Clinical trials: HER2+ Breast Cancer
HER2-negative
NIS Study Determining Prevalence of HER2-low in Metastatic Breast Cancer Patients
This noninterventional, multicenter,retrospective study has been proposed to estimate the prevalence, clinicopathological characteristics,treatment patterns and clinical outcomes of human epidermal growth factor receptor 2…
- Trial name
- iRetroBC (NCT06131424)
- Where
- 31 sites in Argentina, Brazil and 11 more
- Volunteers
- 1,151 people
- Sponsor
- AstraZeneca
Breast Cancer
Multi-4SCAR-T Therapy Targeting Breast Cancer
The purpose of this study is to assess the feasibility, safety and efficacy of multiple 4th generation CAR-T cells targeting Her2, GD2, and CD44v6 surface antigen in breast cancer.
- Trial name
- NCT04430595
- Testing
- 4SCAR T cells
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Shenzhen Geno-Immune Medical Institute
Breast Neoplasms, HER2-positive Breast Cancer
Real World Study on the Efficacy and Safety of Anti-HER2 Therapy
Anti HER2 therapy can improve the survival of HER2 positive patients and reduce mortality. The aim of the open-label, real-world study is to assess efficacy and safety of Anti-HER2 treatment drugs.
- Trial name
- NCT05367739
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Hunan Cancer Hospital
Breast Cancer
A Study of GDC-0810 Versus Fulvestrant in Postmenopausal Women With Advanced or Metastatic Breast Cancer Resistant to Aromatase Inhibitor (AI) Therapy
The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of GDC-0810 compared with fulvestrant in postmenopausal women with advanced or metastatic estrogen receptor positive (ER+)/ human epidermal…
- Trial name
- HydranGea (NCT02569801)
- Testing
- Fulvestrant, GDC-0810
- Where
- 44 sites in United States, Australia and 4 more
- Volunteers
- 71 people
- Sponsor
- Genentech, Inc.
Locally Advanced or Metastatic ER+ HER2- Breast Cancer, Locally Advanced or Metastatic Castration-resistant Prostate Cancer
Study of PF-07248144 in Advanced or Metastatic Solid Tumors
This is an open-label, multi center study to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-07248144 and early signs of clinical efficacy of PF-07248144 as a single agent and in combination…
- Conditions
- Locally Advanced or Metastatic ER+ HER2- Breast Cancer, Locally Advanced or Metastatic Castration-resistant Prostate Cancer, Locally Advanced or Metastatic Non-small Cell Lung Cancer
- Trial name
- KAT6 (NCT04606446)
- Testing
- PF-07248144, Fulvestrant, Letrozole
- Where
- 43 sites in United States, Australia and 3 more
- Volunteers
- 320 people
- Sponsor
- Pfizer
Breast Neoplasms
A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer
The main purpose of this study is to compare progression-free survival for women with hormone receptor positive (HR+), human epidermal growth factor receptor (HER2) negative advanced breast cancer receiving either abemaciclib +…
- Trial name
- MONARCH 2 (NCT02107703)
- Testing
- Abemaciclib, Fulvestrant
- Where
- 146 sites in United States, Australia and 18 more
- Volunteers
- 669 people
- Sponsor
- Eli Lilly and Company
Breast Cancer
Efficacy and Safety of Disitamab Vedotin Plus Pyrotinib or Naratinib in HER2-positive Breast Cancer Patients With Brain Metastasis
Basis: Brain metastasis is very common in breast cancer, and HER2 positivity is a risk factor for high incidence of brain metastasis, with approximately 50% of HER2+ MBC cases experiencing brain metastasis.
- Trial name
- NCT06015113
- Testing
- Disitamab Vedotin plus pyrotinib or naratinib
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Xi'an International Medical Center Hospital
Breast Neoplasm
SFX-01 in the Treatment and Evaluation of Metastatic Breast Cancer
This is a Phase 2 study to demonstrate the safety and efficacy of SFX-01 when used in combination with aromatase inhibitors (AIs), tamoxifen and fulvestrant.
- Trial name
- STEM (NCT02970682)
- Testing
- SFX-01, Fulvestrant, Tamoxifen
- Where
- 10 sites in Belgium, France and 2 more
- Volunteers
- 60 people
- Sponsor
- Evgen Pharma
Early-stage Breast Cancer, HER2 Positive Breast Cancer
Three Antidiarrheal Strategies in HER2+/HR+ Early Breast Cancer Patients Treated With Extended Adjuvant Neratinib
A Randomized Phase II Study to Evaluate the Incidence of Discontinuations due to Diarrhoea at 3 Cycles in patients with Early-stage HER2-positive (HER2+), Hormone Receptor-positive (HR+) Breast Cancer treated with Neratinib plus…
- Conditions
- Early-stage Breast Cancer, HER2 Positive Breast Cancer, Hormone Receptor Positive
- Trial name
- DIANER (NCT05252988)
- Testing
- Neratinib, Loperamide, Colesevelam
- Where
- 55 sites in Spain
- Volunteers
- 177 people
- Sponsor
- Spanish Breast Cancer Research Group
Breast Cancer
Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BTX-9341 in Advanced and/or Metastatic Breast Cancer
The purpose of this study is to test BTX-9341 alone or in combination with fulvestrant (a currently marketed medication for breast cancer) in participants with advanced and/or metastatic hormone receptor positive (HR+)/human…
- Trial name
- NCT06515470
- Testing
- BTX-9341, Fulvestrant
- Where
- 6 sites in United States
- Volunteers
- 82 people
- Sponsor
- Biotheryx, Inc.
Neoplasms, Breast
Phase I/II Study of Lapatinib in Combination With Paclitaxel as 1L Chemotherapy for ErbB2-positive MBC
This is an open-label, non-randomized, multi-center study of lapatinib plus paclitaxel to evaluate safety, tolerability and efficacy in Japanese patients with ErbB2 over expressing advanced or metastatic breast cancer.
- Trial name
- NCT01138046
- Testing
- Lapatinib in combination with weekly paclitaxel
- Where
- 10 sites in Japan
- Volunteers
- 12 people
- Sponsor
- GlaxoSmithKline
Metastatic Breast Cancer
A Trial Comparing Docetaxel Plus Fulvestrant With Docetaxel in Metastatic Breast Cancer
Comparing Docetaxel Plus Fulvestrant With Docetaxel in Patients With Metastatic Breast Cancer
- Trial name
- NCT02137083
- Testing
- Docetaxel, Fulvestrant
- Where
- China
- Volunteers
- 22 people
- Sponsor
- Fudan University
Metastatic or Locally Advanced Solid Tumors
A Trial of Oral BEZ235 and BKM120 in Combination With Paclitaxel With or Without Trastuzumab
The purpose of the trial is to determine the maximum tolerated dose (MTD) of BEZ235 and BKM120 in combination with weekly paclitaxel and weekly paclitaxel/trastuzumab.
- Trial name
- NCT01285466
- Testing
- BEZ235 + paclitaxel, BKM120 + paclitaxel, BEZ235 + paclitaxel + trastuzumab
- Where
- 10 sites in Belgium, Germany and 3 more
- Volunteers
- 110 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Investigation of Gene Mutations in Patients With Triple-negative and Patients With HER2+ Breast Cancer Adenocarcinoma
The present study is a transnational study in patients with high risk recurrent breast cancer who receive adjuvant chemotherapy with epirubicin and cyclophosphamide followed by docetaxel or paclitaxel.
- Trial name
- NCT04365790
- Where
- Greece
- Volunteers
- 500 people
- Sponsor
- Hellenic Cooperative Oncology Group
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 Carcinoma, Locally Advanced Breast Cancer
Repeatability of 68-GaNOTA-Anti-HER2 VHH1 PET/CT in Breast Carcinoma Patients
Study objective: Cohort 1: To quantify the uptake of 68GaNOTA-Anti-HER2 VHH1 in local or distant metastases from breast carcinoma patients and to assess repeatability of the image-based HER2 quantification.
- Conditions
- Metastatic Breast Carcinoma, Locally Advanced Breast Cancer, Cancer of Pancreas, Solid Tumor With Intermediate or High HER2 Expression
- Trial name
- VUBAR (NCT03924466)
- Testing
- 68GaNOTA-Anti-HER2 VHH1
- Where
- Belgium
- Volunteers
- 55 people
- Sponsor
- Universitair Ziekenhuis Brussel
Breast Cancer
Pyrotinib Plus Trastuzumab Versus Pertuzumab Plus Trastuzumab
Pyrotinib Plus Trastuzumab Versus Pertuzumab Plus Trastuzumab
- Trial name
- NCT05572645
- Testing
- Pyrotinib Plus Trastuzumab, Pertuzumab Plus Trastuzumab
- Where
- China
- Volunteers
- 333 people
- Sponsor
- Fudan University
Cancer
Study of Prophylactic Octreotide to Prevent or Reduce the Frequency and Severity of Diarrhoea in Subjects Receiving Lapatinib With Capecitabine for the Treatment of Metastatic Breast Cancer
Diarrhoea is the most commonly reported adverse event (AE) associated with Lapatinib treatment, and is also commonly associated with Capecitabine treatment.
- Trial name
- NCT02294786
- Testing
- Lapatinib, Capecitabine, Octreotide
- Where
- 17 sites in Czechia, Israel and 3 more
- Volunteers
- 62 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer Metastatic
ABemaciclib, ET ± paclItaxel in aGgressive HR+/HER2- MBC trIaL
This is a multicenter, randomized, 2 arm, open label, phase II study. It is designed to compare the efficacy and safety of abemaciclib combined with ET (letrozole or fulvestrant) versus a short course with induction chemotherapy…
- Trial name
- ABIGAIL (NCT04603183)
- Testing
- Abemaciclib, Paclitaxel, Letrozole
- Where
- 31 sites in Italy, Portugal and 1 more
- Volunteers
- 162 people
- Sponsor
- MedSIR
Breast Cancer
A Study of Trastuzumab Emtansine Versus Capecitabine + Lapatinib in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer
This is a Phase III, randomized, multicenter, international, 2-arm, open-label clinical trial designed to compare the safety and efficacy of trastuzumab emtansine (T-DM1) with that of capecitabine + lapatinib in participants with…
- Trial name
- EMILIA (NCT00829166)
- Testing
- Trastuzumab emtansine, Lapatinib, Capecitabine
- Where
- 323 sites in United States, Bosnia and Herzegovina and 25 more
- Volunteers
- 991 people
- Sponsor
- Hoffmann-La Roche
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