Clinical trials: HER2 Positive Metastatic Breast Cancer
Advanced Breast Cancer
A Study of Everolimus Plus Exemestane in Chinese Postmenopausal Women With Estrogen Receptor Positive, Locally Advanced, Recurrent, or Metastatic Breast Cancer After Recurrence or Progression on Non-steroidal Aromatase Inhibitor
This study aimed at evaluating the safety and efficacy of everolimus plus exemestane in Chinese postmenopausal women with ER+ HER2- locally advanced, recurrent, or metastatic breast cancer after recurrence or progression on…
- Trial name
- BOLERO-5 (NCT03312738)
- Testing
- Everolimus, Exemestane
- Where
- 15 sites in China
- Volunteers
- 159 people
- Sponsor
- Novartis Pharmaceuticals
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
Breast Cancer, Metastatic Breast Cancer
Anastrazole, Fulvestrant & Abemaciclib for HR+HER2- Metastatic Breast Cancer
This is a phase 2, open-label, singled-arm clinical trial determining efficacy of combination therapy with anastrozole, fulvestrant and abemaciclib in subjects with breast cancer.
- Conditions
- Breast Cancer, Metastatic Breast Cancer, Hormone Receptor-positive Breast Cancer, HER2-negative Breast Cancer
- Trial name
- NCT05524584
- Testing
- Fulvestrant, Anastrozole, Abemaciclib
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of California, Irvine
Breast Cancer
Trial of BKM120/Tamoxifen-combination in Patients With HR-pos, HER2-neg Breast Cancer
This is a clinical trial with a molecularly stratified parallel cohort, single arm design to explore the efficacy and safety of BKM120 in combination with tamoxifen in patients with ER/PR-positive, HER2-negative breast cancer…
- Trial name
- PIKTAM (NCT02404844)
- Testing
- BKM120, Tamoxifen
- Where
- Germany
- Volunteers
- 48 people
- Sponsor
- University Hospital, Essen
HER2-positive Recurrent/Metastatic Breast Cancer
A Study to Evaluate Inetetamab + Pyrotinib + Chemotherapy in Previously Untreated HER2-Positive Metastatic Breast Cancer
Studies H0648g and M77001 confirmed that the combination of trastuzumab with taxanes significantly improved TTP and OS, establishing the status of trastuzumab combined with taxanes as first-line standard therapy.The CLEOPATRA and…
- Trial name
- NCT05621434
- Testing
- Inetetamab, pyrotinib, chemotherapy
- Volunteers
- 63 people
- Sponsor
- Fujian Medical University
Breast Cancer Stage IV
Detection of Tumor DNA in the Blood of Patients Receiving Standard Therapy for Hormone Receptor-positive (HR+) Non-HER2 Expressing (HER2-) Metastatic Breast Cancer as a Tool to Select Those Who May Benefit From the Next Course of Fulvestrant in Combination With Alpelisib or Ribociclib
After an initial screening phase (SAFIR 03 - SCREENING) to identify patients with blood circulating mutated-PIK3CA tumours persistent, patients will be enrolled in the treatment phase of SAFIR 03 (SAFIR 03 - ARRIBA) that was…
- Trial name
- SAFIR 03 (NCT05625087)
- Testing
- Alpelisib, Ribociclib
- Where
- 44 sites in France
- Volunteers
- 4 people
- Sponsor
- UNICANCER
Neoplasms, Breast
A Study to Compare the Safety and Efficacy of an Aromatase Inhibitor in Combination With Lapatinib, Trastuzumab or Both for the Treatment of Hormone Receptor Positive, HER2+ Metastatic Breast Cancer
A study to compare the safety and efficacy of an aromatase inhibitor in combination with lapatinib, trastuzumab or both for the treatment of hormone receptor positive, HER2+ metastatic breast cancer (MBC).
- Trial name
- NCT01160211
- Testing
- Lapatinib, Trastuzumab, Aromatase Inhibitor
- Where
- 110 sites in United States, Argentina and 27 more
- Volunteers
- 369 people
- Sponsor
- Novartis Pharmaceuticals
HER2-positive Breast Cancer, Metastatic Cancer
PRE-ISPY Phase I/II Oncology Platform Program
PRE-ISPY Phase I/II (I-SPY-P1) is an open-label, multisite platform study with multiple ongoing drug regimen arms added by protocol amendment which is designed to evaluate single agents or combinations in locally advanced…
- Conditions
- HER2-positive Breast Cancer, Metastatic Cancer, Metastatic Breast Cancer, Metastatic
- Trial name
- PRE-ISPY (NCT05868226)
- Testing
- ALX148, Fam-Trastuzumab Deruxtecan-Nxki, Zanidatamab
- Where
- 10 sites in United States
- Volunteers
- 280 people
- Sponsor
- QuantumLeap Healthcare Collaborative
Her2 Positive Metastatic Breast Cancer
The Myocet/Lapatinib Study. ICORG 10-03, V5
This study is a Phase I/II open label, multi-centre trial. Patients with HER2+ve metastatic breast cancer, following disease progression during, or after, treatment with trastuzumab and taxanes, will be treated with Lapatinib…
- Trial name
- NCT01495884
- Testing
- non-pegylated liposomal doxorubicon (Myocet™), Lapatinib (Tyverb™)
- Where
- 10 sites in Ireland
- Volunteers
- 11 people
- Sponsor
- Cancer Trials Ireland
HER2-Positive Metastatic Breast Cancer, HER2-Negative Metastatic Breast Cancer
Safety and Pharmacokinetics of Atezolizumab Combination Treatments in Participants With HER2-Positive and HER2-Negative Breast Cancer
This is a Phase Ib, open-label, two-stage study with two active regimens in each stage designed to evaluate the safety and tolerability of combination treatment with atezolizumab, trastuzumab, and pertuzumab (with and without…
- Conditions
- HER2-Positive Metastatic Breast Cancer, HER2-Negative Metastatic Breast Cancer, Locally Advanced or Early Breast Cancer
- Trial name
- NCT02605915
- Testing
- Atezolizumab, Carboplatin, Docetaxel
- Where
- 20 sites in United States
- Volunteers
- 98 people
- Sponsor
- Hoffmann-La Roche
HR+ HER2- Breast Cancer
Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced/Metastatic Breast Cancer
The study is a Phase 1b/2, multi-center, open-label, dose escalation trial evaluating the safety and preliminary efficacy of sapanisertib and serabelisib (PIKTOR) with fulvestrant and/or other anticancer therapies in participants…
- Trial name
- NCT07558733
- Testing
- Serabelisib, Sapanisertib, Fulvestrant
- Where
- 7 sites in United States
- Volunteers
- 32 people
- Sponsor
- Faeth Therapeutics
Metastatic Breast Cancer
Study to Describe the Real-world Treatment Patterns and Associated Outcomes in Patients With HER2-positive Unresectable or Metastatic Breast Cancer
This multicountry, multicenter, retrospective, non-interventional study involving patients diagnosed with HER2-positive unresectable or metastatic breast cancer mBC will be conducted to understand the demographic and…
- Trial name
- NCT04857619
- Testing
- None (Observational study)
- Where
- 44 sites in Australia, Brazil and 4 more
- Volunteers
- 763 people
- Sponsor
- AstraZeneca
HER2-positive Breast Cancer, Recurrent Breast Cancer
Trastuzumab and Ixabepilone in Treating Women With HER2-Positive Metastatic Breast Cancer
This phase II trial is studying how well giving trastuzumab together with ixabepilone works in treating women with HER2-positive metastatic breast cancer.
- Conditions
- HER2-positive Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer
- Trial name
- NCT00079326
- Testing
- trastuzumab, ixabepilone, laboratory biomarker analysis
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- National Cancer Institute (NCI)
Estrogen Receptor-positive Breast Cancer, HER2-negative Breast Cancer
BYL719 and Letrozole in Post-Menopausal Patients With Hormone Receptor-Positive Metastatic Breast Cancer
This phase I trial studies the side effects and best dose of the PI3K inhibitor BYL719 when given together with letrozole in treating patients with hormone receptor-positive metastatic breast cancer.
- Conditions
- Estrogen Receptor-positive Breast Cancer, HER2-negative Breast Cancer, Invasive Ductal Breast Carcinoma, Progesterone Receptor-positive Breast Cancer
- Trial name
- NCT01791478
- Testing
- PI3K inhibitor BYL719, letrozole, laboratory biomarker analysis
- Where
- 2 sites in United States
- Volunteers
- 46 people
- Sponsor
- Vanderbilt-Ingram Cancer Center
HER2+ Advanced Breast Cancer Patients Progressing on TKI Therapy
Phase II Clinical Study of T-DM1 and Pyrotinib Maleate in Patients With HER2-positive Metastatic Breast Cancer Who Had Progressed on TKI Therapy
This trial is a combination of trastuzumab and pyrotinib in the treatment of patients with HER2-positive metastatic breast cancer who have progressed on TKI therapy. A total of 50 patients were enrolled in the study design.
- Trial name
- NCT05560308
- Testing
- Trastuzumab Emtansine for Injection, Pyrotinib Maleate Tablets
- Volunteers
- 50 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
Breast Neoplasms, Breast Cancer
Trial of H3B-6545, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer
The primary purpose of phase 1 portion of this study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of H3B-6545 in women with locally advanced or metastatic estrogen receptor (ER)-positive…
- Conditions
- Breast Neoplasms, Breast Cancer, Estrogen-receptor Positive Breast Cancer, Cancer, Breast
- Trial name
- NCT03250676
- Testing
- H3B-6545
- Where
- 39 sites in United States, France and 1 more
- Volunteers
- 151 people
- Sponsor
- Eisai Inc.
Advanced Solid Tumors, Hematologic Neoplasms
A Study of MGD013 in Patients With Unresectable or Metastatic Neoplasms
The primary goal of this Phase 1 study is to characterize the safety and tolerability of tebotelimab and establish the maximum tolerated dose (MTD) of tebotelimab in advanced solid tumors, and tebotelimab in combination with…
- Conditions
- Advanced Solid Tumors, Hematologic Neoplasms, Ovarian Cancer, HER2-positive Advanced Solid Tumors
- Trial name
- NCT03219268
- Testing
- tebotelimab 1 mg, tebotelimab 3 mg, tebotelimab 10 mg
- Where
- 40 sites in United States, Australia and 6 more
- Volunteers
- 277 people
- Sponsor
- MacroGenics
Breast Cancer, Brain Metastases
A Two-cohort Study of SHR-A1811 in the Treatment of HER2-positive Breast Cancer With Brain Metastases
This is a multi-center, open-label, two-cohort study. The purpose of this study is to evaluate the safety, tolerability and efficacy of SHR-A1811 in the treatment of HER2-positive breast cancer with brain and leptomeningeal…
- Conditions
- Breast Cancer, Brain Metastases, Leptomeningeal Metastasis
- Trial name
- NCT07177950
- Testing
- SHR-A1811, radiotherapy
- Volunteers
- 51 people
- Sponsor
- Peking University Cancer Hospital & Institute
Bone Metastases, HER2-positive Breast Cancer
Copper Cu 64-DOTA-Trastuzumab PET in Predicting Response to Treatment With Ado-Trastuzumab Emtansine in Patients With Metastatic HER2 Positive Breast Cancer
This pilot clinical trial studies how well copper Cu 64-tetra-azacyclododecanetetra-acetic acid (DOTA)-trastuzumab positron emission tomography (PET) works in predicting response to treatment with ado-trastuzumab emtansine in…
- Conditions
- Bone Metastases, HER2-positive Breast Cancer, Liver Metastases, Lung Metastases
- Trial name
- NCT02226276
- Testing
- fludeoxyglucose F 18, positron emission tomography, computed tomography
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- City of Hope Medical Center
Neoplasms, Breast
Treatment Options in Human Epidermal Growth Factor Receptor 2 (HER2) Positive Metastatic Breast Cancer Patients
This study will describe the treatment paradigm used over recent years in the clinical management of Human Epidermal Growth Factor Receptor 2 (HER2)+ metastatic breast cancer in Hungary.
- Trial name
- NCT01782651
- Testing
- Lapatinib plus capecitabine
- Where
- Hungary
- Volunteers
- 1 people
- Sponsor
- GlaxoSmithKline