Clinical trials: Early Hormone Receptor-positive Breast Cancer
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
Hormone Receptor-Positive Breast Cancer, High-risk Breast Cancer
CDK4/6 Inhibitors Combined With Endocrine Therapy for Neoadjuvant Treatment
Exploring the dynamics of ctDNA following neoadjuvant therapy with CDK4/6 inhibitors combined with endocrine treatment, and its potential to guide de-escalation of adjuvant chemotherapy
- Conditions
- Hormone Receptor-Positive Breast Cancer, High-risk Breast Cancer, Early-Stage Breast Cancer, HER2-negative Breast Cancer
- Trial name
- DNACDKHR (NCT07366112)
- Testing
- CDK4/6 inhibitor with endocrine therapy
- Where
- China
- Volunteers
- 158 people
- Sponsor
- Peking University People's Hospital
Hormone Receptor Positive,Human Epidermal Receptor 2 Negative, Node-positive, High Risk, Early Stage，Female Breast Cancer
Phase III Study ：SHR6390/Placebo Combined With Endocrine Therapy for the Adjuvant Treatment of Hormone Receptor Positive,Human Epidermal Receptor 2 Negative
The study is to evaluate the efficacy and safety of SHR6390 combined with endocrine therapy for the adjuvant treatment of hormone receptor positive,Human Epidermal Receptor 2 negative.
- Trial name
- NCT04842617
- Testing
- SHR6390
- Where
- China
- Volunteers
- 5,274 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Operable Breast Neoplasms
Trial of Endocrine Against Locoregional Therapy First in Postmenopausal Women With Early Breast Cancer
The hypothesis to be addressed in this randomized phase III trial is that 4 months of letrozole may be superior to surgery as primary therapy for early stage hormone receptor positive breast cancer in postmenopausal women…
- Trial name
- REAL (NCT00908531)
- Testing
- letrozole (Femara)
- Where
- 9 sites in Denmark
- Volunteers
- 123 people
- Sponsor
- Danish Breast Cancer Cooperative Group
Hormone-receptor-positive Breast Cancer, Early Breast Cancer
Clinical Study of Local and Systemic Biological Impact of GLP1/GIP-Receptor Agonists in Patients With Breast Cancer: The CLARA Trial
The CLARA trial is a phase II window-of-opportunity trial evaluating how a commonly used weight-loss medication (tirzepatide, a GLP-1/GIP receptor agonist) affects breast cancer biology, alone and in combination with standard…
- Trial name
- CLARA (NCT07676331)
- Testing
- Tirzepatide, Letrozole (Aromatase Inhibitors)
- Volunteers
- 168 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Dose Escalation, Safety
Phase Ib, Dose Escalation Study of Oral LDE225 in Combination With BKM120 in Patients With Advanced Solid Tumors
The purpose of this study is to determine the maximum dose of LDE225 and BKM120 that can be safely given together to patients and/or the dose that will be used in future studies.
- Conditions
- Dose Escalation, Safety, Preliminary Efficacy, Advanced Solid Tumors
- Trial name
- NCT01576666
- Testing
- LDE225, BKM120
- Where
- 23 sites in United States, Australia and 6 more
- Volunteers
- 120 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer (Early Breast Cancer), Obesity
Semaglutide for Weight Management During Hormone Therapy for Early Breast Cancer
This study will assess whether women with obesity and early estrogen receptor-positive breast cancer can complete 26 weeks of semaglutide treatment while continuing their prescribed hormone therapy for breast cancer.
- Trial name
- WISPER (NCT07909889)
- Testing
- Semaglutide (Wegovy®)
- Where
- 2 sites in Denmark
- Volunteers
- 32 people
- Sponsor
- Aarhus University Hospital
Breast Cancer, Hormone Receptor-positive Breast Cancer
A Randomized Study Comparing the Immune Modulation Effect of Ribociclib, Palbociclib, and Abemaciclib in ER+/HER2- EBC
The 3 FDA-approved CDK4, 6 inhibitors, palbociclib, ribociclib, and abemciclib, all provided progression-free survival benefits when combined with endocrine therapy in advanced ER+/HER2- breast cancer.
- Conditions
- Breast Cancer, Hormone Receptor-positive Breast Cancer, Hormone Therapy
- Trial name
- ORACLE-RIPA (NCT05766410)
- Testing
- Palbociclib, Ribociclib, Abemaciclib
- Where
- 2 sites in Taiwan
- Volunteers
- 60 people
- Sponsor
- National Taiwan University Hospital
Breast Cancer
Treatment Decision Impact of OncotypeDX™ in HR+, N- Breast Cancer Patients
Primary objective: Determine the impact of the Oncotype DX Recurrence Score (RS) on the treatment recommendation made (administration of chemotherapy or not, in addition to hormonotherapy) in a HR+, N- or pN1(mi), Her2- breast…
- Trial name
- SWITCH (NCT01446185)
- Testing
- Oncotype DX breast cancer test
- Where
- 6 sites in France
- Volunteers
- 100 people
- Sponsor
- Genomic Health®, Inc.
Early-Stage Breast Carcinoma, Hormone Receptor Positive Tumor
Neoadjuvant Response-guided Treatment of Slowly Proliferating Hormone Receptor Positive Tumors
The purpose of this neoadjuvant trial is to evaluate efficacy and toxicity of the cdk 4/6 inhibitor palbociclib when added to standard endocrine treatment. Initially, patients receive endocrine treatment for 4 weeks.
- Trial name
- PREDIX LumA (NCT02592083)
- Testing
- Tamoxifen or Aromatase Inhibitor or Aromatase Inhibitor + goserelin, Palbociclib
- Where
- Sweden
- Volunteers
- 10 people
- Sponsor
- Thomas Hatschek
Early Breast Cancer
This Clinical Trial is a Retrospective, Multicenter Cohort Study Evaluating the Real-world Characteristics and Risk of Disease Recurrence in Hormone Receptor-positive, HER2-negative Early Breast Cancer.
Primary objective: To describe event-free survival (EFS) in patients with stage I-III HR+/HER2- early breast cancer (EBC) who received curative surgery followed by systemic therapy.
- Trial name
- PRIORITY (NCT07309887)
- Where
- South Korea
- Volunteers
- 100,000 people
- Sponsor
- Samsung Medical Center
Breast Cancer Stage III, Breast Cancer Stage II
The Efficacy and Safety of CDK4/6 Inhibitors in Combination with Endocrine Therapy in the Neoadjuvant Treatment
To explore the efficacy and safety of CDK4/6 inhibitors combined with endocrine neoadjuvant therapy for stage II-III HR-positive/HER2-negative breast cancer.
- Trial name
- NCT06810492
- Testing
- Ribociclib; abemaciclib; palbociclib; Dalpiciclib
- Volunteers
- 40 people
- Sponsor
- Hongmei Zheng, PhD
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
Breast Cancer
Phase 0 Study of Metronomic Oral Vinorelbine and Letrozole in HR+/HER2-negative Early Breast Cancer Patients (VENTANA)
VENTANA is a "window-of-opportunity" trial that will explore whether, similar to CDK4/6 inhibitors, Oral Metronomic Vinorelbine in combination with Letrozole induces a superior anti-proliferative effect than Letrozole alone.
- Trial name
- NCT02802748
- Testing
- Oral Vinorelbine, Letrozole
- Where
- 10 sites in Spain
- Volunteers
- 60 people
- Sponsor
- SOLTI Breast Cancer Research Group
HR Negative HER2 Positive Early Breast Cancer or Locally Advanced Breast Cancer Patients
Efficacy and Safety of the Proposed Biosimilar Pertuzumab (PERT-IJS) Versus EU-Perjeta® Along With Trastuzumab and Chemotherapy (Carboplatin and Docetaxel) as Neoadjuvant Treatment in Chemotherapy naïve Patients With Early Stage or Locally Advanced HR Negative and HER2 Positive Breast Cancer
To compare the efficacy and safety of PERT-IJS (Proposed biosimilar Pertuzumab) plus trastuzumab and chemotherapy (carboplatin and docetaxel) versus EU-Perjeta plus trastuzumab and chemotherapy (carboplatin and docetaxel) in…
- Trial name
- NCT06038539
- Testing
- PERT-IJS plus trastuzumab, carboplatin and docetaxel, Perjeta plus trastuzumab, carboplatin and docetaxel
- Where
- India
- Volunteers
- 55 people
- Sponsor
- Biocon Biologics UK Ltd
Breast Cancer Stage II
Anlotinib Combined With Chemotherapy and Neoadjuvant Therapy for Hormone Receptor-positive HER-2 Negative Breast Cancer
Anlotinib is an oral multi-targeted tyrosine kinase inhibitor (TKI) that strongly inhibits VEGFR, PDGFR, FGFR, and c-kit. Combining anti-angiogenesis with chemotherapy yielded increased response rates in patients with early-stage…
- Trial name
- ACNTBC (NCT05558722)
- Testing
- Anlotinib
- Where
- China
- Volunteers
- 31 people
- Sponsor
- Xijing Hospital
Breast Cancer Females
A Real-world Study on the Compliance of OFS-assisted Endocrine Therapy for Hormone Receptor-positive(HR+) Premenopausal Breast Cancer
The goal of this observational study is to observe the long-term prognosis of patients with early HR-positive premenopausal breast cancer.
- Trial name
- NCT07180914
- Volunteers
- 300 people
- Sponsor
- Zhejiang Cancer Hospital
Breast Cancer
A Phase II Window of Opportunity Trial of PRMT5 Inhibitor, GSK3326595, in Early Stage Breast Cancer
This is a Phase II Randomized Window of Opportunity Trial Evaluating Clinical and Biological effects of PRMT5 inhibitor, GSK3326595, in Early Stage Breast Cancer
- Trial name
- OTT-19-06 (NCT04676516)
- Testing
- GSK3326595
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- Ottawa Hospital Research Institute
Breast Neoplasms, Triple Negative Breast Neoplasms
A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)
Researchers are looking for new ways to treat types of breast cancer that are both: High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment Early-stage, which means the cancer is…
- Conditions
- Breast Neoplasms, Triple Negative Breast Neoplasms, HR Low-Positive/HER2-Negative Breast Neoplasms
- Trial name
- NCT06966700
- Testing
- Sacituzumab tirumotecan, Pembrolizumab, Rescue Medication
- Where
- 331 sites in United States, Argentina and 39 more
- Volunteers
- 2,400 people
- Sponsor
- Merck Sharp & Dohme LLC
Early-stage Breast Cancer, Hypoactive Sexual Desire Disorder
BRE-06: Study to Increase Tolerance to Aromatase Inhibitors for Patients With Early-Stage Hormone Receptor Positive Breast Cancer Who Developed Hypoactive Sexual Desire Disorder
This study is open to women who have early-stage breast cancer and are on aromatase inhibitor (AI) therapy, and who have hypoactive sexual desire disorder (HSDD).
- Conditions
- Early-stage Breast Cancer, Hypoactive Sexual Desire Disorder, Hormone Receptor Positive Breast Carcinoma, Breast Cancer
- Trial name
- NCT07596212
- Testing
- Aromatase Inhibitors, Bupropion, GnRH agonist
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- University of Illinois Chicago