Clinical trials: ER+ Breast Cancer
ER+/HER2- Breast Cancer
Neoadjuvant High-Intensity Focused Ultrasound (HIFU) Combined With Toripalimab and Chemotherapy for ER-Positive /HER2-Negative Breast Cancer
The purpose of this study is to evaluate the efficacy and safety of high-intensity focused ultrasound (HIFU) combined with toripalimab and chemotherapy as neoadjuvant therapy for ER+/HER2- breast cancer.
- Trial name
- NeoHunter (NCT06964906)
- Testing
- HIFU, Toripalimab, nab-Paclitaxel (nab-P)
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
ER+ Breast Cancer
4FMFES-PET Imaging of ER+ Advanced Breast Cancers
Estrogen Receptor (ER) is a crucial prognostic factor and treatment target in breast cancer patients. Knowledge of its status greatly influences the choice of the optimal course of treatment.
- Trial name
- NCT04824014
- Testing
- 4FMFES-PET
- Where
- Canada
- Volunteers
- 150 people
- Sponsor
- Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Estrogen Receptor (ER)-Positive, HER2-negative, Locally Advanced or Metastatic Breast Cancer
A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With the Physician's Choice of Endocrine Therapy Plus Everolimus in Participants With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer (evERA Breast Cancer)
This Phase III, randomized, open-label, multicenter study will evaluate the efficacy and safety of giredestrant plus everolimus compared with the physician's choice of endocrine therapy plus everolimus in participants with…
- Trial name
- NCT05306340
- Testing
- Giredestrant, Exemestane, Fulvestrant
- Where
- 136 sites in United States, Argentina and 11 more
- Volunteers
- 373 people
- Sponsor
- Genentech, Inc.
ER+, HER 2- Breast Cancer, Non-small Cell Lung Cancer (NSCLC)
A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of IDE574 Therapy in Adult Participants With Advanced Solid Tumors
IDE574 is a synthetically manufactured small molecule inhibitor that co-targets the lysine acetyltransferase enzymes KAT6 and KAT7.
- Conditions
- ER+, HER 2- Breast Cancer, Non-small Cell Lung Cancer (NSCLC), Castration-resistant Prostate Cancer (CRPC), Microsatellite Stable (MSS) Colorectal Carcinoma
- Trial name
- NCT07540572
- Testing
- IDE574, Fulvestrant injection
- Where
- 11 sites in United States
- Volunteers
- 160 people
- Sponsor
- IDEAYA Biosciences
Breast Cancer, HER2-negative Breast Cancer
A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Lobular Breast Cancer
The purpose of this study is to look at how effective neoadjuvant (before surgery) endocrine therapy (NET) is in participants with invasive lobular carcinoma (ILC) who have breast-conserving surgery (BCS).
- Conditions
- Breast Cancer, HER2-negative Breast Cancer, HER2 Negative Breast Carcinoma, ER+ Breast Cancer
- Trial name
- NCT07483307
- Testing
- Neoadjuvant endocrine therapy
- Where
- 7 sites in United States
- Volunteers
- 176 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Breast Cancer, ER Positive Breast Cancer
Phase II Study of Neoadjuvant ArOMatase Inhibitor Therapy for ER+ Breast Cancer (NAOMI)
This is a single-arm, open-label study testing the effects of neoadjuvant therapy with the aromatase inhibitor letrozole in post-menopausal women with Stage I-III ER+, HER2- breast cancer.
- Trial name
- NAOMI (NCT04568616)
- Testing
- Letrozole 2.5mg
- Where
- 2 sites in United States
- Volunteers
- 178 people
- Sponsor
- Dartmouth-Hitchcock Medical Center
ER-Positive, HER2-Negative Breast Cancer
A Phase 1 Study of HRS8807 Monotherapy and in Combination With SHR6390 in Subjects With ER-Positive, HER2-Negative Metastatic or Locally Advanced Breast Cancer
The study is to assess safety and tolerability of HRS8807 monotherapy and in combination with SHR6390 in subjects with metastatic or locally advanced breast cancer in order to estimate the Dose-Limiting Toxicity (DLT), Maximum…
- Trial name
- NCT04993430
- Testing
- HRS8807, HRS8807、SHR6390
- Where
- China
- Volunteers
- 46 people
- Sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
ER Positive, HER2 Positive Breast Cancer
Elacestrant in Advanced Triple Positive Breast Cancer
The purpose of this study to assess the safety and efficacy of elacestrant, a selective estrogen receptor degrader (SERD) and dual biologic therapy, trastuzumab and pertuzumab, in patients with triple-positive breast cancer with…
- Trial name
- NCT07612215
- Testing
- Elacestrant, Trastuzumab, Pertuzumab
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- NYU Langone Health
Advanced ER+/HER2- Breast Cancer
Phase Ib/II Clinical Study of QLS1304 Combined With Endocrine Therapy in the Treatment of ER+/HER2- Breast Cancer Patients
This study is a multi-center, open label, phase Ib/II clinical trial aimed at evaluating the safety, preliminary efficacy characteristic and PK characteristics of QLS1304 in combined with endocrine therapy in ER+/HER2- breast…
- Trial name
- NCT07235176
- Testing
- QLS1304 tablet+Fulvestrant or QLC1401, QLS1304 tablet+Fulvestrant，AI or QLC1401+CDK4/6i
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Breast Cancer, Early Breast Cancer
Independent, External, Blinded Retrospective Validation of an AI-based Prognostic Assay in ER-Positive/HER2-Negative Early Breast Cancer
This retrospective observational study evaluates the prognostic performance of a locked Artificial Intelligence (AI)-based assay in patients with Estrogen Receptor (ER)-positive, Human Epidermal Growth Factor Receptor 2…
- Conditions
- Breast Cancer, Early Breast Cancer, ER-Positive HER2-Negative Breast Cancer
- Trial name
- NCT07541703
- Testing
- Locked AI-based prognostic assay
- Where
- Austria
- Volunteers
- 2,200 people
- Sponsor
- Spotlight Medical
Breast Cancer, Triple Negative Breast Cancer
Breast Cancer Evolution During Neoadjuvant Systemic Therapy
BELIEVE is a translational research study that aims to collect samples of breast cancer tissue and blood from individuals undergoing breast cancer treatment (such as chemotherapy, targeted therapy and immunotherapy) before…
- Conditions
- Breast Cancer, Triple Negative Breast Cancer, ER+ Breast Cancer, HER2+ Breast Cancer
- Trial name
- BELIEVE (NCT06681064)
- Where
- United Kingdom
- Volunteers
- 500 people
- Sponsor
- Royal Marsden NHS Foundation Trust
Metastatic Breast Cancer, ER+ Breast Cancer
Fulvestrant, Ipatasertib and CDK4/6 Inhibition in Metastatic ER+/HER2- Breast Cancer Patients Without ctDNA Suppression
Analysis of circulating tumour DNA (ctDNA) found in a patient's peripheral blood can identify cancer progression and predict a patient's response to therapy.
- Conditions
- Metastatic Breast Cancer, ER+ Breast Cancer, Advanced Breast Cancer
- Trial name
- FAIM (NCT04920708)
- Testing
- Ipatasertib 300mg, Fulvestrant 500g, Palbociclib 75mg-125mg
- Where
- 13 sites in United Kingdom
- Volunteers
- 57 people
- Sponsor
- Royal Marsden NHS Foundation Trust
Advanced or Metastatic Solid Tumors, Breast Cancer
A Study of PARG Inhibitor ETX-19477 in Patients With Advanced Solid Malignancies
This is a two-part, open-label, multicenter, dose escalation and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and anti- tumor activity of ETX-19477, a novel…
- Conditions
- Advanced or Metastatic Solid Tumors, Breast Cancer, Ovarian Cancer, Prostate Cancer
- Trial name
- ERADIC8 (NCT06395519)
- Testing
- ETX-19477
- Where
- 14 sites in United States
- Volunteers
- 120 people
- Sponsor
- 858 Therapeutics, Inc.
Early Stage Triple Negative ER Low Breast Cancer
IL-1 Inhibition in Early TNBC
This study will examine changes in the tumor microenvironment (TME) induced by 14 days of pre-operative IL-1-inhibiting therapy among patients with early breast cancer (including TNBC and ER-low positive).
- Trial name
- OZM-034 (NCT06710197)
- Testing
- Anakinra (Kineret®)
- Where
- Canada
- Sponsor
- University Health Network, Toronto
Breast Cancer, HER2-negative Breast Cancer
Study of Infigratinib in Combination With Tamoxifen in Hormone Receptor Positive, HER2 Negative, FGFR Altered Advanced Breast Cancer
The purpose of the study is identify the dose(s) of infigratinib to use in combination with tamoxifen to treat patients with a particular type of advanced breast cancer (hormone receptor-positive, HER2-negative, FGFR-altered…
- Conditions
- Breast Cancer, HER2-negative Breast Cancer, ER Positive Breast Cancer, PR-Positive Breast Cancer
- Trial name
- NCT04504331
- Testing
- Infigratinib, Tamoxifen, Omnipaque 350
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Jennifer Lee Caswell-Jin
Breast Cancer, HER2-negative Breast Cancer
Umbrella Trial of Subtype-Targeted Therapies in ER+/HER2- Breast Cancer
The purpose of this study is to learn if adding a new drug that is targeted at a specific genetic change found in some breast tumors pre-operatively will slow the growth of the tumor more than standard anti-hormone therapy used…
- Conditions
- Breast Cancer, HER2-negative Breast Cancer, ER Positive Breast Cancer
- Trial name
- NCT05101564
- Testing
- Alpelisib, Tamoxifen, Zotatifin
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Jennifer Lee Caswell-Jin
Metastatic Breast Cancer, ER-positive Breast Cancer
A Randomised Trial Comparing Trastuzumab Deruxtecan to CDK4/6 Inhibitors in Non-luminal A, ER-positive/HER2-low Metastatic Breast Cancer
The objective of this trial, DBCG R25, will be to evaluate the effect of trastuzumab-deruxtecan versus standard of care on progression-free survival (PFS) in first-line for patients with non-Luminal A, ER-positive/HER2-negative…
- Conditions
- Metastatic Breast Cancer, ER-positive Breast Cancer, Luminal B, Her2 Enriched
- Trial name
- DISCORDANT (NCT06585969)
- Testing
- Trastuzumab deruxtecan (T-DXd), Ribociclib with ET, Abemaciclib with ET
- Sponsor
- Danish Breast Cancer Cooperative Group
Breast Cancer, Breast-conserving Surgery
Feasibility Study for the SIRA-1000, SIRA® RFA Electrosurgical Device as an Adjunct to Breast Conserving Surgery
This study aims to assess the safety and clinical accuracy of the SIRA-1000, SIRA® RFA Electrosurgical Device in ablating margins post-lumpectomy in patients undergoing breast conserving surgery for breast cancer.
- Conditions
- Breast Cancer, Breast-conserving Surgery, Breast Cancer - Infiltrating Ductal Carcinoma, ER/PR+Her2neu
- Trial name
- NCT07206121
- Testing
- Radiofrequency ablation alone, Radiofrequency ablation Electrosurgical Device
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Innoblative Designs, Inc.
Metastatic Breast Cancer, Locally Advanced Breast Cancer
A Phase I/II Study of FWD1802 in Patients With ER+/HER2- Advanced BC.
A Phase I/II, Open-label study to assess the safety, tolerability, pharmacokinetic, and antitumor efficacy of FWD1802 monotherapy in patients with ER+/HER2- unresectable locally advanced or metastatic breast cancer.
- Conditions
- Metastatic Breast Cancer, Locally Advanced Breast Cancer, Breast Cancer Stage IV, ER+/HER2- Breast Cancer
- Trial name
- NCT06064812
- Testing
- FWD1802
- Where
- 22 sites in China
- Volunteers
- 99 people
- Sponsor
- Forward Pharmaceuticals Co., Ltd.
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