Clinical trials: HR+/HER2- Early Breast Cancer
Breast Cancer
RADIANT: Pre-op Radiation With Abemaciclib and Letrozole
This phase 1b study investigates the safety and feasibility of combining pre-operative radiation therapy with Cyclin-Dependent Kinase 4 (CDK4/6) inhibitors in participants with hormone receptor positive/HER2 negative (HR+/HER2-)…
- Trial name
- NCT06139107
- Testing
- Abemaciclib, Letrozole
- Where
- 4 sites in United States
- Volunteers
- 15 people
- Sponsor
- Mridula George, MD
Female Breast Cancer
PROOFS-Registry - Premenopausal Women With Breast Cancer Optimally Treated With OFS
There is only limited data for premenopausal patients in general, as well as for differences in the use of OFS in the subgroups of pre- and perimenopausal patients, respectively.
- Trial name
- PROOFS (NCT05792150)
- Where
- 71 sites in Germany
- Volunteers
- 1,470 people
- Sponsor
- Women's Cancer Study Group GmbH
Breast Cancer, HER2 + Breast Cancer
Pragmatic Study to Optimize Neoadjuvant Treatment and Surgical De-escalation in HR+/HER2- Early Breast Cancer Using Oncotype DX and Abemaciclib
This is a pragmatic phase 2 study to determine the proportion of patients with ER+ (≥10%)/HER2- EBC in whom neoadjuvant chemotherapy can be replaced by NET plus abemaciclib based on the results of the ODX RS obtained in the…
- Conditions
- Breast Cancer, HER2 + Breast Cancer, HR Positive, Neoadjuvant Therapy
- Trial name
- VIOLET (NCT07428018)
- Testing
- Abemaciclib
- Where
- Italy
- Volunteers
- 150 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Breast Cancer, Adherence, Medication
Adherence and Safety of Ribociclib Plus Aromatase Inhibitors in Patients With Early Stage, HR+ and HER2- Breast Cancer
Breast cancer is the most common malignancy in women, with HR+/HER2- early breast cancer accounting for approximately 70% of cases.
- Trial name
- riboADHERE (NCT07630948)
- Testing
- Adherence package consisting of additional education and adherence reminders
- Where
- Slovenia
- Volunteers
- 90 people
- Sponsor
- Institute of Oncology Ljubljana
Breast Cancer
A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population
This trial is a multicenter, open-label, non-comparative, phase II, biomarker-driven adjuvant treatment study involving the periodic collection and analysis of blood samples from patients with HR-positive/HER2-negative…
- Trial name
- MiRaDoR (NCT05708235)
- Testing
- Giredestrant, Abemaciclib, Inavolisib
- Where
- 41 sites in Spain, United Kingdom
- Volunteers
- 976 people
- Sponsor
- MedSIR
Early Breast Cancer
Phase IIIb Study of Ribociclib + ET in Early Breast Cancer
The purpose of this open-label, multicenter, phase IIIb, single-arm study is to characterize the efficacy and safety of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free…
- Trial name
- Adjuvant WIDER (NCT05827081)
- Testing
- Ribociclib, Letrozole, Ansastrozole
- Where
- 214 sites in United States, Argentina and 14 more
- Volunteers
- 1,464 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Breast Cancer
Observational Retrospective Study to Assess the Use of Ribociclib in Patients With HR+, HER2- Metastatic Breast Cancer Treated With Chemotherapy
EILEEN was a non-interventional/observational, retrospective, multi-center, real life cohort study conducted in 14 private and academic oncology clinics in Turkey.
- Trial name
- NCT06619704
- Where
- United States
- Volunteers
- 194 people
- Sponsor
- Novartis Pharmaceuticals
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
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
Locally Advanced Breast Cancer, Hormone Receptor Positive，HER2-negative Breast Cancer
Select the Appropriate Population for Adding CDK4/6i to Neoadjuvant Endocrine Therapy
Select the appropriate population for adding CDK4/6 inhibitors therapy in high risk early HR+/HER2-breast cancer based on molecular detection
- Trial name
- NCT05809024
- Testing
- letrozole
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Yongsheng Wang
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
Breast Cancer, Chemotherapeutic Toxicity
AC vs TC in Patients With HR-positive, HER2-negative Early Breast Cancer
Anthracycline-paclitaxel sequential combination therapy is the standard regimen for perioperative chemotherapy in breast cancer. The strategy of perioperative chemotherapy is based on breast cancer subtype, i.e.
- Trial name
- NCT05302336
- Testing
- Liposomal doxorubicin + Cyclophosphamide vs Docetaxel + Cyclophosphamide
- Where
- China
- Volunteers
- 402 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
HR+/HER2- Early Breast Cancer
RWE Non-Interventional Prospective Study of Ribociclib Effectiveness and Safety in Patients With HR+/HER2- Early Breast Cancer in Saudi Arabia
This is a non-interventional, prospective, single-arm, observational study describing the real-world effectiveness, safety, and PRO and HCRU data of ribociclib combined with adjuvant ET under conditions of routine clinical…
- Trial name
- NISLEESA (NCT06797531)
- Testing
- ribociclib
- Where
- 2 sites in Saudi Arabia
- Volunteers
- 177 people
- Sponsor
- Novartis Pharmaceuticals
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
Breast Cancer, HR+/HER2- Breast Cancer
Marker - Adjusted Therapy Comparing Adjuvant Elacestrant With Standard Endocrine Treatment in Genomically and/or Clinically High-risk ER+/HER2- eBC
In this clinical trial, the Sponsor plans to investigate whether patients with HR+/HER2- eBC identified during routine clinical assessments and treatments as having intermediate to high-risk (based on Oncotype DX® or similar…
- Trial name
- ADAPTela (NCT07242352)
- Testing
- Elacestrant, Standard-of-care endocrine treatment
- Where
- 33 sites in Germany
- Volunteers
- 1,520 people
- Sponsor
- Women's Cancer Study Group GmbH
Early Breast Cancer, Hormone Receptor Positive Tumor
Adherence to Aromatase Inhibitors ± Abemaciclib Treatment in Patients With Early-stage HER2-negative Breast Cancer
Around 90% of breast cancer patients are diagnosed at an early stage and approximately 70% are hormone receptor-positive and HER2-negative (HR+/HER2-).
- Conditions
- Early Breast Cancer, Hormone Receptor Positive Tumor, HER2-negative Breast Cancer
- Trial name
- ONCO-Adher (NCT06650423)
- Where
- Slovenia
- Volunteers
- 319 people
- Sponsor
- Institute of Oncology Ljubljana
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 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
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
Serplulimab Plus Chemotherapy for Early-stage HR+/HER2- Breast Cancer
The goal of this clinical trial is to learn if serplulimab is effective in early HR+/HER2- breast cancer. It will also learn about the safety of serplulimab.
- Trial name
- NCT06394661
- Testing
- Serplulimab+NabPE
- Where
- China
- Volunteers
- 109 people
- Sponsor
- Henan Cancer Hospital