Clinical trials: HER2+ Breast Cancer
HER2-positive Breast Cancer
A Randomized Controlled Trial of HER-2 Positive Breast Cancer Patients Treated With Lapatinib vs Herceptin
This is a randomized controlled trial of HER-2 positive breast cancer patients treated with lapatinib and paclitaxel vs herceptin and paclitaxel with sequential and synchronous anthracycline
- Trial name
- NCT03085368
- Testing
- lapatinib/herceptin
- Where
- China
- Volunteers
- 482 people
- Sponsor
- Peking Union Medical College Hospital
Breast Cancer
A Study of Pegylated Liposomal Doxorubicin and Cyclophosphamide in Her2-negative Stage I and II Breast Cancer Patients
Primary objective: To evaluate the disease-free survival (DFS) in the two randomized arms after therapy with LC vs. EC in chemo-naive Her2-patients with stage I or II breast cancer Secondary objectives: To assess the overall…
- Trial name
- NCT01210768
- Testing
- Epirubicin+Cyclophosphamide, liposomal-doxorubicin+Cyclophosphamide
- Where
- 9 sites in Taiwan
- Volunteers
- 254 people
- Sponsor
- TTY Biopharm
Breast Cancer
12 weekS Adjuvant dOcetaxel Plus trastuzumaB in Patients With Small, Node-negative, HER2-positive Breast cancER (SOBER)
This phase II trial aims to study the efficacy and safety of 12 weeks adjuvant docetaxel plus trastuzumab in patients with tumors ≤1cm, node-negative, HER2-positive breast cancer.
- Trial name
- SOBER (NCT03367676)
- Testing
- Trastuzumab, Docetaxel
- Where
- China
- Volunteers
- 78 people
- Sponsor
- Ruijin Hospital
Breast Cancer
A Study to Evaluate the Efficacy and Safety of Herceptin® (Trastuzumab) in Combination With Arimidex® (Anastrozole) an Aromatase Inhibitor Compared to Arimidex® Alone in Patients With Metastatic Breast Cancer
This 2 arm study assessed the safety and efficacy of adding intravenous trastuzumab (Herceptin®) to daily oral anastrozole (Arimidex®) tablets as first- and second-line treatment in postmenopausal patients with human epidermal…
- Trial name
- NCT00022672
- Testing
- trastuzumab (Herceptin®), anastrazole (Arimidex®)
- Where
- 132 sites in United States, Australia and 24 more
- Volunteers
- 208 people
- Sponsor
- Hoffmann-La Roche
ER+ HER2- Advanced Breast Cancer, High-grade Serous Ovarian Cancer (HGSOC)
A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors
This study is designed to evaluate AZD8421 alone and in combination with selected targeted anti-cancer drugs in patients with ER+HER2- advanced breast cancer, and patients with metastatic high-grade serious ovarian cancer.
- Trial name
- CYCAD-1 (NCT06188520)
- Testing
- AZD8421, Camizestrant, Ribociclib
- Where
- 13 sites in United States, Australia and 3 more
- Volunteers
- 55 people
- Sponsor
- AstraZeneca
Breast Neoplasms, Breast Diseases
A Study of RC48-ADC Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer With or Without Liver Metastases
This is a randomized, open, parallel-controlled, multicenter, phase II/III, seamless design clinical trial to compare the efficacy and safety of RC48-ADC with capecitabine + lapatinib in locally advanced or metastatic human…
- Conditions
- Breast Neoplasms, Breast Diseases, Capecitabine, HER2-positive Breast Cancer
- Trial name
- NCT03500380
- Testing
- RC48-ADC, Lapatinib, Capecitabine
- Where
- 67 sites in China
- Volunteers
- 301 people
- Sponsor
- RemeGen Co., Ltd.
Breast - Female, Male Breast Cancer
Pilot Study of Paclitaxel Plus Pembrolizumab in Metastatic HER2-Negative Breast Cancer
The primary objective of this study is to assess the safety and feasibility of the following two regimens: Cohort A) phased regimen of pembrolizumab in which paclitaxel is followed by paclitaxel plus pembrolizumab and Cohort B)…
- Trial name
- PePPy (NCT03018080)
- Testing
- Pembrolizumab, Paclitaxel
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Wake Forest University Health Sciences
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
Breast Cancer
Efficacy and Safety of Fluzoparib Combined With Adjuvant Endocrine Therapy for HR+/HER2- SNF3-subtype Early Breast Cancer (BCTOP-L-A01)
This is a prospective, randomized, open-label phase III clinical study on the efficacy and safety of fluzoparib combined with adjuvant endocrine therapy versus adjuvant endocrine therapy for HR+/HER2- SNF3-subtype early breast…
- Trial name
- NCT05891093
- Testing
- Fluzoparib, Anastrozole, Letrozole
- Where
- 15 sites in China
- Volunteers
- 766 people
- Sponsor
- Fudan University
Advanced Breast Carcinoma
Estrogen Receptors and HER2 Levels' Expression in Luminal Metastatic Breast Cancer
CYCLHER is a retrospective observational multicentric italian study aimed to evaluate the correlation between hormone receptors (HR) and HER2 immunohistochemistry (IHC) levels and treatment'response in patients affected by…
- Trial name
- CYCLHER (NCT06243432)
- Where
- Italy
- Volunteers
- 600 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Metastatic Breast Cancer, HER2 Low Breast Carcinoma
ERADICATE: A Phase Ib/II Study of Elacestrant Plus Trastuzumab Deruxtecan in Patients With CDK4/6 Inhibitor and Endocrine-resistant HR+/HER2-low or HER2-ultralow Metastatic Breast Cancer
The goal of this study is to evaluate the safety and efficacy of elacestrant in combination with trastuzumab deruxtecan (T-DXd) in participants with hormone receptor-positive (HR+), HER2-low or HER2-ultralow, metastatic breast…
- Conditions
- Metastatic Breast Cancer, HER2 Low Breast Carcinoma, HER2-negative Breast Cancer, Breast Cancer
- Trial name
- ERADICATE (NCT07198724)
- Testing
- Elacestrant, Trastuzumab Deruxtecan
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- Kristina A. Fanucci
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
Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
Myocet + Cyclophosphamide + Metformin Vs Myocet + Cyclophosphamide in 1st Line Treatment of HER2 Neg. Metastatic Breast Cancer Patients
This is a phase II comparative randomized clinical trial. Eligible patients will be randomized (1:1) to: Arm A: Myocet plus Cyclofosfamide plus Metformin Arm B: Myocet plus Cyclofosfamide Statistical Considerations: In this…
- Trial name
- MYME (NCT01885013)
- Testing
- Metformin + Myocet + Cyclophosphamide, Myocet + Cyclophosphamide
- Where
- 25 sites in Italy
- Volunteers
- 126 people
- Sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
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
Adult Solid Neoplasm, Estrogen Receptor Negative
Talazoparib and HSP90 Inhibitor AT13387 in Treating Patients With Metastatic Advanced Solid Tumor or Recurrent Ovarian, Fallopian Tube, Primary Peritoneal, or Triple Negative Breast Cancer
This phase I trial studies the side effects and best dose of talazoparib and heat shock protein (HSP)90 inhibitor AT13387 when given together in treating patients with solid tumors that have spread to other places in the body…
- Conditions
- Adult Solid Neoplasm, Estrogen Receptor Negative, Fallopian Tube Serous Neoplasm, HER2/Neu Negative
- Trial name
- NCT02627430
- Testing
- Hsp90 Inhibitor AT13387, Laboratory Biomarker Analysis, Pharmacological Study
- Sponsor
- National Cancer Institute (NCI)
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
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