Clinical trials: HER2+ Breast Cancer
Breast Cancer, Early Stage
Ablation Compare With Surgery for Early Breast Cancer
Breast-conserving surgery has been widely used in clinical practice, but surgical incisions still impact postoperative patient satisfaction with breast appearance.
- Conditions
- Breast Cancer, Early Stage, Hormone Receptor Positive, Ablation
- Trial name
- NCT07484087
- Testing
- breast conserving surgery, cryo-thermal ablation
- Where
- China
- Volunteers
- 264 people
- Sponsor
- Peking University People's Hospital
HER2-positive Breast Cancer, Neoadjuvant Therapy
Neoadjuvant Chemotherapy Plus Pyrotinib and Trastuzumab for HER2-positive Breast Cancer (NEOTORCH-BREAST05)
This study is a prospective, single arm, multi-center clinical trial. The primary study objective is to evaluate the pathologic complete response (pCR）and clinical complete response（cCR) of neodjuvant treatment of HER2-positive…
- Conditions
- HER2-positive Breast Cancer, Neoadjuvant Therapy, Pyrotinib
- Trial name
- NCT06832904
- Testing
- pyrotinib and trastuzumab in combinition with neoadjuvant chemotherapy
- Where
- China
- Volunteers
- 33 people
- Sponsor
- First Affiliated Hospital of Zhejiang University
Carcinoma, Non-Small Cell Lung, Squamous Cell Carcinoma of Head and Neck
A Study of Sigvotatug Vedotin in Advanced Solid Tumors
This trial will look at a drug called sigvotatug vedotin (SGN-B6A) alone and with pembrolizumab, with or without chemotherapy, to find out whether it is safe for people who have solid tumors.
- Conditions
- Carcinoma, Non-Small Cell Lung, Squamous Cell Carcinoma of Head and Neck, HER2 Negative Breast Neoplasms, Esophageal Squamous Cell Carcinoma
- Trial name
- NCT04389632
- Testing
- sigvotatug vedotin, pembrolizumab, cisplatin
- Where
- 158 sites in United States, France and 5 more
- Volunteers
- 1,006 people
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
Metastatic Breast Cancer
Effects of Granulocyte Colony-stimulating Factor (G-CSF), Trastuzumab, and Vinorelbine on Immune Cell Function
Trastuzumab or Herceptin is an antibody directed against Her-2. Her-2 is a growth factor receptor which is present on the tumors of 25% of patients with breast cancer.
- Trial name
- NCT00169104
- Testing
- G-CSF, trastuzumab, vinorelbine
- Volunteers
- 23 people
- Sponsor
- Dartmouth-Hitchcock Medical Center
Solid Tumors, Breast Cancer
Clinical Trial of the Combination of Trastuzumab (Herceptin) and Tanespimycin in Patients With Solid Tumors and Her2 Positive Metastatic Breast Cancer That Have Previously Failed Herceptin
The primary purpose(s) of this study is to determine the highest tolerated dose of tanespimycin and to determine anti-tumor activity (via objective response rate) of tanespimycin in patients with breast cancer who have not…
- Trial name
- NCT00773344
- Testing
- Tanespimycin
- Where
- 3 sites in United States
- Volunteers
- 25 people
- Sponsor
- Bristol-Myers Squibb
Breast Cancer
A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer
This study will evaluate the efficacy and safety of the combination of inavolisib plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole versus placebo plus a CDK4/6i and letrozole in the first-line setting in…
- Trial name
- INAVO123 (NCT06790693)
- Testing
- Inavolisib, CDK4/6i, Letrozole
- Where
- 242 sites in United States, Argentina and 18 more
- Volunteers
- 450 people
- Sponsor
- Hoffmann-La Roche
HER2 Positive Breast Cancer
A Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of HD201 to Herceptin® in HER2+ Early Breast Cancer Patients
In the TROIKA study, the proposed biosimilar HD201 will be compared to its reference product Herceptin®. The aim of the study is to demonstrate equivalence of HD201 and Herceptin® in terms of efficacy, safety and pharmacokinetics.
- Trial name
- TROIKA (NCT03013504)
- Testing
- HD201, Herceptin, Docetaxel
- Where
- 15 sites in Belarus, Bulgaria and 11 more
- Volunteers
- 503 people
- Sponsor
- Prestige Biopharma Limited
Breast Neoplasms, Neoplasm Metastasis
Efficacy and Resistant Mechanism of Eribulin and Bevacizumab for Advanced HER2 Negative Breast Cancer
This study is a prospective, multicenter, phase II randomized clinical trial. It is planned to enroll 60 patients with advanced HER2 negative breast cancer, who will be randomly assigned to the experimental group and the control…
- Conditions
- Breast Neoplasms, Neoplasm Metastasis, Drug Therapy, Bevacizumab
- Trial name
- NCT06539559
- Testing
- Eribulin, Bevacizumab
- Where
- 3 sites in China
- Volunteers
- 60 people
- Sponsor
- Wang Jiayu
Breast Cancer
Neoadjuvant Run-In Study With TAK-228 Followed by Letrozole/TAK-228 in Women With High-Risk ER+/HER2- Breast Cancer
Millennium has developed TAK-228, which is a novel, highly selective, orally bioavailable adenosine 5' triphosphate (ATP)-competitive inhibitor of the serine/threonine kinase referred to as the mechanistic target of rapamycin…
- Trial name
- NCT02619669
- Testing
- TAK-228, Letrozole
- Where
- United States
- Sponsor
- Gary Schwartz
Breast Cancer
Pyrotinib After Trastuzumab-based Adjuvant Therapy in Patients With HER2-positive Breast Cancer
This trial is a multicenter, open-label, phase II trial conducted at 23 centers in China. High-risk HER2 positive patients receive pyrotinib 400mg/day for one year or half year for extented adjuvant therapy.
- Trial name
- NCT05880927
- Testing
- Pyrotinib
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Taizhou Hospital
Breast Neoplasms
First-line Palbociclib and Endocrine Therapy for Patients With HR+/HER2- Advanced Breast Cancer in the Real-world Setting.
This is a prospective, single-arm, multi-center observational non-interventional study (NIS) in Germany and Austria.
- Trial name
- PERFORM (NCT04767594)
- Testing
- Palbociclib + endocrine therapy
- Where
- 192 sites in Austria, Germany
- Volunteers
- 1,407 people
- Sponsor
- Pfizer
HER2 + Breast Cancer
A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of HLX319 vs. EU-Phesgo® in the Neoadjuvant Therapy of HER2-Positive Early or Locally Advanced Breast Cancer
This is a study to compare the similarity in Pharmacokinetics (PK) profile of HLX319 vs. EU-Phesgo® in patients with HER2-positive early or locally advanced breast cancer .
- Trial name
- NCT07601620
- Testing
- HLX319, EU-Phesgo®
- Volunteers
- 258 people
- Sponsor
- Shanghai Henlius Biotech
Trastuzumab-rezetecan, HER2-low Breast Cancer
Efficacy and Safety of Trastuzumab-rezetecan in HER2-Expressing Breast Cancer
This study is a multicenter, observational, real-world investigation. The research plans to enroll 300 HER2-positive and HER2-low breast cancer patients who meet the inclusion criteria.
- Conditions
- Trastuzumab-rezetecan, HER2-low Breast Cancer, HER2-positive Breast Cancer
- Trial name
- NCT07358182
- Testing
- Trastuzumab-rezetecan Treatment Group
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
HER2-positive Breast Cancer, HER2 Gene Mutation
Study of A166 in Patients With Relapsed/Refractory Cancers Expressing HER2 Antigen or Having Amplified HER2 Gene
Open-label, Phase I-II, first-in-human (FIH) study for A166 monotherapy in HER2-expressing or amplified patients who progressed on or did not respond to available standard therapies.
- Conditions
- HER2-positive Breast Cancer, HER2 Gene Mutation, HER-2 Gene Amplification, HER2 Positive Gastric Cancer
- Trial name
- NCT03602079
- Testing
- A166
- Where
- 10 sites in United States
- Volunteers
- 49 people
- Sponsor
- Klus Pharma Inc.
Metastatic Breast Cancer
Corrected QT Interval Effects of Trastuzumab Emtansine (T-DM1) in Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Locally Advanced or Metastatic Breast Cancer and the Safety and Tolerability of Combined T-DM1 and Pertuzumab in Patients With Early Disease Progression
This is a multicenter, open-label, single-arm Phase II study designed to evaluate the effect of T-DM1 on the duration of corrected QT (QTc) interval in patients with HER2-positive locally advanced or metastatic breast cancer and…
- Trial name
- NCT00943670
- Testing
- pertuzumab, Trastuzumab emtansine [Kadcyla]
- Volunteers
- 51 people
- Sponsor
- Genentech, Inc.
HER2+ Advanced Breast Cancer Patients Progressing on TKI Therapy
Phase II Clinical Study of T-DM1 and Pyrotinib Maleate in Patients With HER2-positive Metastatic Breast Cancer Who Had Progressed on TKI Therapy
This trial is a combination of trastuzumab and pyrotinib in the treatment of patients with HER2-positive metastatic breast cancer who have progressed on TKI therapy. A total of 50 patients were enrolled in the study design.
- Trial name
- NCT05560308
- Testing
- Trastuzumab Emtansine for Injection, Pyrotinib Maleate Tablets
- Volunteers
- 50 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
Advanced Breast Cancer, Female Breast Cancer
This is a Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of FCN-437c in Combination With Fluvestrant ± Goseraline Versus Placebo Combined With Fulvestrant ± Goserelin in Women With HR+ and HER2- Advanced Breast Cancer.
This is a multicenter, randomized, double-blind, placebo-controlled Phase iii clinical study evaluating the efficacy and safety of FCN- 437c in combination with fluvestrant ± goseraline versus placebo in combination with…
- Trial name
- NCT05438810
- Testing
- FCN-437c,Fulvestrant,Goserelin acetate
- Where
- China
- Volunteers
- 312 people
- Sponsor
- Ahon Pharmaceutical Co., Ltd.
Breast Cancer
HER-2 Pulsed DC Vaccine to Prevent Recurrence of Invasive Breast Cancer
The purpose of this study is to determine the safety and immunogenicity of HER-2 pulsed DC1 vaccine in high risk HER-2 high and intermediate expression breast cancers.
- Trial name
- Adjuvant (NCT02063724)
- Testing
- HER-2 pulsed Dendritic Cell Vaccine
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Metastatic Breast Cancer, Recurrent Breast Cancer
A Study of TQB2930 for Injection Monotherapy or Combination Therapy in Patients With Recurrent/Metastatic Breast Cancer
This is a phase Ib/II exploratory study. Phase Ib includes the dose escalation and expansion study of monotherapy, as well as the dose escalation study of combination therapy.
- Conditions
- Metastatic Breast Cancer, Recurrent Breast Cancer, Advanced Malignancies
- Trial name
- NCT06202261
- Testing
- TQB2930 for injection, Paclitaxel for injection (albumin-bound), TQB3616 capsule
- Where
- 2 sites in China
- Volunteers
- 154 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Breast Cancer
A Real-World Study of Early Breast Cancer Patients Eligible for Treatment With CDK4/6 Inhibitors
The aim of this study was to describe treatment patterns, patient characteristics and clinical outcomes among hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) early breast cancer (eBC)…
- Trial name
- LEEWARD (NCT07647042)
- Where
- United States
- Volunteers
- 750 people
- Sponsor
- Novartis Pharmaceuticals
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