Clinical trials: HER2 Negative Breast Cancer
Breast Cancer
A First-in-Human Study of D-0502 Alone and in Combination With Palbociclib in Women With Advanced or Metastatic ER-Positive and HER2-Negative Breast Cancer
This is a phase I, open-label study of D-0502 single agent and D-0502 in combination with standard dose of palbociclib to assess the safety and tolerability, identify an MTD, and/or RP2D, evaluate the PK properties and evaluate…
- Trial name
- NCT03471663
- Testing
- D-0502, palbociclib
- Where
- 15 sites in United States, China
- Volunteers
- 200 people
- Sponsor
- InventisBio Co., Ltd
Advanced Breast Cancer
POL6326 (Balixafortide) Plus Nab-paclitaxel or Eribulin in Patients With HER2-negative Advanced Breast Cancer
This is a multicenter Phase Ib/II, open-label, dose-escalation study to optimize POL6326 (balixafortide) in combination with nab-paclitaxel or eribulin in patients with HER2-negative advanced breast cancer.
- Trial name
- POLTER (NCT04826016)
- Testing
- POL6326, Eribulin, Nab paclitaxel
- Sponsor
- MedSIR
Leptomeningeal Disease, Triple Negative Breast Cancer
A First in Human Dose Escalation of Dendritic Cell Vaccine (DCV)
The purpose of this study is to learn about the effects of the study treatment, Dendritic Cell Vaccine (DCV), to find the highest dose of the study treatment that can be given safely to Breast Cancer patients with Leptomeningeal…
- Conditions
- Leptomeningeal Disease, Triple Negative Breast Cancer, HER2-positive Breast Cancer
- Trial name
- NCT05809752
- Testing
- Dendritic Cell Vaccine
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
HR+ Breast Cancer, Triple Negative Breast Cancer (TNBC)
A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors
The goal of this open-label dose escalation and expansion study is to evaluate the safety and tolerability of NKT5097 in adults with advanced/metastatic tumors (emphasis on breast cancer and solid tumors with CCNE1…
- Conditions
- HR+ Breast Cancer, Triple Negative Breast Cancer (TNBC), CCNE1 Amplified Advanced Solid Tumors, HR+ HER2- Breast Cancer
- Trial name
- NCT07029399
- Testing
- NKT5097 CDK2/CDK4 dual degrader, Fulvestrant, Letrozole
- Where
- 18 sites in United States
- Volunteers
- 361 people
- Sponsor
- NiKang Therapeutics, Inc.
Breast Cancer
Study of AC699 in Patients With Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Locally Advanced or Metastatic Breast Cancer
This clinical trial is evaluating a drug called AC699 in participants with estrogen receptor positive/human epidermal growth factor 2 negative (ER+/HER2-) locally advanced or metastatic breast cancer.
- Trial name
- NCT05654532
- Testing
- AC699
- Where
- 9 sites in United States
- Volunteers
- 100 people
- Sponsor
- Accutar Biotechnology Inc
Advanced or Metastatic Breast Cancer
A Study of AND019 in Women With ER Positive HER2 Negative Advanced or Metastatic Breast Cancer
This is a first in human dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) activity, and preliminary anti-tumor activity of AND019 in postmenopausal women with…
- Trial name
- NCT05187832
- Testing
- AND019 PO QD
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Kind Pharmaceuticals LLC
Breast Cancer
A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer
This study will evaluate the efficacy and safety of the combination of inavolisib plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole versus placebo plus a CDK4/6i and letrozole in the first-line setting in…
- Trial name
- INAVO123 (NCT06790693)
- Testing
- Inavolisib, CDK4/6i, Letrozole
- Where
- 242 sites in United States, Argentina and 18 more
- Volunteers
- 450 people
- Sponsor
- Hoffmann-La Roche
ER+ HER2- Advanced Breast Cancer
A Phase 1 Study of AZD9833 in Japanese Women With ER Positive, HER2 Negative Advanced Breast Cancer
This is a Phase 1, open-label study designed to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of AZD9833 in Japanese women with endocrineresistant ER+ HER2- breast cancer that is not amenable to…
- Trial name
- NCT04541433
- Testing
- AZD9833
- Where
- 3 sites in Japan
- Volunteers
- 10 people
- Sponsor
- AstraZeneca
Breast Cancer
Tesetaxel Plus 3 Different PD-(L)1 Inhibitors in Patients With Triple-Negative MBC and Tesetaxel Monotherapy in Patients With HER2-Negative MBC
CONTESSA TRIO is a multi-cohort, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC).
- Trial name
- CONTESSA TRIO (NCT03952325)
- Testing
- Tesetaxel, Nivolumab, Pembrolizumab
- Where
- 12 sites in United States, Singapore and 1 more
- Volunteers
- 294 people
- Sponsor
- Odonate Therapeutics, Inc.
Breast Cancer
S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate, goserelin acetate, leuprolide acetate, anastrozole, letrozole, or exemestane, may fight breast cancer by lowering the…
- Trial name
- e3 (NCT01674140)
- Testing
- anastrozole, everolimus, exemestane
- Where
- 1,458 sites in United States, Puerto Rico
- Volunteers
- 1,939 people
- Sponsor
- SWOG Cancer Research Network
Breast Cancer (Locally Advanced or Metastatic), HER2-positive Breast Cancer
Dual-Target CAR-NK Cells for Advanced Breast Cancer (HER2+ and TNBC)
This study tests the safety and preliminary anti-tumor activity of an investigational dual-target chimeric antigen receptor natural killer (CAR-NK) cell therapy in adults with advanced breast cancer.
- Conditions
- Breast Cancer (Locally Advanced or Metastatic), HER2-positive Breast Cancer, Triple-Negative Breast Cancer (TNBC)
- Trial name
- DUAL-NK-BC (NCT07486089)
- Testing
- Dual-target CAR-NK cells (EB-DT-CAR-NK), Lymphodepleting chemotherapy, Supportive care
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Beijing Biotech
Breast Cancer
Phase II Study With Abraxane, Bevacizumab and Carboplatin in Triple Negative Metastatic Breast Cancer
Taxanes (such as paclitaxel) are highly active to treat breast cancer. Abraxane® (nanoparticle albumin-bound paclitaxel) compared to standard paclitaxel improves efficacy and tolerability.
- Trial name
- ABC (NCT00479674)
- Testing
- Abraxane, Bevacizumab, Carboplatin
- Where
- 4 sites in United States
- Volunteers
- 41 people
- Sponsor
- Duke University
ER-Positive Breast Cancer, HER2-negative Breast Cancer
Fulvestrant+Abemaciclib With Run-In of Fulvestrant in Er-Positive, Her2-Negative Metastatic Breast Cancer
The study will investigate if CDK4/6 inhibitor holiday will reset the cell cycle process to respond to the combination of fulvestrant and abemaciclib, and this approach may represent an effective therapeutic strategy to manage…
- Trial name
- NCT05305924
- Testing
- Fulvestrant Run-In
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- The Methodist Hospital Research Institute
Neoadjuvant Therapy
Neoadjuvant SNF Precision Therapy Phase III
This study is a prospective, open-label, multicenter, randomized controlled Phase III clinical trial designed to compare the efficacy and safety of neoadjuvant chemotherapy based on SNF classification with or without precision…
- Trial name
- NCT06913777
- Testing
- Targeted therapy agents: SNF2 -adebrelimab + famitinib; SNF3 -fluzoparib; SNF4 -apatinib, Chemotherapy (wP-EC)
- Where
- China
- Volunteers
- 404 people
- Sponsor
- Fudan University
Breast Neoplasm
Impact of eHealth-support on Quality of Life in Metastatic Breast Cancer Patients Treated With Palbociclib and Endocrine Therapy
In this study the investigators assess the impact of the eHealth-supported therapy management system CANKADO on Quality of Life in patients with HR+, HER2-locally advanced or metastatic breast cancer treated with the cyclin…
- Trial name
- PRECYCLE (NCT03220178)
- Testing
- Palbociclib, Fulvestrant, Anastrozole
- Where
- Germany
- Volunteers
- 532 people
- Sponsor
- Palleos Healthcare GmbH
Breast Cancer
Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC
The purpose of this study is to collect additional safety and efficacy data for the combination of ribociclib + letrozole in men and pre/postmenopausal women with HR+HER2- advanced breast cancer and no prior hormonal treatment…
- Trial name
- COMPLEEMENT-1 (NCT02941926)
- Testing
- Ribociclib, Letrozole, Goserelin
- Where
- 495 sites in United States, Argentina and 36 more
- Volunteers
- 3,246 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer, Metastatic Breast Cancer
Trastuzumab and Vinorelbine in Advanced Breast Cancer
The purpose of this research study is to see what effects trastuzumab in combination with vinorelbine has on breast cancer when the participant has circulating tumor cells that are positive for the protein called HER2.
- Trial name
- NCT01185509
- Testing
- trastuzumab, vinorelbine
- Where
- 3 sites in United States
- Volunteers
- 31 people
- Sponsor
- Dana-Farber Cancer Institute
Breast Cancer, Breast Carcinoma
Safety and Immune Response to a Mammaglobin-A DNA Vaccine In Breast Cancer Patients Undergoing Neoadjuvant Endocrine Therapy
The purpose of this research study is to find out about the safety of injecting the gene (DNA) for mammaglobin-A into people with breast cancer.
- Conditions
- Breast Cancer, Breast Carcinoma, Malignant Neoplasm of Breast
- Trial name
- NCT02204098
- Testing
- Mammaglobin-A DNA Vaccine, Optional biopsy
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Washington University School of Medicine
Breast Cancer
Neoadjuvant Doxorubicin/Cyclophosphamide Followed by Eribulin Chemotherapy (ACE) in Operable HER2-negative Breast Cancer
This is a phase II, single institutional study, to evaluate a novel neo-adjuvant regimen in patients with operable, HER2-negative, breast cancer.
- Trial name
- NCT02215876
- Testing
- Doxorubicin, Cyclophosphamide, Eribulin
- Where
- Singapore
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Breast Cancer
A Study to Develop Predictive and Prognostic Tools for Optimizing Therapy With Bevacizumab Frontline Cancer Therapy in Participants With HER 2-Negative Aggressive Metastatic Breast Cancer
This multicenter, observational, prospective study will identify a powerful and easy predictive/prognostic marker to use with participants under bevacizumab.
- Trial name
- Argo (NCT02613208)
- Testing
- Bevacizumab, Paclitaxel
- Where
- 25 sites in Spain
- Volunteers
- 111 people
- Sponsor
- Hoffmann-La Roche
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