Clinical trials: HER2-positive Breast Cancer
ER+/HER2- Breast Cancer
Neoadjuvant High-Intensity Focused Ultrasound (HIFU) Combined With Toripalimab and Chemotherapy for ER-Positive /HER2-Negative Breast Cancer
The purpose of this study is to evaluate the efficacy and safety of high-intensity focused ultrasound (HIFU) combined with toripalimab and chemotherapy as neoadjuvant therapy for ER+/HER2- breast cancer.
- Trial name
- NeoHunter (NCT06964906)
- Testing
- HIFU, Toripalimab, nab-Paclitaxel (nab-P)
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Breast Cancer
Neoadjuvant Inetetamab and Pyrotinib and Nab-paclitaxel for HER2+Breast Cancer
Explore the efficacy and safety of the combination of inetetamab, pyrotinib and nab-paclitaxel in the neoadjuvant treatment of HER2 positive early or locally advanced breast cancer
- Trial name
- NCT05444998
- Testing
- Inetetamab, pyrotinib, nab-paclitaxel
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Xijing Hospital
HER2-positive Breast Cancer
De-escalation Neoadjuvant Therapy for Intermediate Risk HER2-positive Early Breast
High pathological complete response (pCR) rates are seen using different neoadjuvant chemotherapy schedules with trastuzumab and pertuzumab in HER2-positive stage II-III breast cancer patients.
- Trial name
- neoDIRHP (NCT07748260)
- Testing
- THP×4 Q3W (n=296) (Investigator-selected taxane* + Trastuzumab IV 6 mg/kg, loading dose 8 mg/kg + Pertuzumab IV 420 mg, loading dose 840mg), THP×6 Q3W (n=296) (Investigator-selected taxane* + Trastuzumab IV 6 mg/kg, loading dose 8 mg/kg + Pertuzumab IV 420 mg, loading dose 840mg)
- Volunteers
- 592 people
- Sponsor
- Guangdong Provincial People's Hospital
Cardiotoxicity., Anti Her2 Therapy.
Cardiotoxicity in Metastatic Her 2 Positive Patients Treated With Trastuzumab ,Pertuzumab and Taxanes
Approximately 15-25% of all breast cancers are human epidermal growth factor receptor 2 (HER2) positive and it has been well known that HER2 overexpression is associated with more aggressive phenotype and poor prognosis with…
- Conditions
- Cardiotoxicity., Anti Her2 Therapy., Metastatic Breast Cancer
- Trial name
- NCT02101879
- Where
- Israel
- Volunteers
- 20 people
- Sponsor
- Rambam Health Care Campus
Breast Neoplasms
6 Weeks Treatment of Locally Advanced Breast Cancer With BIBW 2992 (Afatinib) or Lapatinib or Trastuzumab
An open-label, randomized three-arm Phase II trial to explore the efficacy of BIBW 2992 as a single agent versus lapatinib versus trastuzumab in patients with HER2-positive treatment-naïve Stage IIIa locally advanced breast…
- Trial name
- NCT00826267
- Testing
- lapatinib, BIBW 2992, trastuzumab
- Where
- 17 sites in United States, Brazil and 2 more
- Volunteers
- 29 people
- Sponsor
- Boehringer Ingelheim
Breast Adenocarcinoma, Stage II Breast Cancer AJCC v6 and v7
TPIV100 and Sargramostim for the Treatment of HER2 Positive, Stage II-III Breast Cancer in Patients With Residual Disease After Chemotherapy and Surgery
This phase II trial studies how well TPIV100 and sargramostim work in treating patients with HER2 positive, stage II-III breast cancer that has residual disease after chemotherapy prior to surgery.
- Conditions
- Breast Adenocarcinoma, Stage II Breast Cancer AJCC v6 and v7, Stage IIA Breast Cancer AJCC v6 and v7, Stage IIB Breast Cancer AJCC v6 and v7
- Trial name
- NCT04197687
- Testing
- Multi-epitope HER2 Peptide Vaccine TPIV100, Pertuzumab, Sargramostim
- Where
- 30 sites in United States
- Volunteers
- 480 people
- Sponsor
- Academic and Community Cancer Research United
HER2-positive Breast Cancer
A Study of SHR-A1811 Monotherapy or Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients
This is a phase II trial evaluating the efficacy and safety of SHR-A1811 monotherapy or combined with pyrotinib maleate in Stage II-III HER2-positive breast cancer.
- Trial name
- NCT05635487
- Testing
- SHR-A1811, Pyrotinib
- Where
- China
- Volunteers
- 65 people
- Sponsor
- Shengjing Hospital
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
Circulating Tumor DNA Based Minimal Residual Disease Detection for Patients With Early-Stage Breast Cancer
This clinical trial studies how well circulating tumor deoxyribonucleic acid (ctDNA) based minimal residual disease (MRD) detection works for patients with early-stage breast cancer.
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Estrogen Receptor-Positive Breast Carcinoma
- Trial name
- NCT07136493
- Testing
- Biospecimen Collection, Electronic Health Record Review, Survey Administration
- Where
- 5 sites in United States
- Sponsor
- City of Hope Medical Center
HER2-positive Breast Cancer, Breast Cancer
Neoadjuvant Her2-targeted Therapy and Immunotherapy With Pembrolizumab [IIT2018-04-MCARTHUR-NEOHP]
A phase 2 open-label, randomized, multi-center trial to evaluate the efficacy and safety of neoadjuvant trastuzumab, pertuzumab and weekly paclitaxel (THP) as compared to neoadjuvant trastuzumab, pertuzumab, pembrolizumab and…
- Trial name
- NCT03747120
- Testing
- Paclitaxel, Trastuzumab, Pertuzumab
- Where
- 5 sites in United States
- Volunteers
- 138 people
- Sponsor
- University of Texas Southwestern Medical Center
Breast Cancer, HER2-positive Breast Cancer
HERizon-Breast: A ctDNA-Guided Adaptive Study of Sequential Anti-HER2 Therapies and CNS Prophylaxis to Induce Long-Term Remission
Thie purpose of this study is to find out whether a personalized treatment approach-using a series of ctDNA tests along with standard imaging scans to help decide when to step up (escalate) or decrease (de-escalate) sequential…
- Conditions
- Breast Cancer, HER2-positive Breast Cancer, Breast Cancer Stage IV
- Trial name
- NCT07459673
- Testing
- Personalis NeXT Personal, Natera Signatera, fam-trastuzumab deruxtecan-nxki (T-DXd)
- Where
- 7 sites in United States
- Volunteers
- 60 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
HER2-positive Breast Cancer
Identification of Risk Factors for Brain Recurrence in Patients With HER2-positive Localised Breast Cancer
HER2 gene amplification, detected in 20% to 30% of breast cancers, was a poor prognostic factor before the advent of anti-HER2 therapies.
- Trial name
- CRANIUM (NCT06358625)
- Testing
- Pre-treatment biopsy
- Where
- France
- Volunteers
- 120 people
- Sponsor
- Center Eugene Marquis
Breast Cancer
A Study of Ipatasertib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Hormone Receptor Positive and HER2 Negative Locally Advanced Unresectable or Metastatic Breast Cancer
The open-label Phase Ib portion of this study will evaluate the safety and pharmacokinetics of ipatasertib in combination with palbociclib and fulvestrant to identify a dose of ipatasertib that can be combined with palbociclib…
- Trial name
- IPATunity150 (NCT04060862)
- Testing
- Ipatasertib, Palbociclib, Fulvestrant
- Where
- 20 sites in United States, Australia and 6 more
- Volunteers
- 20 people
- Sponsor
- Hoffmann-La Roche
Trastuzumab-rezetecan, HER2-low Breast Cancer
Efficacy and Safety of Trastuzumab-rezetecan in HER2-Expressing Breast Cancer
This study is a multicenter, observational, real-world investigation. The research plans to enroll 300 HER2-positive and HER2-low breast cancer patients who meet the inclusion criteria.
- Conditions
- Trastuzumab-rezetecan, HER2-low Breast Cancer, HER2-positive Breast Cancer
- Trial name
- NCT07358182
- Testing
- Trastuzumab-rezetecan Treatment Group
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Breast Cancer
Neoadjuvant Chemotherapy With Myocet/Taxotere/Herceptin for HER2 Positive Breast Cancer Patients
This is an open-label study to assess the efficacy and tolerability of the combination Myocet®/Taxotere®/Herceptin® as primary treatment for HER2 positive breast cancer patients.
- Trial name
- NCT00129896
- Testing
- Myocet, Taxotere, Herceptin
- Where
- 16 sites in Spain
- Volunteers
- 73 people
- Sponsor
- Spanish Breast Cancer Research Group
Breast Cancer
A Study of Avastin (Bevacizumab) Plus Herceptin (Trastuzumab) in Patients With Primary Inflammatory HER2-Positive Breast Cancer.
This single arm study will assess the efficacy and safety of preoperative treatment with Avastin combined with Herceptin-based chemotherapy in patients with primary inflammatory HER2-positive breast cancer.
- Trial name
- NCT00717405
- Testing
- Standard chemotherapy, bevacizumab [Avastin], trastuzumab [Herceptin]
- Where
- 28 sites in France
- Volunteers
- 52 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer, Breast Neoplasms
Establishment of Molecular Profiling for Individual Clinical Routine Treatment Decision in Early Breast Cancer
The present project focuses on how to reduce both over- and under-treatment with adjuvant chemotherapy to a large number of breast cancer patients in Norway.
- Conditions
- Breast Cancer, Breast Neoplasms, Hormone Receptor Positive Tumor
- Trial name
- EMIT (NCT03904173)
- Testing
- Multi-parameter tests
- Where
- 5 sites in Norway
- Volunteers
- 2,300 people
- Sponsor
- Oslo University Hospital
Breast Cancer
Study of Neoadjuvant Endocrine Therapy in HR Positive and HER2 Negative Premenopausal Breast Cancer Patients
A multicenter, prospective, open, randomized cohort, non controlled phase II clinical study to evaluate the effectiveness and safety of Darxil combined with Exemestane+goserelin neoadjuvant endocrine therapy in HR positive and…
- Trial name
- NCT06009627
- Testing
- dalpiciclib、Exemestane、Gosserine, Docetaxel for injection、Epirubicin hydrochloride for injection、Cyclophosphamide for injection
- Where
- China
- Volunteers
- 119 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
HER2/Neu Negative, Progesterone Receptor Negative
FES PET/CT in Predicting Response in Patients With Newly Diagnosed Metastatic Breast Cancer Receiving Endocrine Therapy
This phase II trial studies F-18 16 alpha-fluoroestradiol (FES) positron emission tomography (PET)/computed tomography (CT) in predicting response to endocrine therapy in patients with newly diagnosed breast cancer that has…
- Conditions
- HER2/Neu Negative, Progesterone Receptor Negative, Progesterone Receptor Positive, Stage IV Breast Cancer AJCC v6 and v7
- Trial name
- NCT02398773
- Testing
- Computed Tomography, F-18 16 Alpha-Fluoroestradiol, Laboratory Biomarker Analysis
- Where
- 25 sites in United States
- Volunteers
- 99 people
- Sponsor
- National Cancer Institute (NCI)
HER2-positive Breast Cancer, HER2+ Breast Cancer
HER2HEART-US: Prevention of Cardiotoxicity in Breast Cancer Patients Receiving HER2-directed Therapy
Ten to 15% of patients with breast cancer are HER2 positive, with treatment focused on targeting the HER2 receptor. Although these treatments are generally well tolerated, they are associated with an increased risk of…
- Trial name
- NCT06844669
- Testing
- Carvedilol, Empagliflozin
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Washington University School of Medicine
Advanced Breast Cancer, HER2-positive Breast Cancer
A Study to Compare Pertuzumab + Trastuzumab + Vinorelbine vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-positive Metastatic Breast Cancer
This is a randomized, open-label, two-arm, phase III trial in Germany to investigate whether vinorelbine-based triple combination presents a less toxic treatment option than docetaxel-based triple combination in patients with…
- Trial name
- ATTILA (NCT03811418)
- Testing
- Trastuzumab, Pertuzumab, Vinorelbine
- Where
- Germany
- Sponsor
- iOMEDICO AG
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