Clinical trials: HER2 Positive Metastatic Breast Cancer
HER2/Neu Positive, Recurrent Breast Carcinoma
Vaccine Therapy With or Without Polysaccharide-K in Patients With Stage IV HER2 Positive Breast Cancer Receiving HER2-Targeted Monoclonal Antibody Therapy
This randomized phase I/II trial studies the side effects of vaccine therapy with or without polysaccharide-K and to see how well it works in treating patients with stage IV human epidermal growth factor receptor 2 (HER2)…
- Conditions
- HER2/Neu Positive, Recurrent Breast Carcinoma, Stage IV Breast Cancer
- Trial name
- NCT01922921
- Testing
- HER-2/neu Intracellular Domain Protein, Laboratory Biomarker Analysis, Pertuzumab
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- University of Washington
Breast Cancer Stage IV
Inetetamab Combined With Paclitaxel With/Without Pertuzumab for Previously Treated HER2-positive Advanced Breast Cancer
This study is designed to comprehensively evaluate the HER2 positive recurrent/metastatic breast cancer patients in the real world who receive the combination of Inetetamab and Paclitaxel ± Pertuzumab, including basic…
- Trial name
- NCT06578299
- Testing
- Inetetamab and Paclitaxel ± Pertuzumab
- Volunteers
- 100 people
- Sponsor
- Fudan University
Breast Cancer
DWI in Assessing Treatment Response in Patients With Breast Cancer Receiving Neoadjuvant Chemotherapy
RATIONALE: Imaging procedures, such as diffusion-weighted magnetic resonance imaging (DWI) and dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI), may help in evaluating how well patients with breast cancer respond to…
- Trial name
- ACRIN6698 (NCT01564368)
- Testing
- diffusion-weighted magnetic resonance imaging
- Where
- 7 sites in United States
- Volunteers
- 406 people
- Sponsor
- American College of Radiology Imaging Network
Breast Cancer, Breast Neoplasms
Study of XL147 (SAR245408) in Combination With Trastuzumab or Paclitaxel and Trastuzumab in Subjects With Metastatic Breast Cancer Who Have Progressed on a Previous Trastuzumab-based Regimen
Phase 1 of this study will evaluate the maximum tolerated dose (MTD) of XL147 when given in combination with trastuzumab (Herceptin) and in combination with trastuzumab and paclitaxel.
- Trial name
- NCT01042925
- Testing
- XL147 (SAR245408), trastuzumab, paclitaxel
- Where
- 9 sites in United States, Spain
- Volunteers
- 42 people
- Sponsor
- Sanofi
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
Breast Cancer
A Phase II Study of Rapamycin and Trastuzumab for Patients With HER-2 Receptor Positive Metastatic Breast Cancer
Rapamune (generic name: Sirolimus®) is a drug that has been approved by the Food and Drug Administration (government) for use in patients receiving a kidney transplant to prevent the patient's body from rejecting the transplanted…
- Trial name
- NCT00411788
- Testing
- Rapamycin, Trastuzumab
- Where
- 2 sites in United States
- Volunteers
- 11 people
- Sponsor
- Yale University
HER2/Neu Positive, Recurrent Breast Carcinoma
Z-Endoxifen Hydrochloride in Treating Patients With Metastatic or Locally Recurrent Estrogen Receptor-Positive Breast Cancer
This phase I trial studies the side effects and the best dose of Z-endoxifen hydrochloride in treating patients with estrogen receptor-positive (ER+) breast cancer that has spread to other places in the body (metastatic) or has…
- Conditions
- HER2/Neu Positive, Recurrent Breast Carcinoma, Stage IIIC Breast Cancer AJCC v7, Stage IV Breast Cancer AJCC v6 and v7
- Trial name
- NCT01327781
- Testing
- Endoxifen Hydrochloride, Laboratory Biomarker Analysis, Pharmacological Study
- Where
- 3 sites in United States
- Volunteers
- 62 people
- Sponsor
- National Cancer Institute (NCI)
Breast Cancer Metastatic
MCLA-128 With Trastuzumab/Chemotherapy in HER2+ and With Endocrine Therapy in ER+ and Low HER2 Breast Cancer.
A Phase 2, open-label, multicenter international study will be performed to evaluate the efficacy of MCLA-128-based combinations. Three combination treatments will be evaluated, two in Cohort 1 and one in Cohort 2.
- Trial name
- NCT03321981
- Testing
- Zenocutuzumab, Trastuzumab, Vinorelbine
- Where
- 25 sites in United States, Belgium and 5 more
- Volunteers
- 105 people
- Sponsor
- Merus B.V.
Breast Cancer, Pyrotinib
Pyrotinib Plus Vinorelbine in Participants With HER2-positive Previously Treated Locally Advanced or Metastatic Breast Cancer
The purpose of this study is to identify the highest tolerable dose of pyrotinib in combination with vinorelbine and to assess the safety and efficacy of the combination in Patients With HER2-Positive Locally Advanced or…
- Conditions
- Breast Cancer, Pyrotinib, Breast Diseases, Vinorelbine
- Trial name
- NCT04605575
- Testing
- Pyrotinib 320mg + Vinorelbine, Pyrotinib 400mg + Vinorelbine, Pyrotinib plus Vinorelbine
- Where
- China
- Volunteers
- 208 people
- Sponsor
- Sun Yat-sen University
Metastatic Breast Cancer, HER2-negative Breast Cancer
Trial of 225Ac-DOTATATE (RYZ101) in Subjects With ER+, HER2-negative Unresectable or Metastatic Breast Cancer Expressing SSTRs.
Phase 1b/2 open-label trial of 225Ac-DOTATATE (RYZ101) in subjects with ER+, HER2-negative unresectable or metastatic breast cancer expressing SSTRs.
- Conditions
- Metastatic Breast Cancer, HER2-negative Breast Cancer, ER+ Breast Cancer, Advanced Breast Cancer
- Trial name
- TRACY-1 (NCT06590857)
- Testing
- RYZ101, Standard of Care Endocrine Therapy
- Where
- 31 sites in United States, Canada and 1 more
- Volunteers
- 64 people
- Sponsor
- RayzeBio, Inc.
Primary Non-metastatic Breast Cancer, Who Remain Disease-free
Safety Study of Adding Everolimus to Adjuvant Hormone Therapy in Women With High Risk of Relapse, ER+ and HER2- Primary Breast Cancer, Free of Disease After Receiving at Least One Year of Adjuvant Hormone Therapy
A significant number of patients relapse and eventually die, particularly if they were initially diagnosed with large nodes involvement and/or T3/4 diseases.
- Trial name
- NCT01805271
- Testing
- Everolimus
- Where
- 2 sites in France
- Volunteers
- 1,278 people
- Sponsor
- UNICANCER
Breast Cancer, Ovarian Cancer
Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors
This is a phase 1/1b, open-label, multicenter study consisting of sequential parts designed to evaluate the safety, tolerability, and effects pharmacokinetic (PK) profile, and antitumor activity of RGT-490, an investigational…
- Conditions
- Breast Cancer, Ovarian Cancer, Endometrial Cancer, PIK3CA Mutation
- Trial name
- NCT07524322
- Testing
- RGT-490
- Where
- 6 sites in United States
- Volunteers
- 63 people
- Sponsor
- Regor Pharmaceuticals Inc.
Breast Cancer
Targeting the PAM50 Her2-Enriched Phenotype With Enzalutamide in Hormone Receptor-Positive/Her2-Negative Metastatic BC
The main hypothesis of the study is that enzalutamide induces a significant proliferative arrest in HR+/HER2-negative breast cancer falling into the PAM50 HER2-E subtype.
- Trial name
- ARIANNA (NCT04142060)
- Testing
- Enzalutamide
- Where
- 8 sites in Spain
- Volunteers
- 34 people
- Sponsor
- SOLTI Breast Cancer Research Group
Hormone Receptor-positive Metastatic Breast Cancer, HER2-negative Metastatic Breast Cancer
Combination of Abemaciclib and Endocrine Therapy in Hormone Receptor Positive HER2 Negative Locally Advanced or Metastatic Breast Cancer With Focus on Digital Side Effect Management
The MINERVA Trial aims to evaluate safety, efficacy and quality of life (QoL) for the combination of Abemaciclib with an Aromatase Inhibitor or Fulvestrant in pre- and postmenopausal patients with metastatic hormone receptor…
- Trial name
- MINERVA (NCT05362760)
- Testing
- Abemaciclib + Aromatase Inhibitor, Abemaciclib + Fulvestrant
- Where
- 54 sites in Germany, Switzerland
- Volunteers
- 300 people
- Sponsor
- Prof. Wolfgang Janni
Estrogen Receptor Negative, Estrogen Receptor Positive
Paclitaxel, Nab-paclitaxel, or Ixabepilone With or Without Bevacizumab in Treating Patients With Stage IIIC or Stage IV Breast Cancer
This randomized phase III trial studies the side effects and how well different chemotherapy regimens with or without bevacizumab work in treating patients with stage IIIC or stage IV breast cancer.
- Conditions
- Estrogen Receptor Negative, Estrogen Receptor Positive, HER2/Neu Negative, HER2/Neu Positive
- Trial name
- NCT00785291
- Testing
- Bevacizumab, Ixabepilone, Laboratory Biomarker Analysis
- Where
- 704 sites in United States, Puerto Rico
- Volunteers
- 799 people
- Sponsor
- National Cancer Institute (NCI)
Anatomic Stage IV Breast Cancer AJCC v8, Estrogen-receptor-positive Breast Cancer
Adaptive Therapy With Capecitabine for Treatment of Metastatic ER Positive, HER2 Negative Breast Cancer
This phase II trial evaluates the effect of capecitabine on tumor response using imaging and tumor markers to adjust dose (adaptive therapy) in patients with estrogen receptor (ER) positive, HER2 negative breast cancer that has…
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Estrogen-receptor-positive Breast Cancer, Metastatic HER2-Negative Breast Carcinoma, Metastatic Breast Cancer
- Trial name
- NCT06525766
- Testing
- Biospecimen Collection, Bone Scan, Capecitabine
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Mayo Clinic
HER2 Positive Metastatic Breast Cancer
ARX788 in HER2-positive, Metastatic Breast Cancer Subjects (ACE-Breast-03)
A Global, Phase 2 Study of ARX788 in HER2-positive Metastatic Breast Cancer Patients who were previously treated with T-DXd
- Trial name
- NCT04829604
- Testing
- ARX788
- Where
- 33 sites in United States, Australia and 1 more
- Volunteers
- 72 people
- Sponsor
- Ambrx, Inc.
Breast Cancer, HER2-positive Breast Cancer
Screening Magnetic Resonance Imaging of the Brain in Patients With Breast Cancer
This research study is studying the usefulness of magnetic resonance imaging (MRI) to screen for brain metastases (spread of the breast cancer to the brain).
- Conditions
- Breast Cancer, HER2-positive Breast Cancer, Triple Negative Breast Cancer, Hormone Receptor Positive Malignant Neoplasm of Breast
- Trial name
- NCT04030507
- Testing
- MRI
- Where
- United States
- Volunteers
- 214 people
- Sponsor
- Brigham and Women's Hospital
HER2-positive Breast Cancer, Male Breast Cancer
Ex Vivo-Expanded HER2-Specific T Cells and Cyclophosphamide After Vaccine Therapy in Treating Patients With HER2-Positive Stage IV Breast Cancer
RATIONALE : Laboratory-treated T cells may stimulate the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor…
- Conditions
- HER2-positive Breast Cancer, Male Breast Cancer, Stage IV Breast Cancer
- Trial name
- NCT01219907
- Testing
- HER-2/neu peptide vaccine, cyclophosphamide, ex vivo-expanded HER2-specific T cells
- Where
- United States
- Sponsor
- University of Washington
Breast Cancer
A Study To Assess The Tolerability And Clinical Activity Of Gedatolisib In Combination With Palbociclib/Letrozole Or Palbociclib/Fulvestrant In Women With Metastatic Breast Cancer
This is a multicenter, open label, Phase 1b study in patients with mBC. This study will have a dose escalation to identify the maximum tolerated dose (MTD) of the combination of gedatolisib plus palbociclib/fulvestrant and…
- Trial name
- NCT02684032
- Testing
- Gedatolisib, Palbociclib, Letrozole
- Where
- 41 sites in United States
- Volunteers
- 141 people
- Sponsor
- Celcuity Inc