Clinical trials: HR+ Breast Cancer
Metastatic Breast Cancer
Mecapegfilgrastim for the Prevention of Dalpiciclib -Induced Neutropenia in Advanced Breast Cancer
Neutropenia is a common complication from dalpiciclib. Mecapegfilgramtim (code name HHPG-19K), a long-acting recombinant human granulocyte colony-stimulating factor (rhG-CSF), has been developed.
- Trial name
- NCT05463601
- Testing
- Mecapegfilgrastim, dalpiciclib, exemestane, fulvestrant, letrozole, tamoxifen
- Where
- China
- Volunteers
- 132 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Breast Cancer, Solid Tumors
A Study to Learn About the Study Medicine (Called PF-07220060 in Combination With PF-07104091) In Participants With Breast Cancer and Solid Tumors
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07220060 and PF-07104091) in people with breast cancer. This clinical study consists of 2 parts (part 1 and part 2).
- Trial name
- NCT05262400
- Testing
- PF-07220060 + PF-07104091 combination dose escalation, PF-07104091 + PF-07220060 + fulvestrant dose expansion, PF-07104091 + PF-07220060 + letrozole dose expansion
- Where
- 44 sites in United States, Argentina and 7 more
- Volunteers
- 235 people
- Sponsor
- Pfizer
Avelumab in Combination With Talazoparib Will be Investigated in Patients With Locally Advanced (Primary or Recurrent) or Metastatic Solid Tumors
Javelin Parp Medley: Avelumab Plus Talazoparib In Locally Advanced Or Metastatic Solid Tumors
Avelumab in combination with talazoparib will be investigated in patients with locally advanced (primary or recurrent) or metastatic solid tumors, including non-small cell lung cancer (NSCLC), triple negative breast cancer…
- Trial name
- NCT03330405
- Testing
- Avelumab Phase 1b, Talazoparib Phase 1b, Avelumab Phase 2
- Where
- 66 sites in United States, Australia and 7 more
- Volunteers
- 223 people
- Sponsor
- Pfizer
Breast Cancer
A Short-term Preoperative, Evaluating Activity and Safety of Elacestrant Monotherapy as Compared to Elacestrant + Ovarian Function Suppression (LHRH Agonist) in Premenopausal Patients With Stage I-II ER+/HER2- Breast Cancer
A prospective randomized trial designed to evaluate the mean decrease in Ki67 after 4 weeks of elacestrant monotherapy and in combination with leuprorelin in patients with early-stage HR+ BC.
- Trial name
- POP-ELA (NCT07159451)
- Testing
- Elacestrant, Leuprorelin
- Where
- France
- Volunteers
- 140 people
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
Breast Neoplasms
First-line Palbociclib and Endocrine Therapy for Patients With HR+/HER2- Advanced Breast Cancer in the Real-world Setting.
This is a prospective, single-arm, multi-center observational non-interventional study (NIS) in Germany and Austria.
- Trial name
- PERFORM (NCT04767594)
- Testing
- Palbociclib + endocrine therapy
- Where
- 192 sites in Austria, Germany
- Volunteers
- 1,407 people
- Sponsor
- Pfizer
Advanced Solid Tumor, HR+/HER2- Breast Cancer
A Study of BPI-1178 in Patients With Advanced Solid Tumor and HR+/HER2- Breast Cancer
BPI-1178 is a novel, orally administered inhibitor of both cyclin-dependent kinase 4（CDK4）and CDK6 kinase activity. This Phase I study is a first-in-human (FIH) clinical trial designed to evaluate the safety, tolerability, and…
- Trial name
- NCT04282031
- Testing
- BPI-1178, Fulvestrant, Letrozole
- Where
- China
- Volunteers
- 224 people
- Sponsor
- Beta Pharma (Suzhou) Co., Ltd.
Breast Cancer
FREDO-ODX Study: FREnch Data on Outcomes in HR+/HER2- Early Breast Cancer Patients With oncotypeDX Recurrence Score-guided Therapy
The aim of this study is to assess the clinical outcomes in real-life setting of early breast cancer RH+ HER2- patients with systemic therapy guided by Oncotype DX (ODX) Breast Recurrence Score®.
- Trial name
- FREDO-ODX-23 (NCT06185569)
- Where
- 5 sites in France
- Volunteers
- 4,500 people
- Sponsor
- Centre Hospitalier Universitaire de Besancon
Breast Cancer, HR+/HER2- Breast Cancer
QL1706 for the Neoadjuvant Treatment of HR+/HER2- Breast Cancer
The goal of this clinical trial is to learn if QL1706 is effective in early HR+/HER2- breast cancer. It will also learn about the safety of QL1706.
- Trial name
- NCT06967103
- Testing
- QL1706, Nab-PE
- Where
- China
- Volunteers
- 238 people
- Sponsor
- Henan Cancer Hospital
Breast Cancer
Study of Disitamab Vedotin and Anlotinib in Patients With HR-Negative, HER2-Low-Expressing Metastatic Breast Cancer
Disitamab Vedotin (RC48) contains the novel humanized anti-HER2 antibody conjugated to monomethyl auristatin E (MMAE) via a cleavable linker , which is the first ADC drug that was independently developed by Rongchang Biology .The…
- Trial name
- NCT06000033
- Testing
- Disitamab Vedotin+Anlotinib
- Volunteers
- 35 people
- Sponsor
- Qilu Hospital of Shandong University
Breast Cancer
Study of Safety and Efficacy of Dapagliflozin + Metformin XR Versus Metformin XR in Participants With HR+, HER2-, Advanced Breast Cancer While on Treatment With Alpelisib and Fulvestrant
This study was designed to assess the safety and efficacy of the combination of dapagliflozin plus metformin extended release (XR) compared with metformin XR during treatment with alpelisib plus fulvestrant in participants with…
- Trial name
- EPIK-B4 (NCT04899349)
- Testing
- Alpelisib, Fulvestrant, Metformin XR
- Where
- 2 sites in United States, Malaysia
- Volunteers
- 2 people
- Sponsor
- Novartis Pharmaceuticals
Sarcoma, Castrate Resistant Prostate Cancer
A Study of PRT2527 in Participants With Advanced Solid Tumors
This is a Phase 1 dose-escalation and confirmation study of PRT2527, a Cyclin-dependent Kinase 9 (CDK9) inhibitor, in participants with advanced solid tumors.
- Conditions
- Sarcoma, Castrate Resistant Prostate Cancer, Hormone Receptor Positive HER2 Negative Breast Cancer, Non-small Cell Lung Cancer
- Trial name
- NCT05159518
- Testing
- PRT2527
- Where
- 8 sites in United States
- Volunteers
- 30 people
- Sponsor
- Prelude Therapeutics Incorporated
Metastatic Breast Cancer
Description of Treatment Patterns and Description and Comparison of Healthcare Resource Utilization and Costs of Women With Metastatic HR+/HER2- Breast Cancer Treated With CDK4/6 Inhibitors
The study was an observational, retrospective cohort design, using US administrative insurance claims data, to better understand Healthcare resource utilization (HRU) and healthcare costs among women with mBC initiated on a…
- Trial name
- NCT05153135
- Testing
- Ribociclib, Palbociclib, Abemaciclib
- Where
- United States
- Volunteers
- 4,320 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Breast Cancer (HR+/ HER2-)
Predicting Endocrine Resistance Using Molecular Imaging and Liquid Biopsy in Metastatic Breast Cancer
This prospective observational study aims to evaluate the prognostic value of molecular imaging biomarkers derived from baseline [18F]FES and [18F]FDG PET/CT for progression-free survival in patients with estrogen receptor…
- Trial name
- NCT07867925
- Testing
- [18F] FES
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- Asan Medical Center
Breast Cancer
Study of the Molecular Features of Postmenopausal Women With HR+ HER2-negative aBC on First-line Treatment With Ribociclib and Letrozole and, in Patients With a PIK3CA Mutation, on Second-line Treatment With Alpelisib Plus Fulvestrant
The purpose of this clinical trial is to study of the molecular features of postmenopausal women with hormone receptor-positive (HR+) HER2-negative advanced breast cancer on first-line treatment with ribociclib and letrozole and…
- Trial name
- BioItaLEE (NCT03439046)
- Testing
- Ribociclib, Letrozole, Alpelisib
- Where
- 41 sites in Italy
- Volunteers
- 287 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Breast Cancer, Female Breast Cancer
This is a Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of FCN-437c in Combination With Fluvestrant ± Goseraline Versus Placebo Combined With Fulvestrant ± Goserelin in Women With HR+ and HER2- Advanced Breast Cancer.
This is a multicenter, randomized, double-blind, placebo-controlled Phase iii clinical study evaluating the efficacy and safety of FCN- 437c in combination with fluvestrant ± goseraline versus placebo in combination with…
- Trial name
- NCT05438810
- Testing
- FCN-437c,Fulvestrant,Goserelin acetate
- Where
- China
- Volunteers
- 312 people
- Sponsor
- Ahon Pharmaceutical Co., Ltd.
HR Positive HER2 Negative Advanced Breast Cancer
Different Doses of Dalpicicl Combined With Letrozole in the First-line Treatment of HR-positive, HER2-negative Advanced Breast Cancer
This study is a prospective, open-label, randomized, multicenter, two-cohort phase II clinical trial. Starting from December 1, 2024, it plans to enroll 120 patients with advanced first-line HR-positive, HER2-negative breast…
- Trial name
- NCT07285382
- Testing
- Dalpiciclib 125mg, Dalpiciclib 150mg, Letrozole 2.5mg
- Where
- 2 sites in China
- Volunteers
- 120 people
- Sponsor
- wanghaibo
HR+/HER2- Advanced/Metastatic Breast Cancer
Sirolimus for Injection (Albumin-bound) in Combination With Endocrine Therapy for HR+/HER2- Advanced/Metastatic Breast Cancer Patients Who Have Failed Standard Therapy
This study is a multicenter, open, non-randomized phase II clinical trial consisting of a safety introduction phase followed by a single-arm phase 2 phase.
- Trial name
- NCT06957379
- Testing
- Letrozole, Anastrozole, Exemestane
- Where
- China
- Volunteers
- 78 people
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.