Clinical trials: HR+ HER2 Breast Cancer
Breast Cancer, Metastatic Cancer
Immune Therapy in HR-positive/HER2-negative Metastatic Breast Cancer(ENIGMA)-BCTOP-L-M02
This study is a prospective, open-label, phase II clinical study for patients with HR+/HER2- advanced breast cancer.
- Trial name
- NCT05205200
- Testing
- SHR-1316, SHR6390, Nab paclitaxel
- Where
- China
- Volunteers
- 338 people
- Sponsor
- Fudan University
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
Early Breast Cancer
Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in HR+/ HER2- Early Breast Cancer
The investigator conduct a phase II multi-center, open-label trial to evaluate efficacy and safety of dalpiciclib with endocrine therapy as adjuvant treatment in patients with medium /high risk hormone receptor-positive…
- Trial name
- NCT06341894
- Testing
- Dalpiciclib, Endocrine therapy
- Where
- China
- Volunteers
- 1,163 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors
Study of GVV858 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
Phase I: Characterize safety and tolerability of GVV858 as a single agent and in combination with fulvestrant or letrozole. Identify dose range for optimization/recommended dose for further clinical evaluation.
- Conditions
- Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors, Metastatic Castration-resistant Prostate Cancer
- Trial name
- NCT07288359
- Testing
- GVV858, Fulvestrant, Letrozole
- Where
- 16 sites in United States, Canada and 9 more
- Volunteers
- 205 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Breast Cancer, Advanced Breast Cancer
Patritumab Deruxtecan (U3-1402) in Unresectable Locally Advanced or Metastatic Breast Cancer
This study aims to evaluate the efficacy and safety of U3-1402 in participants with advanced breast cancer (ABC). Participants have to be hormone-receptor positive (HR+) and have to be resistant to endocrine therapy and…
- Trial name
- ICARUS BREAST (NCT04965766)
- Testing
- U3-1402
- Where
- 11 sites in France
- Volunteers
- 139 people
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
Breast Cancer
Inetetamab Plus Cyclophosphamide Metronomic Chemotherapy Plus Aromatase Inhibitor in Metastatic HER2+/HR+ Breast Cancer
Antibody-dependent cell-mediated cytotoxicity (ADCC) is one of the important mechanisms for suppressing tumors of Trastuzumab. Pre-clinical data suggest that the ADCC effect of Inetetamab, an anti-HER2 monoclonal antibody with a…
- Trial name
- Increase (NCT04941885)
- Testing
- Inetetamab Plus Cyclophosphamide Metronomic Chemotherapy Plus AI
- Where
- China
- Volunteers
- 78 people
- Sponsor
- Sun Yat-sen University
Metastatic Breast Cancer (MBC), HER2-Positive Breast Cancer
Trastuzumab Rezetecan Followed by Pyrotinib, Fulvestrant, and Dalpiciclib in HR-Positive, HER2-Positive Advanced Breast Cancer
The purpose of this clinical trial is to evaluate whether, in patients with hormone receptor-positive (HR-positive) and HER2-positive advanced breast cancer whose disease has progressed after trastuzumab-based therapy, switching…
- Conditions
- Metastatic Breast Cancer (MBC), HER2-Positive Breast Cancer, Hormone Receptor-Positive Breast Cancer
- Trial name
- NCT07892274
- Testing
- Fulvestrant, Pyrotinib, Dalpiciclib
- Where
- China
- Volunteers
- 226 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Breast Neoplasms, Lung Neoplasms
Preventing Dato-DXd Associated Stomatitis With Dexamethasone Mouthwash, TROPION-DM
TROPION-DM/BrUOG-431 is a prospective, , phase 2 trial with two non-comparative cohorts analyzed jointly for primary endpoint in adult patients with either (Cohort 1:) advanced/metastatic hormone-receptor positive ([HR+]…
- Trial name
- NCT06974604
- Testing
- Dexamethasone oral
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Brown University
Breast Cancer, Locoregional Recurrence
Adjuvant Abemaciclib for Locoregional Recurrence of HR-positive, HER2-negative Breast Cancer (JCOG2313, AURA)
The JCOG2313 trial is a multicenter, randomized, phase III study designed to evaluate the efficacy and safety of adjuvant abemaciclib in combination with endocrine therapy versus endocrine therapy alone in patients with hormone…
- Conditions
- Breast Cancer, Locoregional Recurrence, Abemaciclib, Endocrine Therapy
- Trial name
- AURA (NCT07190443)
- Testing
- Endocrine therapy + Abemaciclib, Endocrine Therapy (ET): letrozole, anastrozole, exemestane, tamoxifen
- Where
- Japan
- Volunteers
- 290 people
- Sponsor
- Japanese Foundation for Cancer Research
Breast Cancer Metastatic, Breast Cancer Stage IV
Detecting Tumor DNA in the Blood of HR+/HER2-low Metastatic Breast Cancer Patients to Find Candidates for T-DXd Therapy
After an initial screening phase to identify patients with persistent blood circulating DNA tumors, patients will be enrolled in the treatment phase that was designed as an open-label, multicentre, phase II study, to test the…
- Trial name
- SAFIR3LibHERty (NCT06680596)
- Testing
- trastuzumab derxutecan
- Where
- 40 sites in France
- Volunteers
- 80 people
- Sponsor
- UNICANCER
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
Initial CDK 4/6 Inhibitor Plus Endocrine Therapy Versus Initial Chemotherapy in HR Positive, HER2 Negative Unresectable or Metastatic Breast Cancer
A multi-center, real world study to evaluate the clinical outcomes between initial CDK 4/6 Inhibitor plus endocrine therapy and initial chemotherapy in HR positive, HER2 negative unresectable or metastatic breast cancer.
- Trial name
- NCT06344793
- Where
- China
- Volunteers
- 608 people
- Sponsor
- Fudan University
Breast Cancer Early Stage Breast Cancer (Stage 1-3), HR Positive/HER2 Low Breast Cancer
Chemotherapy With or Without Adebrelimab and T-DXh as Neoadjuvant Therapy for HR+/HER2 Low Early Stage Breast Cancer
The goal of this clinical trial is to learn if add SHR-A1811 and/or Adebrelimab on standard chemotherapy could further improve the pCR rate in HR+/HER2 low early stage breast cancer patients.
- Trial name
- NCT07317778
- Testing
- SHR-A1811, Adebrelimab (PD-L1 inhibitor), Taxane Chemotherapy
- Where
- China
- Volunteers
- 249 people
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Breast Cancer
CIMER: Combined Immunotherapies in Metastatic ER+ Breast Cancer
Women with Hormone Receptor (HR)+ Human Epidermal growth factor Receptor (HER)2- metastatic breast cancer are eligible to a randomized trial.
- Trial name
- CIMER (NCT04220476)
- Testing
- Stereotactic Body Radiation Therapy (SBRT) (50GY in 5 fractions), Letrozole 2.5Mg Tab, Palbociclib 125mg
- Sponsor
- Weill Medical College of Cornell University
Breast Cancer
Sac-TMT Plus KL-A167 in PD-L1+, HR+/HER2- Metastatic Breast Cancer After CDK4/6 Inhibitors
This is a Phase II single-arm study designed to evaluate the efficacy and safety of Sac-TMT + KL-A167 in 35 patients with PD-L1+, HR+/HER2- metastatic breast cancer who previously treated with CDK4/6 inhibitor.
- Trial name
- NCT07258108
- Testing
- Lucanisatuzumab plus tagolimumab
- Where
- China
- Volunteers
- 35 people
- Sponsor
- Sun Yat-sen University
HR+ HER2- Breast Cancer
Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced/Metastatic Breast Cancer
The study is a Phase 1b/2, multi-center, open-label, dose escalation trial evaluating the safety and preliminary efficacy of sapanisertib and serabelisib (PIKTOR) with fulvestrant and/or other anticancer therapies in participants…
- Trial name
- NCT07558733
- Testing
- Serabelisib, Sapanisertib, Fulvestrant
- Where
- 7 sites in United States
- Volunteers
- 32 people
- Sponsor
- Faeth Therapeutics
Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors
Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and in Patients With Other Advanced Solid Tumors
Phase I: Characterize safety and tolerability of ECI830 as a single agent and in combination with ribociclib and fulvestrant. Identify dose range for optimization/recommended dose for future studies.
- Conditions
- Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors, Extensive-stage Small Cell Lung Cancer
- Trial name
- NCT06726148
- Testing
- ECI830, ribociclib, fulvestrant
- Where
- 33 sites in United States, Australia and 14 more
- Volunteers
- 280 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Breast Cancer
A Study of XZP-3287 in Combination With Fulvestrant in Patients With Advanced Breast Cancer
This is a phase III clinical trial to evaluate the efficacy and safety of XZP-3287 in combination with Fulvestrant versus placebo combined with Fulvestrant in Patients who have HR positive and Her2 negative recurrent/metastatic…
- Trial name
- NCT05077449
- Testing
- XZP-3287+Fulvestrant
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.
Breast Cancer
Efficacy and Safety of Fluzoparib Combined With Adjuvant Endocrine Therapy for HR+/HER2- SNF3-subtype Early Breast Cancer (BCTOP-L-A01)
This is a prospective, randomized, open-label phase III clinical study on the efficacy and safety of fluzoparib combined with adjuvant endocrine therapy versus adjuvant endocrine therapy for HR+/HER2- SNF3-subtype early breast…
- Trial name
- NCT05891093
- Testing
- Fluzoparib, Anastrozole, Letrozole
- Where
- 15 sites in China
- Volunteers
- 766 people
- Sponsor
- Fudan University
Breast Cancer
Phase Ib Trial of LEE011 With Everolimus (RAD001) and Exemestane in the Treatment of Hormone Receptor Positive HER2 Negative Advanced Breast Cancer
Dose Escalation part of the study: To estimate the MTD(s) and/ or RP2D of LEE011 in combination with everolimus + exemestane, and LEE011 in combination with exemestane, and to characterize the safety and tolerability of the…
- Trial name
- NCT01857193
- Testing
- ribociclib (LEE011), Exemestane, Everolimus (RAD001)
- Where
- 13 sites in United States, Belgium and 3 more
- Volunteers
- 132 people
- Sponsor
- Novartis Pharmaceuticals