Clinical trials: HER2-Positive Early Breast Cancer
Breast Cancer, Breast Cancer Female
Preoperative Stereotactic Ablative Body Radiotherapy (SABR) for Early-Stage Breast Cancer
This study involves a course of radiation to the tumor that is delivered BEFORE surgery. The type of radiation is called stereotactic ablative body radiation therapy (SABR).
- Conditions
- Breast Cancer, Breast Cancer Female, Breast Adenocarcinoma
- Trial name
- NCT03137693
- Testing
- Standard of Care Schedule Variation: SABR, Breast-conserving Surgery
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
HER2-positive Early Breast Cancer
Neoadjuvant Trastuzumab-rezetecan Plus Pertuzumab or Nab-Paclitaxel, Carboplatin, Trastuzumab, and Pyrotinib After Suboptimal Response to Neoadjuvant Dual HER2-Targeted Therapy Combined With Chemotherapy in HER2-Positive Early Breast Cancer
This prospective, response-guided phase II study investigates individualized neoadjuvant treatment strategies for patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer.
- Trial name
- TAYLOR (NCT07340398)
- Testing
- Nab paclitaxel, Carboplatin, Trastuzumab
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Breast Cancer, Triple Negative Breast Neoplasms
Assessing the Efficacy of Paclitaxel and Olaparib in Comparison to Paclitaxel / Carboplatin Followed by Epirubicin/Cyclophosphamide as Neoadjuvant Chemotherapy in Patients With HER2-negative Early Breast Cancer and Homologous Recombination Deficiency
This is a multicenter, prospective, randomized, open-label phase II study evaluating the efficacy and safety of PO→EC as neoadjuvant treatment of operable and locally advanced breast cancer in patients with HR deficiency.
- Conditions
- Breast Cancer, Triple Negative Breast Neoplasms, HRpos Breast Neoplasms, BRCA 1 /2 and / or HRD
- Trial name
- GeparOla (NCT02789332)
- Testing
- PwO, PwCb, EC
- Where
- 12 sites in Germany
- Volunteers
- 107 people
- Sponsor
- GBG Forschungs GmbH
HER2-positive Breast Cancer
PIK3CA in HER2+ BC and pCR Trial
The goal of the study is to evaluate the impact of somatic PI3KCA mutations on pCR in HER2-positive early breast cancer in real life. The main question it aims to answer iS.
- Trial name
- NCT05750693
- Testing
- PIK3CA analysis
- Where
- Italy
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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
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
Hormone Receptor Positive HER-2 Negative Breast Cancer
Impact of Endocrine Therapy, Menstrual Cycle, PAM50, Ki67 on Treatment Decisions in HR+ and HER2- Breast Cancer
PEAK is a prospective, multicenter, non-interventional investigator-initiated trial (IIT) that aims to investigate the influence of the menstrual cycle phase on Ki67 in patients who either receive Tamoxifen, Aromatase inhibitors…
- Trial name
- NCT05878314
- Where
- Germany
- Volunteers
- 504 people
- Sponsor
- University Hospital Tuebingen
HER-2 Positive Advanced Breast Cancer
A Real-World Study of Pyrrolitinib Maleate Tablets for HER-2-Positive Early or Locally Advanced Breast Cancer After Adjuvant Trastuzumab Therapy
Purpose of the Study: Primary Study Objective: To evaluate the efficacy of pyrrolitinib maleate tablets in the treatment of HER-2-positive early or locally advanced breast cancer after adjuvant therapy with trastuzumab Secondary…
- Trial name
- NCT06470347
- Testing
- A Real-World Study of Pyrrolitinib Maleate Tablets for HER-2-Positive Early or Locally Advanced Breast Cancer After Adjuvant Trastuzumab Therapy
- Where
- China
- Volunteers
- 67 people
- Sponsor
- Zunyi Medical College
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
Breast Cancer Early Stage Breast Cancer (Stage 1-3)
De-escalation Therapy in Stage I ER-Positive Breast Cancer: A Non-Inferiority Trial
This study is a prospective, randomized, open-label, non-inferiority Phase III clinical trial, planning to enroll 2,934 patients, with a 1:1 allocation to either the conventional endocrine therapy group or the de-escalation…
- Trial name
- DESCENT (NCT07153757)
- Testing
- Endocrine Therapy of Physician's Choice
- Where
- China
- Volunteers
- 2,934 people
- Sponsor
- Fudan University
Breast Cancer
Study of Preoperative Chemotherapy for Early Triple Negative or HER2-positive Operable Breast Cancer
The investigators research aim to explores the optimal comprehensive treatment for TNBC and her2 positive breast cancer by comparing the efficacy of neoadjuvant with that of adjuvant treatment in improvement of RFS.
- Trial name
- NCT02934828
- Testing
- Neoadjuvant Chemotherapy, postoperative chemotherapy
- Where
- China
- Volunteers
- 230 people
- Sponsor
- Chinese Academy of Medical Sciences
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, Estrogen Receptor Positive Tumor
Dalpiciclib in Combination With Exemestane and Trastuzumab Plus Pyrotinib in Early Triple Positive Breast Cancer
This is a phase II open-label, multicenter trial assessing the efficacy of combination regimen"Dalpiciclib plus Exemestane plus trastuzumab plus pyrotinib"in early triple positive breast cancer patients.
- Conditions
- Breast Cancer, Estrogen Receptor Positive Tumor, HER2-positive Breast Cancer
- Trial name
- NCT04997798
- Testing
- Trastuzumab Pyrotinib Exemestane Dalpiciclib
- Where
- China
- Volunteers
- 30 people
- Sponsor
- First Affiliated Hospital of Zhejiang University
Breast Cancer
Carvedilol for the Prevention of Anthracycline/Anti-HER2 Therapy Associated Cardiotoxicity Among Women With HER2-Positive Breast Cancer Using Myocardial Strain Imaging for Early Risk Stratification
The purpose of this study is to find out the effects, good and/or bad, of a beta blocker (carvedilol) on heart function during treatment with anti-HER2 medication(s) including trastuzumab (Herceptin).
- Trial name
- NCT02177175
- Testing
- Carvedilol
- Where
- 2 sites in United States
- Volunteers
- 82 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Early-stage Breast Cancer, HER2-positive Breast Cancer
Adjuvant Trastuzumab Plus Neratinib in Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer After Neoadjuvant Trastuzumab Plus Pertuzumab
Neratinib is an irreversible pan-HER tyrosine kinase inhibitor (TKI). Currently, no studies have investigated the use of macromolecular anti-HER2 agents combined with TKIs for the treatment of non-pCR HER2-positive breast cancer…
- Conditions
- Early-stage Breast Cancer, HER2-positive Breast Cancer, Adjuvant Treatment After Trastuzumab, RCB Classification 1-2
- Trial name
- NCT05760612
- Testing
- Trastuzumab and neratinib, Trastuzumab and Pertuzumab
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Early Breast Cancer
A Study Of PF-05280014 Or Trastuzumab Plus Taxotere® And Carboplatin In HER2 Positive Breast Cancer In The Neoadjuvant Setting (REFLECTIONS B327-04)
The current study will compare PK, efficacy, safety, and immunogenicity of PF-05280014 (Trastuzumab-Pfizer) in combination with Taxotere® and Carboplatin (Paraplatin) versus Herceptin® (Trastuzumab-EU) approved in the EU in…
- Trial name
- NCT02187744
- Testing
- PF-05280014, Taxotere®, Paraplatin®
- Where
- 52 sites in United States, Belarus and 8 more
- Volunteers
- 226 people
- Sponsor
- Pfizer
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 Neoplasms, Breast Cancer
Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)
Researchers are looking for new ways to treat triple-negative breast cancer (TNBC) and hormone receptor (HR) low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer.
- Trial name
- NCT06797635
- Testing
- Patritumab deruxtecan, Pembrolizumab, Paclitaxel
- Where
- 17 sites in United States, South Korea and 2 more
- Volunteers
- 372 people
- Sponsor
- Merck Sharp & Dohme LLC
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
Estrogen Receptor Positive, HER2/Neu Negative
FLT PET in Measuring Treatment Response in Patients With Newly Diagnosed Estrogen Receptor-Positive, HER2-Negative Stage I-III Breast Cancer
This clinical trial studies fluorine F 18 fluorothymidine (FLT) positron emission tomography (PET) in measuring treatment response in patients with newly diagnosed estrogen receptor (ER)-positive, human epidermal growth factor…
- Conditions
- Estrogen Receptor Positive, HER2/Neu Negative, Male Breast Carcinoma, Stage IA Breast Cancer
- Trial name
- NCT01928186
- Testing
- Fluorothymidine F-18, Positron Emission Tomography, Laboratory Biomarker Analysis
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- University of Washington