Clinical trials: HER2 Positive Metastatic Breast Cancer
Breast Cancer
A Study Evaluating the Safety and Efficacy of Venetoclax in Combination With Trastuzumab Emtansine in Patients With Previously Treated HER2-Positive Locally Advanced or Metastatic Breast Cancer
This two-part study is composed of two stages: a Phase Ib stage consisting of a dose-escalation phase and an expansion phase; and a Phase II, randomized, placebo-controlled, double-blind, multicenter stage.
- Trial name
- NCT04298918
- Testing
- Venetoclax, Trastuzumab emtansine
- Where
- 3 sites in Australia, South Korea
- Volunteers
- 1 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
A Phase ll, Interventional, Single-arm Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib and Fulvestrant in Chinese Patients With PIK3CA-mutant, HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer.
This is a prospective, multicenter, open-label, single-arm phase II investigator-initiated study designed to evaluate the efficacy and safety of inavolisib in combination with ribociclib and fulvestrant as first-line treatment in…
- Trial name
- NCT07618390
- Testing
- Inavolisib + Ribociclib + Fulvestrant
- Volunteers
- 160 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Breast Cancer Metastatic
DZD1516 in Combination With Trastuzumab and Capecitabine, or in Combination With T-DM1, in Patients With Metastatic HER2 Positive Breast Cancer
DZD1516 is an oral, blood brain barrier penetrable, selective HER2 tyrosine kinase inhibitor. This study is designed to evaluate the safety and tolerability of DZD1516 in patients with metastatic HER2 positive breast cancer who…
- Trial name
- NCT04509596
- Testing
- DZD1516 mono therapy in Part A, DZD1516 in combination with trastuzumab and/or capecitabine in Part B, DZD1516 in combination with T-DM1 in Part C
- Where
- 3 sites in United States, China
- Volunteers
- 23 people
- Sponsor
- Dizal Pharmaceuticals
Metastatic Breast Cancer, Locally Advanced Breast Cancer
A Study of Treatment Patterns and Outcomes in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Unresectable Locally Advanced or Metastatic Breast Cancer
This disease registry is a prospective, multicenter non-interventional study designed to observe anti-cancer treatment regimens and clinical outcomes in participants with HER2-positive unresectable locally advanced breast cancer…
- Trial name
- NCT02595762
- Where
- 12 sites in Cyprus, Greece
- Volunteers
- 110 people
- Sponsor
- Hoffmann-La Roche
HER2-positive Breast Cancer
Real-world Outcomes of Patients With HER2+ Metastatic Breast Cancer After Treatment With Trastuzumab Deruxtecan
This study will explore treatment patterns and clinical outcomes using the US-based Flatiron Health database to describe patients with HER2+ mBC who were previously treated with T-DXd to better characterize this population and…
- Trial name
- NCT06833268
- Testing
- No drug
- Where
- United States
- Volunteers
- 228 people
- Sponsor
- Daiichi Sankyo
HER2 + Breast Cancer
A Phase II Study of HLX22 in Combination With Trastuzumab and Chemotherapy in HER2-Positive Locally Advanced or Metastatic Breast Cancer Patients
This is a phase II study of HLX22 in combination with trastuzumab and chemotherapy versus placebo in combination with trastuzumab and chemotherapy in locally advanced and/or metastatic HER2-Positive breast cancer previously…
- Trial name
- NCT07824869
- Testing
- HLX22, Trastuzumab, Capecitabine
- Volunteers
- 90 people
- Sponsor
- Shanghai Henlius Biotech
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
Central Nervous System Metastases, HER2-positive Breast Cancer
Phase 1b/2 Trial Using Lapatinib, Everolimus and Capecitabine for Treatment of HER-2 Positive Breast Cancer With CNS Metastasis
This is a phase 1b/2 study to evaluate the safety and clinical activity of the combination of lapatinib, everolimus and capecitabine for the treatment of participants with HER2+ breast cancer with metastases in the brain who have…
- Conditions
- Central Nervous System Metastases, HER2-positive Breast Cancer, Male Breast Cancer, Recurrent Breast Cancer
- Trial name
- NCT01783756
- Testing
- lapatinib ditosylate, everolimus, capecitabine
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Jonsson Comprehensive Cancer Center
Breast Cancer
A Study of HR+/HER2- Metastatic Breast Cancer Patients Treated With Palbociclib Together With an Aromatase Inhibitor From 2017 to 2023 in Denmark.
The purpose of this study is to describe the effect of the medicine palbociclib when given together with an aromatase inhibitor for treatment of breast cancer.
- Trial name
- NCT06307457
- Testing
- Palbociclib in combination with AI
- Where
- Denmark
- Volunteers
- 604 people
- Sponsor
- Pfizer
Metastatic Breast Cancer
Lapatinib+Vinorelbine vs Vinorelbine HER2 Positive Metastatic Breast Cancer Progressed After Lapatinib/Trastuzumab
The investigators address the clinical efficacy of continuing lapatinib treatment combined with vinorelbine after the progression of both trastuzumab and lapatinib treatment compared with vinorelbine alone in HER2 positive…
- Trial name
- LV (NCT01730677)
- Testing
- Lapatinib, Vinorelbine
- Where
- South Korea
- Volunteers
- 150 people
- Sponsor
- National Cancer Center, Korea
Metastatic Breast Cancer, Advanced Breast Cancer
Implementing Patients´ Competence in Oral Breast Cancer Therapy
The aim of the IMPACT - Implementing Patients' competence in oral breast cancer therapy - study is to evaluate the effectiveness of a standardized patient education and coaching and optional eMBSR for therapy management provided…
- Trial name
- IMPACT (NCT04030728)
- Volunteers
- 212 people
- Sponsor
- Onco Medical Consult GmbH
Breast Cancer, Metastatic Breast Cancer
Capecitabine (Xeloda) and Lapatinib (Tykerb) as First-line Therapy in HER2/Neu-positive Breast Cancer
Subjects with advanced or metastatic (spread to other parts of the body) breast cancer that is HER2/neu-positive will take part in this study. This type of breast cancer has a high amount of a protein called HER2.
- Conditions
- Breast Cancer, Metastatic Breast Cancer, Advanced Breast Cancer, HER2/Neu-positive Breast Cancer
- Trial name
- NCT00496366
- Testing
- Capecitabine, Lapatinib
- Where
- 2 sites in United States
- Volunteers
- 11 people
- Sponsor
- Rutgers, The State University of New Jersey
HER-2 Positive Breast Cancer, Metastatic Malignant Neoplasm to Brain
Study of the Combination of KD019 and Trastuzumab in Subjects With HER2-Positive Metastatic Breast Cancer
Evaluate the safety and tolerability and determine the maximum tolerated dose (MTD) of the combination of tesevatinib and trastuzumab in subjects with HER2-positive metastatic breast cancer
- Trial name
- NCT02154529
- Testing
- Tesevatinib, Trastuzumab
- Where
- 6 sites in United States
- Volunteers
- 17 people
- Sponsor
- Kadmon Corporation, LLC
HER2-positive Breast Cancer, Metastatic Breast Cancer
Pyrotinib Combined With Trastuzumab And Chemotherapy in HER2-positive MBC
To explore the real world data of trastuzumab Combined With Trastuzumab And Chemotherapy in China, and to explore the relationship between progression free survival and treatment pattern.
- Trial name
- NCT04609540
- Testing
- Trastuzumab
- Volunteers
- 200 people
- Sponsor
- Shandong Cancer Hospital and Institute
HER2 Positive Breast Cancer
A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer
This study is being done to see if tucatinib works better than placebo when given with other drugs to treat participants with HER2-positive breast cancer.
- Trial name
- HER2CLIMB-05 (NCT05132582)
- Testing
- Tucatinib, Trastuzumab, Pertuzumab
- Where
- 307 sites in United States, Australia and 21 more
- Volunteers
- 654 people
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
Breast Cancer
Pyrotinib Plus Trastuzumab and Chemotherapy in HER2+ Metastatic Breast Cancer Patients
To evaluate the patterns and treatment outcomes of pyrotinib plus trastuzumab and chemotherapy in the real world.
- Trial name
- NCT05839288
- Where
- China
- Volunteers
- 161 people
- Sponsor
- Fudan University
HER2-positive Breast Cancer
Treatment Protocol of Tucatinib With Capecitabine and Trastuzumab in Patients With Unresectable Previously Treated HER2+ Breast Cancer
The purpose of this program is to provide access to tucatinib in the United States before FDA approval. Participants will receive a combination treatment of capecitabine, trastuzumab, and tucatinib.
- Trial name
- NCT04220203
- Testing
- Tucatinib, Capecitabine, Trastuzumab
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
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
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
Breast Cancer
Tucidinostat Combined With Metronomic Capecitabine and Endocrine Therapy for Advanced HR-positive, HER2-negative Breast Cancer After CDK4/6 Inhibitor.
The study is designed to explore the clinical benefit following treatment with tucidinosta in combination with metronomic capecitabine and endocrine therapy in patients with hormone receptor-positive, Her2-negative advanced…
- Trial name
- NCT05411380
- Testing
- Tucidinostat, Capecitabine, Endocrine Therapy
- Where
- China
- Volunteers
- 73 people
- Sponsor
- wang shusen