced breast cancer for whom letrozole therapy is deemed appropriate.
- Trial name
- NCT02679755
- Testing
- Palbociclib, Letrozole
- Where
- 34 sites in Australia, India
- Volunteers
- 252 people
- Sponsor
- Pfizer
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.