Clinical trials: HER2/Neu Positive
Gastrointestinal Neoplasms, Adenocarcinoma
A Study of IMU-131(HER-Vaxx) and Chemotherapy Compared to Chemotherapy Only in Patients With HER2 Positive Advanced Gastric Cancer
The Phase 1b study is an open-label, multicenter dose escalation study designed to assess the safety, tolerability, immunogenicity and recommended phase 2 dose (RP2D) of IMU-131.
- Trial name
- NCT02795988
- Testing
- IMU-131, Cisplatin and either Fluorouracil (5-FU) or Capecitabine or Oxaliplatin and capecitabine.
- Where
- 22 sites in Georgia, India and 5 more
- Volunteers
- 64 people
- Sponsor
- Imugene Limited
Breast Cancer
Pharmacokinetics and Pharmacogenomics of Ribociclib in Race-based Cohorts
The aim is to determine the pharmacological and biochemical association between ribociclib exposure and CYP3A variants in African American/Blacks and Non-Hispanic White patients.
- Trial name
- LEANORA (NCT04657679)
- Testing
- Ribociclib
- Where
- 3 sites in United States
- Volunteers
- 21 people
- Sponsor
- Georgetown University
Breast Cancer
A Study to Assess Efficacy and Safety of Pertuzumab Given in Combination With Trastuzumab and Vinorelbine in Participants With Metastatic or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2-Positive Breast Cancer
This two-cohort, open-label, multicenter, phase 2 study will assess the safety and efficacy of pertuzumab given in combination with trastuzumab (Herceptin) and vinorelbine in first line participants with metastatic or locally…
- Trial name
- VELVET (NCT01565083)
- Testing
- Pertuzumab, Trastuzumab, Vinorelbine
- Where
- 80 sites in United States, Brazil and 5 more
- Volunteers
- 213 people
- Sponsor
- Hoffmann-La Roche
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 Female
Letrozole in Post-Menopausal Patients With Operable Hormone-Sensitive Breast Cancer
A short pre-surgical non-therapeutic trial involving postmenopausal women with newly diagnosed eR+, HeR2-negative operable breast cancers.
- Trial name
- NCT03747042
- Testing
- Letrozole
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- University of Texas Southwestern Medical Center
HER2/Neu Over-expressing Locally Advanced Breast Cancer, Metastatic Breast Cancer
Daily Everolimus in Combination With Trastuzumab and Vinorelbine in HER2/Neu Positive Women With Locally Advanced or Metastatic Breast Cancer
This phase III, double-blind, placebo-controlled multinational study will assess the combination everolimus, vinorelbine, and trastuzumab compared to the combination vinorelbine and trastuzumab with respect to progressive-free…
- Trial name
- BOLERO-3 (NCT01007942)
- Testing
- everolimus, vinorelbine, trastuzumab
- Where
- 161 sites in United States, Argentina and 19 more
- Volunteers
- 569 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Genetic Testing in Predicting Response to Paclitaxel in Women With Breast Cancer
RATIONALE: Analyzing genes for changes before and after chemotherapy may help doctors predict a patient's response to treatment and help plan the most effective treatment.
- Trial name
- NCT00088829
- Testing
- paclitaxel, microarray analysis, biopsy
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Georgetown University
Adenocarcinoma Gastric Stage IV With Metastases, Adenocarcinoma - GEJ
DS-8201a in HER2-positive Gastric Cancer That Cannot Be Surgically Removed or Has Spread (DESTINY-Gastric02)
This study will find out if trastuzumab deruxtecan is safe and works for participants with gastric or gastroesophageal junction cancer.
- Trial name
- NCT04014075
- Testing
- Trastuzumab deruxtecan
- Where
- 37 sites in United States, Belgium and 3 more
- Volunteers
- 79 people
- Sponsor
- Daiichi Sankyo
Breast Neoplasms
PD 0332991 and Anastrozole for Stage 2 or 3 Estrogen Receptor Positive and HER2 Negative Breast Cancer
A Phase II study to investigate the potential utility of PD 0332991 in the treatment of early stage ER+ Human epidermal growth factor receptor 2 (HER2)- breast cancer, to investigate whether the combination of PD 0332991 and…
- Trial name
- NCT01723774
- Testing
- PD0332991, Anastrozole, Goserelin
- Where
- 4 sites in United States
- Volunteers
- 84 people
- Sponsor
- Washington University School of Medicine
Estrogen Receptor Negative, Estrogen Receptor Positive
Taselisib and Enzalutamide in Treating Patients With Androgen Receptor Positive Triple-Negative Metastatic Breast Cancer
This partially randomized phase Ib/II trial studies the side effects and best dose of taselisib when given together with enzalutamide and to see how well they work in treating patients with androgen receptor positive…
- Conditions
- Estrogen Receptor Negative, Estrogen Receptor Positive, HER2/Neu Negative, Progesterone Receptor Negative
- Trial name
- NCT02457910
- Testing
- Biomarker Analysis, Enzalutamide, Pharmacological Study
- Where
- 12 sites in United States
- Volunteers
- 30 people
- Sponsor
- Vanderbilt-Ingram Cancer Center
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
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
HER2-positive Breast Cancer, HER2-positive Gastric Cancer
A Safety and Activity Study of SBT6050 in Combination With Other HER2-directed Therapies for HER2-positive Cancers
This study is designed to assess the safety and preliminary activity of SBT6050 in combination with trastuzumab deruxtecan (Part 1) or tucatinib plus trastuzumab +/- capecitabine (Part 2).
- Conditions
- HER2-positive Breast Cancer, HER2-positive Gastric Cancer, HER2-positive Colorectal Cancer, HER2-expressing Non-small Cell Lung Cancer
- Trial name
- NCT05091528
- Testing
- SBT6050, trastuzumab deruxtecan, tucatinib
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Silverback Therapeutics
Metastatic Breast Cancer With Intracranial Metastases
Cabazitaxel Plus Lapatinib as Therapy for HER2-Positive Metastatic Breast Cancer Patients With Intracranial Metastases
This phase II trial will combine two agents, cabazitaxel and lapatinib, to treat patients with metastatic breast cancer (MBC) which has metastasized to the brain.
- Trial name
- NCT01934894
- Testing
- cabazitaxel, lapatinib
- Where
- 4 sites in United States
- Volunteers
- 11 people
- Sponsor
- SCRI Development Innovations, LLC
HER2-positive Carcinoma of Breast
Efficacy and Safety Evaluating Study of CT-P6 in Her2 Positive Early Breast Cancer
This study will determine whether CT-P6 and Herceptin are equivalent in patients with early-stage breast cancer undergoing neoadjuvant chemotherapy.
- Trial name
- NCT02162667
- Testing
- Trastuzumab
- Where
- 98 sites in Argentina, Belarus and 20 more
- Volunteers
- 562 people
- Sponsor
- Celltrion
Gastric Neoplasms, Gastroesophageal Junction Adenocarcinoma
Pembrolizumab/Placebo Plus Trastuzumab Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-811/KEYNOTE-811)
The study will compare the efficacy and safety of pembrolizumab plus trastuzumab in combination with standard of care (SOC) chemotherapy versus trastuzumab in combination with SOC chemotherapy in participants with HER2-positive…
- Trial name
- NCT03615326
- Testing
- Pembrolizumab, Cisplatin, 5-FU
- Where
- 192 sites in United States, Australia and 18 more
- Volunteers
- 738 people
- Sponsor
- Merck Sharp & Dohme LLC
Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer
A Study Evaluating the Efficacy and Safety of Giredestrant Compared With Physician's Choice of Endocrine Monotherapy in Participants With Previously Treated Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (acelERA Breast Cancer)
This Phase II, randomized, open-label, multicenter study will evaluate the efficacy and safety of giredestrant compared with physician's choice of endocrine monotherapy in participants with estrogen receptor (ER)-positive, human…
- Trial name
- NCT04576455
- Testing
- Giredestrant, Fulvestrant or an Aromatase Inhibitor (Physician Choice), LHRH Agonist
- Where
- 81 sites in United States, Argentina and 15 more
- Volunteers
- 303 people
- Sponsor
- Hoffmann-La Roche
Gastric Cancer, Gastroesophageal Junction Cancer
Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer
This is a Phase 2/3, randomized, open-label study for the treatment of patients with HER2-positive Gastric cancer (GC) or Gastroesophageal Junction (GEJ) cancer conducted in two parts.
- Conditions
- Gastric Cancer, Gastroesophageal Junction Cancer, HER2-positive Gastric Cancer
- Trial name
- MAHOGANY (NCT04082364)
- Testing
- margetuximab, Retifanlimab, Tebotelimab
- Where
- 73 sites in United States, China and 7 more
- Volunteers
- 82 people
- Sponsor
- MacroGenics
Neoplasms, Breast
A Study to Compare the Safety and Efficacy of an Aromatase Inhibitor in Combination With Lapatinib, Trastuzumab or Both for the Treatment of Hormone Receptor Positive, HER2+ Metastatic Breast Cancer
A study to compare the safety and efficacy of an aromatase inhibitor in combination with lapatinib, trastuzumab or both for the treatment of hormone receptor positive, HER2+ metastatic breast cancer (MBC).
- Trial name
- NCT01160211
- Testing
- Lapatinib, Trastuzumab, Aromatase Inhibitor
- Where
- 110 sites in United States, Argentina and 27 more
- Volunteers
- 369 people
- Sponsor
- Novartis Pharmaceuticals
ER-positive Breast Cancer, HER2-negative Breast Cancer
Onapristone and Fulvestrant for ER+ HER2- Metastatic Breast Cancer After Endocrine Therapy and CDK4/6 Inhibitors (The SMILE Study)
A phase II single-arm trial of onapristone in combination with fulvestrant for women and men with ER-positive, PgR-positive or negative and HER2-negative locally advanced or metastatic breast cancer after progression on aromatase…
- Conditions
- ER-positive Breast Cancer, HER2-negative Breast Cancer, Metastatic Cancer
- Trial name
- NCT04738292
- Testing
- Onapristone, Fulvestrant
- Where
- 2 sites in United States
- Volunteers
- 11 people
- Sponsor
- University of Wisconsin, Madison