Clinical trials: HER2-Positive Breast Cancer
HR+/HER2- Advanced and/or Metastatic Breast Cancer
A Study of HS-10342 in Chinese Patients With HR+/HER2- Advanced and/or Metastatic Breast Cancer
HS-10342 is a selective CDK4/6 kinase inhibitor. This study is conducted to evaluate the safety and efficacy of HS-10342 at repeated doses.
- Trial name
- NCT05044988
- Testing
- HS-10342
- Volunteers
- 20 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Breast Cancer
A Study of Gemcitabine and Carboplatin (Plus Herceptin in Human Epidermal Growth Factor Receptor 2 Positive [HER2+] Patients) With Metastatic Breast Cancer
The purposes of this study are to determine the safety of gemcitabine and paraplatin either with or without trastuzumab Any side effects that might be associated with these compounds.
- Trial name
- NCT00191451
- Testing
- Gemcitabine, Carboplatin, Herceptin
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Eli Lilly and Company
HER2 Positive Breast Cancer
Study Evaluating Hemay022 In Subjects With HER2-Positive Advanced Breast Cancer
The purposes of this study are to assess the safety, tolerability and pharmacokinetics of Hemay022. The secondary purpose of this study is to assess the efficacy of Hemay022 in the treatment of HER2-positive advanced breast…
- Trial name
- NCT02476539
- Testing
- Hemay022
- Where
- China
- Volunteers
- 28 people
- Sponsor
- Tianjin Hemay Pharmaceutical Co., Ltd
HER2-positive Breast Cancer
Molecular Pathway Activation Markers Predicting Efficacy of Trastuzumab Therapy for HER2-positive Breast Cancer
The purpose of the study is to identify molecular markers at the level of molecular pathway activation to predict efficacy of anti-HER2 therapy with Trastuzumab.
- Trial name
- NCT03521245
- Testing
- RNA sequencing, Transcriptome analysis, Trastuzumab
- Where
- 4 sites in United States, Russia
- Volunteers
- 40 people
- Sponsor
- OmicsWay Corp.
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
HR+ / HER2- Advanced Breast Cancer
A Study of SH3765 Tablets in Combination With Fulvestrant in Patients With HR+/HER2- Advanced Breast Cancer.
Evaluate the efficacy and safety of the SH3765 tablet combined with fulvestrant in the treatment of patients with advanced HR-positive breast cancer
- Trial name
- NCT07557004
- Testing
- SH3765+Fulvestrant
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Nanjing Sanhome Pharmaceutical, Co., Ltd.
HER2 Expressing Solid Tumors
Gene Therapy for HER-Positive Cancer (SENTRY-HER2)
This is a Phase 1/2, first-in-human, open-label, dose-escalating and expansion trial designed to assess the safety and efficacy of VNX-202 in patients with HER2 positive cancers.
- Trial name
- SENTRY-HER2 (NCT07192432)
- Testing
- Dose Level 1, VNX-202, Dose Level 2, VNX-202, Dose Level 3, VNX-202
- Where
- 11 sites in United States
- Volunteers
- 27 people
- Sponsor
- Vironexis Biotherapeutics Inc.
HER2-positive Breast Cancer, HER2-positive Gastric Cancer
A Study of XMT-2056 in Advanced/Recurrent Solid Tumors That Express HER2
A Study of XMT-2056 in advanced/recurrent solid tumors that express HER2.
- Conditions
- HER2-positive Breast Cancer, HER2-positive Gastric Cancer, HER2-positive Non-Small Cell Lung Cancer, HER2-positive Colorectal Cancer
- Trial name
- NCT05514717
- Testing
- XMT-2056
- Where
- 14 sites in United States
- Volunteers
- 57 people
- Sponsor
- Day One Biopharmaceuticals, Inc.
Locally Advanced Breast Cancer, Metastatic Breast Cancer
A Study of the Efficacy, Safety and Pharmacokinetics of RPH-051 and Perjeta® in Combination With Trastuzumab and Docetaxel as the 1st Line Therapy in Patients With HER2-positive Breast Cancer
The main purpose of this study is to prove non-inferiority, as well as to demonstrate the comparability of safety and immunogenicity of RPH-051 and Perjeta® in combination with trastuzumab and docetaxel as the 1st line therapy…
- Trial name
- NCT07386938
- Testing
- RPH-051, Docetaxel, Perjeta®
- Where
- 45 sites in Russia
- Volunteers
- 246 people
- Sponsor
- R-Pharm
HER2 Positive Breast Neoplasms, Hormone Receptor Positive Breast Neoplasms
A Safety Study of SGN-LIV1A in Breast Cancer Patients
This study will examine the safety and tolerability of ladiratuzumab vedotin (LV) in patients with metastatic breast cancer. LV will be given alone or in combination with trastuzumab.
- Conditions
- HER2 Positive Breast Neoplasms, Hormone Receptor Positive Breast Neoplasms, Triple Negative Breast Neoplasms, HER2 Mutations Breast Neoplasms
- Trial name
- NCT01969643
- Testing
- ladiratuzumab vedotin, Trastuzumab
- Where
- 38 sites in United States
- Volunteers
- 290 people
- Sponsor
- Seagen Inc.
Breast Cancer
Tesetaxel Plus Reduced Dose of Capecitabine vs. Capecitabine in HER2 Negative, HR Positive, LA/MBC
CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel in patients with HER2 negative, HR positive LA/MBC previously treated with a taxane in the neoadjuvant or adjuvant setting.
- Trial name
- CONTESSA (NCT03326674)
- Testing
- Tesetaxel and Capecitabine, Capecitabine
- Where
- 207 sites in United States, Australia and 17 more
- Volunteers
- 685 people
- Sponsor
- Odonate Therapeutics, Inc.
Breast Cancer, HER2 Positive Breast Cancer
Efficacy and Safety of IPI-504 With Trastuzumab Pretreated, Locally Advanced or Metastatic HER2 Positive Breast Cancer
The purpose of this study is to see if IPI-504 in combination with trastuzamab is an effective treatment in HER2 positive metastatic breast cancer
- Conditions
- Breast Cancer, HER2 Positive Breast Cancer, Metastatic Breast Cancer, Cancer of the Breast
- Trial name
- NCT00817362
- Testing
- IPI-504, Trastuzumab
- Where
- 11 sites in United States, Spain
- Volunteers
- 29 people
- Sponsor
- Infinity Pharmaceuticals, Inc.
Breast Cancer
A Study of Herceptin (Trastuzumab) in Women With Metastatic Breast Cancer
This 2 arm study will assess the efficacy and safety of intravenous Herceptin with or without a taxane for the first line treatment of metastatic breast cancer in women who have relapsed at least 12 months after a minimum of 10…
- Trial name
- NCT00475670
- Testing
- Trastuzumab, Taxane (docetaxel or paclitaxel)
- Where
- 57 sites in Australia, Austria and 13 more
- Volunteers
- 44 people
- Sponsor
- Hoffmann-La Roche
HR-positive, HER2-negative and PIK3CA Mutation Advanced Breast Cancer
A Study of TQ-B3525 Tablets Combined With Fulvestrant Injection in Subjects With HR-positive, HER2-negative and PIK3CA Mutation Advanced Breast Cancer
This is a open-label, multicenter phase Ib study to evaluate safety and efficacy of TQ-B3525 tablets combined with fulvestrant injection in subjects with HR-positive, HER2-negative and PIK3CA mutation advanced breast cancer.
- Trial name
- NCT04355520
- Testing
- TQ-B3525, Fulvestrant injection
- Where
- 4 sites in China
- Volunteers
- 42 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Breast Cancer
A Prospective Observational Study of Clinical Outcomes for the NanoString® Technologies Prosigna Gene Signature Assay
The primary objective of this study is to assess the extent to which the Prosigna™ Breast Cancer Prognostic Gene Signature Assay affects the medical oncologist's treatment recommendations regarding adjuvant chemotherapy and…
- Trial name
- NCT01899079
- Where
- 7 sites in Spain
- Volunteers
- 217 people
- Sponsor
- NanoString Technologies, Inc.
Metastatic Breast Cancer
A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer Who Have Previously Received a Trastuzumab-Containing Regimen
This is a phase I, multicenter, open-label, dose-escalation study of single-agent trastuzumab-MCC-DM1 administered by intravenous (IV) infusion in patients with HER2-positive metastatic breast cancer (MBC) who have previously…
- Trial name
- NCT00932373
- Testing
- trastuzumab-MCC-DM1
- Volunteers
- 54 people
- Sponsor
- Genentech, Inc.
HER2-positive Metastatic Breast Cancer
Study of KN026 in Combination With Palbociclib and Fulvestrant in Patients With Advanced Breast Cancer
This is an open-label, multicenter, dose-escalation and parallel-group expansion Phase II clinical trial to evaluate the efficacy, safety and tolerability of KN026 in combination with palbociclib and fulvestrant in women or male…
- Trial name
- NCT04778982
- Testing
- KN026 combined with Palbociclib and Fulvestrant
- Where
- China
- Volunteers
- 4 people
- Sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Breast Neoplasms
LUX-Breast 1: BIBW 2992 (Afatinib) in HER2-positive Metastatic Breast Cancer Patients After One Prior Herceptin Treatment
To investigate the efficacy and safety of BIBW 2992 in combination with vinorelbine i.v. chemotherapy as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed one prior trastuzumab (Herceptin®)…
- Trial name
- NCT01125566
- Testing
- BIBW 2992, trastuzumab, vinorelbine
- Where
- 207 sites in United States, Argentina and 36 more
- Volunteers
- 508 people
- Sponsor
- Boehringer Ingelheim
HER2-positive Breast Cancer
Study to Evaluate the Efficacy and Safety of SYSA1901 vs. Perjeta® of HER2-Positive Breast Cancer
This is a phase Ⅲ, double-blind, randomized, parallel-controlled, multicenter equivalence study to compare the efficacy and safety of SYSA1901 + trastuzumab + docetaxel vs.
- Trial name
- NCT05720026
- Testing
- SYSA1901, Pertuzumab, Trastuzumab
- Where
- China
- Volunteers
- 560 people
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Breast Neoplasms
Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49)
The safety and efficacy of pembrolizumab plus the investigator's choice of chemotherapy will be assessed compared to placebo plus the investigator's choice of chemotherapy in the treatment of chemotherapy-candidate hormone…
- Trial name
- NCT04895358
- Testing
- pembrolizumab, paclitaxel, nab-paclitaxel
- Where
- 256 sites in United States, Argentina and 29 more
- Volunteers
- 342 people
- Sponsor
- Merck Sharp & Dohme LLC