Clinical trials: Early Stage HER2-Positive Breast Carcinoma
Breast Cancer
Clinical Trial Assessing the Safety of Neoadjuvant Palbociclib in Combination With Endocrine Therapy
Patients with estrogen receptor positive (ER+) and/or progesterone receptor positive (PR+) breast cancer do not achieve good responses with pre-operative chemotherapy.
- Trial name
- NCT05069038
- Testing
- Palbociclib 125mg
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- University of Nebraska
Early Breast Cancer
A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer
A phase III, multicenter, randomized, open-label trial to evaluate the efficacy and safety of ribociclib with Endocrine Therapy (ET) as an adjuvant treatment in women and men with Hormone Receptor positive (HR+), Human Epidermal…
- Trial name
- NATALEE (NCT03701334)
- Testing
- Ribociclib, Endocrine Therapy (ET)
- Where
- 387 sites in United States, Argentina and 18 more
- Volunteers
- 5,101 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
A Study of Subcutaneously Administered Herceptin (Trastuzumab) in Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Early Breast Cancer
This open-label, randomized crossover study evaluated the quality of life, efficacy, and safety of subcutaneous Herceptin (trastuzumab) injected either into the thigh or the upper arm of participants with early HER2-positive…
- Trial name
- LISAH (NCT01928615)
- Testing
- Trastuzumab - intravenous solution, Trastuzumab - subcutaneous solution, Chemotherapy
- Where
- 2 sites in Austria
- Volunteers
- 2 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer, Breast Cancer, Male
Phase I-II Study of Interferon-gamma in Patients With HER-2 Positive Breast Cancer
This purpose of this study is to evaluate the safety and to find the optimal dose in participants with human epidermal growth factor receptor 2 (HER2) positive breast cancer who are given the combination of Interferon-gamma with…
- Conditions
- Breast Cancer, Breast Cancer, Male, Breast Cancer Female, HER2-positive Breast Cancer
- Trial name
- NCT03112590
- Testing
- Interferon-gamma (IFN-γ), Paclitaxel, Trastuzumab
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
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.
Hormone Receptor-Positive, HER2-Negative, Node Positive Breast Cancer
Neoadjuvant Letrozole in Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative, Node Positive, Early-Stage Breast Cancer.
The goal of this clinical trial is to learn whether letrozole, a hormone therapy drug, is effective in treating early-stage, hormone receptor-positive, HER2-negative breast cancer that has spread to nearby lymph nodes in…
- Trial name
- NELOPHER (NCT07394946)
- Testing
- Letrozole
- Where
- Pakistan
- Volunteers
- 126 people
- Sponsor
- Cancer Care Hospital & Research Centre Foundation, Lahore
Breast Neoplasms, Breast Cancer
I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer
The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early…
- Conditions
- Breast Neoplasms, Breast Cancer, Breast Tumors, Angiosarcoma
- Trial name
- I-SPY (NCT01042379)
- Testing
- Standard Therapy, AMG 386 with or without Trastuzumab, AMG 479 (Ganitumab) plus Metformin
- Where
- 42 sites in United States
- Volunteers
- 5,000 people
- Sponsor
- QuantumLeap Healthcare Collaborative
Breast Cancer, HR Positive, HER2 Positive Breast Cancer
Culmerciclib Combined With Letrozole and Dual HER2 Blockade as Neoadjuvant Therapy for HR+/HER2+ Breast Cancer
This is a single-arm, prospective, multicenter, phase II clinical study evaluating the efficacy and safety of a chemotherapy-free neoadjuvant regimen in patients with HR-positive/HER2-positive (HR+/HER2+) early or locally…
- Trial name
- NCT07795424
- Testing
- Culmerciclib, Letrozole, Trastuzumab (TQB211)
- Where
- China
- Volunteers
- 33 people
- Sponsor
- Shengjing Hospital
HER2 + Breast Cancer
A Phase II/III Clinical Study to Evaluate the Efficacy and Safety of HLX87in Combination With HLX22 or Pertuzumab in the Neoadjuvant Therapy of HER2-Positive Bresat Cancer
The study is being conducted to evaluate the clinical efficacy of HLX87 in combination with HLX22 or pertuzumab vs. TCbHP in the neoadjuvant therapy of HER2-positive early or locally advanced breast cancer.
- Trial name
- NCT07294534
- Testing
- HLX87+HX22, HLX87 + Pertuzumab, TCbHP
- Volunteers
- 817 people
- Sponsor
- Shanghai Henlius Biotech
HER2-positive Breast Cancer
A Trial of Eribulin in Combination With HP Neoadjuvant Therapy in Patients With for HER2-Positive BC
To evaluate the pathology complete response rate (pathology Complete Response, pCR) of eribulin combined with trastuzumab + pertuzumab in neoadjuvant therapy for HER-2 positive early or locally advanced breast cancer.
- Trial name
- NCT05945368
- Testing
- Eribulin mesylate injection、Pertuzumab、Trastuzumab
- Where
- China
- Volunteers
- 78 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Breast Cancer
Efficacy and Safety Study of EG12014 Compared With Herceptin in Subjects With HER2 Positive Early Breast Cancer
The purpose of this research study is to compare the efficacy and safety of EG12014 with Herceptin as neoadjuvant treatment for 12 weeks, followed by surgery and subsequent EG12014 or Herceptin adjuvant treatment for up to 12…
- Trial name
- NCT03433313
- Testing
- EG12014, Herceptin
- Where
- 91 sites in United States, Belarus and 9 more
- Volunteers
- 807 people
- Sponsor
- EirGenix, Inc.
Breast Cancer
Miti-gene Recurrence Score in HR+/HER2- Chinese Breast Cancer Patients
Update and validate the performance of the 21-gene score in prognostic stratification for early-stage HR-positive, HER2-negative breast cancer in China.
- Trial name
- BC-MRS-01 (NCT07052734)
- Where
- China
- Volunteers
- 2,843 people
- Sponsor
- Sun Yat-sen University
Breast Cancer
A Study of Neoadjuvant Letrozole + Taselisib Versus Letrozole + Placebo in Post-Menopausal Women With Breast Cancer (LORELEI)
This is a two-arm, randomized, double-blind, multicenter, pre-operative study to evaluate the effect of combining letrozole and GDC-0032 (also known as taselisib) versus letrozole and placebo in postmenopausal women with estrogen…
- Trial name
- NCT02273973
- Testing
- Letrozole, Taselisib
- Where
- 117 sites in United States, Australia and 20 more
- Volunteers
- 334 people
- Sponsor
- Genentech, Inc.
Breast Neoplasms, Breast Cancer
Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer
This study will look at the efficacy and safety of trastuzumab deruxtecan (T-DXd) in a neoadjuvant setting, in high-risk, HER2-positive early non-metastatic breast cancer.
- Conditions
- Breast Neoplasms, Breast Cancer, HER2-positive Early Breast Cancer
- Trial name
- NCT05113251
- Testing
- Trastuzumab Deruxtecan, Paclitaxel, Trastuzumab
- Where
- 145 sites in United States, Brazil and 16 more
- Volunteers
- 927 people
- Sponsor
- AstraZeneca
Breast Cancer
Trastuzumab in Treating Older Women With Early-Stage Breast Cancer
RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread.
- Trial name
- NCT00796978
- Testing
- trastuzumab, laboratory biomarker analysis, adjuvant therapy
- Where
- 11 sites in United States
- Volunteers
- 56 people
- Sponsor
- Cynthia Owusu, MD
Breast Cancer, TNBC - Triple-Negative Breast Cancer
Evaluating Minimal Residual Disease (MRD) Through Longitudinal Circulating Tumor DNA (ctDNA) Profiling in Breast Malignancies
For patients with breast cancer, it's important to find any remaining cancer cells after they've had their main treatment. Even a few cells, called minimal residual disease (MRD), can lead to the cancer coming back later.
- Conditions
- Breast Cancer, TNBC - Triple-Negative Breast Cancer, HR Positive/HER-2 Negative Breast Cancer, HER2 + Breast Cancer
- Trial name
- GEMINI Breast (NCT07211178)
- Testing
- There are no interventions in this observational study.
- Where
- 16 sites in United States
- Volunteers
- 900 people
- Sponsor
- Tempus AI
Early or Locally Advanced HER2-positive Breast Cancer
A Phase III Study of KN026 in Combination With HB1801 ± Carboplatin as Neoadjuvant Treatment for Early or Locally Advanced HER2-Positive Breast Cancer
This randomized, controlled, open-label, multicenter study will evaluate the safety and efficacy of KN026 in combination with HB1801 ± Carboplatin as neoadjuvant therapy in patients with early or locally advanced HER2-positive…
- Trial name
- Neo-Healer (NCT06747338)
- Testing
- KN026, HB1801, Pertuzumab
- Where
- China
- Volunteers
- 520 people
- Sponsor
- Shanghai JMT-Bio Inc.
Early-stage Breast Cancer, HER2-positive Breast Cancer
Improving Pre-operative Systemic Therapy for Human Epidermal Growth Factor Receptor 2 (HER2) Amplified Breast Cancer
This is a phase 2 study evaluating medical treatment before surgery in HER2-amplified early breast cancer patients. Patients receive chemotherapy with HER2-targeted antibodies and are randomised to receive the checkpoint…
- Trial name
- PREDIXIIHER2 (NCT03894007)
- Testing
- Docetaxel, Carboplatin, Trastuzumab
- Where
- 8 sites in Sweden
- Volunteers
- 6 people
- Sponsor
- Renske Altena
Breast Cancer
Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+/HER2- Intermediate Risk Early Breast Cancer
This is an international, multi-center, randomized, double-blinded, placebo-controlled clinical study evaluating the efficacy and safety of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone…
- Trial name
- EarLEE-2 (NCT03081234)
- Testing
- Ribociclib, Adjuvant endocrine therapy
- Sponsor
- Novartis Pharmaceuticals
HER2-positive Breast Cancer
Monitoring Early Response to Targeted Therapy in Stage IV HER2+ Breast Cancer Patients With Advanced PET/MR Imaging
The purpose of the study is to see if a new group of imaging tests can help identify response to stage IV HER2+ breast cancer before treatment.
- Trial name
- NCT04273555
- Testing
- [18F]-FDG
- Where
- United States
- Sponsor
- University of Alabama at Birmingham