Clinical trials: HER-2 Positive Breast Cancer, open to volunteers
PIK3CA Mutations, Advanced Solid Tumors, Adult
A Study of Mutant Selective-Inhibitor (CGT6297), in Patients With Advanced Solid Tumors
This is a Phase 1, two-part, open-label, nonrandomized, dose-escalation and signal-seeking study of CGT6297, evaluating the safety, tolerability, PK, pharmacodynamic (what the drug does to the body), and antitumor activity of…
- Conditions
- PIK3CA Mutations, Advanced Solid Tumors, Adult, Endometrial Cancer, HR Positive/HER-2 Negative Breast Cancer
- Trial name
- NCT07383506
- Testing
- CGT6297
- Where
- 12 sites in United States
- Volunteers
- 90 people
- Sponsor
- Cogent Biosciences, Inc.
Advanced Solid Tumor, Advanced Breast Cancer
BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors
This is a dose escalation and dose expansion study to compare how well BGB-43395, a selective cyclin-dependent kinase 4 (CDK4) inhibitor, works as monotherapy or in combination with fulvestrant, letrozole, or elacestrant in…
- Conditions
- Advanced Solid Tumor, Advanced Breast Cancer, Metastatic Breast Cancer, Hormone-receptor-positive Breast Cancer
- Trial name
- NCT06120283
- Testing
- BGB-43395, Fulvestrant, Letrozole
- Where
- 61 sites in United States, Australia and 9 more
- Volunteers
- 433 people
- Sponsor
- BeOne Medicines
Hormone Receptor Positive HER-2 Negative Metastatic Breast Cancer
Zunsemetinib in Combination With Capecitabine in Patients With Hormone Receptor-Positive and HER2-Negative Metastatic Breast Cancer With Bone Metastasis
This is a phase Ib/II study evaluating the safety and efficacy of zunsemetinib (ATI-450) with capecitabine in patients with hormone receptor-positive and HER2-negative (HR+/HER2-) metastatic breast cancer (MBC).
- Trial name
- NCT06374459
- Testing
- Zumsemetinib, Capecitabine, Zoledronic acid
- Where
- 3 sites in United States
- Volunteers
- 152 people
- Sponsor
- Washington University School of Medicine
Metastatic Urothelial Carcinoma, Breast Cancer
Imaging Study in Metastatic UC, HR+ and HER2- Breast Cancer, TNBC, and NSCLC
This imaging study aims to assess the feasibility, biodistribution, and dosimetry of the imaging agent in subjects with metastatic UC, HR+ and HER2- breast cancer, TNBC, or NSCLC.
- Conditions
- Metastatic Urothelial Carcinoma, Breast Cancer, TNBC - Triple-Negative Breast Cancer, Hormone Receptor Positive HER-2 Negative Breast Cancer
- Trial name
- NCT07671092
- Testing
- RYZ211/212
- Where
- 6 sites in Australia, New Zealand and 1 more
- Volunteers
- 40 people
- Sponsor
- RayzeBio, Inc.
Hormone Receptor Positive HER-2 Negative Breast Cancer, Metastatic Breast Cancer
A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer
PUMA-ALI-1201 is a randomized, dose optimization, multicenter, Phase 2 study of alisertib administered in combination with endocrine therapy in participants with pathology-confirmed HR-positive/HER2-negative metastatic breast…
- Conditions
- Hormone Receptor Positive HER-2 Negative Breast Cancer, Metastatic Breast Cancer, Recurrent Breast Cancer
- Trial name
- ALISCA-Breast1 (NCT06369285)
- Testing
- Alisertib, Endocrine therapy
- Where
- 53 sites in United States, Portugal and 1 more
- Volunteers
- 225 people
- Sponsor
- Puma Biotechnology, Inc.
HER2-positive Breast Cancer, Metastatic Cancer
PRE-ISPY Phase I/II Oncology Platform Program
PRE-ISPY Phase I/II (I-SPY-P1) is an open-label, multisite platform study with multiple ongoing drug regimen arms added by protocol amendment which is designed to evaluate single agents or combinations in locally advanced…
- Conditions
- HER2-positive Breast Cancer, Metastatic Cancer, Metastatic Breast Cancer, Metastatic
- Trial name
- PRE-ISPY (NCT05868226)
- Testing
- ALX148, Fam-Trastuzumab Deruxtecan-Nxki, Zanidatamab
- Where
- 10 sites in United States
- Volunteers
- 280 people
- Sponsor
- QuantumLeap Healthcare Collaborative
HER 2 Positive Advanced Breast Cancer
HER2-positive Breast Cancer Without Intravenous Neoadjuvant Therapy
1. The primary goal of this clinical trial is to evaluate the pathological complete response (pCR) rate of oral paclitaxel solution combined with subcutaneous pertuzumab and trastuzumab in the neoadjuvant treatment of early or…
- Trial name
- NCT07848633
- Testing
- - Oral paclitaxel solution: 200 mg/m² orally twice daily on Day 1 and Day 8 of each cycle, subcutaneous pertuzumab and trastuzumab fixed-dose combination for a total of 6 cycles
- Volunteers
- 65 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Hormone Receptor Positive HER-2 Negative Breast Cancer
TCb vs EC-T in High Risk ER+/HER2- Breast Cancer
This study will evaluate the efficacy and safety of docetaxel plus carboplatin (TCb) regimen compared with conventional chemotherapy regimen (epirubicin plus cyclophosphamide followed by docetaxel, EC-T) regimen as adjuvant…
- Trial name
- NCT05901428
- Testing
- Docetaxel, Carboplatin, Epirubicin
- Where
- China
- Volunteers
- 1,736 people
- Sponsor
- Fudan University
Breast Cancer, TNBC - Triple-Negative Breast Cancer
Evaluating Minimal Residual Disease (MRD) Through Longitudinal Circulating Tumor DNA (ctDNA) Profiling in Breast Malignancies
For patients with breast cancer, it's important to find any remaining cancer cells after they've had their main treatment. Even a few cells, called minimal residual disease (MRD), can lead to the cancer coming back later.
- Conditions
- Breast Cancer, TNBC - Triple-Negative Breast Cancer, HR Positive/HER-2 Negative Breast Cancer, HER2 + Breast Cancer
- Trial name
- GEMINI Breast (NCT07211178)
- Testing
- There are no interventions in this observational study.
- Where
- 16 sites in United States
- Volunteers
- 900 people
- Sponsor
- Tempus AI
HR Positive/HER-2 Negative Breast Cancer
Adding Capivasertib to Standard Treatment in HR Positive, HER2 Negative Metastatic Breast Cancer Based on ctDNA Testing
The purpose of this research is to see if adding the investigational targeted drug capivasertib to standard endocrine therapy (hormone-blocking treatment) combined with a medicine that slows cancer cell growth can improve…
- Trial name
- MONITOR (NCT07802626)
- Testing
- NSAI + CDK4/6i, NSAI + CDK4/6i + Capivasertib, Fulvestrant + CDK4/6i + Capivasertib
- Volunteers
- 1,084 people
- Sponsor
- SWOG Cancer Research Network
Metastatic Breast Cancer, HER2-positive Breast Cancer
HER-2 B Cell Peptide Vaccine
This phase I trial studies the side effects and best dose of vaccine therapy in treating patients with metastatic solid tumors. Vaccines made from antibodies and peptides combined with tumor cells may help the body build an…
- Conditions
- Metastatic Breast Cancer, HER2-positive Breast Cancer, EGFR Overexpression, Metastatic Esophageal Carcinoma
- Trial name
- NCT06414733
- Testing
- Combination of MVF-HER-2 (597-626) and MVF-HER-2 (266-296) emulsified with ISA 51
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- Pravin T.P Kaumaya
Her 2 Positive Breast Cancer, Cancer
HER2+ CNS Surveillance
A multi-centre, randomised study, to determine the feasibility of recruiting men and women with metastatic HER2 positive breast cancer to a study with a baseline MRI scan followed by randomising to surveillance by two further…
- Conditions
- Her 2 Positive Breast Cancer, Cancer, CNS
- Trial name
- HER2+ CNS (NCT07748598)
- Testing
- Intervention for Arm 2: Brain MRI Surveillance
- Where
- United Kingdom
- Volunteers
- 69 people
- Sponsor
- The Clatterbridge Cancer Centre NHS Foundation Trust
Advanced/ Metastatic Her-2 Positive Breast Cancer
GQ1001 Combined With Pyrotinib for Treatment With HER2 Positive Metastatic Breast Cancer
The aim of this trial is to study the safety, pharmacokinetics and preliminary efficacy of the HER2-targeted antibody-drug conjugate GQ1001 in combination with pyrotinib in patients with HER2-positive metastatic breast cancer…
- Trial name
- NCT05575804
- Testing
- GQ1001+pyrotinib
- Where
- China
- Volunteers
- 32 people
- Sponsor
- Fudan University
Hormone Receptor-positive Breast Cancer, Hormone Receptor Positive HER-2 Negative Breast Cancer
Phase 1/2 Study to Evaluate EP0062 as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer
The aim of this study is to identify the optimal dose for EP0062 as monotherapy and in combination with standard-of-care therapies to assess its Safety, Tolerability, Pharmacokinetics, and Efficacy in Patients with Relapsed…
- Conditions
- Hormone Receptor-positive Breast Cancer, Hormone Receptor Positive HER-2 Negative Breast Cancer, Metastatic Breast Cancer
- Trial name
- NCT05573126
- Testing
- EP0062, Elacestrant, Everolimus
- Where
- 14 sites in United States, Spain and 1 more
- Volunteers
- 95 people
- Sponsor
- Ellipses Pharma
Breast Cancer, HER 2 Negative Breast Cancer
Efti in Patients With Hormone Receptor Positive/HER2-neg Breast Cancer
The goal of this interventional study is to determine pathological complete response (pCR) after neoadjuvant chemotherapy (NAC) and Efti treatment.
- Conditions
- Breast Cancer, HER 2 Negative Breast Cancer, HR Positive/HER-2 Negative Breast Cancer, Stage 1-3
- Trial name
- NCT07102940
- Testing
- Eftilagimod Alfa (Efti), Docetaxel-cyclophosphamide (TC) intravenous (i.v), Dose dense Adriamycin-cyclophosphamide (AC) i.v
- Volunteers
- 50 people
- Sponsor
- George Washington University
Her 2 Positive Breast Cancer
A Study of A166 in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer
Evaluation of the efficacy of A166 in Patients with HER2-Positive unresectable or metastatic breast cancer previously treated with TOP1 inhibitor Antibody-Drug Conjugates
- Trial name
- NCT07299825
- Testing
- A166
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
HER-2 Positive Breast Cancer
Phase II Study of Ultrasound and ctDNA Guided Neoadjuvant Systemic Therapy for Patients With HER2-positive Early Breast Cancer (UC HER Trial)
Although neoadjuvant dual anti-HER2-targeted therapy, pertuzumab and trastuzumab, combined with taxanes increased the pCR rate for patients with early-stage HER2-positive breast cancer when compared with single blockade combined…
- Trial name
- UC HER (NCT07565324)
- Testing
- Lipo-Dox®, Cyclophosphamide, Trastuzumab (Herceptin)
- Where
- Taiwan
- Volunteers
- 54 people
- Sponsor
- National Taiwan University Hospital
Breast Cancer - Infiltrating Ductal Carcinoma, HER-2 Positive Breast Cancer
Concurrent Neoadjuvant Chemo/Endocrine Therapy in HER2+ Breast Cancer
The usual approach to care for hormone receptor positive, HER2 positive breast cancer is chemotherapy and HER2 targeted therapy followed by endocrine therapy and surgery.
- Trial name
- NCT07506876
- Testing
- Concurrent endocrine therapy with the chemotherapy and HER2 directed therapy
- Where
- 4 sites in United States
- Volunteers
- 30 people
- Sponsor
- Legacy Health System
Breast Cancer, Hormone Receptor-positive Breast Cancer
VS-6766+Abema+Fulv in Met HR+/HER- BC
This research is being done to evaluate the safety and effectiveness of a drug currently known as VS-6766 in combination with the drugs abemaciclib and fulvestrant in HR+/HER2-negative breast cancer.
- Conditions
- Breast Cancer, Hormone Receptor-positive Breast Cancer, Hormone Receptor Positive HER-2 Negative Breast Cancer
- Trial name
- NCT05608252
- Testing
- VS-6766, Abemaciclib, Fulvestrant
- Where
- 3 sites in United States
- Volunteers
- 63 people
- Sponsor
- Adrienne G. Waks
HER 2 Positive Advanced Breast Cancer, Breast Cancer
Phase Ib/II Study of Zanidatamab Plus Tucatinib and Chemotherapy in HER2-Positive Advanced Breast Cancer
The JAZMINE study is a multicenter, open-label, non-comparative, phase Ib/II clinical trial to evaluate safety and preliminary efficacy of zanidatamab in combination with tucatinib and chemotherapy (capecitabine or eribulin…
- Trial name
- JAZMINE (NCT07494448)
- Testing
- Zanidatamab, Tucatinib, Capecitabine
- Volunteers
- 24 people
- Sponsor
- MedSIR