Clinical trials: HER2-positive
Her 2 Positive Breast Cancer, Breast Cancer Female
A Single-arm Phase II Trial of SAcituzumab Govitecan and Trastuzumab for HER2+ Metastatic Breast Cancer After Trastuzumab dEruxtEcaN (SATEEN)
This research study is being done to evaluate the safety and effectiveness of sacituzumab govitecan with trastuzumab (Herceptin, Herceptin Hylecta, or trastuzumab biosimilar) in metastatic HER2+ breast cancer.
- Conditions
- Her 2 Positive Breast Cancer, Breast Cancer Female, Breast Cancer Metastatic
- Trial name
- NCT06100874
- Testing
- Sacituzumab Govitecan, Trastuzumab, Trastuzumab and Hyaluronidase-oysk
- Where
- 4 sites in United States
- Volunteers
- 28 people
- Sponsor
- Adrienne G. Waks
Hormone Receptor-Positive Breast Cancer, HER2 Low Breast Carcinoma
Neoadjuvant Culmerciclib Combined With Endocrine Therapy for Hormone Receptor-Positive， Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer
This is a single-center, open-label, randomized phase II clinical trial designed to evaluate the efficacy and safety of neoadjuvant Culmerciclib combined with aromatase inhibitor versus aromatase-inhibitor monotherapy in patients…
- Conditions
- Hormone Receptor-Positive Breast Cancer, HER2 Low Breast Carcinoma, Early-Stage Breast Cancer
- Trial name
- NCT07796880
- Testing
- Culmerciclib, Aromatase Inhibitor (AI)
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Melanoma, Stage II, HER2-positive
A Study of RC48-ADC in Advanced Melanoma Subjects With HER2 Variant (Mutation, Amplification, Overexpression)
This is a Phase IIa, single-arm, multicentre, open-label clinical trial aims to evaluate the effectiveness and safety of RC48-ADC in the treatment of HER2 Variant (Mutation, Amplification, Overexpression) advanced melanoma.
- Conditions
- Melanoma, Stage II, HER2-positive, Advanced Melanoma
- Trial name
- NCT05135715
- Testing
- RC48-ADC
- Where
- 4 sites in China
- Volunteers
- 50 people
- Sponsor
- RemeGen Co., Ltd.
Advanced or Metastatic Breast Cancer
Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer
This study will evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy in human epidermal growth factor receptor (HER)2-low, hormone receptor (HR) positive breast…
- Trial name
- DB-06 (NCT04494425)
- Testing
- Trastuzumab deruxtecan, Capecitabine, Paclitaxel
- Where
- 293 sites in United States, Argentina and 26 more
- Volunteers
- 866 people
- Sponsor
- AstraZeneca
Adenocarcinoma of the Rectum, Locally Advanced Rectal Adenocarcinoma
A Study of Tucatinib and Trastuzumab in People With Rectal Cancer
The study researchers believe that a combination of the drugs trastuzumab and tucatinib, given with standard chemotherapy (capecitabine and oxaliplatin/FOLFOX), may help participants with rectal cancer.
- Conditions
- Adenocarcinoma of the Rectum, Locally Advanced Rectal Adenocarcinoma, Rectal Adenocarcinoma, HER2 Positive Rectal Adenocarcinoma
- Trial name
- NCT05672524
- Testing
- Trastuzumab, Tucatinib
- Where
- 7 sites in United States
- Volunteers
- 37 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Advanced HER2-positive Breast Cancer
Combination of AUY922 With Trastuzumab in HER2+ Advanced Breast Cancer Patients Previously Treated With Trastuzumab
The phase Ib part of the trial will assess the MTD of AUY922 in combination with Trastuzumab in patients with Trastuzumab-refractory locally advanced or metastatic HER2+.
- Trial name
- NCT01271920
- Testing
- AUY922, Trastuzumab
- Where
- 16 sites in United States, France and 6 more
- Volunteers
- 45 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Metastatic Breast Cancer
Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
The purpose of this study was to determine whether treatment with tamoxifen or a non-steroidal aromatase inhibitors (NSAI) + goserelin + LEE011 prolonged progression-free survival (PFS) compared to treatment with tamoxifen or a…
- Trial name
- MONALEESA-7 (NCT02278120)
- Testing
- Ribociclib, Tamoxifen, Letrozole
- Where
- 183 sites in United States, Argentina and 28 more
- Volunteers
- 672 people
- Sponsor
- Novartis Pharmaceuticals
Advanced/Metastatic Breast Cancer, HER2-Positive Metastatic Breast Cancer
Dalpiciclib, Anti-HER2 Therapy, and Endocrine Therapy for Hormone-Receptor-Positive, HER2-Positive Metastatic Breast Cancer
Efficacy and Safety of Dalpiciclib Combined with Anti-HER2 Targeted Therapy and Endocrine Therapy as First-line Maintenance Treatment for Patients with Recurrent or Metastatic Hormone-Receptor-Positive, HER2-positive Breast…
- Trial name
- NCT07610720
- Testing
- Dalpiciclib, Trastuzumab (Herceptin), Pertuzumab
- Where
- China
- Volunteers
- 57 people
- Sponsor
- Sun Yat-sen University
Advanced Solid Tumors, HER2-positive Breast Cancer
A Phase 1 Trial of ZN-A-1041 Enteric Capsules or Combination in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Solid Tumors
This will be a Phase 1, multicenter, open-label trial to evaluate the safety, tolerability, PK and efficacy of ZN-A-1041 as a monotherapy or in combination in participants with HER2-positive advanced solid tumors with or without…
- Trial name
- NCT05593094
- Testing
- ZN-A-1041, ZN-A-1041 + T-DM1 3.6 mg/kg iv. for Phase 1b, ZN-A-1041 + T-Dxd 5.4 mg/kg iv. for Phase 1b
- Where
- 36 sites in United States, Australia and 5 more
- Volunteers
- 210 people
- Sponsor
- Hoffmann-La Roche
Breast Neoplasms
Chidamide Combined With Exemestane (+/- Goserelin) Versus Neoadjuvant Chemotherapy in Patients of Stage II-III HR-positive/HER2-negative Breast Cancer
This is an open, multicenter, randomized controlled clinical study aimed to explore the efficacy and safety of chidamide combined with exemestane (+/- goserelin) versus chemotherapy in the neoadjuvant treatment of stage II-III HR…
- Trial name
- NCT05253066
- Testing
- Chidamide combined with exemestane (+/- goserelin), Chemotherapy with docetaxel plus epirubicin or change of chemotherapy regimen (at the discretion of the clinician)
- Volunteers
- 130 people
- Sponsor
- Shengjing Hospital
Advanced Solid Tumor, Metastatic Solid Tumor
BGB-43395 Alone or as Part of Combination Therapies in Chinese Participants With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
This is an open-label, multicenter, phase 1a/1b clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BGB-43395, a cyclin-dependent kinase 4 (CDK4)…
- Conditions
- Advanced Solid Tumor, Metastatic Solid Tumor, Hormone-receptor-positive Breast Cancer, Breast Cancer
- Trial name
- NCT06253195
- Testing
- BGB-43395, Fulvestrant, Letrozole
- Where
- 7 sites in China
- Volunteers
- 33 people
- Sponsor
- BeOne Medicines
HER2-positive Breast Cancer
Neoadjuvant Endocrine Therapy +/- the PI3K Inhibitor Inavolisib in HER2+, HR+, PIK3CA Mutant Early Breast Cancer
Evaluation of the potential incremental efficacy and safety of inavolisib in the neoadjuvant endocrine treatment of early-stage HER2-positive, HR-positive, PIK3CA mutant breast cancer.
- Trial name
- GeparPiPPa (NCT05306041)
- Testing
- Inavolisib, PHESGO, Endocrine therapy
- Where
- 62 sites in Germany, Italy and 4 more
- Volunteers
- 170 people
- Sponsor
- GBG Forschungs GmbH
ER Positive, HER2 Negative Breast Cancer Neoplasms
Investigating Patient Satisfaction With Oral Anti-cancer Treatment in Patients With Hormone-receptor Positive, HER2-receptor Negative, Advanced Breast Cancer
A prospective, non-interventional, non-controlled multicenter observational study to evaluate aspects of pharmaceutical care and the treatment of postmenopausal patients with hormone-receptor positive, HER2-receptor negative…
- Trial name
- IPSOC-mamma (NCT02875951)
- Where
- Belgium
- Volunteers
- 100 people
- Sponsor
- KU Leuven
Breast Cancer
Observational Study of Effectiveness and Safety of Trastuzumab Emtansine (T-DM1) in HER2-positive Breast Cancer Patients With Residual Invasive Disease Following Neoadjuvant Chemotherapy and Anti-HER2 Target Therapy
This is an observational, multi-centre study analysing data from patients treated with T-DM1 within the compassionate use program AL41711.
- Trial name
- NCT05754502
- Testing
- Trastuzumab emtansine
- Where
- 28 sites in Italy
- Volunteers
- 300 people
- Sponsor
- Consorzio Oncotech
Breast Cancer Early Stage Breast Cancer (Stage 1-3), HER2
A Composite Assay for HER2-positive Early-stage Breast Cancer Management
The goal of this observational study is to assess the prognostic value of a genomic classifier (S18) and its refined version (S*) in women with early-stage HER2-positive breast cancer.
- Trial name
- HERCard (NCT06762977)
- Where
- 2 sites in Italy
- Volunteers
- 180 people
- Sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Breast Neoplasms
Paclitaxel and BKM120 Before Surgery in Treating Patients With Stage II or III Estrogen Receptor-Positive and HER2-Negative Breast Cancer
This phase II trial studies the effects of paclitaxel combined with phosphoinositide 3-kinase (PI3K) inhibitor BKM120 in patients with stage II or III breast cancer that is described as estrogen receptor-positive, human epidermal…
- Trial name
- NCT01953445
- Testing
- paclitaxel, BKM120
- Sponsor
- Washington University School of Medicine
Breast Cancer, Chemotherapy Effect
Efficacy of Supplement Adjuvant Capecitabine in HR+/HER2- Breast Cancer Patients With High Risks
According to the latest data from the World Health Organization's International Agency for Research on Cancer (IARC) for 2020, breast cancer has been the most prevalent cancer with 2.26 million new cases.
- Trial name
- NCT05212454
- Testing
- Capecitabine
- Where
- China
- Volunteers
- 400 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Advanced Gastric Cancer, HER2
PF-00299804 Monotherapy in Patients With HER-2 Positive Advance Gastric Cancer
In case of gastric cancer, the incidence of HER-2 positivity (2+, 3+ on IHC and/or FISH (+)) is reported as similar as that of breast cancer, that is 22% of all cases.
- Trial name
- PF299804-AGC (NCT01152853)
- Testing
- PF00299804
- Where
- South Korea
- Volunteers
- 28 people
- Sponsor
- Seoul National University Hospital
Breast Cancer
Treatment With Pyrotinib-Based Therapy in Lapatinib Resistant HER2-Positive Metastatic Breast Cancer
This is a multicenter, observational, single-arm real world study to evaluate the efficacy and safety of pyrotinib after lapatinib progression.
- Trial name
- NCT04899128
- Testing
- Pyrotinib
- Where
- China
- Volunteers
- 100 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Breast Cancer, Metastatic HER2-negative Breast
T-Cell Therapy for Advanced Breast Cancer
The purpose of this study is to test the safety of different doses of specially prepared T cells collected from the blood. The investigators want to find a safe dose of these modified T cells for patients who have metastatic…
- Trial name
- NCT02792114
- Testing
- Cyclophosphamide, Mesothelin-targeted T cells, AP1903
- Where
- 7 sites in United States
- Volunteers
- 186 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
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