Clinical trials: HER2-Positive Breast Cancer
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 Study of Subcutaneous At Home Administration of Trastuzumab (Herceptin) in Participants With Human Epidermal Growth Factor Receptor 2-positive (HER2+) Early Breast Cancer (eBC)
This single arm, multicenter study will evaluate the safety of assisted subcutaneous administration of trastuzumab in participants with HER2+ eBC.
- Trial name
- NCT01926886
- Testing
- Trastuzumab
- Where
- 23 sites in Belgium, Israel
- Volunteers
- 102 people
- Sponsor
- Hoffmann-La Roche
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
HER2-positive Breast Cancer
DP303c in Patients With HER2-positive Unresectable Locally Advanced, Relapsed, or Metastaticbreast Cancer
This is a study of DP303c in patients with HER2-positive advanced breast cancer.
- Trial name
- NCT05334810
- Testing
- DP303c
- Volunteers
- 191 people
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Resectable HER2-positive Breast Cancer
A Phase III Study of KN026 in Combination With HB1801 as Adjuvant Therapy for Resectable HER2-Positive Breast Cancer
This is a randomized, controlled, open-label, multicenter, Phase Ⅲ clinical study designed to compare the efficacy and safety of KN026 combined with HB1801 and chemotherapy versus trastuzumab combined with pertuzumab and…
- Trial name
- NCT07441460
- Testing
- KN026, HB1801, Trastuzumab
- Where
- China
- Volunteers
- 1,800 people
- Sponsor
- Shanghai JMT-Bio Inc.
Metastatic Breast Cancer
A Study to Observe Treatment Patterns and Outcomes in Participants in Saudi Arabia With Human Epidermal Growth Factor Receptor 2 (HER2-Positive) Unresectable Locally Advanced or Metastatic Breast Cancer (LA/mBC)
This is a prospective, national, multicenter, non-interventional study designed to enroll participants who have an initial diagnosis of unresectable LA/mBC made up to 6 months prior to registry enrollment.
- Trial name
- NCT02611310
- Testing
- No intervention
- Where
- 3 sites in Saudi Arabia
- Volunteers
- 15 people
- Sponsor
- Hoffmann-La Roche
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
Metastatic Breast Cancer
A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02)
The goal of this clinical trial is to assess the efficacy of DB-1303/BNT323 compared with investigator's choice chemotherapy in terms of progression-free survival (PFS) by blinded independent central review (BICR) in the HR+…
- Trial name
- NCT06018337
- Testing
- DB-1303/BNT323, Capecitabine, Paclitaxel
- Where
- 258 sites in United States, Argentina and 15 more
- Volunteers
- 541 people
- Sponsor
- DualityBio Inc.
Metastatic Breast Cancer
Study of Belzutifan (MK-6482) Plus Fulvestrant for ER+/HER2- Metastatic Breast Cancer (MK-6482-029/LITESPARK-029)
The purpose of this study is to assess the efficacy and safety of belzutifan (MK-6482) plus fulvestrant compared to everolimus plus endocrine therapy (ET) (investigator's choice of fulvestrant or exemestane) in adults with…
- Trial name
- NCT06428396
- Testing
- Belzutifan, Fulvestrant, Everolimus
- Where
- 41 sites in United States, Argentina and 7 more
- Volunteers
- 120 people
- Sponsor
- Merck Sharp & Dohme LLC
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, Cancer
A Study to Evaluate the Safety and Tolerability of Venetoclax Tablets in Combination With Capecitabine Tablets in Adult Participants With Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer Who Had Disease Progression During or After CDK4/6 Inhibitor Therapy
Endocrine therapy is the initial treatment for most hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancers.
- Trial name
- NCT04274933
- Testing
- Venetoclax, Capecitabine
- Where
- 18 sites in United States, Germany and 2 more
- Volunteers
- 4 people
- Sponsor
- AbbVie
Advanced Solid Tumors, Advanced Breast Cancer
Phase 1/2 Study of ETX-636 in Participants With Advanced Solid Tumors
Phase 1/2, open-label study of ETX-636 in participants with advanced solid tumors
- Trial name
- NCT06993844
- Testing
- ETX-636 dose escalation, ETX-636 dose escalation in combination with fulvestrant, ETX-636 dose expansion in combination with fulvestrant
- Where
- 15 sites in United States, China
- Volunteers
- 233 people
- Sponsor
- Ensem Therapeutics
Unresectable Breast Cancer, Metastatic Breast Cancer
HER-TEMPO - Real World Treatment-related Outcomes on T-DXd in Canada
Trastuzumab deruxtecan (T-DXd) has been studied in multiple global prospective DESTINY-Breast trials and has a marketing authorization from Health Canada for patients with HER2-positive metastatic breast cancer (mBC) and HER2-low…
- Conditions
- Unresectable Breast Cancer, Metastatic Breast Cancer, HER2-low Expressing Breast Cancer, HER2-positive Breast Cancer
- Trial name
- HER-TEMPO (NCT06386263)
- Testing
- Trastuzumab deruxtecan
- Where
- Canada
- Volunteers
- 22 people
- Sponsor
- AstraZeneca
Breast Neoplasms
Study of the Pharmacokinetics and Safety of Trastuzumab Emtansine in Chinese Participants With Locally Advanced Inoperable or Metastatic HER2+ Breast Cancer
This is an open-label Phase I study of single-agent trastuzumab emtansine administered by intravenous (IV) infusion. The study will characterize the pharmacokinetics of trastuzumab emtansine and its relevant analytes and the…
- Trial name
- NCT03153163
- Testing
- Trastuzumab Emtansine
- Where
- China
- Volunteers
- 11 people
- Sponsor
- Hoffmann-La Roche
Solid Tumor, Breast Cancer
Phase 1 Study of FS-1502 in Patients With HER2 Expressed Advanced Solid Tumors and Breast Cancer.
The study comprises two phases: Phase 1a and Phase 1b. The purpose of the study is to observe the safety， tolerability and efficacy of FS-1502.
- Trial name
- NCT03944499
- Testing
- FS-1502
- Where
- 12 sites in China
- Volunteers
- 161 people
- Sponsor
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Metastatic Breast Cancer
Study of KN026 Monotherapy or Combination Therapy in Patients With Metastatic Breast Cancer
This is an open-label, three-cohort phase 2 study of KN026 in subjects with advanced breast Cancer.
- Trial name
- NCT04165993
- Testing
- Concurrent chemotherapy and KN026, KN026 monotherapy, KN026 combination
- Where
- China
- Volunteers
- 68 people
- Sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Advanced Breast Cancer
Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer
The primary objective of the study is to measure efficacy of saruparib (AZD5305) plus camizestrant compared with physician's choice CDK4/6i plus ET in patients with BRCA1, BRCA2, or PALB2m, HR-positive, HER2-negative (defined as…
- Trial name
- EvoPAR-BR01 (NCT06380751)
- Testing
- Saruparib (AZD5305), Camizestrant, Abemaciclib
- Where
- 306 sites in United States, Argentina and 27 more
- Volunteers
- 788 people
- Sponsor
- AstraZeneca
Breast Cancer
An Indirect Treatment Comparison of the Effectiveness of Ribociclib Combined With Non-steroidal Aromatase Inhibitors vs. Tamoxifen for the Adjuvant Treatment of Premenopausal Women With Hormon Receptor-positive, HER2-negative Early Breast Cancer
The purpose of this indirect treatment comparison (ITC) was to generate comparative evidence on the effectiveness and safety in premenopausal women of ribociclib+Non-steroidal Aromatase Inhibitor (NSAI)+Ovarian Function…
- Trial name
- IRINA (NCT07072013)
- Testing
- ribociclib
- Where
- Germany
- Volunteers
- 1,937 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
HER2-positive Breast Cancer
Clinical Study of ALT-P7 to Determine Safety, Tolerability and Pharmacokinetics in Breast Cancer Patients
This open-label study assessed the safety, tolerability and pharmacokinetics of ALT-P7(HM2-Drug Conjugate) in patients with HER2-positive metastatic breast cancer who have progressed on previous Trastuzumab-based therapy.
- Trial name
- NCT03281824
- Testing
- ALT-P7 (HM2-MMAE)
- Where
- South Korea
- Volunteers
- 27 people
- Sponsor
- Alteogen, Inc.