Clinical trials: HER2-positive Metastatic Breast Cancer
HR Positive/HER2 Low Expression Metastatic Breast Cancer
Disitamab Vedotin (RC48) in Hormone Receptor Positive, HER2-low Metastatic Breast Cancer (the Rosy Trial)
Hormone receptor positive, HER2-low expression metastatic breast cancer is the main type of breast cancer, accounting for about 50% - 60%.
- Trial name
- NCT05904964
- Testing
- Disitamab vedotin, Endocrine therapy
- Where
- 3 sites in China
- Volunteers
- 288 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
HER2-positive Recurrent / Metastatic Breast Cancer
Effect of Montmorillonite Power or Loperamide on the Pharmacokinetics of Pyrotinib in Healthy Subjects
The study will assess the effect of anti-diarrhea drug Montmorillonite Power or Loperamide on the single dose pharmacokinetic parameters of pyrotinib in healthy Chinese subjects.
- Trial name
- NCT05252546
- Testing
- pyrotinib tablet, Montmorillonite Power, Loperamide
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
HER2-positive Recurrent/Metastatic Breast Cancer
A Study to Evaluate Inetetamab + Pyrotinib + Chemotherapy in Previously Untreated HER2-Positive Metastatic Breast Cancer
Studies H0648g and M77001 confirmed that the combination of trastuzumab with taxanes significantly improved TTP and OS, establishing the status of trastuzumab combined with taxanes as first-line standard therapy.The CLEOPATRA and…
- Trial name
- NCT05621434
- Testing
- Inetetamab, pyrotinib, chemotherapy
- Volunteers
- 63 people
- Sponsor
- Fujian Medical University
HER2 Positive Metastatic Breast Cancer
A Study of Pyrotinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer
Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is a randomized, multi-center, multinational, double blind, active-controlled, parallel design study of the combination of…
- Trial name
- NCT02973737
- Testing
- pyrotinib, Capecitabine
- Where
- China
- Volunteers
- 279 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Metastatic Breast Cancer, Advanced Breast Cancer
Margetuximab Plus Tucatinib and Capecitabine in HER2-positive Metastatic Breast Cancer
This is a multicenter, open-label, single-arm, phase II clinical trial to evaluate the efficacy and safety of margetuximab in combination with tucatinib and capecitabine in patients with human epidermal growth factor receptor 2…
- Conditions
- Metastatic Breast Cancer, Advanced Breast Cancer, HER2-positive Breast Cancer
- Trial name
- MARGARET (NCT05227131)
- Testing
- Margetuximab, Tucatinib, Capecitabine
- Sponsor
- MedSIR
Estrogen Receptor-positive (ER+)/Human Epidermal Growth Factor Receptor (HER2)-Negative Locally Advanced or Metastatic Breast Cancer
A Phase II Study Comparing The Efficacy Of Venetoclax + Fulvestrant Vs. Fulvestrant In Women With Estrogen Receptor-Positive, Her2-Negative Locally Advanced Or Metastatic Breast Cancer Who Experienced Disease Recurrence Or Progression During Or After CDK4/6 Inhibitor Therapy
This is a Phase II, multicenter, open-label, randomized study to compare the efficacy of venetoclax in combination with fulvestrant compared with fulvestrant alone in women with ER+, HER2-negative, locally advanced or Metastatic…
- Trial name
- Veronica (NCT03584009)
- Testing
- Venetoclax, Fulvestrant
- Where
- 40 sites in United States, Australia and 3 more
- Volunteers
- 103 people
- Sponsor
- Hoffmann-La Roche
Advanced Breast Adenocarcinoma, Advanced HER2-Negative Breast Carcinoma
Effects of Ribociclib and Palbociclib on Tumor and Blood Characteristics in Patients With Metastatic Breast Cancer
This clinical trial attempts to understand the differences between two chemotherapy drugs, ribociclib and palbociclib, and how they fight cancer.
- Conditions
- Advanced Breast Adenocarcinoma, Advanced HER2-Negative Breast Carcinoma, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
- Trial name
- NCT05244434
- Testing
- Best Practice, Biopsy, Biospecimen Collection
- Sponsor
- City of Hope Medical Center
HER2-positive, Metastatic Breast Cancer
ARX788 in HER2-positive Breast Cancer Patients With Brain Metastases
A Phase 2 Study of ARX788 in HER2-positive, Metastatic Breast Cancer Patients whose Disease is resistant or refractory to Tyrosine kinase inhibitors (TKI).
- Trial name
- NCT05018702
- Testing
- ARX788
- Where
- China
- Volunteers
- 32 people
- Sponsor
- Fudan University
Anatomic Stage IV Breast Cancer AJCC v8, HER2 Positive Breast Carcinoma
T-DM1 With or Without Abemaciclib for the Treatment of HER2-Positive Metastatic Breast Cancer
This phase II trial studies how well T-DMI with or without abemaciclib works for the treatment of HER2-positive breast cancer that has spread to other places in the body (metastatic).
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, HER2 Positive Breast Carcinoma, Metastatic Breast Carcinoma, Prognostic Stage IV Breast Cancer AJCC v8
- Trial name
- NCT04351230
- Testing
- Abemaciclib, Trastuzumab Emtansine
- Where
- 6 sites in United States
- Sponsor
- Academic and Community Cancer Research United
HER2-positive Breast Cancer, Postmenopausal
Phase IB & II Study of Ribociclib With Trastuzumab Plus Letrozole in Postmenopausal HR+, HER2+ Advanced Breast Cancer Patients
Survival benefit and quality of life are two key elements that should be kept in mind in the treatment of metastatic breast cancer.
- Conditions
- HER2-positive Breast Cancer, Postmenopausal, Metastatic Breast Cancer
- Trial name
- NCT03913234
- Testing
- Ribociclib, Trastuzumab, Letrozole
- Where
- South Korea
- Volunteers
- 95 people
- Sponsor
- Yonsei University
HER2-positive Breast Cancer, Metastatic Breast Cancer
Pyrotinib Rechallenge in Her2-positive Metastatic Breast Cancer Pretreated With Pyrotinib and Trastuzumab
Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is a randomized, open-label, multi-center, parallel design study of the combination of pyrotinib, trastuzumab and chemotherapy…
- Trial name
- NCT05346861
- Testing
- Trastuzumab plus chemotherapy, Trastuzumab in combination with pyrotinib plus chemotherapy
- Where
- China
- Volunteers
- 240 people
- Sponsor
- Fudan University
Estrogen Receptor-Positive, HER2-Negative
ER+/HER2- Locally Advanced or Metastatic Breast Cancer (ENZENO Study)
For patients with ER-positive, HER2-negative breast cancer, blockage of the ER pathway has been proven to be an effective anticancer approach. These patients showed good response to endocrine therapy.
- Conditions
- Estrogen Receptor-Positive, HER2-Negative, Locally Advanced Breast Cancer, Metastatic Breast Cancer
- Trial name
- ENZENO (NCT04669587)
- Testing
- ZB716, Palbociclib
- Where
- 8 sites in United States, South Korea
- Volunteers
- 106 people
- Sponsor
- EnhancedBio USA Inc.
HER2-positive Metastatic Breast Cancer, Previously Treated With Trastuzumab
Trastuzumab(Henlius®) Combined With Pertuzumab(Perjeta®) and Chemotherapy in Chinese Patients With Her2-Positive Metastatic Breast Cancer Previously Treated With Trastuzumab
Currently, data of the efficacy of trastuzumab plus pertuzumab and chemotherapy is limited in the HER2 positive metastatic breast cancer patients previously treated with trastuzumab during (neo)adjuvant and metastatic setting…
- Conditions
- HER2-positive Metastatic Breast Cancer, Previously Treated With Trastuzumab, Trastuzumab Combined With Pertuzumab and Chemotherapy
- Trial name
- HELP (NCT05188495)
- Testing
- trastuzumab(Henlius®) combined with Pertuzumab(Perjeta®) and Chemotherapy
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Peking University Cancer Hospital & Institute
HER2-positive Metastatic Breast Cancer, Ovarian Cancer
Feasibility of a New Technology for Isolating Circulating Tumour Cells
This is a prospective interventional single-site research with a collection of biological samples. The primary objective of the trial is to assess the ability of the "new technology" to isolating circulating tumor cells (CTC) in…
- Conditions
- HER2-positive Metastatic Breast Cancer, Ovarian Cancer, Hormone-resistant Prostate Cancer, Circulating Tumor Cell
- Trial name
- CTC-SMMiL-E (NCT03979339)
- Testing
- Blood sample collection
- Where
- France
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Centre Oscar Lambret
HER2 Positive Metastatic Breast Cancer
A Study to Evaluate the Pharmacokinetics of Margetuximab in Chinese Patients With HER2+ MBC
This is an open-label, Single-arm, Phase I clinical study to evaluate the pharmacokinetics, tolerability and safety of margetuximab plus chemotherapy in Chinese patients with advanced HER2+ breast cancer who have received…
- Trial name
- NCT04398108
- Testing
- Margetuximab Margetuximab-IV
- Where
- 3 sites in China
- Volunteers
- 16 people
- Sponsor
- Zai Lab (Shanghai) Co., Ltd.
Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer, Metastatic Cervical Cancer
HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research Studies of Neratinib
This is a multi-center, observational genomic screening protocol to identify participants whose tumors harbor somatic mutations in the ERBB2 (HER2) gene, as measured in circulating tumor DNA (ctDNA) .
- Trial name
- NCT03786107
- Testing
- Almac HER-Seq Assay
- Where
- 22 sites in United States, France and 5 more
- Volunteers
- 1,583 people
- Sponsor
- Puma Biotechnology, Inc.
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Abexinostat, Palbociclib, and Fulvestrant for the Treatment of Breast or Gynecologic Cancer
This phase I trial investigates the side effects and best dose of abexinostat and palbociclib when given together with fulvestrant in treating patients with breast or gynecologic cancer.
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8
- Trial name
- NCT04498520
- Testing
- Abexinostat Tosylate, Fulvestrant, Palbociclib
- Sponsor
- Pamela Munster
Advanced Solid Tumor, Metastatic Cancer
Safety and Preliminary Efficacy of SNK01 in Combination With Trastuzumab or Cetuximab in Subjects With Advanced HER2 or EGFR Cancers
The purpose of the Phase 1/2a study is to evaluate the safety and tolerability of SNK01 in combination with trastuzumab or cetuximab in order to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D), and the…
- Conditions
- Advanced Solid Tumor, Metastatic Cancer, HER2-positive Breast Cancer, HER2-positive Gastric Cancer
- Trial name
- NCT04464967
- Testing
- SNK01, Trastuzumab, Cetuximab
- Sponsor
- NKGen Biotech, Inc.
HER2 Positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer
A Study of Trastuzumab Emtansine in Indian Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Unresectable Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Treatment With Trastuzumab and a Taxane
This is a Phase IV, single-arm, multicenter, open-label clinical trial designed to assess the safety of trastuzumab emtansine in Indian patients with HER2-positive unresectable locally advanced breast cancer (LABC) or metastatic…
- Trial name
- NCT02658734
- Testing
- Trastuzumab emtansine
- Where
- 13 sites in India
- Volunteers
- 70 people
- Sponsor
- Hoffmann-La Roche
HER2-positive Breast Cancer, Metastatic Breast Cancer
Phase II Study of Herzuma® Plus Gedatolisib in Patients With HER-2 Positive Metastatic Breast Cancer
Phase II Pilot Study of Trastuzumab Biosimilar (Herzuma®) plus Gedatolisib in Patients with HER-2 Positive Metastatic Breast Cancer Who Progressed after 2 or more HER-2 directed Chemotherapy
- Trial name
- NCT03698383
- Testing
- Trastuzumab biosimilars(Herzuma), Gedatolisib
- Where
- South Korea
- Volunteers
- 15 people
- Sponsor
- Korean Cancer Study Group