Clinical trials: HER2-positive
Fludzoparib" and Anti-angiogenic, HRD-positive/HER2-negative Advanced Breast Cancer
Randomized, Open, Controlled, Multicenter Phase III Clinical Study of Fluzoparib in Combination With Apatinib Versus Investigator-Selected Chemotherapy for HRD-Positive/HER2-negative Advanced Breast Cancer
This study develops a new therapeutic approach for HER2-negative advanced breast cancer patients without precise treatment targets.
- Trial name
- NCT06255392
- Testing
- Fluzoparib, Apatinib Mesylate, Capecitabine tablets
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
HER2-positive Breast Cancer
HB1801 Combined Treatment of HER2-positive Breast Cancer
This study is designed to evaluate the safety and efficacy of HB1801 combination therapy as first-line treatment in HER2-positive unresectable locally advanced or metastatic breast cancer.
- Trial name
- NCT07116824
- Testing
- HB1801, Trastuzumab, Pertuzumab
- Volunteers
- 80 people
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Advanced Solid Tumors, HER2-positive Breast Cancer
Trial of ZN-A-1041 Enteric Capsules in Patients With HER2-Positive Advanced Solid Tumors
This will be a phase 1, multicenter, open-label trial to evaluate the safety, tolerability, PK and efficacy of ZN-A-1041 as a monotherapy or in combination in patients with HER2-positive advanced solid tumors.
- Trial name
- NCT04487236
- Testing
- ZN-A-1041 50mg BID, ZN-A-1041 100mg BID, ZN-A-1041 200mg BID
- Where
- China
- Volunteers
- 61 people
- Sponsor
- Suzhou Zanrong Pharma Limited
HER2-positive Breast Cancer
Tumor Markers for Efficacy of Dual-Target Therapy in HER2+ Breast Cancer
This is a prospective, randomized study to compare the efficacy of TP (Taxane plus Carboplatin) chemotherapy combined with dual-HER2 blockade (trastuzumab and pertuzumab) versus TP chemotherapy plus single-HER2 blockade…
- Trial name
- NCT07115095
- Testing
- TP Chemotherapy + Trastuzumab + Pertuzumab, TP Chemotherapy + Trastuzumab
- Where
- China
- Volunteers
- 98 people
- Sponsor
- Nanlin Li
Rectal Cancer, HER2-positive
Efficacy and Safety of Trastuzumab Biosimilars and Pertuzumab Biosimilars Combined With Chemotherapy for Neoadjuvant Treatment of Patients With Locally Advanced HER2-positive Rectal Cancer
The purpose of this study was to evaluate the complete response rate (CR) of trastuzumab biosimilars and pertuzumab biosimilars combined with oxaliplatin and capecitabine in neoadjuvant treatment of patients with locally advanced…
- Trial name
- NePHera (NCT07108127)
- Testing
- Trastuzumab biosimilars and pertuzumab biosimilars plus XELOX
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Peking Union Medical College Hospital
HER2-positive Breast Cancer
This Study Aims to Optimize Neoadjuvant Therapy for HER2-positive Breast Cancer by Implementing a Dynamic Monitoring-guided Treatment Strategy.
This study aims to optimize neoadjuvant therapy for HER2-positive breast cancer by implementing a dynamic monitoring-guided treatment strategy. Patients will initially receive trastuzumab, pyrotinib, and albumin-bound paclitaxel.
- Trial name
- HER2-DM-NACT (NCT06973525)
- Testing
- Patients will initially receive trastuzumab, pyrotinib, and albumin-bound paclitaxel. Those who do not achieve a radiological response after Cycle 2 will switch to SHR-A1811 (a HER2-targeted antibody, Patients will initially receive trastuzumab, pyrotinib, and nab-paclitaxel. Those who achieve a partial response (PR) or complete response (CR) after cycle 2 will continue on the same regimen.
- Volunteers
- 30 people
- Sponsor
- Hebei Medical University Fourth Hospital
Early Breast Cancer, Adjuvant Therapy
Dalpiciclib as Adjuvant Therapy for HR-positive/HER2-negative Early-stage Patients
This study aims to evaluate the efficacy and safety of adjuvant endocrine therapy combined with dalpiciclib at different doses and durations in patients with hormone receptor (HR)-positive, HER2-negative early-stage breast…
- Conditions
- Early Breast Cancer, Adjuvant Therapy, Hormone Receptor Positive / HER2-negative Breast Cancer
- Trial name
- NCT07101159
- Testing
- Dalpiciclib, Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)
- Volunteers
- 200 people
- Sponsor
- Fujian Cancer Hospital
HER2-positive Breast Cancer
Identification of Risk Factors for Brain Recurrence in Patients With HER2-positive Localised Breast Cancer
HER2 gene amplification, detected in 20% to 30% of breast cancers, was a poor prognostic factor before the advent of anti-HER2 therapies.
- Trial name
- CRANIUM (NCT06358625)
- Testing
- Pre-treatment biopsy
- Where
- France
- Volunteers
- 120 people
- Sponsor
- Center Eugene Marquis
Advanced Breast Cancer, Hormone Receptor Positive Breast Carcinoma
Retrospective Study of 2nd-line Therapies After CDK4/6i + Hormonal Therapy in HR+/HER2- Advanced Breast Cancer
Description of the choices for second line treatment, in the normal clinical practice of the centers adhering to the Hermione Network, in patients affected by advanced HR+/HER2- breast cancer who progressed after CDK4/6i in…
- Conditions
- Advanced Breast Cancer, Hormone Receptor Positive Breast Carcinoma, HER2-negative Breast Cancer
- Trial name
- HERMIONE-13 (NCT05173103)
- Where
- 29 sites in Italy
- Volunteers
- 254 people
- Sponsor
- University of Milano Bicocca
Locally Advanced/Metastatic HER2 Positive Solid Tumors
A First-in-human Study of Multiple Doses of BB-1701 in Subjects With Locally Advanced/Metastatic HER2 Expressing Solid Tumors
This is an open-label, first-in-human (FIH), phase 1 dose-escalation and cohort expansion study of BB-1701 in subjects with locally advanced/metastatic HER2 expressing solid tumors.
- Trial name
- NCT04257110
- Testing
- BB-1701
- Where
- 12 sites in United States, China
- Volunteers
- 117 people
- Sponsor
- Bliss Biopharmaceutical (Hangzhou) Co., Ltd
HER2-positive Breast Cancer, Metastatic Breast Cancer
Efficacy and Safety of Trastuzumab Biosimilar (Herzuma®) Plus Treatment of Physician's Choice (TPC) in Patients With HER-2 Positive Metastatic Breast Cancer
Trastuzumab combined with chemotherapy has been approved as the first line therapy in HER2+ metastatic breast cancer. When patients experienced progression beyond trastuzumab containing therapy, T-DM1 is considered as the second…
- Trial name
- NCT03755141
- Testing
- Herzuma
- Where
- South Korea
- Volunteers
- 109 people
- Sponsor
- National Cancer Center, Korea
HER2-positive Breast Cancer, Metastatic Breast Cancer
Copanlisib in Combination With T-DM1 in Pretreated Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer
This study is a Phase 1b open label, single arm, adaptive multi-centre trial of copanlisib in combination with trastuzumab emtansine (T-DM1) in pretreated locally advanced or metastatic HER2-positive breast cancer.
- Conditions
- HER2-positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer, Unresectable Breast Cancer
- Trial name
- Panthera (NCT04042051)
- Testing
- Copanlisib, Trastuzumab emtansine
- Where
- 3 sites in Ireland, Spain
- Volunteers
- 2 people
- Sponsor
- Cancer Trials Ireland
HER2-Positive Solid Tumors
A Study of M802 (HER2 and CD3) in HER2-Positive Advanced Solid Tumors
The purpose of this study is to evaluate the safety and tolerability of different doses of M802 in patients with HER2-positive advanced solid tumors, and to determine the dose limiting toxicity (DLT) and the maximum tolerated…
- Trial name
- NCT04501770
- Testing
- Chort 1 of M802, Chort 2 of M802, Cohort 3 of M802
- Where
- China
- Volunteers
- 34 people
- Sponsor
- Wuhan YZY Biopharma Co., Ltd.
HER2-positive Breast Cancer
A Randomized, Open-label, Multi-center Phase III Study Comparing the Efficacy of Oral Chemotherapy Combined With Trastuzumab Versus Paclitaxel Combined With Trastuzumab in the Adjuvant Treatment of HER2-positive, Lymph Node-negative Early Breast Cancer Patients(ORCHID-PLUS)
Although there is a certain risk of recurrence of HER2-positive small tumors, the overall prognosis is relatively good. In order to further reduce the toxicity and side effects of treatment and explore the best strategy for…
- Trial name
- NCT06992882
- Testing
- Capecitabine, Paclitaxel
- Where
- China
- Volunteers
- 2,306 people
- Sponsor
- Fudan University
Metastatic Breast Cancer, Drug Resistance
Real-World Study of Post-Resistance Treatment Strategies in Advanced Breast Cancer Following CDK4/6i, PIK3CA Inhibitors, or T-DXd
This is a real-world observational study aiming to evaluate the effectiveness of post-progression treatment strategies in patients with advanced breast cancer who have developed resistance to prior targeted therapies, including…
- Conditions
- Metastatic Breast Cancer, Drug Resistance, Hormone Receptor-Positive Breast Cancer, HER2-positive Breast Cancer
- Trial name
- NCT07073755
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Hunan Cancer Hospital
HER2 Mutant Non-small Cell Lung Cancer, HER2-positive Metastatic Breast Cancer
ELVN-002 in HER2 Mutant Non-Small Cell Lung Cancer
The goal of this clinical trial is to test ELVN-002 in people with cancers that have an abnormal HER2 gene. The main question the trial aims to answer is if ELVN-002 is safe and tolerable at different doses.
- Conditions
- HER2 Mutant Non-small Cell Lung Cancer, HER2-positive Metastatic Breast Cancer, HER2 Gene Mutation, HER2 Amplification
- Trial name
- HER2 (NCT05650879)
- Testing
- ELVN-002, Fam-Trastuzumab Deruxtecan-Nxki, Trastuzumab emtansine
- Where
- 39 sites in United States, Australia and 5 more
- Volunteers
- 198 people
- Sponsor
- Enliven Therapeutics
HER2/Neu Positive, Progesterone Receptor Positive
Chemotherapy With or Without Trastuzumab After Surgery in Treating Women With Invasive Breast Cancer
This randomized phase III clinical trial studies chemotherapy with or without trastuzumab after surgery to see how well they work in treating women with invasive breast cancer.
- Conditions
- HER2/Neu Positive, Progesterone Receptor Positive, Recurrent Breast Carcinoma, Stage IA Breast Cancer AJCC v7
- Trial name
- NCT01275677
- Testing
- Cyclophosphamide, Docetaxel, Doxorubicin
- Where
- 1,283 sites in United States, Canada and 2 more
- Volunteers
- 3,270 people
- Sponsor
- National Cancer Institute (NCI)
Biliary Tract Cancer, HER2-positive Cancer
Trastuzumab Plus Chemotherapy vs Chemotherapy Alone in First-line HER2 Positive Advanced Biliary Tract Cancer Patients
This is a randomized, open-label, two-arm, Phase III clinical trial evaluating the efficacy and safety of trastuzumab plus chemotherapy versus chemotherapy alone as first-line treatment in patients with HER2-positive advanced or…
- Conditions
- Biliary Tract Cancer, HER2-positive Cancer, Advanced Cancer, Unresectable Biliary Tract Carcinoma
- Trial name
- TAB-2 (NCT07062263)
- Testing
- Trastuzumab, Chemotherapy
- Where
- 6 sites in India
- Volunteers
- 220 people
- Sponsor
- Tata Memorial Centre
Hormone Receptor-Positive and HER2-Negative Advanced Breast Cancer
Comparing Endocrine Therapy Combined With High-Dose Palbociclib and Hydroxychloroquine to Endocrine Therapy Combined With Standard-Dose Palbociclib for Hormone Receptor-Positive and HER2-Negative Advanced Breast Cancer
This is a a phase III, randomized, open-label clinical trial comparing endocrine therapy combined with high-dose palbociclib and hydroxychloroquine to endocrine therapy combined with standard-dose palbociclib for hormone…
- Trial name
- NCT07061717
- Testing
- Palbociclib 125mg qd (3 weeks of treatment followed by 1 week off) + Anastrozole 1mg qd / Letrozole 2.5mg qd / Exemestane 25mg qd, Palbociclib 125mg qd (3 weeks of treatment followed by 1 week off) + Anastrozole 1mg qd / Letrozole 2.5mg qd / Exemestane 25mg qd + Hydroxychloroquine 600mg bid, Palbociclib 200mg qd (3 weeks of treatment followed by 1 week off) + Anastrozole 1mg qd / Letrozole 2.5mg qd / Exemestane 25mg qd + Hydroxychloroquine 600mg bid
- Where
- China
- Volunteers
- 474 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
HER2 Positive, Colorectal Cancer (CRC)
Dual EGFR/HER2 Blockade Combined With Irinotecan for the Treatment of HER2-Positive Metastatic Colorectal Cancer
In colorectal cancer (CRC), HER2 has emerged as a critically targeted biomarker in recent years. Although multiple clinical trials have demonstrated the potential of HER2-targeted therapies in HER2-positive…
- Trial name
- HERBIC (NCT07059338)
- Testing
- Trastuzumab +Cetuximab β+Irinotecan
- Where
- China
- Volunteers
- 34 people
- Sponsor
- Sun Yat-sen University