Clinical trials: HER2 Positive Breast Cancer
Early Breast Cancer
Efficacy and Safety Study of EG1206A (EirGenix' Pertuzumab) Compared With EU-sourced Perjeta® (Pertuzumab) in Patients With HER2-positive Hormone Receptor Negative Early Breast Cancer.
The purpose of this research study is to compare the efficacy and safety of EG1206A with Perjeta in combination with trastuzumab and chemotherapy as neoadjuvant treatment for 18 weeks, followed by surgery and subsequent EG1206A…
- Trial name
- EGC102 (NCT06884254)
- Testing
- EG1206A, Perjeta
- Where
- United States
- Sponsor
- EirGenix, Inc.
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
Breast Cancer
A Study of Trastuzumab Emtansine Versus Capecitabine + Lapatinib in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer
This is a Phase III, randomized, multicenter, international, 2-arm, open-label clinical trial designed to compare the safety and efficacy of trastuzumab emtansine (T-DM1) with that of capecitabine + lapatinib in participants with…
- Trial name
- EMILIA (NCT00829166)
- Testing
- Trastuzumab emtansine, Lapatinib, Capecitabine
- Where
- 323 sites in United States, Bosnia and Herzegovina and 25 more
- Volunteers
- 991 people
- Sponsor
- Hoffmann-La Roche
Breast Neoplasms
Study to Compare Neoadjuvant Combination of Trastuzumab and Pertuzumab With Concurrent Taxane Chemotherapy or Endocrine Therapy and Quality of Life Assessment Under Adjuvant Therapy in Operable HER2+/HR+ Breast Cancer Patients
This is a prospective, phase IIa, multicenter, randomized, open-label study comparing a pre-surgical combination of trastuzumab and pertuzumab with concurrent weekly paclitaxel chemotherapy or endocrine therapy given for 12 weeks…
- Trial name
- TP-II (NCT03272477)
- Testing
- Perjeta Injectable Product, Herceptin, Tamoxifen
- Where
- Germany
- Volunteers
- 257 people
- Sponsor
- Palleos Healthcare GmbH
Breast Cancer
An Observational Study of the Mean Duration of Trastuzumab (Herceptin) Treatment in Participants With Early or Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer
This single arm observational study will assess the duration and safety of treatment with trastuzumab in routine clinical practice in participants with early or metastatic HER2-positive breast cancer.
- Trial name
- HERODOT (NCT01187381)
- Testing
- Trastuzumab
- Where
- Romania
- Volunteers
- 250 people
- Sponsor
- Hoffmann-La Roche
Metastatic Breast Cancer
BEZ235 Trial in Patients With HER2-(Human Epidermal Growth Factor Receptor 2 Negative) /HR+ (Hormonal Receptor Positive) Metastatic Breast Cancer
This is a prospective, multi-center, open-label, single arm, phase II study with a 2-stage design and Bayesian interim monitoring to investigate the safety and efficacy of BEZ235 in patients with progressive metastatic HR+ HER2…
- Trial name
- NCT01288092
- Testing
- BEZ235
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
A Study of Tucatinib (MK-7119) in Combination With Trastuzumab and Capecitabine in Participants With Previously Treated Locally Advanced Unresectable or Metastatic Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Breast Carcinoma (MK-7119-001)
The goal of this study is to evaluate the efficacy and safety of tucatinib in combination with trastuzumab and capecitabine in participants with unresectable locally advanced or metastatic HER2+ breast cancer who have had prior…
- Trial name
- NCT04721977
- Testing
- Tucatinib, Trastuzumab, Capecitabine
- Where
- 28 sites in Japan, South Korea and 1 more
- Volunteers
- 66 people
- Sponsor
- Pfizer
Advanced HER2-positive Breast Cancer or Gastric Cancer
Phase I Study LJM716 Combined With Trastuzumab in Patients With HER2 Overexpressing Metastatic Breast or Gastric Cancer
This is a multicenter, open-label, dose escalation, phase I study to estimate the Maximum Tolerated Dose (MTD) or a lower Recommended Dose for Expansion (RDE) of LJM716 in combination with trastuzumab in patients with Human…
- Trial name
- NCT01602406
- Testing
- LJM716, Trastuzumab
- Where
- 11 sites in United States, Belgium and 7 more
- Volunteers
- 64 people
- Sponsor
- Novartis Pharmaceuticals
Neoplasms, Breast
Treatment Options in Human Epidermal Growth Factor Receptor 2 (HER2) Positive Metastatic Breast Cancer Patients
This study will describe the treatment paradigm used over recent years in the clinical management of Human Epidermal Growth Factor Receptor 2 (HER2)+ metastatic breast cancer in Hungary.
- Trial name
- NCT01782651
- Testing
- Lapatinib plus capecitabine
- Where
- Hungary
- Volunteers
- 1 people
- Sponsor
- GlaxoSmithKline
Metastatic Breast Cancer
A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer Who Have Previously Received a Trastuzumab-Containing Regimen
This is a phase I, multicenter, open-label, dose-escalation study of single-agent trastuzumab-MCC-DM1 administered by intravenous (IV) infusion in patients with HER2-positive metastatic breast cancer (MBC) who have previously…
- Trial name
- NCT00932373
- Testing
- trastuzumab-MCC-DM1
- Volunteers
- 54 people
- Sponsor
- Genentech, Inc.
HR-positive,HER2-negative in Advanced Breast Cancer
TQB3616 Capsules Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer in Clinical Trail
This is a Phase III, a randomized, double-blind, parallel , multi-center trail to evaluate the efficacy and safety of TQB3616 capsules plus fulvestrant compared to placebo plus fulvestrant in participants with estrogen…
- Trial name
- NCT05375461
- Testing
- TQB3616 capsules, Fluvestrin injection
- Where
- 2 sites in China
- Volunteers
- 293 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Breast Cancer
An Observational Study of Patients With HER2-Positive Metastatic or Locally Advanced Breast Cancer Treated With Herceptin (Trastuzumab) in 1st Line and Without Progression For 3 Years
This observational study will characterize retrospectively patients with HER2-positive metastatic or locally advanced breast cancer who had received treatment with Herceptin (trastuzumab) in 1st line and who were without…
- Trial name
- NCT01480674
- Testing
- Trastuzumab
- Where
- 78 sites in France
- Volunteers
- 160 people
- Sponsor
- Hoffmann-La Roche
Locally Advanced Breast Cancer, Metastatic Breast Cancer
A Study of the Efficacy, Safety and Pharmacokinetics of RPH-051 and Perjeta® in Combination With Trastuzumab and Docetaxel as the 1st Line Therapy in Patients With HER2-positive Breast Cancer
The main purpose of this study is to prove non-inferiority, as well as to demonstrate the comparability of safety and immunogenicity of RPH-051 and Perjeta® in combination with trastuzumab and docetaxel as the 1st line therapy…
- Trial name
- NCT07386938
- Testing
- RPH-051, Docetaxel, Perjeta®
- Where
- 45 sites in Russia
- Volunteers
- 246 people
- Sponsor
- R-Pharm
HER2-Positive Primary Breast Cancer, Residual Invasive Breast Cancer
A Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants With Residual Invasive Breast Cancer Following Neoadjuvant Therapy (DESTINY-Breast05)
Patients with HER2-positive primary breast cancer (BC) who do not achieve complete response after appropriate neoadjuvant therapy are at higher risk of disease recurrence.
- Trial name
- NCT04622319
- Testing
- DS-8201a, T-DM1
- Where
- 482 sites in United States, Argentina and 29 more
- Volunteers
- 1,600 people
- Sponsor
- Daiichi Sankyo
Breast Cancer
ALEXANDRIA Study Egypt
Breast Cancer (BC) is one of the most frequent cancers in women and is the most frequent cause of death in the female population.
- Trial name
- NCT03583463
- Where
- 8 sites in Egypt
- Volunteers
- 436 people
- Sponsor
- AstraZeneca
HR Positive/HER2 Negative Advanced or Metastatic Breast Cancer
A Phase III Clinical Trial of NTQ1062 in Combination With Fulvestrant for the Treatment of Advanced or Metastatic HR+/HER2- Breast Cancer
NTQ1062-301 is a randomized, double-blind, placebo-controlled Phase III clinical trial to evaluate the efficacy and safety of the small-molecule AKT inhibitor NTQ1062 combined with fulvestrant versus placebo combined with…
- Trial name
- NCT07393321
- Testing
- NTQ1062+Fulvestrant
- Volunteers
- 210 people
- Sponsor
- Nanjing Chia-tai Tianqing Pharmaceutical
Breast Neoplasms
Study of Disitamab Vedotin With Toripalimab Verus Disitamab Vedotin in Hormone Receptor Positive, HER2-low Locally Advanced or Metastatic Breast Cancer
This study will evaluate the efficacy, safety and tolerability of RC48-ADC with JS001 compared with RC48-ADC in endocrine-resistant hormone receptor (HR) positive, human epidermal growth factor receptor (HER)2-low advanced breast…
- Trial name
- NCT06105008
- Testing
- Disitamab Vedotin, Toripalimab
- Where
- 3 sites in China
- Sponsor
- RemeGen Co., Ltd.
HER2 Expressing Solid Tumors
Gene Therapy for HER-Positive Cancer (SENTRY-HER2)
This is a Phase 1/2, first-in-human, open-label, dose-escalating and expansion trial designed to assess the safety and efficacy of VNX-202 in patients with HER2 positive cancers.
- Trial name
- SENTRY-HER2 (NCT07192432)
- Testing
- Dose Level 1, VNX-202, Dose Level 2, VNX-202, Dose Level 3, VNX-202
- Where
- 11 sites in United States
- Volunteers
- 27 people
- Sponsor
- Vironexis Biotherapeutics Inc.
HER2-positive Breast Cancer
A Study of A166 Versus Trastuzumab Emtansine (T-DM1) in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane Therapy
Evaluation of the efficacy of A166 versus trastuzumab emtansine (T-DM1) in Patients with HER2-Positive unresectable or metastatic breast cancer previously treated with trastuzumab and taxane therapy
- Trial name
- A166 (NCT06968585)
- Testing
- A166, T-DM1
- Where
- China
- Volunteers
- 365 people
- Sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
ER+ HER2- Advanced Breast Cancer
Study of AZD9833 Alone or in Combination in Women With Advanced Breast Cancer.
A Phase 1 Dose Escalation and Expansion Study of AZD9833 Alone or in Combination in Women with ER Positive, HER2 Negative Advanced Breast Cancer (SERENA-1)
- Trial name
- SERENA-1 (NCT03616587)
- Testing
- AZD9833, AZD9833 with palbociclib, AZD9833 with everolimus
- Where
- 17 sites in United States, Spain and 1 more
- Volunteers
- 396 people
- Sponsor
- AstraZeneca