Clinical trials: HER2 Amplified, open to volunteers
Locally Advanced or Metastatic Breast Cancers
Study Aiming to Compare the Plasma Exposure of the Payload (Free-DXd) in Patients Treated by T-DXd for Locally Advanced or Metastatic Breast Cancer According to Their BMI.
This is a multicenter, prospective, non-randomized, open-label, pharmacokinetic study, aiming to compare the plasma exposure of the payload (free-DXd) in patients treated by T-DXd for locally advanced or metastatic breast cancer…
- Trial name
- TDXdose (NCT07195344)
- Testing
- Pharmacokinetics blood samples
- Where
- 10 sites in France
- Volunteers
- 210 people
- Sponsor
- Institut Claudius Regaud
HER2-positive Breast Cancer, LMD
Tucatinib, Trastuzumab and Capecitabine With Brain and/or Spinal Radiotherapy (XRT) in Patients With HER2+, HER2 Mutated and/or HER2-amplified Metastatic Breast Cancer and Leptomeningeal Disease: A Multi-centre Phase II, Single Arm Feasibility Study
The proposed study will evaluate the safety and efficacy of XRT followed by systemic therapy among patients with HER2+, HER2 mutated and/or HER2-amplified metastatic breast cancer and LMD
- Trial name
- NCT06016387
- Testing
- Tucatinib 150 MG, Trastuzumab, Capecitabine
- Where
- 2 sites in Canada
- Volunteers
- 30 people
- Sponsor
- Sunnybrook Health Sciences Centre
Metastatic Breast Cancer ( HER2 Negative), Unresectable Breast Cancer
Tucatinib and Trastuzumab in HER3-mutant and HER2-not Amplified Metastatic Breast Cancer
The H3RAKLES trial would allow patients with a progressive metastatic breast cancer to have access to one more line of systemic therapy.
- Trial name
- H3RAKLES (NCT07193394)
- Testing
- Tucatinib (ONT-380), Trastuzumab (Herceptin)
- Where
- 9 sites in France
- Volunteers
- 20 people
- Sponsor
- Institut Curie
Advanced Breast Cancer
Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer
The primary objective of the study is to measure efficacy of saruparib (AZD5305) plus camizestrant compared with physician's choice CDK4/6i plus ET in patients with BRCA1, BRCA2, or PALB2m, HR-positive, HER2-negative (defined as…
- Trial name
- EvoPAR-BR01 (NCT06380751)
- Testing
- Saruparib (AZD5305), Camizestrant, Abemaciclib
- Where
- 306 sites in United States, Argentina and 27 more
- Volunteers
- 788 people
- Sponsor
- AstraZeneca
Solid Tumours
Beamion PANTUMOR-1: A Study to Test Whether Zongertinib Helps People With Advanced Cancers With HER2 Alterations
This is a study for people with advanced cancer for whom previous treatment was not successful. Adults aged 18 and over with advanced cancer with HER2 alterations can join the study.
- Trial name
- NCT06581432
- Testing
- Zongertinib
- Where
- 92 sites in United States, Australia and 14 more
- Volunteers
- 588 people
- Sponsor
- Boehringer Ingelheim
Breast Cancer
Trial of Neoadjuvant THP vs TCHP for HER2-Amplified/Positive Breast Cancer
This is a randomized phase II study to evaluate the pathological complete response (pCR) rate with two neoadjuvant regimens (Docetaxel+Carboplatin+Herceptin/Perjeta and Docetaxel+Herceptin/Perjeta) in HER2 amplified/positive…
- Trial name
- NeoTHERa (NCT07220135)
- Testing
- Carboplatin, Docetaxel, Trastuzumab (or biosimilar)
- Where
- 8 sites in United States
- Volunteers
- 100 people
- Sponsor
- University of Kansas Medical Center
Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors
Study of GVV858 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 GVV858 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
- Trial name
- NCT07288359
- Testing
- GVV858, Fulvestrant, Letrozole
- Where
- 16 sites in United States, Canada and 9 more
- Volunteers
- 205 people
- Sponsor
- Novartis Pharmaceuticals
Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors
Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and in Patients With Other Advanced Solid Tumors
Phase I: Characterize safety and tolerability of ECI830 as a single agent and in combination with ribociclib and fulvestrant. Identify dose range for optimization/recommended dose for future studies.
- Conditions
- Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors, Extensive-stage Small Cell Lung Cancer
- Trial name
- NCT06726148
- Testing
- ECI830, ribociclib, fulvestrant
- Where
- 33 sites in United States, Australia and 14 more
- Volunteers
- 280 people
- Sponsor
- Novartis Pharmaceuticals
Clinical Stage III Gastric Cancer AJCC v8, Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
Testing the Combination of the Anticancer Drugs Trastuzumab Deruxtecan (DS-8201a) and Azenosertib (ZN-c3) in Patients With Stomach or Other Solid Tumors
This phase I trial tests the safety, side effects, and best dose of azenosertib in combination with trastuzumab deruxtecan in treating patients with HER2-positive gastric or gastroesophageal junction cancer and other…
- Conditions
- Clinical Stage III Gastric Cancer AJCC v8, Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IV Gastric Cancer AJCC v8, Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
- Trial name
- NCT06364410
- Testing
- Azenosertib, Biopsy Procedure, Biospecimen Collection
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- National Cancer Institute (NCI)
Adenocarcinoma of the Rectum, Locally Advanced Rectal Adenocarcinoma
A Study of Tucatinib and Trastuzumab in People With Rectal Cancer
The study researchers believe that a combination of the drugs trastuzumab and tucatinib, given with standard chemotherapy (capecitabine and oxaliplatin/FOLFOX), may help participants with rectal cancer.
- Conditions
- Adenocarcinoma of the Rectum, Locally Advanced Rectal Adenocarcinoma, Rectal Adenocarcinoma, HER2 Positive Rectal Adenocarcinoma
- Trial name
- NCT05672524
- Testing
- Trastuzumab, Tucatinib
- Where
- 7 sites in United States
- Volunteers
- 37 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Non-small Cell Lung Cancer
Phase II Clinical Study of Pyrotinib in First-line Treatment of Primary HER2-amplified/Mutated Advanced Non-small Cell Lung Cancer
This is a multicenter, single-arm phase II clinical study to evaluate the safety and efficacy of pyrotinib maleate as a first-line treatment for HER2-mutated or amplified non-small cell lung cancer.
- Trial name
- NCT05751018
- Testing
- Pyrotinib
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Peking Union Medical College Hospital
Leptomeningeal Metastasis, Leptomeningeal Disease
Capecitabine, Tucatinib, and Intrathecal Trastuzumab for Breast Cancer Patients With Leptomeningeal Disease
The goal of this clinical trial is to evaluate the efficacy of tucatinib and capecitabine in combination with intrathecal trastuzumab on overall survival rate at 12 months in HER2-positive metastatic breast cancer (MBC) patients…
- Conditions
- Leptomeningeal Metastasis, Leptomeningeal Disease, HER2-positive Metastatic Breast Cancer
- Trial name
- ETIC-LM (NCT05800275)
- Testing
- Tucatinib Oral Tablet, Capecitabine tablets, Trastuzumab Injection
- Where
- 11 sites in France
- Volunteers
- 30 people
- Sponsor
- UNICANCER
HR+ Breast Cancer, Triple Negative Breast Cancer (TNBC)
A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors
The goal of this open-label dose escalation and expansion study is to evaluate the safety and tolerability of NKT5097 in adults with advanced/metastatic tumors (emphasis on breast cancer and solid tumors with CCNE1…
- Conditions
- HR+ Breast Cancer, Triple Negative Breast Cancer (TNBC), CCNE1 Amplified Advanced Solid Tumors, HR+ HER2- Breast Cancer
- Trial name
- NCT07029399
- Testing
- NKT5097 CDK2/CDK4 dual degrader, Fulvestrant, Letrozole
- Where
- 19 sites in United States
- Volunteers
- 361 people
- Sponsor
- NiKang Therapeutics, Inc.