Clinical trials: Estrogen Receptor Negative, active
Breast Cancer
Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer
The purpose of this trial is to inform the future clinical development of the two investigational agents in ER+ breast cancer, LEE011 (CDK4/6 inhibitor) and BYL719 (PI3K-alpha inhibitor).
- Trial name
- NCT01872260
- Testing
- LEE011, Letrozole, BYL719
- Where
- 25 sites in United States, Australia and 6 more
- Volunteers
- 259 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Breast Cancer
Minimally Interventional Study on Prevalence of Emerging ESR1 Mutations in Liquid Biopsy in Three Cohorts of Patients With Breast Cancer in Comparison With Patient's Baseline ESR1 Mutation Status as Defined by Tissue Profiling.
Minimally interventional study on prevalence of emerging ESR1 mutations in liquid biopsy in three cohorts of patients with breast cancer (with and without prior therapies in metastatic setting, and during first-line aromatase…
- Trial name
- Pangeia-2 (NCT06417801)
- Where
- 6 sites in Brazil
- Volunteers
- 170 people
- Sponsor
- AstraZeneca
Breast Cancer Stage IV, Radiotherapy
Locoregional Treatment and Palbociclib in de Novo, Treatment Naive, Stage IV ER+, HER2- Breast Cancer Patients
Approximately 3.5% to 6% of newly diagnosed breast cancer patients are stage IV metastatic. De novo metastatic breast cancer accounts for 20% to 25% of these cases.
- Conditions
- Breast Cancer Stage IV, Radiotherapy, Surgery
- Trial name
- PALATINE (NCT03870919)
- Testing
- Palbociclib, locoregional treatment
- Where
- 26 sites in France
- Volunteers
- 200 people
- Sponsor
- UNICANCER
Spasticity
A Study to Investigate Arbaclofen ER Tablets for the Treatment of Spasticity in Patients With Multiple Sclerosis
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of oral arbaclofen ER tablets in MS patients with spasticity.
- Trial name
- NCT05179577
- Testing
- Arbaclofen
- Volunteers
- 442 people
- Sponsor
- RVL Pharmaceuticals, Inc.
Endometrial Cancer, Endometrial Carcinoma (EC)
Prognosis and Therapeutic Implications in Molecular High-Risk Non-Myoinvasive Endometrial Cancer
This multicenter retrospective observational cohort study aims to evaluate the prognosis of patients with non-myoinvasive endometrial cancer harbouring high-risk molecular features by determining the rate of lymph node…
- Conditions
- Endometrial Cancer, Endometrial Carcinoma (EC), p53abn
- Trial name
- MyoNone (NCT07838207)
- Where
- Spain
- Volunteers
- 350 people
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute
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.
Breast Cancer
Preoperative Fulvestrant With or Without Enzalutamide in ER+/Her2- Breast Cancer
This is a randomized two arm phase II study to further evaluate the efficacy of fulvestrant plus enza compared to single agent fulvestrant in postmenopausal women with locally advanced AR+/ER+/Her2- BC who will have local surgery…
- Trial name
- NCT02955394
- Testing
- Enzalutamide, Fulvestrant
- Where
- 3 sites in United States
- Volunteers
- 61 people
- Sponsor
- University of Colorado, Denver
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.
Receptors, Estrogen, Genes, Erbb-2
A Study of H3B-6545 in Combination With Palbociclib in Women With Advanced or Metastatic Estrogen Receptor-Positive Human Epidermal Growth Factor Receptor-2 (HER2)-Negative Breast Cancer
The primary objective of this study is to evaluate the safety and tolerability of H3B-6545 and palbociclib when administered in combination in order to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2…
- Conditions
- Receptors, Estrogen, Genes, Erbb-2, Breast Neoplasms
- Trial name
- NCT04288089
- Testing
- Palbociclib (75, 100, 125 milligram [mg]), H3B-6545 (150, 300, 450 mg)
- Where
- 8 sites in United States, United Kingdom
- Volunteers
- 31 people
- Sponsor
- Eisai Inc.
Breast Cancer
NOSTRA-Feasibility Study: A Study Looking at Ultrasound Guided Biopsies for Breast Cancer
A prospective non-randomised multi-centre feasibility study to assess if patients with residual cancer following dual-targeted neoadjuvant chemotherapy treatment for HER2-positive, ER-negative early breast cancer can be…
- Trial name
- NOSTRA (NCT04118192)
- Testing
- Tumour bed core biopsy
- Where
- 24 sites in United Kingdom
- Volunteers
- 72 people
- Sponsor
- University of Birmingham
Acute Respiratory Infection, Acute Respiratory Tract Infection
POS-ARI-ER Observational Study of Acute Respiratory Infections
Acute respiratory infections (ARI) are one of the most frequent reasons for hospital admission and antibiotic use, and can be caused by a broad range of pathogens, including respiratory viruses with proven epidemic potential…
- Trial name
- POS-ARI-ER (NCT05814237)
- Testing
- Data collection
- Where
- 27 sites in Belgium, Croatia and 8 more
- Volunteers
- 11,750 people
- Sponsor
- European Clinical Research Alliance for Infectious Diseases (ECRAID)
Breast Cancer
Study of Pembrolizumab (MK-3475) Versus Placebo in Combination With Neoadjuvant Chemotherapy & Adjuvant Endocrine Therapy in the Treatment of Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (MK-3475-756/KEYNOTE-756)
The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in the treatment of…
- Trial name
- NCT03725059
- Testing
- Pembrolizumab (K), Paclitaxel (X), Doxorubicin (A)
- Where
- 244 sites in United States, Australia and 22 more
- Volunteers
- 1,240 people
- Sponsor
- Merck Sharp & Dohme LLC
Metastatic Breast Cancer
STUDY02001740;22SCH740: Estradiol For ER+ Advanced Breast Cancer (ESTHER)
Determine whether subjects harboring ESR1-mutant/amplified breast cancer have a higher rate of clinical benefit from 17b-estradiol therapy than subjects with ESR1-wild-type breast cancer
- Trial name
- ESTHER (NCT05716516)
- Testing
- Estradiol
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Dartmouth-Hitchcock Medical Center
Uterine Sarcoma, Uterine Leiomyosarcoma
Ph 2 Elacestrant in ER Positive Uterine Sarcomas
This study is to evaluate the efficacy and safety of elacestrant, in participants with advanced estrogen receptor (ER)-positive uterine sarcomas.
- Conditions
- Uterine Sarcoma, Uterine Leiomyosarcoma, Endometrial Stromal Sarcoma, ESS
- Trial name
- NCT07467772
- Testing
- Elacestrant
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Dana-Farber Cancer Institute
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
This phase III trial compares standard of care hormone therapy plus ribociclib to chemotherapy followed by hormone therapy plus ribociclib for the treatment of patients with high anatomic stage breast cancer with low risk of the…
- Conditions
- Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Estrogen Receptor-Positive Breast Carcinoma
- Trial name
- NCT07391774
- Testing
- Anastrozole, Biospecimen Collection, Bone Scan
- Where
- 258 sites in United States, Puerto Rico
- Volunteers
- 1,978 people
- Sponsor
- National Cancer Institute (NCI)
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
Advanced ER-Positive HER2-Negative Breast Cancer
A Study to Investigate Efficacy and Safety With Oral AZD9833 Compared With Intramuscular Fulvestrant in Post-menopausal Women at Least 18 Years of Age With Advanced ER-positive HER2 Negative Breast Cancer
This study is randomized, open-label, parallel-group, multicentre Phase 2 study aimed to compare the efficacy and safety of oral AZD9833 versus intramuscular (IM) fulvestrant in women with advanced breast cancer.
- Trial name
- SERENA-2 (NCT04214288)
- Testing
- AZD9833, Fulvestrant
- Where
- 85 sites in United States, Belgium and 14 more
- Volunteers
- 240 people
- Sponsor
- AstraZeneca
Stage III Breast Cancer
[18F]FES PET/CT for the Detection of Distant Metastasis in Low-grade ER-positive Stage III Breast Cancer
This study aims to evaluate the detection rate of distant metastases using [18F]FES PET/CT in patients with low-grade, ER-positive stage III breast cancer.
- Trial name
- NCT07314073
- Testing
- Fluoroestradiol (18F)
- Where
- South Korea
- Volunteers
- 85 people
- Sponsor
- Asan Medical Center
Breast Cancer
A Phase Ⅲ Study of Hemay022 in Combination With AI In Advanced Breast Cancer
The purpose of this study is to evaluate the effectiveness of Hemay022 combined with AI (exemestane or letrozole) in the treatment of ER+/HER2+ advanced breast cancer patients based on the progression-free survival (PFS) assessed…
- Trial name
- NCT06313983
- Testing
- Hemay022+AI, Lapatinib+Capecitabine
- Where
- China
- Volunteers
- 339 people
- Sponsor
- Tianjin Hemay Pharmaceutical Co., Ltd
Breast Cancer
S0221 Adjuvant Doxorubicin, Cyclophosphamide, and Paclitaxel in Treating Patients With Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, use different ways to stop tumor cells from dividing so they stop growing or die.
- Trial name
- NCT00070564
- Testing
- pegfilgrastim, AC regimen, cyclophosphamide
- Where
- 542 sites in United States, Canada and 1 more
- Volunteers
- 3,294 people
- Sponsor
- SWOG Cancer Research Network