Clinical trials: Her2 Positive Metastatic Breast Cancer
Hormone Receptor Positive Breast Cancer, HER-2 Positive Breast Cancer
A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer
The purpose of this study is to evaluate the effectiveness of abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus physicians choice standard of care chemotherapy in women with hormone receptor…
- Trial name
- monarcHER (NCT02675231)
- Testing
- Abemaciclib, Trastuzumab, Fulvestrant
- Where
- 93 sites in United States, Argentina and 12 more
- Volunteers
- 237 people
- Sponsor
- Eli Lilly and Company
Breast Cancer
A Randomised, Open-label, Multicentre Phase III Clinical Study to Evaluate the Efficacy and Safety of JS105 Combined With Dalpiciclib and Fulvestrant Compared With Dalpiciclib and Fulvestrant in Patients With PIK3CA-mutated, HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer.
This study is a randomised, open-label, multicentre phase III clinical study evaluating the efficacy and safety of JS105 combined with Dalpiciclib and Fulvestrant compared with Dalpiciclib and Fulvestrant in patients with…
- Trial name
- NCT07207070
- Testing
- JS105, Dalpiciclib, Fulvestrant 50 Mg/mL Intramuscular Solution
- Where
- 2 sites in China
- Volunteers
- 312 people, healthy volunteers welcome
- Sponsor
- Risen (Suzhou) Pharma Tech Co., Ltd.
Breast Cancer
A Phase I/II, Dose Finding and Optimization Study of [177Lu]Lu-NeoB in Combination With Capecitabine in Patients With GRPR+, ER+, HER2- Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inhibitor.
In the phase I part, to determine the recommended doses (RD) and dosing regimens of [177Lu]Lu-NeoB in combination with capecitabine in adult patients with gastrin releasing peptide receptor positive, estrogen receptor-positive…
- Trial name
- NeoB-Cap1 (NCT06247995)
- Testing
- [68Ga]Ga-NeoB, [177Lu]Lu-NeoB, Capecitabine
- Where
- 28 sites in United States, Australia and 11 more
- Volunteers
- 20 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Safety and Efficacy Study of Sapanisertib in Combination With Exemestane or Fulvestrant in Postmenopausal Women With Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Metastatic Breast Cancer
This is a phase 1b/2 study of the safety and efficacy of sapanisertib (MLN0128) in combination with exemestane or fulvestrant therapy in women with estrogen receptor positive/human epidermal growth factor receptor 2 negative…
- Trial name
- NCT02049957
- Testing
- Sapanisertib, Fulvestrant, Exemestane
- Where
- 40 sites in United States, Belgium and 1 more
- Volunteers
- 118 people
- Sponsor
- Calithera Biosciences, Inc
HER2-positive Metastatic Breast Cancer, Central Nervous System Metastases
Atezolizumab + Pertuzumab + Trastuzumab In CNS Mets In BC
This research study is studying a drug called atezolizumab as a possible treatment HER2-positive metastatic breast cancer (MBC) that has spread to the brain.
- Trial name
- NCT03417544
- Testing
- ATEZOLIZUMAB, PERTUZUMAB, TRASTUZUMAB
- Where
- 2 sites in United States
- Volunteers
- 19 people
- Sponsor
- Nancy Lin, MD
Metastatic Breast Cancer in the Liver
Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in Patients w/ Metastatic Breast Cancer w/Liver Dominant Disease
The goal of this clinical trial is to learn if using a liver-directed therapy with high dose chemotherapy followed by approved cancer treatment to treat patients with breast cancer that has spread to the liver is safe and…
- Trial name
- DELUMA (NCT06875128)
- Testing
- Melphalan/HDS followed by Physician's choice of SOC (eribulin, vinorelbine, or capecitabine), Physician's choice of SOC (eribulin, vinorelbine, or capecitabine)
- Where
- 8 sites in United States, Italy and 2 more
- Volunteers
- 90 people
- Sponsor
- Delcath Systems Inc.
Breast Cancer
Trastuzumab and Exemestane in Treating Postmenopausal Women With Metastatic or Locally Advanced Breast Cancer
RATIONALE: The monoclonal antibody trastuzumab can locate breast cancer cells that have HER2 on their surface and either kill them or deliver tumor-killing substances to them without harming normal cells.
- Trial name
- NCT00057993
- Testing
- trastuzumab, exemestane
- Sponsor
- Northwestern University
Anatomic Stage IV Breast Cancer AJCC v8, Estrogen Receptor Positive
S1703 Serum Tumor Marker Directed Disease Monitoring in Patients With Hormone Receptor Positive Her2 Negative Metastatic Breast Cancer
This randomized research trial studies how well serum tumor marker directed disease monitoring works in monitoring patients with hormone receptor positive Her2 negative breast cancer that has spread to other places in the body.
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Estrogen Receptor Positive, HER2/Neu Negative, Progesterone Receptor Positive
- Trial name
- NCT03723928
- Testing
- Usual care disease monitoring, Serum Tumor Marker directed disease monitoring, Quality-of-Life Assessment
- Where
- 723 sites in United States, Guam and 1 more
- Volunteers
- 739 people
- Sponsor
- SWOG Cancer Research Network
HER2-positive Breast Cancer
Safety, Effectiveness and Quality of Life of Trastuzumab Deruxtecan in Patients with HER2+ Breast Cancer
Collection of data in real life conditions on satefy, effectiveness and quality of life of trastuzumab deruxtecan in patients with metastatic or unresectable HER2-positive breast cancer.
- Trial name
- NCT05149014
- Where
- France
- Volunteers
- 306 people
- Sponsor
- Daiichi Sankyo France
Breast Neoplasms, HER2/Neu Positive
Tolerability of the Combination of Lapatinib and Trastuzumab in Adults Age 60 or Older With HER2 Positive Locally Advanced or Metastatic Breast Cancer
This phase II trial studies the side effects and how well lapatinib ditosylate and trastuzumab work in treating older patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer that has spread from where…
- Conditions
- Breast Neoplasms, HER2/Neu Positive, Geriatric Health Services
- Trial name
- NCT01273610
- Testing
- Lapatinib, Trastuzumab, laboratory biomarker analysis
- Where
- 8 sites in United States
- Volunteers
- 40 people
- Sponsor
- City of Hope Medical Center
Breast Cancer
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-0587 as a Monotherapy and in Combination With Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer
This is a first-in-human, Phase Ia/Ib, dose-escalation and expansion study evaluating the safety, pharmacokinetics, and activity of GDC-0587 (cyclin-dependent kinase-4 [CDK4] inhibitor) as a monotherapy and in combination with…
- Trial name
- NCT07214662
- Testing
- GDC-0587, Giredestrant, Omeprazole
- Where
- 4 sites in United States, Taiwan
- Volunteers
- 3 people
- Sponsor
- Genentech, Inc.
Leptomeningeal Metastasis of HER2-positive Breast Cancer
Efficacy and Safety of Intrathecal Administration of Thiotepa in Combination With Trastuzumab in Breast Cancer With Leptomeningeal Metastasis
Evaluate the efficacy and safety of Intrathecal Administration of Thiotepa in Combination with Trastuzumab via the Ommaya Reservoir in Breast Cancer with Leptomeningeal Metastasis
- Trial name
- NCT07263425
- Testing
- Intrathecal Administration of Thiotepa in Combination with Trastuzumab via the Ommaya Reservoir
- Where
- China
- Volunteers
- 26 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
HER2-positive Breast Cancer, HER2-positive Gastric Cancer
PRS-343 in HER2-Positive Solid Tumors
A multi center, open-label, Phase 1 dose escalation study with expansion cohort is designed to determine the MTD, RP2D and dosing schedule of PRS-343 in patients with HER2+ advanced or metastatic solid tumors.
- Conditions
- HER2-positive Breast Cancer, HER2-positive Gastric Cancer, HER2-positive Bladder Cancer, HER2-positive Solid Tumor
- Trial name
- NCT03330561
- Testing
- PRS-343
- Where
- 10 sites in United States
- Volunteers
- 85 people
- Sponsor
- Pieris Pharmaceuticals, Inc.
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-positive Metastatic Breast Cancer, First-line Treatment
Disitamab Vedotin + Pyrotinib Versus THP in the First-line Treatment for HER2+ Advanced Breast Cancer Clinical Trial
The goal of this multicentre, randomized, double-blind controlled, phase III clinical trial is to compare the efficacy and safety of disitamab vedotin in combination with pyrotinib versus the standard first-line treatment of…
- Trial name
- NCT06278870
- Testing
- disitamab vedotin, Pyrotinib, trastuzumab
- Where
- China
- Volunteers
- 312 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Metastatic Breast Cancer With a Isolated Brain Progression
Treatment With Tucatinib in Patients With an Isolated Brain Progression of a Metastatic Breast Cancer
The overall survival of patients with metastatic breast cancer has steadily improved over the past decades, mainly due to advances in systemic treatment.
- Trial name
- InTTercePT (NCT05041842)
- Testing
- Tucatinib, Pertuzumab, Trastuzumab
- Where
- 16 sites in France
- Volunteers
- 53 people
- Sponsor
- UNICANCER
Breast Cancer
A Phase 1 Study of Oral OP-1250 in Combination With Palbociclib in HR+/HER2- Breast Cancer Patients
This is an open-label, Phase 1b dose escalation and expansion study to determine the maximum tolerated dose (MTD) of OP-1250 in combination with palbociclib (Ibrance®️, Pfizer Inc.).
- Trial name
- NCT05266105
- Testing
- Palazestrant, Palbociclib
- Where
- 8 sites in Australia
- Volunteers
- 60 people
- Sponsor
- Olema Pharmaceuticals, Inc.
Metastatic Breast Cancer
A Study of Trastuzumab Emtansine (Trastuzumab-MCC-DM1) Administered Intravenously to Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer
This was a multi-institutional, open-label, single-arm, Phase II study of trastuzumab emtansine (T-DM1) administered by intravenous (IV) infusion to patients with human epidermal growth factor receptor 2 (HER2)-positive…
- Trial name
- NCT00509769
- Testing
- Trastuzumab emtansine [Kadcyla]
- Where
- 40 sites in United States
- Volunteers
- 112 people
- Sponsor
- Genentech, Inc.
Breast Cancer
Efficacy and Safety of T-DXd in Patients With HER2-positive and HER2-low Metastatic Breast Cancer: a Real-world Study
Evaluate the efficacy and safety of T-DXd in patients with HER2-positive and HER2-low metastatic breast cancer
- Trial name
- NCT07108595
- Testing
- T- Dxd
- Where
- China
- Volunteers
- 142 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
HER2-positive Breast Cancer, Metastatic Breast Cancer
SMP-656 for HER2-Positive Advanced Breast Cancer
The goal of this clinical trial is to learn if single-agent SMP-656 works to treat patients with HER2-positive locally advanced or metastatic breast cancer who have progressed after prior HER2-targeted topoisomerase inhibitor…
- Conditions
- HER2-positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer (LABC)
- Trial name
- NCT07726342
- Testing
- SMP-656 Injection
- Where
- 15 sites in China
- Volunteers
- 60 people
- Sponsor
- Chengdu SciMount Pharmatech Co., Ltd.