Clinical trials: HR+/HER2- Early Breast Cancer
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 Neoplasms, Carcinoma, Ductal, Breast
Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer
The purpose of this study is to evaluate the efficacy and safety of ctDNA-guided initiation of CDK4/6 inhibitor therapy using the Signatera™ Designed on Genome test (referred to as "Signatera Genome") in participants with…
- Conditions
- Breast Neoplasms, Carcinoma, Ductal, Breast, Receptors, Estrogen (for ER-positive Requirement)
- Trial name
- SIGNAL-ER 101 (NCT07214532)
- Testing
- ctDNA-Guided Treatment Strategy
- Where
- 49 sites in United States
- Volunteers
- 725 people
- Sponsor
- Natera, Inc.
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
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, 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
Breast Cancer
Ribociclib in Combination With Adjuvant Endocrine Therapy for Patients With Early High-risk HR+HER2- Breast Cancer
The goal of this observational study is to learn about the effects of using ribociclib in combination with physician-selected endocrine therapy as adjuvant therapy for patients with early high-risk HR+HER2- breast cancer.
- Trial name
- NCT06587789
- Testing
- Ribociclib
- Where
- China
- Volunteers
- 286 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Breast Cancer Female, Endocrine Therapy
The Benefits of Continued Use of Ovarian Function Suppression After 5 Years
To observe and evaluate the clinical efficacy and safety of continuous use of OFS for premenopausal patients with early breast cancer after 5 years use of OFS.
- Trial name
- NCT06050109
- Testing
- OFS continues to use group after 5 years use, Immunohistochemical detection of HR status
- Where
- China
- Volunteers
- 1,200 people
- Sponsor
- Hongmei Zheng, PhD
Breast Cancer Invasive, Hormone-receptor-positive Breast Cancer
Neoadjuvant Pyrotinib in HR-positive and HER2-low High-risk Early Breast Cancer
This is a multi-center, open-lable, prospective, randomized phase III clinical trial to further validate the efficacy and safety of neoadjuvant pyrotinib combined with chemotherapy in HR-positive/HER2-low (IHC 2+/FISH-negative)…
- Conditions
- Breast Cancer Invasive, Hormone-receptor-positive Breast Cancer, HER2 Low Breast Carcinoma, Early-stage Breast Cancer
- Trial name
- NCT06144944
- Testing
- Pyrotinib, epirubicin or doxorubicin, cyclophosphamide, paclitaxel, Epirubicin or doxorubicin, cyclophosphamide, paclitaxel
- Where
- China
- Volunteers
- 160 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Breast Cancer
Impact of Intermittent Fasting on Biomarkers of Inflammation and Health-Related Quality of Life: A Feasibility Trial for Women With HR+/HER2- Early Breast Cancer
This single-arm study is designed to test the hypothesis that a six-month intermittent fasting (IF) intervention is feasible for patients to adhere to and improves health-related quality of life while subjects are on adjuvant…
- Trial name
- NCT06106477
- Testing
- Intermittent Fasting
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Medical College of Wisconsin
HR+/HER2- Early Breast Cancer
Efficacy and Safety of Culmerciclib Plus Aromatase Inhibitors in a Response-Adapted Neoadjuvant Strategy for Highly Proliferative ER-Positive/HER2-Negative Breast Cancer
This prospective, response-adapted phase II study evaluates the efficacy and safety of neoadjuvant culmerciclib in combination with aromatase inhibitors in patients with highly proliferative ER-positive/HER2-negative breast…
- Trial name
- TAYLOR-002 (NCT07616453)
- Testing
- Culmerciclib, Aromatase Inhibitors
- Where
- China
- Volunteers
- 45 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Breast Cancer, Adjuvant Therapy
CDK4/6 Inhibitors Combined With Standard Adjuvant Endocrine Therapy in High-Risk, HR+/HER2+ Early Breast Cancer Patients(CHESS)
This study is a prospective, open-label, multicenter, randomized controlled Phase III clinical trial. Building upon anti-HER2 targeted therapy combined with endocrine therapy, the addition of CDK4/6 inhibitors has demonstrated…
- Trial name
- NCT07019363
- Testing
- Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane), Standard endocrine therapy combined with CDK4/6 Inhibitor
- Where
- China
- Volunteers
- 1,903 people
- Sponsor
- Fudan University
Breast Cancer
A Real-World Study of Clinical Adoption, Treatment Patterns and Tolerability of Adjuvant Ribociclib in HR+/HER2- Early Breast Cancer Patients
The aim of this study is to assess the clinical adoption, treatment patterns, and safety of adjuvant ribociclib use in hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer…
- Trial name
- CATTALYST (NCT07710716)
- Where
- Switzerland
- Volunteers
- 3,000 people
- Sponsor
- Novartis Pharmaceuticals
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
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
Dalpiciclib With or Without Entinostat and Letrozole in HR+/HER2- Early Breast Cancer
Brief Summary This is an open-label, randomized, phase II clinical study designed to evaluate neoadjuvant treatment regimens in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative…
- Trial name
- NCT07492394
- Testing
- entinostat, Dalpiciclib, Letrozole
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Hebei Medical University Fourth Hospital
Breast Cancer
Miti-gene Recurrence Score in HR+/HER2- Chinese Breast Cancer Patients
Update and validate the performance of the 21-gene score in prognostic stratification for early-stage HR-positive, HER2-negative breast cancer in China.
- Trial name
- BC-MRS-01 (NCT07052734)
- Where
- China
- Volunteers
- 2,843 people
- Sponsor
- Sun Yat-sen University
Early Breast Cancer, Estrogen Receptor Positive (ER+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-)
A Study of a Medicine Called Atirmociclib in Combination With Giredestrant in Adult Participants With ER-positive, HER2-negative Early-stage Breast Cancer
This Phase 3 study will evaluate whether atirmociclib plus giredestrant improves invasive breast cancer-free survival compared with giredestrant alone in adults with ER-positive, HER2-negative early breast cancer at medium or…
- Trial name
- NCT07890597
- Testing
- Atirmociclib, giredestrant
- Volunteers
- 3,800 people
- Sponsor
- Pfizer
Breast Cancer
A Window-of-opportunity Study of Pelareorep in Early Breast Cancer
The purpose of this study is to find out if pelareorep in combination with different therapies helps to reduce the growth of breast cancer cells and increase the immune system's response to cancer.
- Trial name
- AWARE-1 (NCT04102618)
- Testing
- Pelareorep, Letrozole, Atezolizumab
- Where
- 14 sites in Spain
- Volunteers
- 26 people
- Sponsor
- Oncolytics Biotech
Breast Cancer, Estrogen Receptor-Positive, HER2 Low Breast Cancer
A Study Evaluating the Efficacy and Safety of De Trastuzumab (T-DXd) in Combination with Immunotherapy for the Neoadjuvant Treatment of HR-positive HER2 Low-expressing Chinese Patients with Early-stage Breast Cancer
This is a prospective, open-label, multicenter, single-arm clinical study designed to compare the efficacy and safety of neoadjuvant treatment with T-DXd in combination with an immune checkpoint inhibitor in patients with primary…
- Trial name
- NCT06733233
- Testing
- T-DXd combined with immune checkpoint inhibitor
- Volunteers
- 23 people
- Sponsor
- Guangzhou Women and Children's Medical Center
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