Clinical trials: HER2/Neu Positive
HER-2 Positive Breast Cancer, Metastatic Malignant Neoplasm to Brain
Study of the Combination of KD019 and Trastuzumab in Subjects With HER2-Positive Metastatic Breast Cancer
Evaluate the safety and tolerability and determine the maximum tolerated dose (MTD) of the combination of tesevatinib and trastuzumab in subjects with HER2-positive metastatic breast cancer
- Trial name
- NCT02154529
- Testing
- Tesevatinib, Trastuzumab
- Where
- 6 sites in United States
- Volunteers
- 17 people
- Sponsor
- Kadmon Corporation, LLC
HER2 Positive Breast Cancer
A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer
This study is being done to see if tucatinib works better than placebo when given with other drugs to treat participants with HER2-positive breast cancer.
- Trial name
- HER2CLIMB-05 (NCT05132582)
- Testing
- Tucatinib, Trastuzumab, Pertuzumab
- Where
- 307 sites in United States, Australia and 21 more
- Volunteers
- 654 people
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
Breast Neoplasms
PF-06804103 Dose Escalation in HER2 Positive and Negative (Negative Only in Part 2) Solid Tumors
The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses of PF-06804103 in patients with HER2 positive and negative breast and gastric cancer (HER2 positive only and gastric were studied in…
- Trial name
- NCT03284723
- Testing
- PF-06804103, PF-06804103 + Palbociclib +Letrozole
- Where
- 46 sites in United States, Australia and 4 more
- Volunteers
- 95 people
- Sponsor
- Pfizer
Triple Negative Breast Cancer, Breast Neoplasms
Vaccination of Triple Negative Breast Cancer Patients
The purpose of this study is to evaluate a new investigational cancer vaccine, P10s-PADRE in combination with standard neoadjuvant chemotherapy and surgery in patients with clinical stage I, II or III triple negative breast…
- Trial name
- NCT02938442
- Testing
- P10s-PADRE with MONTANIDE™ ISA 51 VG, Doxorubicin, Cyclophosphamide
- Where
- 2 sites in United States
- Volunteers
- 16 people
- Sponsor
- University of Arkansas
Breast Cancer
Ph II Study of Pembrolizumab & Eribulin in Patients With HR+/HER2- MBC Previously Treated With Anthracyclines & Taxanes
This a multicenter, open-label, phase II clinical trial to assess the efficacy of pembrolizumab in combination with eribulin in female patients older than 18 years old with hormone receptor-(HR)positive/HER2-negative metastatic…
- Trial name
- KELLY (NCT03222856)
- Testing
- Pembrolizumab, Eribulin
- Where
- 11 sites in Spain
- Volunteers
- 44 people
- Sponsor
- MedSIR
HER2-positive Breast Cancer, Early-stage Breast Cancer
Extension Study to Provide Adjuvant Treatment Following Neoadjuvant Treatment and Surgical Resection in Protocol TX05-03
This is an extension study to provide adjuvant treatment with single agent Herceptin or TX05 and assess continued safety and immunogenicity in subjects with HER2-positive early breast cancer following neoadjuvant treatment and…
- Conditions
- HER2-positive Breast Cancer, Early-stage Breast Cancer, Breast Cancer, Breast Neoplasms
- Trial name
- NCT04109391
- Testing
- TX05 (trastuzumab), Herceptin (trastuzumab)
- Where
- 86 sites in Belarus, Chile and 8 more
- Volunteers
- 338 people
- Sponsor
- Tanvex BioPharma USA, Inc.
HER2-positive Newly Diagnosed, Primary Breast Cancer
NeoPHOEBE: Neoadjuvant Trastuzumab + BKM120 in Combination With Weekly Paclitaxel in HER2-positive Primary Breast Cancer
This randomized, parallel cohort, two stage, double-blind, placebo-controlled study evaluated the oral PI3K inhibitor BKM120 in combination with trastuzumab and paclitaxel in HER2-positive, PIK3CA wild-type and PIK3CA mutant…
- Trial name
- NeoPHOEBE (NCT01816594)
- Testing
- BKM120, Trastuzumab, Paclitaxel
- Where
- 7 sites in Australia, Austria and 2 more
- Volunteers
- 50 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
PALbociclib CoLlaborative Adjuvant Study
This is a prospective, two arm, international, multicenter, randomized, open-label Phase III study evaluating the addition of 2 years of palbociclib to standard adjuvant endocrine therapy for patients with HR+ / HER2- early…
- Trial name
- PALLAS (NCT02513394)
- Testing
- Palbociclib, Standard Adjuvant Endocrine Therapy
- Where
- 437 sites in United States, Australia and 19 more
- Volunteers
- 5,796 people
- Sponsor
- Alliance Foundation Trials, LLC.
Breast Cancer
Docetaxel and Cyclophosphamide Compared to Anthracycline-Based Chemotherapy in Treating Women With HER2-Negative Breast Cancer
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of breast cancer cells, either by killing the cells or by stopping them from dividing.
- Trial name
- NCT01547741
- Testing
- Doxorubicin, Cyclophosphamide, Docetaxel
- Where
- 915 sites in United States, Puerto Rico
- Volunteers
- 4,242 people
- Sponsor
- NSABP Foundation Inc
Breast Cancer
Efficacy and Safety of Ribociclib in Pre- and Postmenopausal Chinese Women With HR Positive, HER2-negative, Advanced Breast Cancer.
This was a randomized, double-blind, placebo-controlled study conducted in Chinese women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer, plus an open-label…
- Trial name
- NCT03671330
- Testing
- Ribociclib, NSAI: Letrozole or Anastrazole, Goserelin
- Where
- 24 sites in China
- Volunteers
- 327 people
- Sponsor
- Novartis Pharmaceuticals
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
Breast Cancer
Study to Evaluate Patient Reported Outcome (PRO) and Physical Activity in Japanese Patients With HR+/HER2- Advanced Breast Cancer Treated With Palbociclib Plus Endocrine Therapy or Endocrine Monotherapy
The study is a prospective, multicenter, observational study to evaluate PRO and physical activity using smartphone-based application and wearable device in Japanese patients with HR+/HER2- advanced breast cancer (ABC).
- Trial name
- JBCRG-26 (NCT04736576)
- Testing
- Wearable device
- Where
- 20 sites in Japan
- Volunteers
- 99 people
- Sponsor
- Pfizer
Breast Cancer
A Study of T-DXd in Participants With or Without Brain Metastasis Who Have Previously Treated Advanced or Metastatic HER2 Positive Breast Cancer
This is open-label, multicenter, international study, assessing the efficacy and safety of Trastuzumab deruxtecan (T-DXd) in participants with or without brain metastasis (BMs), with previously-treated advanced/metastatic…
- Trial name
- DESTINY-B12 (NCT04739761)
- Testing
- Trastuzumab Deruxtecan
- Where
- 81 sites in United States, Australia and 16 more
- Volunteers
- 506 people
- Sponsor
- AstraZeneca
Human Epithelial Receptor (HER)-2 Positive Breast Cancer
A Safety and Efficacy Study of BCD-022 With Paclitaxel Compared to Herceptin With Paclitaxel in HER2+ Metastatic Breast Cancer Patients
BCD-022-02 is a double-blind randomized clinical trial comparing efficacy of BCD-022 (INN: trastuzumab) and paclitaxel to Herceptin and paclitaxel in HER2-positive metastatic breast cancer with pharmacokinetics substudy.
- Trial name
- NCT01764022
- Testing
- Trastuzumab, Paclitaxel
- Where
- 36 sites in Belarus, India and 2 more
- Volunteers
- 225 people
- Sponsor
- Biocad
Breast Cancer
Everolimus in Combination With Trastuzumab and Paclitaxel in the Treatment of HER2 Positive Locally Advanced or Metastatic Breast Cancer
The purpose of this Phase III study was to confirm the value of adding everolimus to weekly paclitaxel and trastuzumab as treatment of HER2-overexpressing metastatic breast cancer.
- Trial name
- BOLERO-1 (NCT00876395)
- Testing
- Everolimus, Trastuzumab, Paclitaxel
- Where
- 140 sites in United States, Argentina and 26 more
- Volunteers
- 719 people
- Sponsor
- Novartis Pharmaceuticals
Metastases, Brain
Lapatinib Plus Capecitabine Versus Trastuzumab Plus Capecitabine in ErbB2 (HER2) Positive Metastatic Breast Cancer
This open label study was designed to evaluate Lapatinib effect on incidence of brain metastases in ErbB2 (HER2) positive metastatic breast cancer patients exposed to prior taxanes or anthracyclines.
- Trial name
- NCT00820222
- Testing
- capecitabine, lapatinib, trastuzumab
- Where
- 164 sites in United States, Belgium and 12 more
- Volunteers
- 540 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Study of Poziotinib in Participants With HER2-Positive Metastatic Breast Cancer
The purpose of this study is to establish the dose regimen and evaluate the preliminary efficacy and the safety/tolerability of poziotinib in participants with human epidermal growth factor receptor 2 (HER2)-positive metastatic…
- Trial name
- NCT02659514
- Testing
- Poziotinib
- Where
- 35 sites in United States
- Volunteers
- 67 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
HER2/Neu Positive, HLA-A2 Positive Cells Present
Vaccine Therapy in Treating Patients With Stage IV HLA-A2 and HER2 Positive Breast or Ovarian Cancer Receiving Trastuzumab
This phase I/II trial studies the side effects of vaccine therapy and to see how well it works in treating patients with stage IV major histocompatibility complex, class I, A2 antigen (HLA-A2) and human epidermal growth factor…
- Conditions
- HER2/Neu Positive, HLA-A2 Positive Cells Present, Stage IV Breast Cancer, Stage IV Ovarian Cancer
- Trial name
- NCT00194714
- Testing
- HER-2/neu Peptide Vaccine, Laboratory Biomarker Analysis
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- University of Washington
Breast Cancer
Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer
The purpose of this study is to investigate whether neratinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab.
- Trial name
- ExteNET (NCT00878709)
- Testing
- neratinib
- Where
- 494 sites in United States, Australia and 38 more
- Volunteers
- 2,840 people
- Sponsor
- Puma Biotechnology, Inc.
Breast Cancer
Tucatinib, Palbociclib and Letrozole in Metastatic Hormone Receptor Positive and HER2-positive Breast Cancer
This is a multicenter run-in phase Ib / roll-over phase II study of triple targeted drug combination (HER2-targeted small molecule inhibitor tucatinib, CDK4/6 inhibitor palbociclib and aromatase inhibitor letrozole) as a first or…
- Trial name
- NCT03054363
- Testing
- Tucatinib in Combination with Palbociclib and Letrozole
- Where
- 6 sites in United States
- Volunteers
- 42 people
- Sponsor
- University of Colorado, Denver