Clinical trials: HER2-positive Advanced Breast Cancer
Breast Cancer
Phase I Study of the Combination of MLN9708 and Fulvestrant
Participants in this study will have been diagnosed with advanced breast cancer that has become worse while being treated with fulvestrant. Participants will have estrogen-receptor positive disease, and have completed menopause.
- Trial name
- Millennium (NCT02384746)
- Testing
- Fulvestrant, MLN9708
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Dartmouth-Hitchcock Medical Center
HER2-positive Breast Cancer
Pyrotinib Combined With Trastuzumab and Pertuzumab for Maintenance Therapy in HER2-Positive Advanced Breast Cancer
This is a Prospective, Single-Arm, Observational, Real-World Study. The purpose of this study is to evaluate the safety and efficacy of pyrotinib combined with trastuzumab and pertuzumab for maintenance therapy in HER2-positive…
- Trial name
- NCT07470203
- Testing
- Pyrotinib, Trastuzuma, Pertuzumab
- Volunteers
- 42 people
- Sponsor
- Peking University Cancer Hospital & Institute
NRG1 Fusion, Pancreatic Cancer
Early Access Program Providing HER2/HER3 Bispecific Antibody, MCLA-128, for a Patient With Advanced NRG1-Fusion Positive Solid Tumor
Merus is providing single patient/named access to the HER2/HER3 bispecific antibody, MCLA-128, to patients with advanced NRG1-fusion positive solid tumor under this early access program who are ineligible for an ongoing MCLA-128…
- Conditions
- NRG1 Fusion, Pancreatic Cancer, Non Small Cell Lung Cancer, Solid Tumor, Unspecified, Adult
- Trial name
- NCT04100694
- Testing
- MCLA-128
- Sponsor
- Merus B.V.
Breast Cancer, Non-small Cell Lung Carcinoma
DS8201a and Pembrolizumab in Participants With Locally Advanced/Metastatic Breast or Non-Small Cell Lung Cancer
This two-part study will include a dose escalation part to determine the recommended dose for expansion of DS8201a and pembrolizumab and a dose expansion part to evaluate efficacy, safety, and tolerability of the combination.
- Trial name
- NCT04042701
- Testing
- Trastuzumab deruxtecan (DS-8201a), Pembrolizumab
- Where
- 30 sites in United States, France and 2 more
- Volunteers
- 115 people
- Sponsor
- Daiichi Sankyo
Breast Cancer, HER2-positive Breast Cancer
Trastuzumab Rezetecan (T-DXh) in HER2+ Breast Cancer With Non-pCR After TCbHP
This is a prospective, multi-center, single-arm, phase 2 exploratory study to evaluate the efficacy and safety of adding 4 cycles of Trastuzumab Rezetecan (T-DXh), an anti-HER2 antibody-drug conjugate, as continued neoadjuvant…
- Conditions
- Breast Cancer, HER2-positive Breast Cancer, Early-stage Breast Cancer, Locally Advanced Breast Cancer
- Trial name
- NCT07589699
- Testing
- Trastuzumab Rezetecan
- Volunteers
- 59 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Sarcoma, Castrate Resistant Prostate Cancer
A Study of PRT2527 in Participants With Advanced Solid Tumors
This is a Phase 1 dose-escalation and confirmation study of PRT2527, a Cyclin-dependent Kinase 9 (CDK9) inhibitor, in participants with advanced solid tumors.
- Conditions
- Sarcoma, Castrate Resistant Prostate Cancer, Hormone Receptor Positive HER2 Negative Breast Cancer, Non-small Cell Lung Cancer
- Trial name
- NCT05159518
- Testing
- PRT2527
- Where
- 8 sites in United States
- Volunteers
- 30 people
- Sponsor
- Prelude Therapeutics Incorporated
HER2 Positive Breast Carcinoma, Recurrent Breast Carcinoma
4-1BB Agonist Monoclonal Antibody PF-05082566 With Trastuzumab Emtansine or Trastuzumab in Treating Patients With Advanced HER2-Positive Breast Cancer
This trial studies the best dose and side effects of utomilumab (4-1BB agonist monoclonal antibody PF-05082566) with trastuzumab emtansine or trastuzumab in treating patients with HER2-positive breast cancer that has spread to…
- Conditions
- HER2 Positive Breast Carcinoma, Recurrent Breast Carcinoma, Stage III Breast Cancer, Stage IIIA Breast Cancer
- Trial name
- NCT03364348
- Testing
- Utomilumab, Trastuzumab, Ado-Trastuzumab Emtansine
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- George W. Sledge Jr.
Breast Cancer
Imaging With 111 Indium (111In)-Pertuzumab (PmAb) to Predict Response to Trastuzumab (TmAb) in Human Epidermal Growth Factor-2 (HER2) Positive Metastatic Breast Cancer (MBC) or Locally Advanced Breast Cancer (LABC)
The general objective of the study is to improve the care of women with Human Epidermal Growth Factor Receptor-2 (HER2) positive metastatic or locally advanced breast cancer by using a radio-labelled biomarker with whole body…
- Trial name
- PETRA (NCT01805908)
- Testing
- 111In-Pertuzumab + SPECT-CT
- Where
- 2 sites in Canada
- Volunteers
- 3 people
- Sponsor
- Ontario Clinical Oncology Group (OCOG)
HER2-positive Breast Cancer
A Study Comparing BL-M07D1 With T-DM1 in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer
This study is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with unresectable locally advanced or metastatic HER2-positive breast cancer who had…
- Trial name
- NCT06316531
- Testing
- BL-M07D1, T-DM1
- Where
- China
- Volunteers
- 274 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
Advanced Breast Cancer
Efficacy and Safety of Trastuzumab Rezetecan or Trastuzumab Deruxtecan in Advanced Breast Cancer
This study is a prospective, open-label, multicenter, randomized, parallel Phase II clinical trial. This study aims to investigate the efficacy and safety of trastuzumab rezetecan or trastuzumab deruxtecan in HER2 positive…
- Trial name
- NCT07630103
- Testing
- Trastuzumab Rezetecan for Injection (SHR-A1811), Trastuzumab Deruxtecan for Injection (T-DXd)
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Breast Cancer
Gut and Tumor Microbiome in Patients With Early Stage (II-III), Locally Advanced or Advanced ER-positive and HER2-negative Breast Cancer.
The purpose of this research study is to collect samples of blood and stool and analyse primary tumor from participants with breast cancer to see how the bacteria in the body affect cancer and how well it responds to treatment.
- Trial name
- NCT06126003
- Testing
- Observation
- Where
- 6 sites in United States
- Volunteers
- 2 people
- Sponsor
- BioCorteX Inc
Breast Cancer
Everolimus Combined With Anti-estrogen Therapy in Hormone-Receptor-Positive HER-2 Negative Advanced Breast Cancer
Many patients with ER-positive or PR-positive breast cancer are treated with endocrine therapy. Although most ER/PR-positive tumors initially respond to hormonal therapy, patients often experience disease progression.
- Trial name
- NCT02291913
- Testing
- Everolimus, Exemestane, Tamoxifen
- Where
- 8 sites in United States
- Volunteers
- 48 people
- Sponsor
- SCRI Development Innovations, LLC
Breast Cancer
Study of the Molecular Features of Postmenopausal Women With HR+ HER2-negative aBC on First-line Treatment With Ribociclib and Letrozole and, in Patients With a PIK3CA Mutation, on Second-line Treatment With Alpelisib Plus Fulvestrant
The purpose of this clinical trial is to study of the molecular features of postmenopausal women with hormone receptor-positive (HR+) HER2-negative advanced breast cancer on first-line treatment with ribociclib and letrozole and…
- Trial name
- BioItaLEE (NCT03439046)
- Testing
- Ribociclib, Letrozole, Alpelisib
- Where
- 41 sites in Italy
- Volunteers
- 287 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
microRNA of Human Epidermal Growth Factor Receptor 2 （HER2）Positive Patient Treated With Herceptin
This projective observational study is planned to enroll more than 300 advanced breast cancer patients, who were proved as Her-2 positive using fluorescence in situ hybridization (FISH) and / or immunohistochemistry, and 100…
- Trial name
- NCT02656589
- Testing
- Capecitabine, Trastuzumab
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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.
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
HR Positive HER2 Negative Advanced Breast Cancer
Different Doses of Dalpicicl Combined With Letrozole in the First-line Treatment of HR-positive, HER2-negative Advanced Breast Cancer
This study is a prospective, open-label, randomized, multicenter, two-cohort phase II clinical trial. Starting from December 1, 2024, it plans to enroll 120 patients with advanced first-line HR-positive, HER2-negative breast…
- Trial name
- NCT07285382
- Testing
- Dalpiciclib 125mg, Dalpiciclib 150mg, Letrozole 2.5mg
- Where
- 2 sites in China
- Volunteers
- 120 people
- Sponsor
- wanghaibo
HR+/HER2- Advanced/Metastatic Breast Cancer
Sirolimus for Injection (Albumin-bound) in Combination With Endocrine Therapy for HR+/HER2- Advanced/Metastatic Breast Cancer Patients Who Have Failed Standard Therapy
This study is a multicenter, open, non-randomized phase II clinical trial consisting of a safety introduction phase followed by a single-arm phase 2 phase.
- Trial name
- NCT06957379
- Testing
- Letrozole, Anastrozole, Exemestane
- Where
- China
- Volunteers
- 78 people
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
HER-2-positive Advanced Breast Cancer
Clinical Study of Recombinant Anti-HER2 Humanized Monoclonal Antibody (GB221) for Injection
The primary objective of this trial is to compare the progression-free survival (PFS) in two groups of combined therapy of GB221/ capecitabine tablets versus combined therapy of placebo/capecitabine tablets; the secondary…
- Trial name
- NCT04164615
- Testing
- GB221
- Where
- China
- Volunteers
- 336 people
- Sponsor
- Genor Biopharma Co., Ltd.