Clinical trials: HER2-positive Breast Cancer
Breast Neoplasms
Study Evaluating HKI-272 in Tumors
The purpose of this study is to evaluate the safety and tolerability as well as find the maximum tolerated dose (MTD) for HKI-272.
- Trial name
- NCT00146172
- Testing
- neratinib
- Where
- 5 sites in United States
- Volunteers
- 73 people
- Sponsor
- Puma Biotechnology, Inc.
Advanced Breast Carcinoma, Locally Advanced Breast Carcinoma
Genetic Analysis in Blood and Tumor Samples From Patients With Advanced or Metastatic Estrogen Receptor Positive and HER2 Negative Breast Cancer Receiving Palbociclib and Endocrine Therapy
This research trial studies genetic profiles in blood and tumor samples from patients with estrogen receptor positive and HER2 negative breast cancer that has spread to other places in the body who are receiving palbociclib and…
- Conditions
- Advanced Breast Carcinoma, Locally Advanced Breast Carcinoma, Metastatic Breast Carcinoma, Recurrent Breast Carcinoma
- Trial name
- NCT03281902
- Testing
- Biopsy, Biospecimen Collection, Laboratory Biomarker Analysis
- Where
- 3 sites in United States
- Volunteers
- 68 people
- Sponsor
- Mayo Clinic
Breast Cancer
Study Comparing 4 Cycles With 6 Cycles of TC (Docetaxel+Cyclophosphamide) Adjuvant Chemotherapy for 1-3 Lymph Node Positive ER+/HER2- Early Breast Cancer
This is a prospective, multisite, randomized, open-label Phase III clinical trial (CLOVER study) comparing 4 cycles with 6 cycles of TC (docetaxel+cyclophosphamide) adjuvant chemotherapy for 1-3 positive lymph node, ER+/HER2…
- Trial name
- CLOVER (NCT03926091)
- Testing
- Docetaxel, Cyclophosphamide
- Where
- 14 sites in China
- Volunteers
- 2,172 people
- Sponsor
- Fudan University
Metastatic Breast Cancer
Comparison of Clinical Efficacy Between Letrozole + Ribociclib and Fulvestrant + Letrozole + Ribociclib in Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer
Aromatase inhibitor (AI) + CDK4/6 inhibitor is settled down as the standard first line therapy for HR+/HER2- metastatic breast cancer and all three CDk4/6 inhibitors, palbociclib, ribociclib, and abemaciclib are currently…
- Trial name
- NCT05816655
- Testing
- Fulvestrant plus AI plus ribociclib, AI plus ribociclib
- Where
- 2 sites in South Korea
- Volunteers
- 202 people
- Sponsor
- Korea University Guro Hospital
Advanced Breast Cancer
Efficacy and Safety of Ribociclib Combined With AI Versus Physician&Amp;#39;s Choice of Chemotherapy Sequential Endocrine Therapy in ER Middle-low-expression/HER2-negative Advanced Breast Cancer (Rachel)
To compare the efficacy and safety of ribociclib in combination with aromatase inhibitor and physician's choice of chemotherapy sequential endocrine therapy in the first-line treatment of ER medium to low expression/HER2-negative…
- Trial name
- NCT06656624
- Testing
- Ribociclib combined with AI±OFS, physician's choice of chemotherapy sequential Ribociclib combined with AI±OFS
- Where
- China
- Volunteers
- 190 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Breast Cancer
Study to Compare Overall Survival in Medicare Patients With Metastatic Breast Cancer Treated With a Medicine Called Palbociclib in Combination With Aromatase Inhibitor and Aromatase Inhibitor by Itself.
A retrospective study of de-identified (to preserve patient privacy) patient information from the SEER-Medicare Database to compare overall survival of first line palbociclib + aromatase inhibitor (AI) therapy versus AI therapy…
- Trial name
- NCT06086340
- Testing
- Palbociclib, Aromatase Inhibitor
- Where
- United States
- Volunteers
- 779 people
- Sponsor
- Pfizer
HER2-positive Breast Cancer, HER2 Low
ISPY-P1.01:Evaluating the Safety of Weekly Paclitaxel With Trastuzumab Duocarmazine (SYD985) in Patients With Metastatic Cancer
This is an open-label, single-arm, multi-site phase I/Ib trial with SYD985, an antibody-drug conjugate (ADC) targeting HER2 on the cell membrane, combined with paclitaxel.
- Conditions
- HER2-positive Breast Cancer, HER2 Low, SYD-985, SYD985
- Trial name
- NCT04602117
- Testing
- Vic-trastuzumab duocarmazine (SYD985) + paclitaxel
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- QuantumLeap Healthcare Collaborative
Breast Neoplasms
Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Chinese Men and Postmenopausal Women With Advanced Breast Cancer
The primary objective is to evaluate whether treatment with alpelisib in combination with fulvestrant prolongs Progression Free Survival (PFS) compared to treatment with placebo in combination with fulvestrant.
- Trial name
- NCT04544189
- Testing
- Alpelisib, Fulvestrant
- Where
- 24 sites in China
- Volunteers
- 69 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Pyrotinib Plus Vinorelbine in HER2+ Metastatic Breast Cancer Patients
To evaluate the patterns and treatment outcomes of pyrotinib plus vinorelbine in the real world.
- Trial name
- NCT04517305
- Where
- China
- Volunteers
- 97 people
- Sponsor
- Fudan University
HER2-positive Breast Cancer, Breast Cancer
T-DM1 and Palbociclib for Metastatic HER2 Breast Cancer
This is a single arm, phase II study to evaluate if the combination of T-DM1 with palbociclib improves progression-free survival in patients with metastatic HER2 positive breast cancer.
- Conditions
- HER2-positive Breast Cancer, Breast Cancer, Breast Cancer Stage, Recurrent Breast Cancer
- Trial name
- T-DM1 (NCT03530696)
- Testing
- Palbociclib, T-DM1
- Where
- 16 sites in United States
- Volunteers
- 55 people
- Sponsor
- University of Arizona
HER-2 Positive Breast Cancer, Metastatic Breast Cancer
A Trial l of Panobinostat Given in Combination With Trastuzumab and Paclitaxel in Adult Female Patients With HER2 Positive Metastatic Breast Cancer
The primary purpose of this study is to identify the maximum tolerated dose (MTD) of both intravenous and oral panobinostat when given in combination with trastuzumab and paclitaxel.
- Trial name
- NCT00788931
- Testing
- IV LBH589, Oral LBH589, trastuzumab
- Where
- 7 sites in United States, Australia and 3 more
- Volunteers
- 15 people
- Sponsor
- Novartis Pharmaceuticals
Hormone Receptor-positive Advanced Breast Cancer
Chidamide Combined With Fulvestrant for HR+/HER2-advanced Breast Cancer
evaluate the efficacy and safety of chidamide combined with fulvestrant for HR+ABC
- Trial name
- NCT05808582
- Testing
- chidamide，fulvestrant
- Volunteers
- 60 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8
Abemaciclib and Niraparib Before Surgery for the Treatment of Hormone Receptor Positive HER2 Negative Breast Cancer
This phase I trial tests the side effects and best dose of abemaciclib and niraparib in treating patients with breast cancer that is positive for estrogen or progesterone receptors (hormone receptor positive [HR+]) and HER2…
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
- Trial name
- NCT04481113
- Testing
- Abemaciclib, Niraparib Tosylate Monohydrate
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- OHSU Knight Cancer Institute
Breast Cancer Female
Conformal Ablative Radiotherapy in Older Women (CARMEN) With Breast Cancer Undergoing Non-Operative Management
This phase II study evaluates SABR as non-operative treatment for women aged 65+ with ER-positive, HER2-negative breast cancer ≤5 cm and no lymph node involvement.
- Trial name
- CARMEN (NCT07242118)
- Testing
- SABR
- Where
- 2 sites in United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- University of Kansas Medical Center
Breast Cancer
A Study to Evaluate D-0502 in Subjects With ER+ Her2- Locally Advanced or Metastatic Breast Cancer
This is a randomized, parallel-controlled, open-label, multicenter clinical study to assess the efficacy and safety of D-0502 in the treatment of subjects with ER-positive, HER2-negative locally advanced or metastatic breast…
- Trial name
- NCT06954961
- Testing
- D-0502, Fulvestrant
- Where
- 2 sites in China
- Volunteers
- 640 people
- Sponsor
- InventisBio Co., Ltd
Breast Cancer
A Study of Herceptin (Trastuzumab) in Combination With Whole Brain Radiotherapy in Patients With HER-2 Positive Breast Cancer
This single-arm, multicenter, open-label study will evaluate the efficacy and safety of Herceptin (trastuzumab) in combination with whole brain radiotherapy on brain metastases in patients with HER-2 positive breast cancer.
- Trial name
- NCT01363986
- Testing
- trastuzumab [Herceptin]
- Where
- 16 sites in Italy
- Volunteers
- 3 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
A European Registry Study to Prospectively Observe Treatment Patterns and Outcomes in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Unresectable Locally Advanced (LA) or Metastatic Breast Cancer (mBC) (SAMANTHA)
This disease registry is a prospective, multicenter non-interventional study designed to observe anti-cancer treatment regimens and clinical outcomes in participants with HER2-positive unresectable LA/mBC.
- Trial name
- NCT02913456
- Where
- 54 sites in Austria, Bulgaria and 3 more
- Volunteers
- 629 people
- Sponsor
- Hoffmann-La Roche
Metastatic Breast Cancer
Ipatasertib + Pertuzumab +Trastuzumab in Advanced HER2+ PI3KCA-mutant Breast Cancer Patients
This is an open label, single arm, multicenter, phase Ib study to evaluate the safety and clinical activity of the combination of ipatasertib, trastuzumab and pertuzumab in patients with unresectable locally advanced or…
- Trial name
- IPATHER (NCT04253561)
- Testing
- Ipatasertib, Trastuzumab, Pertuzumab
- Where
- 10 sites in Spain
- Volunteers
- 17 people
- Sponsor
- SOLTI Breast Cancer Research Group
Breast Cancer
A Study of Evaluating The Effects Of Pyrotinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer
This is a randomised, double-blind multicenter Phase III study for evaluating the efficacy and safety of pyrotinib in women with early stage high-risk breast cancer after adjuvant trastuzumab.
- Trial name
- NCT03980054
- Testing
- Pyrotinib
- Where
- China
- Volunteers
- 2,135 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Breast Cancer
Phase II Randomized Trial Evaluating Neoadjuvant Therapy With Neratinib and/or Trastuzumab Followed by Postoperative Trastuzumab in Women With Locally Advanced HER2-positive Breast Cancer
FB-7 is a Phase II, multi-center randomized study of neratinib in combination with weekly paclitaxel with or without trastuzumab followed by doxorubicin and cyclophosphamide (AC) as neoadjuvant therapy for women with…
- Trial name
- NCT01008150
- Testing
- Paclitaxel, Trastuzumab, Neratinib
- Where
- 42 sites in United States, Canada and 3 more
- Volunteers
- 141 people
- Sponsor
- NSABP Foundation Inc
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