Clinical trials: HR+/HER2- Early Breast Cancer
Early Breast Cancer
Neoadjuvant Study Chemotherapy vs Letrozole + Abemaciclib in HR+/HER2- High/Intermediate Risk Breast Cancer Patients
Phase II, randomized, open-label, international, multicenter study to compare efficacy of standard chemotherapy vs. letrozole plus abemaciclib as neoadjuvant therapy in HR-positive/HER2-negative high/intermediate risk breast…
- Trial name
- CARABELA (NCT04293393)
- Testing
- Doxorubicin, Cyclophosphamide, Taxane
- Where
- 28 sites in Spain
- Volunteers
- 200 people
- Sponsor
- Spanish Breast Cancer Research Group
Breast Cancer, Early-Stage Breast Carcinoma
SOLIS: Single-Dose Radiotherapy With Omission of Lumpectomy for Intact Small Breast Cancers
SOLIS is a prospective, single-arm, single-institution pilot trial evaluating single-fraction stereotactic radiotherapy (24 Gy to the planning target volume with a simultaneous integrated boost of 30 Gy to the clinical target…
- Conditions
- Breast Cancer, Early-Stage Breast Carcinoma, Hormone Receptor-Positive Breast Cancer, HER2-Negative Breast Cancer
- Trial name
- SOLIS (NCT07844759)
- Testing
- Stereotactic Radiation Therapy, Endocrine Therapy
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Renaissance Institute of Precision Oncology and Radiosurgery
ER-Positive HER2-Negative Breast Cancer
Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)
The study is intended to show superiority of AZD9833 in combination with CDK4/6 inhibitor (palbociclib, abemaciclib or ribociclib) versus aromatase inhibitors (anastrozole or letrozole) in combination with CDK4/6 inhibitor in…
- Trial name
- SERENA-6 (NCT04964934)
- Testing
- AZD9833, Anastrozole, Letrozole
- Where
- 264 sites in United States, Australia and 21 more
- Volunteers
- 315 people
- Sponsor
- AstraZeneca
Breast Cancer Invasive
NabPE With or Without Serplulimab for Early-stage HR+/HER2- Breast Cancer.
The goal of this clinical study is to learn if serplulimab is effective in early HR+/HER2- breast cancer. This trial serves a prospective parallel control cohort for HELEN-018 (NCT).
- Trial name
- NCT06781281
- Testing
- Serplulimab, NabPE
- Where
- China
- Volunteers
- 709 people
- Sponsor
- Henan Cancer Hospital
Hormone Receptor Positive HER-2 Negative Breast Cancer
Impact of Endocrine Therapy, Menstrual Cycle, PAM50, Ki67 on Treatment Decisions in HR+ and HER2- Breast Cancer
PEAK is a prospective, multicenter, non-interventional investigator-initiated trial (IIT) that aims to investigate the influence of the menstrual cycle phase on Ki67 in patients who either receive Tamoxifen, Aromatase inhibitors…
- Trial name
- NCT05878314
- Where
- Germany
- Volunteers
- 504 people
- Sponsor
- University Hospital Tuebingen
Breast Cancer (Early Breast Cancer), Breast Cancer Survivors
Real-life Evaluation of Endopredict® in Early HR+/HER2- Breast Cancer
EndoPredict is a genomic signature used to determine the 10-year risk of recurrence in early HR+/HER2- breast cancers classified as of intermediate risk according to conventional clinical and pathological criteria, and to guide…
- Conditions
- Breast Cancer (Early Breast Cancer), Breast Cancer Survivors, Breast Cancer Prognostic, Early Hormone Receptor-positive (HR-positive)
- Trial name
- SiMoSein (NCT07379918)
- Testing
- Endopredict test
- Where
- France
- Volunteers
- 1,000 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Breast Cancer Patients, Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Hormonal Receptor (HR)-Positive HER2 Negative Breast Cancer Patients Treated With Preoperative ELacestrant and PULSAR Radiotherapy
This is a proof-of-concept phase II trial to assess the safety (as primary endpoint) and clinical efficacy of neoadjuvant therapy with Elacestrant and PULSAR.
- Conditions
- Breast Cancer Patients, Breast Cancer Early Stage Breast Cancer (Stage 1-3), HR+/HER2- Breast Cancer, Radiation Therapy
- Trial name
- HELP (NCT07005882)
- Testing
- Elacestrant, PULSAR
- Where
- Italy
- Volunteers
- 21 people
- Sponsor
- Azienda Ospedaliero-Universitaria Careggi
Breast Cancer
A Prospective, Phase II, Exploratory Study Protocol of a Chemotherapy Sensitivity-based Culmerciclib Combination Regimen in Neoadjuvant Therapy for HR+/HER2- Breast Cancer.
To explore the efficacy and safety of Culmerciclib combined with chemotherapy as neoadjuvant therapy for HR+/HER2- breast cancer patients who are insensitive to neoadjuvant TAC (docetaxel, doxorubicin, cyclophosphamide)…
- Trial name
- NCT07900516
- Testing
- Kumoxili, Docetaxel, Epirubicin
- Where
- China
- Volunteers
- 48 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Breast Cancer
Use of Sentinel Lymph Node Biopsy in Patients With Early-Stage, Palpable Node-Positive HR+/HER2- Breast Cancer Having Upfront Surgery and Adjuvant Radiation
The purpose of this study is to find out how often the researchers can avoid an ALND in patients with early-stage, node-positive HR+/HER2- breast cancer who are having upfront surgery.
- Trial name
- NCT04854005
- Testing
- Breast surgery
- Where
- 10 sites in United States
- Volunteers
- 78 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Breast Cancer
Study of Amcenestrant (SAR439859) Versus Tamoxifen for Patients With Hormone Receptor-positive (HR+) Early Breast Cancer, Who Have Discontinued Adjuvant Aromatase Inhibitor Therapy Due to Treatment-related Toxicity
This was a phase III, randomized, double blind, multicenter, 2-arm study evaluating the efficacy and safety of amcenestrant compared with tamoxifen in participants with hormone receptor-positive early breast cancer who…
- Trial name
- AMEERA-6 (NCT05128773)
- Testing
- Amcenestrant, Tamoxifen
- Where
- 2 sites in Chile, China
- Volunteers
- 3 people
- Sponsor
- Sanofi
Breast Cancer (Early Breast Cancer)
Skipping Hormone Therapy in Low-Risk Early Breast Cancer
The goal of this clinical trial is to determine whether a selected population of women with early-stage, low-risk breast cancer can avoid hormone therapy without increasing their risk of relapse.
- Trial name
- NoELA (NCT07661927)
- Testing
- Removing Endocrine Therapy
- Where
- 41 sites in France
- Volunteers
- 700 people
- Sponsor
- UNICANCER
Breast Neoplasms
A Non-interventional Study for Kisqali (Ribociclib) in Combination With an Aromatase Inhibitor for Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer at High Risk of Recurrence
This non-interventional observational study evaluates the real-world effectiveness and safety profile of ribociclib in combination with an aromatase inhibitor for adjuvant treatment in patients with HR+/HER2- early breast cancer…
- Trial name
- CAROLEEN (NCT06830720)
- Testing
- ribociclib + AI ± LHRH, abemaciclib + ET ± LHRH, ET mono ± LHRH
- Where
- 287 sites in Austria, Germany
- Volunteers
- 3,250 people
- Sponsor
- Novartis Pharmaceuticals
Early-stage Breast Cancer, HER2 Positive Breast Cancer
Three Antidiarrheal Strategies in HER2+/HR+ Early Breast Cancer Patients Treated With Extended Adjuvant Neratinib
A Randomized Phase II Study to Evaluate the Incidence of Discontinuations due to Diarrhoea at 3 Cycles in patients with Early-stage HER2-positive (HER2+), Hormone Receptor-positive (HR+) Breast Cancer treated with Neratinib plus…
- Conditions
- Early-stage Breast Cancer, HER2 Positive Breast Cancer, Hormone Receptor Positive
- Trial name
- DIANER (NCT05252988)
- Testing
- Neratinib, Loperamide, Colesevelam
- Where
- 55 sites in Spain
- Volunteers
- 177 people
- Sponsor
- Spanish Breast Cancer Research Group
Breast Diseases, Breast Neoplasms
Efficacy and Safety of Dalpiciclib Combined With Endocrine Adjuvant Therapy for Early HR +/HER2- Breast Cancer: a Multicenter, Prospective Clinical Study
This study is a multicenter, prospective, randomized, open-label clinical study to assess the efficacy and safety of endocrine combined with different doses and treatment duration of darisenatide adjuvant therapy in HR +/HER2…
- Conditions
- Breast Diseases, Breast Neoplasms, Dalpiciclib, Endocrine Breast Diseases
- Trial name
- NCT07581834
- Testing
- Dalpiciclib 125mg, Dalpiciclib 100mg, Endocrine Therapy (ET): letrozole, anastrozole, exemestane, tamoxifen
- Where
- 2 sites in China
- Volunteers
- 2,000 people
- Sponsor
- Fujian Cancer Hospital
Breast Cancer
A Study With Pembrolizumab in Combination With Dual Anti-HER2 Blockade With Trastuzumab and Pertuzumab in Early Breast Cancer Patients With Molecular HER2-enriched Intrinsic Subtype (Keyriched-1)
Keyriched-1 is a multicenter, interventional, prospective, single arm, open label, neoadjuvant phase II trial evaluating the pathological complete response (pCR) rate induced by pembrolizumab in combination with the dual…
- Trial name
- Keyriched-1 (NCT03988036)
- Testing
- Pembrolizumab, Trastuzumab Biosimilar ABP 980, Pertuzumab
- Where
- 12 sites in Germany
- Volunteers
- 46 people
- Sponsor
- Women's Cancer Study Group GmbH
Breast Cancer
ctDNA-Guided Chemotherapy Omission With Ribociclib Plus Endocrine Therapy in HR-Positive/HER2-Negative Breast Cancer
This study is a prospective, multicenter, open-label, randomized controlled clinical trial designed to determine whether ribociclib plus endocrine therapy (ET) is non-inferior to adjuvant chemotherapy followed by ribociclib plus…
- Trial name
- RACE (NCT07423611)
- Testing
- Aromatase inhibitor (± ovarian suppression) plus Ribociclib, 4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy
- Where
- China
- Volunteers
- 388 people
- Sponsor
- Fudan University
Breast Cancer
Chidamide Plus PD-1 Plus Paclitaxel of Neoadjuvant Treatment in Low HR Expression,HER2-negative Early Breast Cancer.
Triple-negative breast cancer has always been a difficult problem in clinical practice because of its young onset age, high aggressiveness, no clear therapeutic target and poor clinical prognosis.
- Trial name
- NCT05749575
- Testing
- Chidamide Plus Toripalimab Plus Paclitaxel
- Where
- China
- Volunteers
- 28 people
- Sponsor
- Sun Yat-sen University
Early Breast Cancer
A Pharmacodynamics Pre-surgical Study of LEE011 in Early Breast Cancer Patients (MONALEESA-1)
This is a multi-center, open-label Phase II randomized pre-surgical pharmacodynamics study.
- Trial name
- MONALEESA-1 (NCT01919229)
- Testing
- LEE011 (ribociclib), letrozole
- Where
- 7 sites in United States, Singapore and 1 more
- Volunteers
- 14 people
- Sponsor
- Novartis Pharmaceuticals
HR+/HER2- Breast Cancer
Efficacy and Safety of CDK4/6 Inhibitors Combined With Endocrine Therapy in HR+/HER2- Neoadjuvant Therapy for Early Breast Cancer
This is a single arm, open label, phase 2 trial aimed to investigate the effects and safety of neoadjuvant CDK4/6 inhibitors in combination with endocrine for HR+/HER2- breast cancer.
- Trial name
- NCT07130643
- Testing
- CDK4/6 inhibitors+Endocrine Therapy
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Xinhong Wu, PhD
Breast Cancer, Breast Neoplasms
A Study to Evaluate the Efficacy and Safety of HLX11 vs. EU-Perjeta® in the Neoadjuvant Therapy of HER2-Positive and HR-Negative Early-stage or Locally Advanced Breast Cancer
This is a phase III, double-blind, randomized, parallel-controlled, multicenter equivalence study to compare the efficacy and safety of pertuzumab biosimilar HLX11 vs.
- Conditions
- Breast Cancer, Breast Neoplasms, HER2-positive Breast Cancer
- Trial name
- NCT05346224
- Testing
- HLX11, EU-Perjeta®
- Where
- 79 sites in China, Hungary and 2 more
- Volunteers
- 900 people
- Sponsor
- Shanghai Henlius Biotech