Clinical trials: HER2 Negative Breast Neoplasms
Breast Neoplasms
A Study of E7090 as Monotherapy and in Combination With Other Anticancer Agents in Participants With Estrogen Receptor Positive (ER+) and Human Epidermal Growth Receptor 2 Negative (HER2-) Recurrent/Metastatic Breast Cancer
The primary purpose of this study is to evaluate the tolerability and safety of E7090 as monotherapy and in combination with other anticancer agents in participants with ER+, HER2- recurrent/metastatic breast cancer and to…
- Trial name
- NCT04572295
- Testing
- E7090, Fulvestrant, Exemestane
- Where
- 11 sites in Japan
- Volunteers
- 51 people
- Sponsor
- Eisai Co., Ltd.
HER2-negative Metastatic Breast Cancer
A Dose-escalation Study of the Safety and Pharmacology of DAN-222 in Subjects With Metastatic Breast Cancer
This was an open-label, multicenter, dose-escalation study designed to assess the safety, tolerability, and PK of IV administered DAN-222 followed by a dose-escalation of DAN-222 in combination with niraparib: Part A is dose…
- Trial name
- NCT05261269
- Testing
- DAN-222, Niraparib
- Where
- 9 sites in United States
- Volunteers
- 30 people
- Sponsor
- Dantari, Inc.
HR-positive, HER2-negative Breast Cancer, TNBC - Triple-Negative Breast Cancer
Gene-edited T Regulatory Cells (CRG-150) for the Treatment of Relapsed/Refractory Malignancies
The goal of this Phase 1/2a interventional study is to evaluate the safety and tolerability of CRG-150 in relapsed/refractory HR+HER2- breast cancer, Triple Negative Breast Cancer (TNBC) and prostate cancer.
- Conditions
- HR-positive, HER2-negative Breast Cancer, TNBC - Triple-Negative Breast Cancer, Prostate Cancer
- Trial name
- NCT07730125
- Testing
- CRG-150
- Volunteers
- 67 people
- Sponsor
- CoRegen, Inc.
Breast Cancer
Safety and Efficacy of Trastuzumab as Part of Breast Cancer Treatment Regimen
This is a prospective, Phase IV, multi-center, single arm, open-label, interventional study to evaluate the safety of trastuzumab for the treatment of human epidermal growth factor receptor 2 protein (HER2)-positive node positive…
- Trial name
- NCT02419742
- Testing
- Carboplatin, Cyclophosphamide, Docetaxel
- Where
- 6 sites in India
- Volunteers
- 110 people
- Sponsor
- Hoffmann-La Roche
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
Triple Negative Locally Advanced Non-resectable Breast Cancer, HR+, HER2-, Advanced Breast Cancer
A Study of Invikafusp Alfa (STAR0602), a Selective T Cell Receptor (TCR)-Targeting, Bifunctional Antibody-fusion Molecule, in Combination With Sacituzumab Govitecan in Participants With Advanced Solid Tumors
This is a Phase 1b/2, Open-label Study to Investigate the Safety and Efficacy of Invikafusp alfa (STAR0602), a Selective T Cell Receptor (TCR)-targeting, Bifunctional Antibody-fusion Molecule, in Combination with Sacituzumab…
- Trial name
- START-002 (NCT06827613)
- Testing
- STAR0602, Sacituzumab Govitecan (SG)
- Where
- 8 sites in United States, Canada
- Volunteers
- 50 people
- Sponsor
- Marengo Therapeutics, Inc.
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
Breast Cancer
Study of Elacestrant in Combination With Onapristone in Patients With Advanced or Metastatic Breast Cancer
This is a multicenter, Phase 1b-2 study of elacestrant in combination with onapristone in patients with advanced/metastatic ER+/PgR+/HER2- breast cancer.
- Trial name
- ELONA (NCT05618613)
- Testing
- Elacestrant, Onapristone
- Where
- 3 sites in United States
- Volunteers
- 4 people
- Sponsor
- Context Therapeutics Inc.
Metastatic Breast Cancer
Pilot Study to Evaluate Reparixin With Weekly Paclitaxel in Patients With HER 2 Negative Metastatic Breast Cancer (MBC)
This is a phase I study to evaluate the safety and define the pharmacokinetic (PK) profile of orally administered reparixin in combination with paclitaxel in HER 2 (Human epidermal growth factor receptor-2) negative metastatic…
- Trial name
- NCT02001974
- Testing
- Paclitaxel+Reparixin
- Where
- 5 sites in United States
- Volunteers
- 33 people
- Sponsor
- Dompé Farmaceutici S.p.A
Recurrent or Metastatic Breast Cancer
A Phase III Study of SYS6010 Versus Chemotherapy in HER2-Negative, EGFR-Positive Recurrent or Metastatic Breast Cancer
This study is a multicenter, randomized, open-label, parallel-control Phase III clinical trial enrolling patients with unresectable HER2-negative, EGFR-positive recurrent/metastatic breast cancer who have previously failed first…
- Trial name
- NCT07406542
- Testing
- SYS6010, Investigator's Choice of Chemotherapy (eribulin, capecitabine, gemcitabine, or vinorelbine)
- Volunteers
- 400 people
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors
Study of GVV858 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
Phase I: Characterize safety and tolerability of GVV858 as a single agent and in combination with fulvestrant or letrozole. Identify dose range for optimization/recommended dose for further clinical evaluation.
- Conditions
- Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors, Metastatic Castration-resistant Prostate Cancer
- Trial name
- NCT07288359
- Testing
- GVV858, Fulvestrant, Letrozole
- Where
- 16 sites in United States, Canada and 9 more
- Volunteers
- 205 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer
This is a Phase III, 2-arm, randomised, open-label, multicentre, global study assessing the efficacy and safety of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy compared with…
- Trial name
- NCT06112379
- Testing
- Dato-DXd, Durvalumab, Pembrolizumab
- Where
- 283 sites in United States, Australia and 24 more
- Volunteers
- 1,902 people
- Sponsor
- AstraZeneca
Breast Cancer
Implementation Study to Describe and Compare Retention Rate and Adherence to Adjuvant Therapy With Ribociclib With and Without Usage of Mobile Application in Patients With HR+ HER2-negative Stage II and III Breast Cancer in Real-world Practice
This study is designed to evaluate the effect of using the application on the adherence of patients with luminal HER2- breast cancer (BC) stage II-III to adjuvant therapy with ribociclib in combination with an aromatase inhibitor…
- Trial name
- IMPULSE (NCT06905301)
- Testing
- Ribociclib, Letrozole, Anastrozole
- Where
- 7 sites in Russia
- Volunteers
- 240 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Solid Tumor, Metastatic Solid Tumor
A Study to Evaluate the Safety and Therapeutic Activity of GI-102 As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patients with Advanced Solid Tumors (KEYNOTE-G08)
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-102 as a single agent and in combination with conventional anti-cancer drugs, pembrolizumab or trastuzumab…
- Conditions
- Advanced Solid Tumor, Metastatic Solid Tumor, Soft Tissue Sarcoma (STS), Platinum-resistant Ovarian Cancer (PROC)
- Trial name
- NCT05824975
- Testing
- GI-102 subcutaneous (SC), GI-102, doxorubicin
- Where
- 11 sites in United States, South Korea
- Volunteers
- 358 people
- Sponsor
- GI Innovation, Inc.
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
A Real-world Study Observing Treatment Patterns and Clinical Results for Patients in China With Hormone Receptor-positive, HER2-negative Metastatic Breast Cancer.
The study aims to describe demographics, clinical characteristics, genetic test diagnosis, treatment patterns, and clinical outcomes in HR+/HER2- (including HER2-low, HER2-ultralow, and HER2-null) unresectable or metastatic…
- Trial name
- VERITAS (NCT07743944)
- Where
- China
- Volunteers
- 2,000 people
- Sponsor
- AstraZeneca
Advanced, Metastatic Breast Cancer
Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer
The primary purpose of this study was to assess the efficacy of ribociclib, as measured by progression free survival (PFS), in postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2…
- Trial name
- MONALEESA-2 (NCT01958021)
- Testing
- Ribociclib, Letrozole
- Where
- 221 sites in United States, Argentina and 27 more
- Volunteers
- 668 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
UNFOLD Study Egypt
Breast cancer is a major public health concern worldwide. In Egypt, it was the most diagnosed cancer among females in 2020 with an incidence rate of 32.4%.
- Trial name
- NCT06188494
- Where
- 7 sites in Egypt
- Volunteers
- 405 people
- Sponsor
- AstraZeneca
Advanced Breast Cancer
A Phase Ib/II Study of QLC1401 Combined With CDK4/6 or mTOR Inhibitors in ER+/HER2- Advanced Breast Cancer
This study is an open-label, multicenter, Phase Ib/II clinical trial designed to evaluate the safety, tolerability, efficacy, and pharmacokinetic characteristics of QLC1401 tablets in combination with CDK4/6 inhibitors or mTOR…
- Trial name
- NCT07173556
- Testing
- QLC1401
- Volunteers
- 96 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Breast Cancer
Neoadjuvant Chemotherapy With WH002 in Women With HER2-negative Breast Cancer
The purpose of this study is to compare the safety and efficacy of bi-weekly WH002(Paclitaxel Medium and Long Chain Fat Emulsion Injection,Cholesterol Bound) vs Paclitaxel both followed by bi-weekly Epirubicin and…
- Trial name
- NCT06513364
- Testing
- WH002, paclitaxel injection
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Beijing Wehand-Bio Pharmaceutical Co., Ltd