Clinical trials: HER2 Negative, open to volunteers
Breast Neoplasms
A Study of Imlunestrant (LY3484356) in Premenopausal Women With Estrogen Receptor-Positive (ER+) Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Early Breast Cancer
This study will include two groups of patients: Cohort 1 and Cohort 2. Cohort 1: will help researchers learn how a medicine called imlunestrant (LY3484356) affects a specific type of breast cancer.
- Trial name
- preEMBER (NCT07287098)
- Testing
- Imlunestrant, Goserelin, Tamoxifen 20 mg
- Where
- 90 sites in United States, Belgium and 5 more
- Volunteers
- 600 people
- Sponsor
- Eli Lilly and Company
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, Advanced HR+/HER2- Breast Cancer
Study of Sacituzumab Govitecan With Atropine to Improve Tolerability in Advanced TNBC and HR+/HER2- Breast Cancer
The SATROPIN study is an international, multicenter, open-label, single-arm, phase II clinical trial to assess whether the use of prophylactic administration of atropine may prevent diarrhea in participants with unresectable…
- Conditions
- Breast Cancer, Advanced HR+/HER2- Breast Cancer, Advanced Triple-Negative Breast Cancer
- Trial name
- SATROPIN (NCT07367178)
- Testing
- Sacituzumab Govitecan (SG), Atropine, G-CSF (Granulocyte colony-stimulating factor)
- Volunteers
- 30 people
- Sponsor
- MedSIR
Hormone Receptor Positive HER-2 Negative Breast Cancer, Metastatic Breast Cancer
A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer
PUMA-ALI-1201 is a randomized, dose optimization, multicenter, Phase 2 study of alisertib administered in combination with endocrine therapy in participants with pathology-confirmed HR-positive/HER2-negative metastatic breast…
- Conditions
- Hormone Receptor Positive HER-2 Negative Breast Cancer, Metastatic Breast Cancer, Recurrent Breast Cancer
- Trial name
- ALISCA-Breast1 (NCT06369285)
- Testing
- Alisertib, Endocrine therapy
- Where
- 53 sites in United States, Portugal and 1 more
- Volunteers
- 225 people
- Sponsor
- Puma Biotechnology, Inc.
Breast Cancer
Molecular Analyses to Predict Pathways of Endocrine Resistance Following Short Term Neoadjuvant Endocrine Treatment in Patients With Hormone Receptor-Positive HER2-negative Breast Cancer
This is an exploratory phase II interventional study that initiates standard-of-care anti-estrogen treatment preoperatively for 4-12 weeks (+/- 2 weeks).
- Trial name
- MAPPER (NCT06361940)
- Testing
- Aromatase inhibitors or tamoxifen
- Where
- United States
- Volunteers
- 185 people
- Sponsor
- Medical College of Wisconsin
Advanced Solid Tumors
A Study to Evaluate ATX-898 in Participants With Advanced Solid Tumors
Study ATX-898-101 is a phase 1/2 open-label study evaluating the safety, tolerability, pharmacokinetic, and preliminary efficacy of ATX-898 as monotherapy and in combination with anti-neoplastic agents in selected solid tumors.
- Trial name
- NCT07767474
- Testing
- ATX-898, ATX-898, fulvestrant, ribociclib
- Where
- 6 sites in United States, Australia
- Volunteers
- 343 people
- Sponsor
- Antares Therapeutics, Inc
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.
Breast Cancer, HER2-negative Breast Cancer
Clinical Study of Breast Conserving Surgery Combined With Intraoperative Radiotherapy for Early Breast Cancer
A Single-center, open, prospective study，for analyzing the local recurrence rate, the incidence of incision complications and the aesthetic effect of intraoperative radiotherapy in early breast cancer patients after…
- Trial name
- NCT06375798
- Testing
- radiotherapy
- Where
- China
- Volunteers
- 620 people, healthy volunteers welcome
- Sponsor
- Hebei Medical University Fourth 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)
Breast Cancer
The Clinical Trial of TQB2102 for Injection Against Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer
This study aims to evaluate the efficacy and safety of TQB2102 for injection in HER2 negative recurrent/metastatic breast cancer.
- Trial name
- NCT06452706
- Testing
- TQB2102 for injection
- Where
- 16 sites in China
- Volunteers
- 42 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Breast Cancer, Triple Negative Breast Cancer (TNBC)
Circulating Tumor DNA Dynamics to Optimize Neoadjuvant Therapy in HER2-Positive and Triple-Negative Breast Cancer
The purpose of this non-interventional, observational study is to evaluate the clinical utility of circulating tumor DNA (ctDNA) utility-specifically how quickly tumor DNA disappears from the bloodstream (ctDNA clearance)-to help…
- Conditions
- Breast Cancer, Triple Negative Breast Cancer (TNBC), HER2 + Breast Cancer
- Trial name
- NEOSHED (NCT07662252)
- Volunteers
- 186 people
- Sponsor
- Federico II University
Breast Cancer - ER+, HER2-, PIK3CA Gene Mutation
PI3K Pathway Activation Markers in ER-Positive, HER2-Negative Breast Cancer: A Clinicopathologic Study
The goal of this observational study is to examine whether markers of PI3K pathway activation are associated with endocrine therapy response and clinicopathologic features in estrogen receptor-positive, HER2-negative breast…
- Trial name
- p-AKT p-S6 (NCT07387861)
- Testing
- Not applicable- observational study
- Volunteers
- 70 people
- Sponsor
- Assiut University
Locally Advanced or Metastatic Breast Cancer
Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of Breast Cancer
This study is designed to evaluate the safety and efficacy of SPH4336 combined with letrozole in first-line treatment of locally advanced or metastatic breast cancer
- Trial name
- NCT05744687
- Testing
- SPH4336 Tablets 400mg
- Where
- 9 sites in China
- Volunteers
- 374 people
- Sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd
Breast Cancer Metastatic
To Investigate the Real-world Efficacy and Safety of Sacituzumab Govitecan for HER2 Negative Metastatic Breast Cancer Patients in China.
To investigate the real-world efficacy and safety of Sacituzumab govitecan for HER2 negative metastatic breast cancer patients in China.
- Trial name
- SACIT-OUT (NCT06784921)
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Zhejiang Cancer Hospital
HR+/HER2- Early Breast Cancer
Efficacy and Safety of Culmerciclib Plus Aromatase Inhibitors in a Response-Adapted Neoadjuvant Strategy for Highly Proliferative ER-Positive/HER2-Negative Breast Cancer
This prospective, response-adapted phase II study evaluates the efficacy and safety of neoadjuvant culmerciclib in combination with aromatase inhibitors in patients with highly proliferative ER-positive/HER2-negative breast…
- Trial name
- TAYLOR-002 (NCT07616453)
- Testing
- Culmerciclib, Aromatase Inhibitors
- Where
- China
- Volunteers
- 45 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Advanced Breast Cancer
Study of ADCs Combined With Adebrelimab in HER2-negative Advanced Breast Cancer
Our study is aimed to evaluate the efficacy and safety of novel ADCs named SHR-A1811, SHR-A1921 and SHR-A2102 combined with adebrelimab in HER2-negative advanced breast cancer.
- Trial name
- NCT06433609
- Testing
- SHR-A1811, SHR-A1921, Adebrelimab
- Where
- China
- Volunteers
- 113 people
- Sponsor
- Beijing GoBroad Hospital
Breast Cancer
EvoLution of Neoadjuvant TreatMent in 'Triple-negative' or 'HER-2-positive' Breast Cancer Diagnosed in the EaRly Phase
The primary objective of this study is to describe the percentage of patients with HER2-positive and Triple Negative tumour underwent neoadjuvant treatment in clinical practice during the past 5 years out of total number of…
- Trial name
- GIM28-ELMER (NCT06894173)
- Where
- 29 sites in Italy
- Volunteers
- 1,000 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Advanced HR+/HER2- Breast Cancer
Study of IEV407 as Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer
The purpose of this study is to evaluate the safety, tolerability and preliminary activity of IEV407 as a single agent and in combination with endocrine therapy (fulvestrant or letrozole) in patients with advanced hormone…
- Trial name
- NCT07604571
- Testing
- IEV407, Fulvestrant, Letrozole
- Where
- 12 sites in United States, Canada and 7 more
- Volunteers
- 194 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Breast Cancer
Fulvestrant Versus Capecitabine as Maintenance Therapy After First-line Chemotherapy in Patients With HR+/HER2- Metastatic Breast Cancer
This phase III trial aims to compare the efficacy and safety of fulvestrant or capecitabine as maintenance therapy after first-line chemotherapy in hormone receptor-positive, human epidermal growth factor receptor-2 negative…
- Trial name
- NCT04263298
- Testing
- Fulvestrant, Capecitabine Oral Product
- Where
- 13 sites in China
- Volunteers
- 210 people
- Sponsor
- Herui Yao
HER2-Negative Locally Advanced Breast Cancer
Evaluate the Efficacy and Safety of Adebrelimab Combined With Chemotherapy With or Without Radiotherapy as Neoadjuvant Treatment for HER2-Negative Locally Advanced Breast Cancer
A Prospective, Multicenter, Randomized Controlled Phase II Study to Evaluate the Efficacy and Safety of Adebrelimab Combined with Chemotherapy with or without Radiotherapy as Neoadjuvant Treatment for HER2-Negative Locally…
- Trial name
- NCT06908668
- Testing
- Neoadjuvant Chemotherapy Combined with Immunotherapy and Radiotherapy, Neoadjuvant Chemotherapy Combined with Immunotherapy
- Where
- China
- Volunteers
- 170 people
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences