Clinical trials: Non Metastatic HER2 Positive Breast Cancer
Breast Cancer
A Study of GB491 in Combination With Letrozole in Patients With HR Positive and HER2 Negative Advanced Breast Cancer
The main purpose of this study is to evaluate the efficacy and safety of GB491 combined with Letrozole versus placebo combined with Letrozole in the treatment of HR+/HER2- locally advanced or metastatic breast cancer without…
- Trial name
- NCT05851014
- Testing
- GB491 combined with Letrozole
- Where
- 52 sites in China
- Volunteers
- 350 people
- Sponsor
- Genor Biopharma Co., Ltd.
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
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
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
High Grade Epithelial Ovarian Cancer, High Grade Serous Ovarian Cancer
Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)
This study will test the safety, including side effects, and determine the characteristics of a drug called Rina-S in participants with solid tumors.
- Conditions
- High Grade Epithelial Ovarian Cancer, High Grade Serous Ovarian Cancer, Primary Peritoneal Carcinoma, Fallopian Tube Cancer
- Trial name
- RAINFOL-01 (NCT05579366)
- Testing
- Rina-S, Carboplatin, Bevacizumab
- Where
- 66 sites in United States, China and 1 more
- Volunteers
- 952 people
- Sponsor
- Genmab
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
Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations
Basket Study of Neratinib in Participants With Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations
This is an open-label, multicenter, multinational, Phase 2 basket study exploring the efficacy and safety of neratinib as monotherapy or in combination with other therapies in participants with HER (EGFR, HER2) mutation-positive…
- Trial name
- SUMMIT (NCT01953926)
- Testing
- Neratinib, Fulvestrant, Trastuzumab
- Where
- 60 sites in United States, Australia and 11 more
- Volunteers
- 582 people
- Sponsor
- Puma Biotechnology, Inc.
Advanced Metastatic Breast Cancer
Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
The purpose of this study was to determine whether treatment with tamoxifen or a non-steroidal aromatase inhibitors (NSAI) + goserelin + LEE011 prolonged progression-free survival (PFS) compared to treatment with tamoxifen or a…
- Trial name
- MONALEESA-7 (NCT02278120)
- Testing
- Ribociclib, Tamoxifen, Letrozole
- Where
- 183 sites in United States, Argentina and 28 more
- Volunteers
- 672 people
- Sponsor
- Novartis Pharmaceuticals
Locally Advanced Solid Tumor, Metastatic Cancer
ACE1702 in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors
ACE1702 (anti-HER2 oNK cells) is an off-the-shelf Natural Killer (NK) cell product that targets human HER2-expressing solid tumors.
- Conditions
- Locally Advanced Solid Tumor, Metastatic Cancer, Solid Tumor, HER2-positive Gastric Cancer
- Trial name
- NCT04319757
- Testing
- ACE1702, Cyclophosphamide, Fludarabine
- Where
- 3 sites in United States, Taiwan
- Volunteers
- 12 people
- Sponsor
- Acepodia Biotech, Inc.
Breast Cancer Stage III, HER2-positive Metastatic Breast Cancer
Evaluate BL-M17D1 in Patients w/HER2-Expressing/Mutant Advanced or Metastatic Solid Tumors
The objective of this study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of BL-M17D1 in patients with HER2-Expressing or HER2-Mutant Advanced or Metastatic Solid Tumors.
- Conditions
- Breast Cancer Stage III, HER2-positive Metastatic Breast Cancer, Unresectable Breast Carcinoma, Her2-Positive
- Trial name
- NCT06714617
- Testing
- BL-M17D1
- Where
- 9 sites in United States
- Volunteers
- 3 people
- Sponsor
- SystImmune Inc.
Hormone Receptor Positive HER2 Negative Breast Cancer With a PIK3CA Mutation
A NIS of Alpelisib in Combination With Fulvestrant in Postmenopausal Women, and Men, With HR+,HER2- , Locally Advanced or Metastatic Breast Cancer With a PIK3CA Mutation, After Disease Progression Following Endocrine Therapy as Monotherapy, in the Real-world Setting
This was a prospective, multi-national, non-interventional study (NIS) collecting data from postmenopausal women, and adult men, with HR+, HER2- locally advanced or metastatic breast cancer whose tumor harbors a PIK3CA mutation…
- Trial name
- NCT04967248
- Testing
- Alpelisib, Fulvestrant
- Volunteers
- 4 people
- Sponsor
- Novartis Pharmaceuticals
HER2-positive Advanced Solid Tumor
A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1303/BNT323 in subjects with advanced solid tumors that express HER2.
- Trial name
- NCT05150691
- Testing
- DB-1303/BNT323, Pertuzumab Injection, Ritonavir
- Where
- 102 sites in United States, Australia and 4 more
- Volunteers
- 796 people
- Sponsor
- DualityBio Inc.
ER-Positive HER2-Negative Breast Cancer
A Comparative Study of AZD9833 Plus Palbociclib Versus Anastrozole Plus Palbociclib in Patients With ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease
The study is intended to show superiority of AZD9833 in combination with palbociclib (a CDK4/6 inhibitor) versus anastrozole (an aromatase inhibitor) and palbociclib as the initial treatment of patients with hormone…
- Trial name
- SERENA-4 (NCT04711252)
- Testing
- AZD9833, Anastrozole, Palbociclib
- Where
- 263 sites in United States, Austria and 25 more
- Volunteers
- 1,371 people
- Sponsor
- AstraZeneca
Breast Cancer
A Non-interventional Study for Women With HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer to Evaluate the Real-world Effectiveness of Treatment Algorithms Beginning With Ribociclib + AI/FUL, or With Endocrine Therapy or Chemotherapy as First Line Treatment
This is a non-interventional observational study conducted in Germany to evaluate the real-world effectiveness, tolerability, safety, and quality of life in patients with locally advanced/metastatic HR+/HER2- breast cancer…
- Trial name
- RIBANNA (NCT06311383)
- Testing
- First-line Ribociclib + endocrine therapy, First-line endocrine therapy, First-line chemtherapy
- Where
- 265 sites in Germany
- Volunteers
- 2,610 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
ALEXANDRIA Study Egypt
Breast Cancer (BC) is one of the most frequent cancers in women and is the most frequent cause of death in the female population.
- Trial name
- NCT03583463
- Where
- 8 sites in Egypt
- Volunteers
- 436 people
- Sponsor
- AstraZeneca
Breast Neoplasms
A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)
The study is designed to compare the clinical benefit following treatment with letrozole in combination with PD-0332991 versus letrozole in combination with placebo in postmenopausal women with ER(+)/HER2(-) advanced breast…
- Trial name
- NCT01740427
- Testing
- PD-0332991, Letrozole
- Where
- 305 sites in United States, Australia and 16 more
- Volunteers
- 666 people
- Sponsor
- Pfizer
Advanced Solid Tumor, Metastatic Cancer
Safety and Preliminary Efficacy of SNK01 in Combination With Trastuzumab or Cetuximab in Subjects With Advanced HER2 or EGFR Cancers
The purpose of the Phase 1/2a study is to evaluate the safety and tolerability of SNK01 in combination with trastuzumab or cetuximab in order to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D), and the…
- Conditions
- Advanced Solid Tumor, Metastatic Cancer, HER2-positive Breast Cancer, HER2-positive Gastric Cancer
- Trial name
- NCT04464967
- Testing
- SNK01, Trastuzumab, Cetuximab
- Sponsor
- NKGen Biotech, Inc.
HER2 Mutant Non-small Cell Lung Cancer, HER2-positive Metastatic Breast Cancer
ELVN-002 in HER2 Mutant Non-Small Cell Lung Cancer
The goal of this clinical trial is to test ELVN-002 in people with cancers that have an abnormal HER2 gene. The main question the trial aims to answer is if ELVN-002 is safe and tolerable at different doses.
- Conditions
- HER2 Mutant Non-small Cell Lung Cancer, HER2-positive Metastatic Breast Cancer, HER2 Gene Mutation, HER2 Amplification
- Trial name
- HER2 (NCT05650879)
- Testing
- ELVN-002, Fam-Trastuzumab Deruxtecan-Nxki, Trastuzumab emtansine
- Where
- 39 sites in United States, Australia and 5 more
- Volunteers
- 198 people
- Sponsor
- Enliven Therapeutics
Hormone Receptor-positive Breast Cancer, HER2-negative Breast Cancer
ONO-4578-06:Phase I Study of ONO-4578 and Letrozole Plus CDK4 /6 Inhibitors in Breast Cancer
This is a multicenter, open-label, non-controlled, phase I study to investigate the tolerability and safety of ONO-4578 used in combination with standard-of-care letrozole and a CDK4/6 inhibitor (palbociclib or Abemaciclib) as…
- Conditions
- Hormone Receptor-positive Breast Cancer, HER2-negative Breast Cancer, Metastatic Breast Cancer, Recurrent Breast Cancer
- Trial name
- NCT06570031
- Testing
- ONO-4578, letrozole, Palbociclib
- Where
- 13 sites in Japan
- Volunteers
- 46 people
- Sponsor
- Ono Pharmaceutical Co., Ltd.
HER2-positive Breast Cancer, HER2-positive Gastric Cancer
A Safety and Activity Study of SBT6050 in Combination With Other HER2-directed Therapies for HER2-positive Cancers
This study is designed to assess the safety and preliminary activity of SBT6050 in combination with trastuzumab deruxtecan (Part 1) or tucatinib plus trastuzumab +/- capecitabine (Part 2).
- Conditions
- HER2-positive Breast Cancer, HER2-positive Gastric Cancer, HER2-positive Colorectal Cancer, HER2-expressing Non-small Cell Lung Cancer
- Trial name
- NCT05091528
- Testing
- SBT6050, trastuzumab deruxtecan, tucatinib
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Silverback Therapeutics