Clinical trials: Estrogen Receptor- Negative Breast Cancer
Advanced Breast Cancer
Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor
The purpose of this study is to learn if certain drug combinations are effective treatments for patients with advanced ER+/HER2- who have previously been treated with palbociclib, ribociclib, or abemaciclib.
- Trial name
- GERTRUDE (NCT05933395)
- Testing
- Fulvestrant, Neratinib, Alpelisib
- Where
- United States
- Volunteers
- 135 people
- Sponsor
- Dartmouth-Hitchcock Medical Center
Breast Cancer
Elacestrant in Patients With ER+ HER2- ESR1-mutated Locally Advanced or Metastatic Breast Cancer
The objective of this non-interventional study (NIS) is to evaluate prevalence of ESR1 mutation after endocrine therapy in the palliative setting, quality of life, tolerability, and safety and to describe treatment detail and…
- Trial name
- ELENI (NCT07563595)
- Testing
- Elacestrant, Standard of care (Investigator Choice)
- Where
- 3 sites in Germany
- Volunteers
- 500 people
- Sponsor
- iOMEDICO AG
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic HER2-Negative Breast Carcinoma
Tka Assay for CDK4/6i
This clinical trial assesses whether using a test developed by DiviTum can identify optimal levels of CDK 4/6 inhibitor medications in the blood and whether assessing medical compliance and drug-drug interactions can optimize…
- Trial name
- NCT06572800
- Testing
- DiviTum-TKa
- Where
- 18 sites in United States
- Volunteers
- 34 people
- Sponsor
- Yale University
Breast Neoplasms
A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer
The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2…
- Trial name
- EMBER-4 (NCT05514054)
- Testing
- Imlunestrant, Tamoxifen, Anastrozole
- Where
- 672 sites in United States, Argentina and 29 more
- Volunteers
- 8,000 people
- Sponsor
- Eli Lilly and Company
Breast Cancer
Paclitaxel Plus Pembrolizumab vs. Paclitaxel Weekly in ER+ Luminal B Metastatic Breast Cancer
PELICAN is a randomised phase II trial that aims to evaluate the efficacy and safety of paclitaxel plus pembrolizumab relative to paclitaxel alone, in patients with locally advanced or metastatic ER-positive, HER2-negative…
- Trial name
- PELICAN (NCT03841747)
- Testing
- Pembrolizumab, Paclitaxel
- Sponsor
- Queen Mary University of London
Breast Neoplasms
Study Of SU011248 Versus Chemotherapy For Patients With Previously Treated Triple Receptor Negative Breast Cancer
The purpose of this study is to compare progression free survival for SU011248 [sutent (sunitinib malate)] versus standard of care therapy in patients with previously treated, advanced, triple receptor negative (ER, PR, HER2)…
- Trial name
- NCT00246571
- Testing
- SU011248, Chemotherapy
- Where
- 113 sites in United States, Bulgaria and 10 more
- Volunteers
- 217 people
- Sponsor
- Pfizer
Metastatic Breast Cancer
ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer Study
The purpose of this study is to evaluate the efficacy and safety of elacestrant over the course of 6 months in patients with estrogen receptor positive (ER+)/human epidermal growth factor receptor-2 negative (HER2-)…
- Trial name
- ELCIN (NCT05596409)
- Testing
- Elacestrant
- Where
- 22 sites in United States, Brazil and 4 more
- Volunteers
- 61 people
- Sponsor
- Stemline Therapeutics, Inc.
Recurrent Breast Carcinoma, Stage III Breast Cancer AJCC v7
Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer
This randomized phase II trial studies how well tamoxifen citrate works compared with z-endoxifen hydrochloride in treating patients with breast cancer that has spread to nearby tissue or lymph nodes or other parts of the body…
- Conditions
- Recurrent Breast Carcinoma, Stage III Breast Cancer AJCC v7, Stage IIIA Breast Cancer AJCC v7, Stage IIIB Breast Cancer AJCC v7
- Trial name
- NCT02311933
- Testing
- Endoxifen Hydrochloride, Laboratory Biomarker Analysis, Pharmacological Study
- Where
- 559 sites in United States
- Volunteers
- 81 people
- Sponsor
- National Cancer Institute (NCI)
Breast Cancer
Dynamic and Test-retest Whole Body [18F]FES PET Imaging in Patients With Metastatic ER+ Breast Cancer
16a-18F-fluoro-17b-estradiol ([18F]FES) is radioactive labeled estradiol, developed for in vivo visualization of the estrogen receptor (ER) using positron emission tomography (PET).
- Trial name
- FEStastic (NCT05088785)
- Testing
- FES
- Where
- Netherlands
- Volunteers
- 15 people
- Sponsor
- Amsterdam UMC, location VUmc
Breast Cancer
A Phase I/II Trial to Evaluate Oral HP568 Tablets in Patients with ER+/HER2 Advanced Breast Cancer
This is a Phase 1/2 dose escalation and cohort expansion study and will assess the safety, tolerability and preliminary efficacy of HP568 alone and in combination with palbociclib in patients with ER+/HER2- locally advanced or…
- Trial name
- NCT06757335
- Testing
- HP568, HP568 in combination with palbociclib
- Volunteers
- 204 people
- Sponsor
- Hinova Pharmaceuticals Inc.
Advanced Solid Malignancy, Safety and Tolerability
Safety, Tolerability & Potential Anti-cancer Activity of Increasing Doses of AZD5363 in Different Treatment Schedules
This study is designed to investigate the safety and tolerability of a new drug, AZD5363, in patients with advanced cancer - and to identify a dose and schedule that can be used in the future.
- Conditions
- Advanced Solid Malignancy, Safety and Tolerability, Pharmacokinetics, Pharmacodynamics
- Trial name
- NCT01226316
- Testing
- AZD5363
- Where
- 34 sites in United States, Canada and 8 more
- Volunteers
- 285 people
- Sponsor
- AstraZeneca
Breast Cancer, Cancer of Breast
Neoadjuvant Study of Palbociclib in Combination With Letrozole and Trastuzumab in Stage II-III ER+ HER2+ Breast Cancer
The investigators propose to influence estrogen receptor (ER) signaling by combining endocrine therapy with CDK4/6 inhibition along with trastuzumab in ER+/ human epidermal growth factor receptor 2 (HER2)+ early stage breast…
- Conditions
- Breast Cancer, Cancer of Breast, Breast Carcinoma
- Trial name
- PALTAN (NCT02907918)
- Testing
- Palbociclib, Letrozole, Trastuzumab
- Where
- 3 sites in United States
- Volunteers
- 26 people
- Sponsor
- Washington University School of Medicine
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Abexinostat, Palbociclib, and Fulvestrant for the Treatment of Breast or Gynecologic Cancer
This phase I trial investigates the side effects and best dose of abexinostat and palbociclib when given together with fulvestrant in treating patients with breast or gynecologic cancer.
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8
- Trial name
- NCT04498520
- Testing
- Abexinostat Tosylate, Fulvestrant, Palbociclib
- Sponsor
- Pamela Munster
Breast Cancer
ALERT: A Phase II Study of Alternating Eribulin and Hormonal Therapy in Pre-treated ER+ve Breast Cancer.
A single centre, single arm phase II study of alternating eribulin and hormonal therapy in 12 patients with locally advanced or metastatic breast cancer who have received at least one hormonal therapy and at least one…
- Trial name
- ALERT (NCT02681523)
- Testing
- Eribulin
- Where
- United Kingdom
- Volunteers
- 8 people
- Sponsor
- Imperial College London
Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8
Nipple Aspirate Fluid in Detecting Breast Cancer
This trial studies nipple aspirate fluid in detecting breast cancer. Nipple aspirate fluid may better detect breast cancer earlier than current methods used for screening such as mammograms and breast examinations.
- Conditions
- Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8
- Trial name
- NCT03715959
- Testing
- Aspiration of Breast, Biospecimen Collection
- Where
- United States
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Ohio State University Comprehensive Cancer Center
Estrogen Receptor-positive Breast Cancer, HER2-negative Breast Cancer
Mucoadhesive Oral Wound Rinse in Preventing and Treating Stomatitis in Patients With ER- or PR-Positive Metastatic or Locally Recurrent Breast Cancer That Cannot be Removed by Surgery Receiving Everolimus
This randomized phase II trial studies how well mucoadhesive oral wound rinse works in preventing and treating stomatitis in patients with estrogen receptor (ER)- or progesterone receptor (PR)-positive metastatic or locally…
- Conditions
- Estrogen Receptor-positive Breast Cancer, HER2-negative Breast Cancer, Oral Complications, Progesterone Receptor-positive Breast Cancer
- Trial name
- NCT02015559
- Testing
- mucoadhesive oral wound rinse, laboratory biomarker analysis
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Jonsson Comprehensive Cancer Center
Breast Cancer
EMERALD: Endocrine Therapy oMission With Radiation in ER+ Breast Cancer: Assessing Quality of Life and Disease Control: a Prospective Phase II Trial
This clinical research study is to learn about the effects of giving radiotherapy alone after lumpectomy to patients who have early-stage, low-risk breast cancers and who are 60 years of age or older.
- Trial name
- NCT06897488
- Testing
- Adjuvant Radiotherapy
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- M.D. Anderson Cancer Center
Triple Negative Breast Neoplasms
A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer
This study is designed to determine the efficacy and safety of durvalumab in combination with novel oncology therapies with or without paclitaxel and durvalumab + paclitaxel for first-line metastatic triple negative breast cancer
- Trial name
- BEGONIA (NCT03742102)
- Testing
- Durvalumab, Capivasertib, Oleclumab
- Where
- 32 sites in United States, Canada and 4 more
- Volunteers
- 243 people
- Sponsor
- AstraZeneca
Invasive Lobular Breast Carcinoma, ER+ Breast Cancer
Neoadjuvant Study of Targeting ROS1 in Combination With Endocrine Therapy in Invasive Lobular Carcinoma of the Breast (ROSALINE)
Despite different clinical characteristics including the response to treatment and the patterns of metastatic relapse, invasive lobular breast carcinoma (ILBC) is treated like invasive ductal breast carcinoma (IDBC) carcinoma…
- Conditions
- Invasive Lobular Breast Carcinoma, ER+ Breast Cancer, HER2-negative Breast Cancer
- Trial name
- ROSALINE (NCT04551495)
- Testing
- Entrectinib, Letrozole, Goserelin
- Where
- 10 sites in Belgium, France
- Volunteers
- 65 people
- Sponsor
- Jules Bordet Institute
Breast Cancer, TNBC - Triple-Negative Breast Cancer
Estrogen Receptor (ER) PET/CT Imaging in Breast Cancer
18F-Fluoroestradiol (18F-FES) is an estrogen receptor-targeting positron emission tomography tracer with high sensitivity and specificity for the detection of estrogen receptor（ER）-positive tumors .
- Conditions
- Breast Cancer, TNBC - Triple-Negative Breast Cancer, Estrogen-receptor-negative Breast Cancer
- Trial name
- NCT05541367
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Tongji Hospital