Clinical trials: HR+/HER2- Early Breast Cancer
HR+/HER2- Early Breast Cancer
IMPLEMENTING PATIENTS' COMPETENCE IN ORAL EBC THERAPY PERSISTENCE
The goal of this interventional study is to evaluate the effect of standardized patient coaching on treatment adherence among patients taking abemaciclib.
- Trial name
- IMPACT PT (NCT07521202)
- Testing
- Standardized patient coaching
- Where
- Germany
- Volunteers
- 257 people
- Sponsor
- Institut fuer Frauengesundheit
Breast Cancer, TNBC - Triple-Negative Breast Cancer
Evaluating Minimal Residual Disease (MRD) Through Longitudinal Circulating Tumor DNA (ctDNA) Profiling in Breast Malignancies
For patients with breast cancer, it's important to find any remaining cancer cells after they've had their main treatment. Even a few cells, called minimal residual disease (MRD), can lead to the cancer coming back later.
- Conditions
- Breast Cancer, TNBC - Triple-Negative Breast Cancer, HR Positive/HER-2 Negative Breast Cancer, HER2 + Breast Cancer
- Trial name
- GEMINI Breast (NCT07211178)
- Testing
- There are no interventions in this observational study.
- Where
- 16 sites in United States
- Volunteers
- 900 people
- Sponsor
- Tempus AI
Early Breast Cancer, Premenopausal Breast Cancer
Optimising Adjuvant Chemotherapy Prescription in Young Patients With Hormone-dependent Breast Cancer Using Genomic Tests
Rationale: Around 70 to 80% of breast cancers are so-called "hormone-dependent" (HR+)/HER2-. For more than 50 years, studies have shown that chemotherapy and optimised hormonal treatments (hormone therapy), including a drug…
- Conditions
- Early Breast Cancer, Premenopausal Breast Cancer, HR+/HER2- Breast Cancer
- Trial name
- OPTIMA-YOUNG (NCT07106632)
- Testing
- test-directed treatment: allocated treatment will depend on the PAM50 score result (centrally assessed) : chemo-endocrine therapy or endocrine therapy alone, In the control arm, the treatment will be as standard of care : chemo-endocrine therapy
- Where
- 105 sites in Belgium, France and 5 more
- Volunteers
- 3,380 people
- Sponsor
- UNICANCER
HR+/HER2- Early Breast Cancer
Evaluating the Effectiveness of Typology-based Coaching on Patients' Therapy Management
The goal of this clinical trial is to evaluate the effect of patient education and patient typology-based coaching on therapy persistence in breast cancer patients taking ribociclib.
- Trial name
- TYPER (NCT07708571)
- Testing
- Typology-based coaching
- Where
- 3 sites in Germany
- Volunteers
- 548 people
- Sponsor
- Institut fuer Frauengesundheit
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
HR+/HER2+ Early Breast Cancer
Fovinaciclib Plus Aromatase Inhibitors and Dual HER2 Blockade in a Response-Adapted Neoadjuvant Strategy for HR-Positive/HER2-Positive Early Breast Cancer
This prospective, response-adapted phase II study evaluates the efficacy and safety of neoadjuvant fovinaciclib in combination with aromatase inhibitors and dual HER2 blockade in patients with HR-positive/HER2-positive early…
- Trial name
- TAYLOR-003 (NCT07616427)
- Testing
- Fovinaciclib, Aromatase Inhibitors, Trastuzumab + Pertuzumab
- Where
- 3 sites in China
- Volunteers
- 100 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
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
HR+/HER2- Early Breast Cancer
Patient Relevant Outcomes Improvement Program in High Risk Hormone Receptor Positive (HR+) Breast Cancer
The goal of this observational study is to evaluate how persistently patients with high-risk early breast cancer take abemaciclib 6 months after therapy start.
- Trial name
- PROSPER (NCT07531693)
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Institut fuer Frauengesundheit
HR+/HER2- Early Breast Cancer
A Study on the Use of Fluzoparib Combined With Chemotherapy for Neoadjuvant Treatment of HRD-positive, HR+/HER2- Breast Cancer
The purpose of this clinical trial is to evaluate the efficacy and safety of Fluzoparib combined with docetaxel in sequential paclitaxel combined with cyclophosphamide for HRD-positive, HR+/HER2- early breast cancer.
- Trial name
- NCT07162051
- Testing
- Fuzaparib, standard chemotherapy
- Where
- China
- Volunteers
- 28 people
- Sponsor
- Xijing Hospital
Breast Cancer, HR+/HER2- Early-Stage
Predicting Recurrence in HR+/HER2- Early Breast Cancer
Hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer constitutes approximately 70% of all breast cancer cases.
- Trial name
- NCT07484763
- Volunteers
- 500 people
- Sponsor
- Shengjing Hospital
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 (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 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
SHR-A1811, HER2-Postive Breast Cancer
SHR-A1811 Plus Pertuzumab as Neoadjuvant Therapy for Early or Locally Advanced HR-Positive HER2-Positive Breast Cancer: A Prospective, Open-Label, Phase II Study
Breast cancer is the most common malignancy in women, with approximately 20% classified as HER2-positive. Anti-HER2 blockade (trastuzumab plus pertuzumab) combined with chemotherapy constitutes the standard neoadjuvant regimen…
- Conditions
- SHR-A1811, HER2-Postive Breast Cancer, HR+ Breast Cancer, Early Breast Cancer
- Trial name
- NCT07307287
- Testing
- SHR- A1811
- Volunteers
- 30 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
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
Early Breast Cancer, Neoadjuvant Therapy
QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Early High-Risk ER+/HER2- Breast Cancer
This study will look at the efficacy and safety of QL1706 plus albumin-bound paclitaxel followed by AC/EC in a neoadjuvant setting, in high-risk, ER+/HER2- early breast cancer.
- Conditions
- Early Breast Cancer, Neoadjuvant Therapy, HR+HER2- Breast Cancer
- Trial name
- QUEEN-Neo (NCT06404463)
- Testing
- QL1706 (bispecific antibody targeting PD-1 and CLTA-4), Albumin-bound paclitaxel, Doxorubicin
- Volunteers
- 76 people
- Sponsor
- Fudan University