Clinical trials: HER2 Positive Metastatic Breast Cancer
HER-2 Positive Breast Cancer
HER2 Imaging Study to Identify HER2 Positive Metastatic Breast Cancer Patient Unlikely to Benefit From T-DM1
T-DM1 , which is a highly innovative but also expensive antiHER2 agent consisting in the coupling of the humanised monoclonal antibody trastuzumab with a cytotoxic agent (maytansine derivate) has shown an encouraging antitumor…
- Trial name
- ZEPHIR (NCT01565200)
- Testing
- T-DM1, 89Zr-trastuzumab
- Where
- 5 sites in Belgium, Netherlands
- Volunteers
- 90 people
- Sponsor
- Jules Bordet Institute
HER2-positive Breast Cancer, Leptomeningeal Metastasis
Radiation Therapy Followed by Intrathecal Trastuzumab/Pertuzumab in HER2+ Breast Leptomeningeal Disease
The purpose of this study is to find out if radiation therapy followed by intrathecal trastuzumab and pertuzumab is safe and will result in improved survival in HER2 positive breast cancer which has metastasized to the…
- Conditions
- HER2-positive Breast Cancer, Leptomeningeal Metastasis, Leptomeningeal Disease
- Trial name
- NCT04588545
- Testing
- Radiation Therapy, Pertuzumab, Trastuzumab
- Where
- 2 sites in United States
- Volunteers
- 33 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Breast Cancer
A Clinical Study of TQB2102 Versus Docetaxel Plus Trastuzumab and Pertuzumab in the Treatment of HER2 Positive Recurrent or Metastatic Breast Cancer
This Phase III trial adopts a randomized, open label, positive drug control, and multicenter trial design. Subjects who meet the criteria are randomly divided into 1:1 groups and receive treatment with TQB2102 injection or…
- Trial name
- NCT07003074
- Testing
- TQB2102 for Injection, Docetaxel combined + Trastuzumab +Pertuzumab
- Where
- 25 sites in China
- Volunteers
- 642 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Breast Cancer, Metastatic Breast Cancer
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
The purpose of this study is to determine whether lucitanib is safe and effective in the treatment of patients with FGF aberrant metastatic breast cancer, as well as in the treatment of patients with biomarker negative (FGF…
- Conditions
- Breast Cancer, Metastatic Breast Cancer, MBC, HER2 Positive
- Trial name
- NCT02202746
- Testing
- Lucitanib
- Where
- 33 sites in United States
- Volunteers
- 178 people
- Sponsor
- Clovis Oncology, Inc.
Metastatic Breast Cancer
Pharmacokinetic Study of Pyrotinib and Docetaxel in Combination With Trastuzumab in Patients With HER2 Metastatic Breast Cancer
The primary objective of the study is to study the pharmacokinetics of pyrotinib and docetaxel plus Trastuzumab in HER2 Positive MBC.
- Trial name
- NCT04367090
- Testing
- Docetaxel, trastuzumab, Pyrotinib
- Where
- China
- Volunteers
- 97 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Breast Cancer
Pyrotinib Plus Vinorelbine Versus Lapatinib Plus Capecitabine
Pyrotinib Plus Vinorelbine Versus Lapatinib Plus Capecitabine
- Trial name
- NCT04850625
- Where
- China
- Volunteers
- 224 people
- Sponsor
- Fudan University
Breast Cancer
Vepdegestrant (ARV-471/PF-07850327) + Palbociclib vs Letrozole + Palbociclib in ER(+)/HER2(-) Advanced Breast Cancer
The purpose of this study is to understand the safety and effects of the study medicine vepdegestrant (ARV-471/PF-07850327) given together with palbociclib in advanced breast cancer.
- Trial name
- VERITAC-3 (NCT05909397)
- Testing
- Vepdegestrant (ARV-471/PF-07850327), Palbociclib, Letrozole
- Where
- 29 sites in United States, Australia and 8 more
- Volunteers
- 59 people
- Sponsor
- Pfizer
Adult Solid Neoplasm, Extensive Stage Lung Small Cell Carcinoma
RO4929097 and Whole-Brain Radiation Therapy or Stereotactic Radiosurgery in Treating Patients With Brain Metastases From Breast Cancer
This randomized phase I/II trial studies the side effects and the best dose of RO4929097 (gamma-secretase/Notch signalling pathway inhibitor RO4929097) when given together with whole-brain radiation therapy or stereotactic…
- Conditions
- Adult Solid Neoplasm, Extensive Stage Lung Small Cell Carcinoma, HER2/Neu Negative, HER2/Neu Positive
- Trial name
- NCT01217411
- Testing
- Cognitive Assessment, Gamma-Secretase Inhibitor RO4929097, Laboratory Biomarker Analysis
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- National Cancer Institute (NCI)
Breast Cancer
Study of Dalpiciclib Combined With Letrozole in the Maintenance Treatment of HR Positive and HER2 Negative Metastatic Breast Cancer After First-line Chemotherapy
This study aimed to evaluate the efficacy and safety of Dalpiciclib combined with Letrozole in the maintenance treatment of HR positive and HER2 negative metastatic breast cancer after first-line chemotherapy.
- Trial name
- NCT05979220
- Testing
- Dalpiciclib combined with Letrozole
- Where
- China
- Volunteers
- 178 people
- Sponsor
- Shuangyue Liu
Breast Cancer, Advanced Breast Cancer
PIK3CA/PTEN-altered Advanced Breast Cancer Treated With MEN1611 Monotherapy or in Combination With Eribulin
The multicenter, two-cohort, non-comparative, open-label, phase II clinical trial SABINA aims to analyze the safety and efficacy of MEN1611 in monotherapy and in combination with eribulin, a non-taxane chemotherapy agent, in…
- Conditions
- Breast Cancer, Advanced Breast Cancer, Metastatic Breast Cancer
- Trial name
- SABINA (NCT05810870)
- Testing
- MEN1611, Eribulin
- Where
- 13 sites in Spain
- Volunteers
- 14 people
- Sponsor
- MedSIR
HER2-positive Breast Cancer, Male Breast Cancer
Vaccine Therapy in Treating Patients With Stage IV Breast Cancer
This phase I/II trial is studying the side effects of escalating doses of adoptive T cell therapy in treating patients with stage IV breast cancer.
- Conditions
- HER2-positive Breast Cancer, Male Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer
- Trial name
- NCT00791037
- Testing
- HER-2/neu peptide vaccine, leukapheresis, ex vivo-expanded HER2-specific T cells
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- University of Washington
Breast Cancer
Weekly Gemcitabine and Trastuzumab in the Treatment of Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Metastatic Breast Cancer
Due to its remarkable activity as salvage treatment in women with metastatic breast cancer as well as the additive activity observed for gemcitabine administered in combination with trastuzumab, the clinical activity of the…
- Trial name
- NCT00193063
- Testing
- Trastuzumab, Gemcitabine
- Volunteers
- 41 people
- Sponsor
- SCRI Development Innovations, LLC
HER2-positive Metastatic Breast Cancer, HER2-positive Advanced Breast Cancer
HER2 Molecular Imaging With 89Zr-trastuzumab PET/CT as a Predictive Biomarker for Antibody-drug Conjugate Sequencing in Patients With Advanced HER2-positive Breast Cancer
ZEPHIR-02 is a multicentre, open-label phase II study that will enroll subjects with HER2-positive advanced/metastatic breast cancer (mBC) who have experienced disease progression under trastuzumab deruxtecan (T-DXd) in the…
- Trial name
- ZEPHIR-02 (NCT06595563)
- Testing
- Trastuzumab emtansine
- Where
- 8 sites in Belgium, Netherlands
- Volunteers
- 87 people
- Sponsor
- Jules Bordet Institute
Advanced Breast Carcinoma, Anatomic Stage III Breast Cancer AJCC v8
Olaparib With Cediranib or AZD6738 for the Treatment of Advanced or Metastatic Germline BRCA Mutated Breast Cancer
This phase II trial studies how well olaparib with cediranib or AZD6738 works in treating patients with germline BRCA mutated breast cancer that has spread to other places in the body (advanced or metastatic).
- Conditions
- Advanced Breast Carcinoma, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8
- Trial name
- NCT04090567
- Testing
- Cediranib, Ceralasertib, Olaparib
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- M.D. Anderson Cancer Center
Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors
Study of ERW316 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
Phase I: Characterize safety and tolerability of ERW316 as a single agent and in combination with fulvestrant or letrozole. Identify dose range for optimization/recommended dose for further clinical evaluation.
- Conditions
- Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors, Metastatic Castration-resistant Prostate Cancer (mCRPC)
- Trial name
- NCT07570966
- Testing
- ERW316, Fulvestrant, Letrozole
- Sponsor
- Novartis Pharmaceuticals
Metastatic Breast Cancer
A Randomized Study of TH Versus THL in First Line Treatment of HER2-positive Metastatic Breast Cancer
The proposed phase III randomised trial will compare the efficacy of trastuzumab and paclitaxel with trastuzumab, paclitaxel and lapatinib in first line treatment of HER2 positive metastatic breast cancer.
- Trial name
- TH V THL (NCT01526369)
- Testing
- Trastuzumab, Paclitaxel, Lapatinib
- Where
- 35 sites in Finland, France and 6 more
- Volunteers
- 75 people
- Sponsor
- Cancer Trials Ireland
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
Thero2-01S22 in HER2-positive Breast Cancer
Trastuzumab and pertuzumab based regimen are the standard of care for patients with human epidermal growth factor receptor 2 (HER2) -positive metastatic breast cancer (MBC), significantly improving survival outcomes.
- Trial name
- NCT05698186
- Testing
- Thero2-01S22
- Volunteers
- 320 people
- Sponsor
- Institut de cancérologie Strasbourg Europe
Breast Neoplasms, HER2-positive Breast Cancer
Circulating Tumor Cells and Treatment De-escalation After Neoadjuvant Therapy for HER2 Positive Breast Cancer
Phase II unicentric randomized trial which will include early HER2 positive breast cancer patients, candidate to neoadjuvant therapy with trastuzumab and pertuzumab.
- Conditions
- Breast Neoplasms, HER2-positive Breast Cancer, Circulating Tumor Cell
- Trial name
- HER2Cell (NCT04993014)
- Testing
- Pertuzumab, Trastuzumab, Circulating tumor cells
- Where
- Brazil
- Volunteers
- 80 people
- Sponsor
- AC Camargo Cancer Center
Breast Neoplasms
The XENERA™ 1 Study Tests Xentuzumab in Combination With Everolimus and Exemestane in Women With Hormone Receptor Positive and HER2-negative Breast Cancer That Has Spread
The main objective of the trial is to assess the efficacy of xentuzumab in combination with everolimus and exemestane over everolimus and exemestane in patients with HR+/ HER2- advanced or metastatic breast cancer and…
- Trial name
- NCT03659136
- Testing
- Xentuzumab, Everolimus, Exemestane
- Where
- 54 sites in United States, Australia and 9 more
- Volunteers
- 103 people
- Sponsor
- Boehringer Ingelheim