Clinical trials: HER2-Positive Breast Cancer
Breast Neoplasms
Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer
Primary objective: Compare disease-free survival in women with human epidermal growth factor receptor 2 (HER2)-neu-expressing node-positive or high-risk node-negative operable breast cancer treated with adjuvant doxorubicin…
- Trial name
- NCT00021255
- Testing
- Doxorubicin, Cyclophosphamide, Docetaxel
- Where
- 42 sites in United States, Argentina and 40 more
- Volunteers
- 3,222 people
- Sponsor
- Sanofi
Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer
A Phase Ib Dose Escalation Study of the Combination of LEE011 With Letrozole and Dose Expansion of LEE011 With Hormonal Therapy for the Treatment of Pre-(With Goserelin) and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer
The purpose of the Phase Ib is to: 1. determine the recommended dose of LEE011 in combination with a standard dose of letrozole as well as to provide additional safety and anti-tumor activity data in Asian non-Japanese patients…
- Trial name
- NCT02333370
- Testing
- LEE011, Letrozole, Tamoxifen
- Where
- 15 sites in Hong Kong, Japan and 1 more
- Volunteers
- 88 people
- Sponsor
- Novartis Pharmaceuticals
HER2 Positive Early or Locally Advanced Breast Cancer
A Study to Compare the Effect of SB3 and Herceptin® in Women With HER2 Positive Breast Cancer
A Phase III Randomised, Double-Blind, Parallel Group, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity between SB3 (proposed trastuzumab biosimilar) and Herceptin® in Women with Newly…
- Trial name
- NCT02149524
- Testing
- Herceptin (trastuzuamb), SB3 (proposed trastuzumab biosimilar)
- Where
- Czechia
- Volunteers
- 875 people
- Sponsor
- Samsung Bioepis Co., Ltd.
Breast Cancer
Study Of SU011248 In Combination With Docetaxel And Trastuzumab In Patients With Advanced Breast Cancer HER-2 Positive
This is an exploratory trial evaluating the tolerability and preliminary anti-tumor activity of SU011248 combined with docetaxel and trastuzumab in patients with locally recurrent or metastatic breast cancer over-expressing…
- Trial name
- NCT00372424
- Testing
- Herceptin, Sunitinib, Taxotere
- Where
- 7 sites in Belgium, Italy
- Volunteers
- 26 people
- Sponsor
- Pfizer
Metastatic Breast Cancer
A Study of Pyrotinib in Combination With Trastuzumab and Docetaxel in Patients With HER2 Metastatic Breast Cancer
This is a randomized, double-blinded, multicenter phase 3 clinical trial to evaluate the efficacy and safety of pyrotinib plus trastuzumab plus docetaxel versus placebo plus trastuzumab plus docetaxel in patients who have HER2…
- Trial name
- NCT03863223
- Testing
- Pyrotinib, Trastuzumab, Docetaxel
- Where
- China
- Volunteers
- 590 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Breast Cancer
A Study of Dato-DXd in Inoperable or Metastatic Hormone Receptor-positive, HER2 IHC 0 Breast Cancer
A study to assess the efficacy and safety of Dato-DXd in the pre-chemotherapy setting for patients with metastatic HR-positive, HER2 IHC 0 breast cancer.
- Trial name
- TB06 (NCT07205822)
- Testing
- Dato-DXd
- Where
- 40 sites in United States, China and 4 more
- Volunteers
- 100 people
- Sponsor
- AstraZeneca
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, Gastric Cancer
Anti-HER2 Bispecific Antibody Zanidatamab (ZW25) Activity in Combination With Chemotherapy With/Without Tislelizumab
The purpose of the study is to assess the safety, tolerability and preliminary antitumor activity of zanidatamab in combination with docetaxel in participants with human epidermal growth factor receptor 2 (HER2)-positive breast…
- Conditions
- Breast Cancer, Gastric Cancer, Gastroesophageal Junction Cancer
- Trial name
- NCT04276493
- Testing
- Zanidatamab, Docetaxel, Tislelizumab
- Where
- 21 sites in China, South Korea and 1 more
- Volunteers
- 71 people
- Sponsor
- BeiGene
Neoplasms, Breast
Study In Women And Men With Metastatic Breast Cancer That Have Overexpression Of ErbB2
This was a randomized, double-blind, placebo-controlled, multicenter, Phase III study to evaluate and compare the efficacy and safety of Lapatinib + Paclitaxel versus Placebo + Paclitaxel in men and women with ErbB2 amplified…
- Trial name
- NCT00281658
- Testing
- Lapatinib (GW572016) oral tablets, Paclitaxel infusion
- Where
- 54 sites in Brazil, China and 6 more
- Volunteers
- 444 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer, Colorectal Cancer
A Study of Poziotinib in Patients With Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Activating Mutations in Advanced Malignancies
This is a Phase 2, open-label, multicenter study whose principal objectives are to evaluate the efficacy and safety/tolerability of poziotinib in five cohorts of 30 previously-treated patients each.
- Conditions
- Breast Cancer, Colorectal Cancer, Solid Tumor, Glioblastome Multiforme
- Trial name
- NCT04172597
- Testing
- Poziotinib Hydrochloride, Loperamide
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
HER2-positive Breast Cancer, HER2-positive Gastric Cancer
ELVN-002 With Trastuzumab +/- Chemotherapy in HER2+ Solid Tumors, Colorectal and Breast Cancer
The purpose of this study is to determine the safety, tolerability, and recommended dose of ELVN-002 in combination with trastuzumab in participants with advanced-stage HER2-positive tumors and in combination with trastuzumab…
- Conditions
- HER2-positive Breast Cancer, HER2-positive Gastric Cancer, HER2 Positive Solid Tumors, HER2 Amplification
- Trial name
- NCT06328738
- Testing
- ELVN-002, Trastuzumab, 5-Fluorouracil
- Where
- 31 sites in United States, Belgium and 5 more
- Volunteers
- 275 people
- Sponsor
- Enliven Therapeutics
HR-positive, HER2-negative Advanced Breast Cancer
Study of TYK-00540 Tablets in Patients With Advanced Solid Tumors
This study is to evaluate the safety, pharmacokinetics, and preliminary antitumor activity of TYK-00540 as monotherapy or combined with fulvestrant in advanced solid tumors.
- Trial name
- NCT06950086
- Testing
- TYK-00540
- Where
- 2 sites in China
- Volunteers
- 180 people
- Sponsor
- TYK Medicines, Inc
HR+/HER2- Locally Advanced, Metastatic Breast Cancer
UK Ibrance Patient Program (IPP) Study
What are the real-world treatment patterns, patients' characteristics, clinical outcomes and healthcare resource utilisation associated with palbociclib treatment in the 3 years following initiation in United Kingdom patients…
- Trial name
- ROIS (NCT03921866)
- Testing
- Palbociclib
- Where
- 8 sites in United Kingdom
- Volunteers
- 191 people
- Sponsor
- Pfizer
Breast Cancer
H.E.R.O.S. Study: An Observational Study of the Cardiac Safety of Herceptin (Trastuzumab) in Patients With HER2-Positive Breast Cancer
This observational study will assess the safety of Herceptin (trastuzumab) in patients with HER2-positive breast cancer in routine clinical practice. Eligible patients will be followed for up to 4 years.
- Trial name
- NCT01991340
- Where
- 19 sites in Algeria, Morocco
- Volunteers
- 657 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer, Gastric Cancer
Phase I Study of Pyrotinib in Patients With HER2-positive Solid Tumors
Part 1: to assess the safety and tolerability of pyrotinib and to define the maximum tolerated dose (MTD) of pyrotinib in patients with Human Epidermal Growth Factor Receptor 2 (HER2)-positive advanced solid tumors (metastatic…
- Conditions
- Breast Cancer, Gastric Cancer, Solid Tumors, NSCLC
- Trial name
- NCT02500199
- Testing
- Pyrotinib
- Where
- 10 sites in United States
- Volunteers
- 50 people
- Sponsor
- Hengrui Therapeutics, Inc.
Breast Neoplasms, Gastroesophageal Junction Adenocarcinoma
A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors
This clinical trial is studying solid tumor cancers. A solid tumor is one that starts in part of your body like your lungs or liver instead of your blood.
- Conditions
- Breast Neoplasms, Gastroesophageal Junction Adenocarcinoma, HER2 Low Breast Neoplasms, HER2 Positive Breast Neoplasms
- Trial name
- NCT06157892
- Testing
- disitamab vedotin, tucatinib
- Where
- 135 sites in United States, Australia and 8 more
- Volunteers
- 54 people
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
Breast Cancer
A Study of HR+/HER2- Metastatic Breast Cancer Patients Treated With Palbociclib Together With an Aromatase Inhibitor From 2017 to 2023 in Denmark.
The purpose of this study is to describe the effect of the medicine palbociclib when given together with an aromatase inhibitor for treatment of breast cancer.
- Trial name
- NCT06307457
- Testing
- Palbociclib in combination with AI
- Where
- Denmark
- Volunteers
- 604 people
- Sponsor
- Pfizer
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
Advanced Breast Cancer
Study to Evaluate the Safety and Tolerability of Camizestrant in Combination With Atirmociclib in Women With Advanced Breast Cancer
A study to investigate camizestrant in combination with atirmociclib in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer previously treated with a…
- Trial name
- SERENA-1b (NCT07427394)
- Testing
- Camizestrant, Atirmociclib
- Where
- 6 sites in United States, United Kingdom
- Volunteers
- 24 people
- Sponsor
- AstraZeneca
Metastatic Breast Cancer
4EVER - Efficacy, Safety, Health Economics, Translational Research of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer
The present multi-center, open-label, single-arm study aims to evaluate the efficacy and safety, quality of life and health resources utilization in postmenopausal women with hormone receptor positive breast cancer progressing…
- Trial name
- MACS2096 (NCT01626222)
- Testing
- Exemestane, Everolimus (RAD001)
- Where
- 84 sites in Germany
- Volunteers
- 301 people
- Sponsor
- Novartis Pharmaceuticals