Clinical trials: Early Breast Cancer (EBC)
Breast Cancer
MRD in High-risk EBC
This study is a multicenter, prospective, observational cohort study, 125 patients with early-stage high-risk breast cancer will be enrolled, perioperative surgical specimens, peripheral blood specimens before and after adjuvant…
- Trial name
- NCT06566729
- Testing
- Peripheral blood sample collection
- Where
- China
- Volunteers
- 125 people
- Sponsor
- Shanghai Jiao Tong University School of Medicine
Breast Cancer
Comparative Study of Oestradiol Suppression: Zoladex 10.8mg/3 Month vs. 3.6mg/Month in ER +ve EBC Pre-menopausal Patients
The primary purpose of this study is to establish if a 10.8 mg dose of ZOLADEX given 3 monthly is non-inferior to a 3.6 mg dose of ZOLADEX given monthly in terms of oestradiol suppression in patients with oestrogen receptor…
- Trial name
- NCT00303524
- Testing
- Goserelin acetate
- Where
- 22 sites in Japan
- Volunteers
- 170 people
- Sponsor
- AstraZeneca
Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Neoadjuvant Pyrotinib-to-pertuzumab in HER2+ eBC
This is a randomized, open-label, superiority, multicenter clinical trial for patients with early or locally advanced (T≥2cm, N0-3, M0) HER2-positive breast cancer.
- Trial name
- NCT07797218
- Testing
- Docetaxel, Pyrotinib, Trastuzumab (Herceptin)
- Where
- China
- Volunteers
- 220 people
- Sponsor
- Shanghai Jiao Tong University School of Medicine
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
Breast Cancer, Breast Neoplasms
Tirzepatide Weight Loss for MRD+ Early Breast Cancer
This trial aims to asses if tirzepatide-induced weight loss will lead to metabolic and hormonal changes in hormone receptor-positive (HR+), human epidermal growth factor receptor-negative (HER2-), node-positive (N+) high risk…
- Conditions
- Breast Cancer, Breast Neoplasms, Breast Cancers
- Trial name
- TRIM-EBC (NCT06517212)
- Testing
- Tirzepatide
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Baylor Research Institute
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
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
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
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
Breast Cancer
Treatment Patterns of Neratinib in HER2+ EBC in China
This is a multicenter, open-label, single-arm, non-interventional study to investigate the treatment patterns of Neratinib in HER2-positive early-stage breast cancer in China
- Trial name
- NCT05491057
- Testing
- Neratinib
- Where
- China
- Volunteers
- 500 people
- Sponsor
- Pierre Fabre Medicament
Breast Cancer
An Observational Time and Motion Study of Trastuzumab Subcutaneous (SC) and Intravenous (IV) Formulations in Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Early Breast Cancer (EBC)
This prospective, non-interventional time and motion study will evaluate the costs of healthcare resource utilization associated with the administration of trastuzumab (Herceptin) SC and IV formulations in HER2-positive EBC.
- Trial name
- NCT02658461
- Testing
- Trastuzumab
- Where
- 4 sites in United Kingdom
- Volunteers
- 36 people
- Sponsor
- Hoffmann-La Roche
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, Neoadjuvant Chemotherapy
ACHP-THP vs EC-THP as Neoadjuvant Therapy for HER2-positive EBC
Breast cancer is the most common malignant tumor in women. EC-TH is one of the standard chemotherapy regimens for HER-2 positive early breast cancer(EBC). Earlier use of trastuzumab may improve DFS rate.
- Trial name
- NCT04172259
- Testing
- Doxorubicin liposome, Cyclophosphamide, Trastuzumab
- Where
- China
- Volunteers
- 156 people
- Sponsor
- Sun Yat-sen University
Breast Cancer
A Study to Compare Subcutaneous (SC) Versus Intravenous (IV) Administration of Herceptin (Trastuzumab) in Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer
In this open-label multicenter trial, participants with operable or locally advanced breast cancer will be randomized to pre-operative treatment with 8 cycles of chemotherapy (4 cycles of docetaxel followed by 4 cycles of…
- Trial name
- NCT00950300
- Testing
- 5-Fluorouracil, Cyclophosphamide, Docetaxel
- Where
- 106 sites in Argentina, Brazil and 24 more
- Volunteers
- 596 people
- Sponsor
- Hoffmann-La Roche
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
A Study of SC Administration of Trastuzumab (Herceptin) by SID at Home in HER2-Positive EBC Participants
This single-arm, open-label, local multicenter study will evaluate the safety and tolerability of trastuzumab administered subcutaneously (SC) by a single-use injection device (SID) in participants with human epidermal growth…
- Trial name
- HOMERUS (NCT02040935)
- Testing
- Trastuzumab
- Where
- 17 sites in Netherlands
- Volunteers
- 128 people
- Sponsor
- Hoffmann-La Roche
HER2-positive Breast Cancer
Real World Patient-Reported Outcomes in Chinese Her2+ EBC Patients Receiving (Neo) Adjuvant Anti-Her2 Based Therapy
This is a non-interventional observational, multi-center cohort study to evaluate patient-reported outcomes in Chinese HER2+ early breast cancer patients undergoing (neo) adjuvant anti-HER2 based therapy and describe changes over…
- Trial name
- NCT06161922
- Where
- China
- Volunteers
- 600 people
- Sponsor
- Fudan University
Early Breast Cancer (EBC)
neoAGORA: Exploring Clinical Utility of Serial Liquid Biopsy (ctDNA) in Patients With Early-Stage Breast Cancer
The goal of this observational study is to explore the utility of analytical techniques that enable the study of small amounts of tumor-derived material circulating in the blood, such as fragments of circulating tumor DNA (also…
- Trial name
- neoAGORA (NCT07718841)
- Testing
- biological samples, images, and clinical data
- Where
- 10 sites in Spain
- Volunteers
- 300 people
- Sponsor
- Spanish Breast Cancer Research Group
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
A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer
A phase III, multicenter, randomized, open-label trial to evaluate the efficacy and safety of ribociclib with Endocrine Therapy (ET) as an adjuvant treatment in women and men with Hormone Receptor positive (HR+), Human Epidermal…
- Trial name
- NATALEE (NCT03701334)
- Testing
- Ribociclib, Endocrine Therapy (ET)
- Where
- 387 sites in United States, Argentina and 18 more
- Volunteers
- 5,101 people
- Sponsor
- Novartis Pharmaceuticals