Clinical trials: HER2+ Metastatic Breast Cancer (MBC)
Breast Cancer
Study of PIK3CA Mutations and Effectiveness and Tolerability Outcomes of Alpelisib in Real-world
SPEAR is a non-interventional / observational, prospective, multicenter study planned to be conducted across ~ 30 sites in India, among HR-positive and HER2-negative ABC/MBC patients.
- Trial name
- SPEAR (NCT05022342)
- Testing
- alpelisib plus fulvestrant
- Where
- 28 sites in India
- Volunteers
- 595 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Breast Cancer
Fulvestrant as Maintenance Therapy After First-line Chemotherapy in HER2 - Postmenopausal MBC Patients
Breast cancer is one of the most prevalent cancers among women, and represents 20 - 25% of all female cancers. Despite earlier diagnosis and improvement in adjuvant therapies, some patients will present metastatic recurrence.
- Trial name
- FUMANCE (NCT02383030)
- Testing
- Fulvestrant
- Where
- 20 sites in Italy
- Volunteers
- 156 people
- Sponsor
- Consorzio Oncotech
Breast Cancer Metastatic
MCLA-128 With Trastuzumab/Chemotherapy in HER2+ and With Endocrine Therapy in ER+ and Low HER2 Breast Cancer.
A Phase 2, open-label, multicenter international study will be performed to evaluate the efficacy of MCLA-128-based combinations. Three combination treatments will be evaluated, two in Cohort 1 and one in Cohort 2.
- Trial name
- NCT03321981
- Testing
- Zenocutuzumab, Trastuzumab, Vinorelbine
- Where
- 25 sites in United States, Belgium and 5 more
- Volunteers
- 105 people
- Sponsor
- Merus B.V.
Metastatic Breast Cancer
A Study of Trastuzumab-Mcc-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer
Study of trastuzumab emtansine (T-DM1) administered to patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer.
- Trial name
- NCT00679211
- Testing
- Trastuzumab emtansine [Kadcyla]
- Volunteers
- 110 people
- Sponsor
- Genentech, Inc.
Breast Neoplasm, Brain Metastases
MRI Screening Versus SYMptom-directed Surveillance for Brain Metastases Among Patients with Triple Negative or HER2+ MBC
In this study, 50 women with either HER2+ or triple negative metastatic breast cancer but no known brain metastases will be recruited at the Sunnybrook Odette Cancer Centre.
- Conditions
- Breast Neoplasm, Brain Metastases, Triple Negative Breast Cancer, HER2-positive Breast Cancer
- Trial name
- SYMPToM (NCT03881605)
- Testing
- MRI screening
- Where
- Canada
- Volunteers
- 50 people
- Sponsor
- Sunnybrook Health Sciences Centre
Metastatic Breast Cancer
Corrected QT Interval Effects of Trastuzumab Emtansine (T-DM1) in Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Locally Advanced or Metastatic Breast Cancer and the Safety and Tolerability of Combined T-DM1 and Pertuzumab in Patients With Early Disease Progression
This is a multicenter, open-label, single-arm Phase II study designed to evaluate the effect of T-DM1 on the duration of corrected QT (QTc) interval in patients with HER2-positive locally advanced or metastatic breast cancer and…
- Trial name
- NCT00943670
- Testing
- pertuzumab, Trastuzumab emtansine [Kadcyla]
- Volunteers
- 51 people
- Sponsor
- Genentech, Inc.
Metastatic Breast Cancer
Study of ASLAN001 in Combination With Capecitabine in MBC That Has Failed on Prior Trastuzumab
This is an open-label, randomized, parallel group Phase 2A/2B study to evaluate the clinical activity of ASLAN001 in combination with capecitabine compared with lapatinib in combination with capecitabine in patients with HER2…
- Trial name
- NCT02338245
- Testing
- ASLAN001, Lapatinib, Capecitabine
- Where
- 19 sites in Australia, Hong Kong and 5 more
- Volunteers
- 200 people
- Sponsor
- ASLAN Pharmaceuticals
Metastatic Breast Cancer (MBC), HER2-Positive Breast Cancer
Trastuzumab Rezetecan Followed by Pyrotinib, Fulvestrant, and Dalpiciclib in HR-Positive, HER2-Positive Advanced Breast Cancer
The purpose of this clinical trial is to evaluate whether, in patients with hormone receptor-positive (HR-positive) and HER2-positive advanced breast cancer whose disease has progressed after trastuzumab-based therapy, switching…
- Conditions
- Metastatic Breast Cancer (MBC), HER2-Positive Breast Cancer, Hormone Receptor-Positive Breast Cancer
- Trial name
- NCT07892274
- Testing
- Fulvestrant, Pyrotinib, Dalpiciclib
- Where
- China
- Volunteers
- 226 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Metastatic Breast Cancer
A Study to Evaluate Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer
This study was a Phase III, randomized, double-blind, placebo-controlled, multicenter international clinical trial conducted to investigate the use of pertuzumab in combination with trastuzumab and docetaxel as first-line…
- Trial name
- CLEOPATRA (NCT00567190)
- Testing
- Pertuzumab, Trastuzumab, Docetaxel
- Where
- 322 sites in United States, Argentina and 24 more
- Volunteers
- 808 people
- Sponsor
- Genentech, Inc.
Progress-free Survival, Overall Response Rate
Study for HER2-Overexpressed MBC Patients Treated by Cipterbin® Plus vinorelbinE
Breast cancer is the most common malignant disease and the most frequent causes of cancer mortality in females worldwide. The situation is same as the world in China.
- Conditions
- Progress-free Survival, Overall Response Rate, Adverse Events
- Trial name
- HOPES (NCT01291667)
- Volunteers
- 330 people
- Sponsor
- Shanghai CP Guojian Pharmaceutical Co., Ltd.
HR+ HER2- Metastatic Breast Cancer, Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Triple Negative Breast Cancer, Male Breast Cancer
A Study of PF-06873600 in People With Cancer
The purpose of this clinical trial is to learn about the safety and effects of study medicine (PF-06873600) when taken alone or with hormone therapy by people with cancer.
- Trial name
- NCT03519178
- Testing
- PF-06873600, Endocrine Therapy 1, Endocrine Therapy 2
- Where
- 54 sites in United States, Bulgaria and 4 more
- Volunteers
- 155 people
- Sponsor
- Pfizer
Metastatic Breast Cancer, Metastatic Solid Cancer
HER2 Targeted Molecular Imaging in mBC and Other Metastatic Solid Carcinomas Using 68Ga-ABS011
This phase II study aims to confirm the diagnostic performance and accuracy of 68Ga-ABS011 PET/CT in determining the HER2 expression status, and to evaluate 68Ga-ABS011's ability to drive changes in therapeutic treatment.
- Trial name
- HERMIA (NCT06369831)
- Testing
- 68Ga-NOTA-ABSCINT-HER2 PET/CT
- Where
- 7 sites in Austria, Belgium
- Volunteers
- 60 people
- Sponsor
- Abscint NV/SA
Estrogen Receptor Negative, Estrogen Receptor Positive
Pembrolizumab and Carboplatin in Treating Patients With Circulating Tumor Cells Positive Metastatic Breast Cancer
The purpose of the study is to evaluate the impact on progression-free survival (PFS) with the combination carboplatin - pembrolizumab in patients with CTC (circulating tumor cells) positive, HER2 negative metastatic breast…
- Conditions
- Estrogen Receptor Negative, Estrogen Receptor Positive, HER2/Neu Negative, Progesterone Receptor Negative
- Trial name
- NCT03213041
- Testing
- Carboplatin, Laboratory Biomarker Analysis, Pembrolizumab
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Northwestern University
Invasive Breast Cancer, Metastatic Breast Cancer
Sacituzumab Govitecan +/- Pembrolizumab In HR+ / HER2 - MBC
This research study is evaluating the safety and effectiveness of Sacituzumab Govitecan with or without Pembrolizumab in metastatic HR+/HER2- breast cancer.
- Conditions
- Invasive Breast Cancer, Metastatic Breast Cancer, HR-Positive Breast Cancer, HER2-negative Breast Cancer
- Trial name
- NCT04448886
- Testing
- Pembrolizumab, Sacituzumab Govitecan
- Where
- 8 sites in United States
- Volunteers
- 110 people
- Sponsor
- Ana C Garrido-Castro, MD
Metastatic Breast Cancer
Maintenance Bevacizumab or Observation After Taxane Based First Line Chemotherapy In Metastatic Breast Cancer
Investigators propose to assess,the safety and tolerability profile (number of participants with adverse events)of bevacizumab (Avastin) when combined with standard chemotherapy as first line treatment of patients with metastatic…
- Trial name
- NCT01978977
- Where
- 6 sites in Greece
- Volunteers
- 400 people
- Sponsor
- Hellenic Oncology Research Group
Hormone-sensitive, HER-2 Negative Metastatic Breast Cancer
Study of MEDI-573 Plus Standard Endocrine Therapy for Women With Hormone-sensitive Metastatic Breast Cancer
Study to evaluate the safety, tolerability, antitumor activity, and pharmacology of MEDI-573 in combination with an aromatase inhibitor (AI) in adult subjects with HR+, HER2-negative MBC.
- Trial name
- NCT01446159
- Testing
- MEDI-573, Aromatase Inhibitor
- Where
- 71 sites in United States, Belgium and 9 more
- Volunteers
- 188 people
- Sponsor
- MedImmune LLC
Breast Cancer, Endocrine Therapy
Real-World Study on CDK4/6 Inhibitors Combined With Endocrine Therapy and Subsequent Treatment in HR+/HER2- MBC.
Exploring the Efficacy and Safety of Different Systemic Treatment Regimens after CDK4/6i Progression in the Real World has significant implications. This study is an observational, real-world study.
- Conditions
- Breast Cancer, Endocrine Therapy, CDK4/6 Inhibitors, Subsequent Treatment
- Trial name
- NCT06033287
- Testing
- Different treatment regimens following progression on CDK4/6 inhibitors.
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Hunan Cancer Hospital
Metastatic Breast Cancer
Phase III Palbociclib With Endocrine Therapy vs. Capecitabine in HR+/HER2- MBC With Resistance to Aromatase Inhibitors
This is an international (4 countries) randomized phase III study with 2 cohorts, patients will be randomized 1:1 to endocrine therapy (cohort 1: exemestane 25 mg daily, cohort 2: fulvestrant 500mg days 1 and 15 cycle 1 and then…
- Trial name
- PEARL (NCT02028507)
- Testing
- Palbociclib, Capecitabine, Exemestane
- Where
- 37 sites in Austria, Hungary and 2 more
- Volunteers
- 693 people
- Sponsor
- Spanish Breast Cancer Research Group
Breast Cancer
Study of Poziotinib in Participants With HER2-Positive Metastatic Breast Cancer
The purpose of this study is to establish the dose regimen and evaluate the preliminary efficacy and the safety/tolerability of poziotinib in participants with human epidermal growth factor receptor 2 (HER2)-positive metastatic…
- Trial name
- NCT02659514
- Testing
- Poziotinib
- Where
- 35 sites in United States
- Volunteers
- 67 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
Metastatic Breast Cancer
Trastuzumab and Trastuzumab-MCC-DM1 Administered Intravenously and GDC-0941 Administered Orally to Patients With HER2-Positive Metastatic Breast Cancer Who Have Progressed on Previous Trastuzumab-Based Therapy
This multicenter, Phase Ib study is an open label, dose escalation, three-arm study evaluating the safety, tolerability, pharmacokinetics, and activity of oral (PO) GDC 0941 administered in combination with either intravenous…
- Trial name
- NCT00928330
- Testing
- GDC-0941, Trastuzumab, trastuzumab-MCC-DM1
- Where
- 3 sites in United States
- Volunteers
- 57 people
- Sponsor
- Genentech, Inc.