Clinical trials: HER2 Positive Metastatic Breast Cancer
Breast Cancer
DiEtary Mimicry by Glucocorticoid Modulation Evaluation in ER+ Metastatic Breast Cancer Treatment: Efficacy and Response (DEMETER Trial)
This is a single centre, open label, phase II clinical study consisting of two parts, each consisting of a different dose of the same intervention to investigate the efficacy of dexamethasone as an adjunct to endocrine therapy in…
- Trial name
- DEMETER (NCT07786051)
- Testing
- Dexamethasone (Oral)
- Volunteers
- 80 people
- Sponsor
- The Netherlands Cancer Institute
Metastatic Breast Cancer
Safety and QoL of Trastuzumab With Lapatinib or Chemiotherapy in MBC and HER2+ Patients Refractory to Anti HER2 Therapies
Recent clinical studies have shown that the combination of lapatinib and trastuzumab has superior antitumor activity compared to either single drug in both neoadjuvant and metastatic setting and is well tolerated.
- Trial name
- NCT02238509
- Testing
- Lapatinib, Trastuzumab
- Where
- 36 sites in Italy
- Volunteers
- 154 people
- Sponsor
- Consorzio Oncotech
Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
Efficacy Study of Herceptin to Treat HER2-negative CTC Breast Cancer
This is a randomized phase II trial for patients with HER2 negative primary Breast Cancer (BC) who after completing (neo) adjuvant chemotherapy and surgery have detectable circulating tumour cells (CTC) in peripheral blood.
- Conditions
- Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, Circulating Tumor Cells
- Trial name
- TREAT-CTC (NCT01548677)
- Testing
- trastuzumab
- Where
- 80 sites in Belgium, France and 2 more
- Volunteers
- 1,317 people
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC
Stage IV (Metastatic) Breast Cancer, Metastatic Breast Cancer
Fulvestrant + Neratinib In Breast Cancer
This is a Phase 2 open label, multi-center non-randomized interventional study designed to evaluate the safety and efficacy of combining Neratinib plus Fulvestrant in previously treated metastatic HR-positive, HER2-negative…
- Conditions
- Stage IV (Metastatic) Breast Cancer, Metastatic Breast Cancer, ER Positive Breast Cancer, PR-Positive Breast Cancer
- Trial name
- HER2-Signal (NCT04901299)
- Testing
- NERATINIB, FULVESTRANT
- Where
- 2 sites in United States
- Sponsor
- Massachusetts General Hospital
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
Testing the Safety of the Combination of Anti-Cancer Drugs CX-5461 (Pidnarulex) and Trastuzumab Deruxtecan (T-DXd) for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Solid Tumors and Breast Cancer
This phase I trial tests the safety, side effects, and best dose of pidnarulex in combination with trastuzumab deruxtecan in treating patients with breast cancer and other solid tumors that express varying levels of a protein…
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Carcinoma, Locally Advanced Breast Carcinoma
- Trial name
- NCT07137416
- Testing
- Biopsy Procedure, Biospecimen Collection, Echocardiography Test
- Where
- 2 sites in United States
- Volunteers
- 36 people
- Sponsor
- National Cancer Institute (NCI)
HER2-positive Breast Cancer, Recurrent Breast Cancer
Capecitabine, Cyclophosphamide, Lapatinib Ditosylate, and Trastuzumab in Treating Patients With HER2-Positive Metastatic Breast Cancer
This phase II trial studies how well capecitabine, cyclophosphamide, lapatinib ditosylate, and trastuzumab work in treating patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer.
- Conditions
- HER2-positive Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer
- Trial name
- NCT01873833
- Testing
- capecitabine, cyclophosphamide, lapatinib ditosylate
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of Southern California
Hormone Receptor Positive Breast Carcinoma, HER2-negative Breast Cancer
A Dose Escalation/Expansion Study of Oral OP-1250 in Subjects With Advanced and/or Metastatic HR+, HER2- Breast Cancer
This clinical trial is a Phase I dose escalation and dose expansion and Phase II monotherapy open-label, first-in-human, multicenter study of OP-1250 in adult subjects with advanced and/or metastatic hormone receptor…
- Trial name
- NCT04505826
- Testing
- OP-1250
- Where
- 19 sites in United States, Australia
- Volunteers
- 153 people
- Sponsor
- Olema Pharmaceuticals, Inc.
Her 2 Positive Breast Cancer, Cancer
HER2+ CNS Surveillance
A multi-centre, randomised study, to determine the feasibility of recruiting men and women with metastatic HER2 positive breast cancer to a study with a baseline MRI scan followed by randomising to surveillance by two further…
- Conditions
- Her 2 Positive Breast Cancer, Cancer, CNS
- Trial name
- HER2+ CNS (NCT07748598)
- Testing
- Intervention for Arm 2: Brain MRI Surveillance
- Where
- United Kingdom
- Volunteers
- 69 people
- Sponsor
- The Clatterbridge Cancer Centre NHS Foundation Trust
Advanced Breast Adenocarcinoma, Advanced HER2-Negative Breast Carcinoma
Effects of Ribociclib and Palbociclib on Tumor and Blood Characteristics in Patients With Metastatic Breast Cancer
This clinical trial attempts to understand the differences between two chemotherapy drugs, ribociclib and palbociclib, and how they fight cancer.
- Conditions
- Advanced Breast Adenocarcinoma, Advanced HER2-Negative Breast Carcinoma, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
- Trial name
- NCT05244434
- Testing
- Best Practice, Biopsy, Biospecimen Collection
- Sponsor
- City of Hope Medical Center
Breast Cancer
A Study of Herceptin (Trastuzumab) in Combination With a Taxane in Participants With HER2-Positive Breast Cancer Who Relapsed After (Neo)Adjuvant Herceptin Treatment
This single arm, open-label study will evaluate the efficacy and safety of Herceptin (trastuzumab) in combination with a taxane as first line therapy in participants with HER2-positive breast cancer who relapsed after neoadjuvant…
- Trial name
- NCT01301729
- Testing
- Docetaxel, Paclitaxel, Trastuzumab
- Where
- 17 sites in China
- Volunteers
- 32 people
- Sponsor
- Hoffmann-La Roche
HER2-positive Breast Cancer, HER2-positive Gastric Cancer
BI-1607 in Combination with Trastuzumab in Subjects with HER2-positive Advanced Solid Tumors
HER2+ breast and gastric cancer patients' survival is significantly improved by trastuzumab alone or in combination with chemotherapy.
- Conditions
- HER2-positive Breast Cancer, HER2-positive Gastric Cancer, HER2-positive Metastatic Breast Cancer, Metastatic Gastroesophageal Junction Adenocarcinoma
- Trial name
- CONTRAST (NCT05555251)
- Testing
- BI-1607, Trastuzumab
- Where
- 6 sites in Germany, Spain and 1 more
- Volunteers
- 18 people
- Sponsor
- BioInvent International AB
Advanced ER-Positive HER2-Negative Breast Cancer
A Study to Investigate Efficacy and Safety With Oral AZD9833 Compared With Intramuscular Fulvestrant in Post-menopausal Women at Least 18 Years of Age With Advanced ER-positive HER2 Negative Breast Cancer
This study is randomized, open-label, parallel-group, multicentre Phase 2 study aimed to compare the efficacy and safety of oral AZD9833 versus intramuscular (IM) fulvestrant in women with advanced breast cancer.
- Trial name
- SERENA-2 (NCT04214288)
- Testing
- AZD9833, Fulvestrant
- Where
- 85 sites in United States, Belgium and 14 more
- Volunteers
- 240 people
- Sponsor
- AstraZeneca
Metastatic Breast Cancer
Palbociclib in Combination With Fulvestrant or Letrozole in Patients With ER+, HER2- Advanced Breast Cancer
This is an international, randomized, open-label, controlled, multicenter phase II clinical trial to investigate and compare the safety and efficacy of palbociclib combined with fulvestrant or letrozole in women with ER+, HER2…
- Trial name
- PARSIFAL (NCT02491983)
- Testing
- Palbociclib, Fulvestrant, Letrozole
- Where
- 48 sites in Czechia, France and 5 more
- Volunteers
- 486 people
- Sponsor
- MedSIR
Metastatic Breast Cancer
Phase II Open-Label Trial of Tarceva in Women With Metastatic, Hormone- and HER2-Negative Breast Cancer
The goal of this trial is to determine the activity of erlotinib in a rationally selected population of women with ER-negative, PR-negative, HER2/neu-negative, EGFR-positive breast cancer.
- Trial name
- NCT00597597
- Testing
- Erlotinib
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Rush University Medical Center
Anatomic Stage IV Breast Cancer AJCC v8, Hormone Receptor Positive Breast Adenocarcinoma
Immunotherapy (NHS-IL12 & Bintrafusp Alfa) and Radiation Therapy for the Treatment of Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer, the REINA Trial
This phase I trial is to find out the best dose, possible benefits and/or side effects of NHS-IL12 given together with bintrafusp alfa and radiation therapy in treating patients with hormone receptor positive, HER2 negative…
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Hormone Receptor Positive Breast Adenocarcinoma, Metastatic Breast Carcinoma, Metastatic HER2 Negative Breast Adenocarcinoma
- Trial name
- NCT04756505
- Testing
- Bintrafusp Alfa, Immunocytokine NHS-IL12, Radiation Therapy
- Sponsor
- M.D. Anderson Cancer Center
Central Nervous System Metastases, HER2-positive Breast Cancer
Lapatinib in Treating Brain Metastases in Patients With Stage IV Breast Cancer and Brain Metastases
Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth. This phase II trial is studying how well lapatinib works in treating brain metastases in patients with stage IV breast cancer…
- Conditions
- Central Nervous System Metastases, HER2-positive Breast Cancer, Male Breast Cancer, Recurrent Breast Cancer
- Trial name
- NCT00098605
- Testing
- lapatinib ditosylate, laboratory biomarker analysis, quality-of-life assessment
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- National Cancer Institute (NCI)
Metastatic Breast Cancer
A Study of Pertuzumab With High-Dose Trastuzumab for the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer (MBC) With Central Nervous System (CNS) Progression Post-Radiotherapy
This study will examine the safety and efficacy of pertuzumab in combination with high-dose trastuzumab in adult participants with HER2-positive MBC with CNS metastases and disease progression in the brain following radiotherapy.
- Trial name
- NCT02536339
- Testing
- Pertuzumab, Trastuzumab
- Where
- 16 sites in United States
- Volunteers
- 40 people
- Sponsor
- Genentech, Inc.
Breast Cancer
A Study Of Pembrolizumab In Combination With Trastuzumab-DM1
This research study is studying a combination of drugs as a possible treatment for metastatic breast cancer. The interventions involved in this study are: Pembrolizumab Trastuzumab emtansine (also called T-DM1)
- Trial name
- NCT03032107
- Testing
- T-DM1, Pembrolizumab
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- Dana-Farber Cancer Institute
Unrespectable Locally Advanced and or Metastatic HER2 Positive Breast Cancer Participants
JSKN003 Versus Trastuzumab Emtansine (T-DM1) for HER2-Positive, Advanced Breast Cancer
This study is designed to compare the safety and efficacy of JSKN003 versus T-DM1 in unrespectable locally advanced and/or metastatic HER2-positive breast cancer participants previously treated with trastuzumab and taxane.
- Trial name
- NCT06846437
- Testing
- JSKN003, Trastuzumab emtansine (T-DM1)
- Where
- China
- Volunteers
- 228 people
- Sponsor
- Shanghai JMT-Bio Inc.
Metastatic Breast Cancer, HER2 Positive
Dose Finding Study for Combination of Capecitabine, Lapatinib and Vinorelbine in Metastatic Breast Cancer
The purpose of the study is to investigate safety and efficiency of the triple combination of capecitabine, lapatinib and vinorelbine in patients with metastatic breast cancer.
- Conditions
- Metastatic Breast Cancer, HER2 Positive, First or Second Line Therapy, Failure or Contraindication of Trastuzumab Therapy
- Trial name
- CELAVIE (NCT01238029)
- Testing
- Lapatinib and Capecitabine and Vinorelbine
- Where
- 11 sites in Germany
- Volunteers
- 12 people
- Sponsor
- Sponsor GmbH