Clinical trials: HER2 Positive Breast Carcinoma, open to volunteers
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer
This phase II trial tests the accuracy of functional imaging (FFNP)-positron emission tomography (PET)/computed tomography (CT) to predict response to abemaciclib plus endocrine therapy.
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Locally Advanced Unresectable HER2-Negative Breast Carcinoma, Locally Advanced Unresectable Hormone Receptor-Positive Breast Carcinoma
- Trial name
- NCT06179303
- Testing
- Abemaciclib, Anastrozole, Biospecimen Collection
- Where
- 3 sites in United States
- Volunteers
- 60 people
- Sponsor
- University of Washington
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
Ph2 Study for Optimization of Adjunct Systemic Therapy in HER2+ Patients, MolecularPCR Trial
This phase II trial tests reduced post surgery (adjuvant) therapy for patients with early breast cancer who have confirmed that the disease has responded completely (pathologic complete response) after pre surgical treatment…
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Early Stage HER2-Positive Breast Carcinoma, Early Stage Triple-Negative Breast Carcinoma
- Trial name
- NCT07407920
- Testing
- Biospecimen Collection, Hormone Therapy, Pembrolizumab
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- M.D. Anderson Cancer Center
Breast Cancer, Locally Advanced Breast Cancer
Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer
This phase 3 clinical trial compares the efficacy and safety of palazestrant with ribociclib to letrozole and ribociclib in women and men who have not received prior systemic anti-cancer treatment for advanced breast cancer.
- Conditions
- Breast Cancer, Locally Advanced Breast Cancer, Metastatic Breast Cancer, ER Positive Breast Cancer
- Trial name
- OPERA-02 (NCT07085767)
- Testing
- Palazestrant, Ribociclib, Letrozole
- Where
- 200 sites in United States, Australia and 21 more
- Volunteers
- 1,000 people
- Sponsor
- Olema Pharmaceuticals, Inc.
Triple Negative Breast Cancer, HER2-positive Breast Cancer
Study of Screening Brain MRIs in Stage IV Breast Cancer
The study is a single arm, nonrandomized phase II prospective study, with the goal of investigating the role of screening brain MRIs in neurologically asymptomatic patients with metastatic breast cancer.
- Conditions
- Triple Negative Breast Cancer, HER2-positive Breast Cancer, Hormone Receptor-positive Breast Cancer
- Trial name
- NCT05115474
- Testing
- Magnetic Resonance Imaging
- Where
- 2 sites in United States
- Volunteers
- 170 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Hormone Receptor-Positive Breast Cancer, HER2 Low Breast Carcinoma
Neoadjuvant Culmerciclib Combined With Endocrine Therapy for Hormone Receptor-Positive， Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer
This is a single-center, open-label, randomized phase II clinical trial designed to evaluate the efficacy and safety of neoadjuvant Culmerciclib combined with aromatase inhibitor versus aromatase-inhibitor monotherapy in patients…
- Conditions
- Hormone Receptor-Positive Breast Cancer, HER2 Low Breast Carcinoma, Early-Stage Breast Cancer
- Trial name
- NCT07796880
- Testing
- Culmerciclib, Aromatase Inhibitor (AI)
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Metastatic Breast Cancer, ER Positive Breast Cancer
To Identify Primary Resistance to CDK4/6 Inhibitors in Breast Cancer
This is a multi-center biomarkers study aiming to prospectively collect biological samples from patients with ER+ and HER2-negative metastatic breast cancer, who are candidate to first-line treatment with an aromatase inhibitor…
- Conditions
- Metastatic Breast Cancer, ER Positive Breast Cancer, HER2-negative Breast Cancer
- Trial name
- TIRESIAS (NCT04660435)
- Testing
- Thymidine kinase activity
- Where
- Italy
- Volunteers
- 150 people
- Sponsor
- Fondazione Sandro Pitigliani
Hormone-receptor-positive Breast Cancer, HER2-negative Breast Cancer
BGB-21447 (Bcl-2 Inhibitor) Combinations for Adults With Hormone-Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Metastatic Breast Cancer
This is a dose escalation and dose expansion study to assess the safety and tolerability of BGB-21447 (a B-cell leukemia/lymphoma 2 inhibitor, Bcl-2i) in combination with fulvestrant, with or without BGB-43395 (cyclin-dependent…
- Conditions
- Hormone-receptor-positive Breast Cancer, HER2-negative Breast Cancer, Metastatic Breast Cancer
- Trial name
- NCT06756932
- Testing
- BGB-21447, Fulvestrant, BGB-43395
- Where
- 14 sites in United States, Australia and 1 more
- Volunteers
- 120 people
- Sponsor
- BeOne Medicines
HER2-positive Breast Cancer
Neoadjuvant Endocrine Therapy +/- the PI3K Inhibitor Inavolisib in HER2+, HR+, PIK3CA Mutant Early Breast Cancer
Evaluation of the potential incremental efficacy and safety of inavolisib in the neoadjuvant endocrine treatment of early-stage HER2-positive, HR-positive, PIK3CA mutant breast cancer.
- Trial name
- GeparPiPPa (NCT05306041)
- Testing
- Inavolisib, PHESGO, Endocrine therapy
- Where
- 62 sites in Germany, Italy and 4 more
- Volunteers
- 170 people
- Sponsor
- GBG Forschungs GmbH
Brain Cancer, Brain Metastases
Stereotactic Brain-directed Radiation With or Without Aguix Gadolinium-Based Nanoparticles in Brain Metastases
The purpose of this study is to determine whether AGuIX (Activation and Guidance of Irradiation by X-ray) gadolinium-based nanoparticles make radiation work more effectively in the treatment of patients with brain metastases that…
- Conditions
- Brain Cancer, Brain Metastases, Melanoma, Lung Cancer
- Trial name
- NCT04899908
- Testing
- Stereotactic Radiation, AGuIX gadolinium-based nanoparticles
- Where
- 2 sites in United States
- Volunteers
- 134 people
- Sponsor
- Brigham and Women's Hospital
HER2 Mutation-Related Tumors, HER2
A Phase 1/1b Study of IAM1363 in HER2 Cancers
This is a Phase 1/1b open-label, multi-center dose escalation and dose optimization study designed to evaluate the safety and preliminary efficacy of IAM1363 in participants with advanced cancers that harbor HER2 alterations.
- Conditions
- HER2 Mutation-Related Tumors, HER2, HER2-positive Breast Cancer, HER2 + Breast Cancer
- Trial name
- NCT06253871
- Testing
- IAM1363
- Where
- 53 sites in United States, France and 6 more
- Volunteers
- 383 people
- Sponsor
- Iambic Therapeutics, Inc
Estrogen-receptor-positive Breast Cancer, HER2/Neu-Negative Breast Cancer
Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor in Patients With ERpositive/HER2-negative Advanced or Metastatic Breast Cancer
Breast cancer is not only the leading cause of cancer in women, but also the leading cause of cancer deaths in women. Estrogen receptor-positive and HER2-negative breast cancer is the most prevalent breast cancer subtype.
- Conditions
- Estrogen-receptor-positive Breast Cancer, HER2/Neu-Negative Breast Cancer, Advanced Breast Cancerv, Metastatic Breast Cancer
- Trial name
- NCT06062498
- Testing
- elacestrant, palbociclib, abemaciclib, ribociclib
- Where
- 3 sites in United States
- Volunteers
- 174 people
- Sponsor
- Northwestern University
Breast Cancer Metastatic, HER2-positive Metastatic Breast Cancer
Dose-Expansion Modular Study To Explore the Safety, Tolerability, and Anti-tumor Activity of HER3- DXd Monotherapy and Combinations in Patients With Inoperable Advanced Breast Cancer (ABC) After Progression on T-DXd
ICARUS-BREAST02 is an open-label, multicenter, phase 1b/2, platform study that aims to evaluate the safety, tolerability, and efficacy of HER3-DXd monotherapy and in combination with other anti-cancer agents in patients with ABC.
- Conditions
- Breast Cancer Metastatic, HER2-positive Metastatic Breast Cancer, HER2 Low Breast Carcinoma, Advanced Breast Cancer
- Trial name
- ICARUSBREAST02 (NCT06298084)
- Testing
- Patritumab deruxtecan, Olaparib
- Where
- France
- Volunteers
- 152 people
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
Breast Cancer, HER2-positive Breast Cancer
Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers
Patient will be treated with neratinib, an aromatase inhibitor and trastuzumab for 24 weeks prior to surgery, following an initial 3 weeks of neratinib alone, aromatase inhibitor alone or the combination of neratinib and an…
- Conditions
- Breast Cancer, HER2-positive Breast Cancer, ER Positive Breast Cancer, PR-Positive Breast Cancer
- Trial name
- NCT04886531
- Testing
- Neratinib, Letrozole (L) or Anastrozole (A), Trastuzumab
- Where
- 4 sites in United States
- Volunteers
- 30 people
- Sponsor
- Ruth O'Regan
Metastatic Breast Cancer, Triple Negative Breast Cancer
Toci +/- SOC Chemo for Metastatic Triple Negative and ER-positive, HER2-negative Breast Cancers
This is a randomized Phase II study of standard of care (SOC) chemotherapy monotherapy vs. SOC chemotherapy combined with tocilizumab biosimilar in Black and non-Black patients with metastatic triple negative and ER-positive…
- Conditions
- Metastatic Breast Cancer, Triple Negative Breast Cancer, Estrogen-receptor-low Breast Cancer, ER Positive, HER2 Negative Breast Cancer
- Trial name
- NCT05846789
- Testing
- SOC Chemotherapy, Tocilizumab/Tocilizumab Biosimilar
- Where
- 7 sites in United States
- Volunteers
- 168 people
- Sponsor
- Kathy Miller
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
HER2-Positive Breast Carcinoma
Impact of Aromatase Inhibitor Therapy on Glucose Homeostasis and Diabetes Risk
This study assesses the effect of hormone directed treatment for breast cancer on glucose metabolism.
- Trial name
- NCT06557057
- Testing
- Non-Interventional Study
- Where
- United States
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Breast Cancer, HR Positive, HER2 Positive Breast Cancer
Culmerciclib Combined With Letrozole and Dual HER2 Blockade as Neoadjuvant Therapy for HR+/HER2+ Breast Cancer
This is a single-arm, prospective, multicenter, phase II clinical study evaluating the efficacy and safety of a chemotherapy-free neoadjuvant regimen in patients with HR-positive/HER2-positive (HR+/HER2+) early or locally…
- Trial name
- NCT07795424
- Testing
- Culmerciclib, Letrozole, Trastuzumab (TQB211)
- Where
- China
- Volunteers
- 33 people
- Sponsor
- Shengjing Hospital
HER2-positive Breast Cancer, Cervical Cancer
Tucatinib Continuation Study
The purpose of this protocol is to give continued access to tucatinib eligible participants. It also enables ongoing safety follow-up for those who continue to benefit from the study treatment.
- Conditions
- HER2-positive Breast Cancer, Cervical Cancer, Biliary Tract Neoplasms, Urothelial Cancer
- Trial name
- NCT07768358
- Testing
- tucatinib
- Volunteers
- 175 people
- Sponsor
- Pfizer
HER2-positive Advanced Solid Tumor
A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1303/BNT323 in subjects with advanced solid tumors that express HER2.
- Trial name
- NCT05150691
- Testing
- DB-1303/BNT323, Pertuzumab Injection, Ritonavir
- Where
- 102 sites in United States, Australia and 4 more
- Volunteers
- 796 people
- Sponsor
- DualityBio Inc.
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