Clinical trials: HR+/HER2- Early Breast Cancer
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
Early-stage Breast Cancer
Impact of Exercise on Quality of Life of EBC Patients on Treatment With Adjuvant AI With or Without CDK4/6 Inhibitors
This is a national clinical trial (Spain), conducted in approximately 5 sites, where patients who agree to participate will be included in one of two exercise program groups: the experimental group (a combined resistance and…
- Trial name
- EX-AI (NCT07215364)
- Testing
- Training program
- Where
- 5 sites in Spain
- Volunteers
- 74 people
- Sponsor
- Spanish Breast Cancer Research Group
Breast Cancer
Clinical Study of SHR-A1811 With or Without Letrozole in Neoadjuvant Therapy for Early-Stage HR-Positive, HER2-Low Breast Cancer
This is a prospective, randomized, multi-cohort, Phase II clinical trial. The study plans to enroll 120 patients with early-stage or locally advanced, HR-positive, HER2-low breast cancer.
- Trial name
- NCT07305246
- Testing
- SHR-A1811, Letrozole, TAC/AC-T
- Volunteers
- 120 people
- Sponsor
- First Hospital of China Medical University
HER2-positive Breast Cancer
Neoadjuvant Endocrine Therapy +/- the PI3K Inhibitor Inavolisib in HER2+, HR+, PIK3CA Mutant Early Breast Cancer
Evaluation of the potential incremental efficacy and safety of inavolisib in the neoadjuvant endocrine treatment of early-stage HER2-positive, HR-positive, PIK3CA mutant breast cancer.
- Trial name
- GeparPiPPa (NCT05306041)
- Testing
- Inavolisib, PHESGO, Endocrine therapy
- Where
- 62 sites in Germany, Italy and 4 more
- Volunteers
- 170 people
- Sponsor
- GBG Forschungs GmbH
Breast Cancer Female
Adjuvant Therapy With Abemaciclib + SOC ET vs. SOC ET in Clinical or Genomic High Risk, HR+/HER2- EBC
Patients with breast cancer, who have completed first line therapy (e.g., radiotherapy, chemotherapy, surgery), and who have to be identified with having a high risk of recurrence of cancer, will be eligible for the study.
- Trial name
- ADAPTlate (NCT04565054)
- Testing
- Abemaciclib 50 MG; 150mg 1-0-1 per os
- Where
- 85 sites in Germany, Poland and 1 more
- Volunteers
- 1,260 people
- Sponsor
- Women's Cancer Study Group GmbH
Neoadjuvant Therapy
Neoadjuvant SNF Precision Therapy Phase III
This study is a prospective, open-label, multicenter, randomized controlled Phase III clinical trial designed to compare the efficacy and safety of neoadjuvant chemotherapy based on SNF classification with or without precision…
- Trial name
- NCT06913777
- Testing
- Targeted therapy agents: SNF2 -adebrelimab + famitinib; SNF3 -fluzoparib; SNF4 -apatinib, Chemotherapy (wP-EC)
- Where
- China
- Volunteers
- 404 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
Early-stage Breast Cancer, Hormone Receptor Positive Tumor
A Window of Opportunity Study of Pre-operative Endocrine Therapy With and Without Prometrium in Postmenopausal Women With Early Stage Breast Hormone Receptor Positive (HR+) Human Epidermal Receptor 2 Negative (HER2-) Breast Cancer.
A phase II randomised, open label study of pre-operative endocrine therapy with \& without prometrium in postmenopausal women with early stage breast hormone receptor positive (HR+) human epidermal receptor 2 negative (HER2-)…
- Trial name
- WinPro (NCT03906669)
- Testing
- Letrozole, Letrozole and Prometrium, Tamoxifen and Prometrium
- Where
- Australia
- Volunteers
- 200 people
- Sponsor
- St Vincent's Hospital
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, Early-stage Breast Cancer
TRADE: Dose Escalation Tolerability of Abemaciclib in HR+ HER2- Early Stage Breast Cancer
In this research study, investigators are testing if a dose-increasing strategy for abemaciclib will have less side effects and be better tolerated than the standard dosage of abemaciclib for participants with early-stage…
- Conditions
- Breast Cancer, Early-stage Breast Cancer, High Risk Breast Carcinoma
- Trial name
- NCT06001762
- Testing
- Abemaciclib, Tamoxifen, Anastrozole
- Where
- 12 sites in United States
- Volunteers
- 90 people
- Sponsor
- Dana-Farber Cancer Institute
HER2-zero, HER2-low and HER2-positive Tumors Distribution Across HR Expression Categories
Clinico-pathological and Genomic Features of HER2-low Early Breast Cancer
Although breast cancer remains one of the most common and fatal cancer types among women worldwide, earlier diagnosis and improved therapeutic approaches have led to decreased mortality over last years.
- Trial name
- NCT07561346
- Where
- Greece
- Volunteers
- 3,648 people
- Sponsor
- Hellenic Cooperative Oncology Group
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
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
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
Early and Locally Advanced Breast Cancer
ABCSG 61 / TEODOR : Neoadjuvant TrEatment Optimization Driven by Circulating Tumor DNA and endOcrine Responsiveness
The goal of this performance study is to learn if treatment with neoadjuvant endocrine therapy compared to chemotherapy has comparable efficacy, but better quality of life outcomes in endocrine responsive participants with early…
- Trial name
- TEODOR (NCT07084558)
- Testing
- blood sample for Signatera (TM) test, biopsy for Ki-67 assessment, FFPE tumor sample for Signatera (TM) test (archived)
- Where
- 14 sites in Austria
- Volunteers
- 350 people
- Sponsor
- Austrian Breast & Colorectal Cancer Study Group
Breast Cancer
Tolerability of Dalpiciclib vs. Abemaciclib/Ribociclib in Early HR+/HER2- Breast Cancer
In recent years, the successful application of cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) has transformed the treatment landscape for HR+/HER2- advanced breast cancer and driven research into their use in adjuvant settings.
- Trial name
- NCT07706933
- Testing
- Dalpiciclib, Abemaciclib/Ribociclib
- Volunteers
- 456 people
- Sponsor
- Henan Cancer Hospital
Breast Cancer Female
Adj. Marker-adjusted Personalized Therapy Comparing ET+Ribociclib vs Chemotherapy in Intermediate Risk, HR+/HER2- EBC
The study investigates, whether the patient group with intermediate-risk early breast cancer benefits from treatment with ribociclib in combination with endocrine therapy compared to standard-of-care chemotherapy (followed by…
- Trial name
- ADAPTcycle (NCT04055493)
- Testing
- Ribociclib 200Mg Oral Tablet
- Where
- 86 sites in Germany
- Volunteers
- 1,684 people
- Sponsor
- Women's Cancer Study Group GmbH
Untreated Early-stage or Locally Advanced Breast Cancer
Neoadjuvant SHR-A1811 Plus Adebrelimab in HR Negative/Low & HER2 Low Breast Cancer Patients
The study is being conducted to evaluate the preliminary efficacy, safety, and pharmacokinetic characteristics of the combination of SHR-A1811 with Adebrelimab Injection in treatment-naive patients with early-stage or locally…
- Trial name
- NCT06592625
- Testing
- SHR-A1811, Adebrelimab
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
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