Clinical trials: HER2 Positive Metastatic Breast Cancer
Breast Neoplasms, Breast Cancer
Trial of H3B-6545, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer
The primary purpose of phase 1 portion of this study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of H3B-6545 in women with locally advanced or metastatic estrogen receptor (ER)-positive…
- Conditions
- Breast Neoplasms, Breast Cancer, Estrogen-receptor Positive Breast Cancer, Cancer, Breast
- Trial name
- NCT03250676
- Testing
- H3B-6545
- Where
- 39 sites in United States, France and 1 more
- Volunteers
- 151 people
- Sponsor
- Eisai Inc.
Breast Cancer
A Study of the Efficacy and Safety of Trastuzumab Emtansine (Trastuzumab-MCC-DM1) vs. Trastuzumab (Herceptin®) and Docetaxel (Taxotere®) in Patients With Metastatic HER2-positive Breast Cancer Who Have Not Received Prior Chemotherapy for Metastatic Disease
This was a Phase II, randomized, multicenter, international, 2-arm, open-label clinical trial designed to explore the efficacy and safety of trastuzumab emtansine (T-DM1) relative to the combination of trastuzumab and docetaxel…
- Trial name
- NCT00679341
- Testing
- Trastuzumab emtansine [Kadcyla], Trastuzumab, Docetaxel
- Volunteers
- 137 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
Study to Evaluate Safety and Dosimetry of [18F]GEH121224 in Patients With Locally Advanced or Metastatic Breast Cancer
The study described in this protocol is a Phase 1, single center clinical trial to evaluate the safety and potential of [18F]GEH121224 as a PET radiotracer for the diagnostic imaging of HER2 positive breast cancer lesions.
- Trial name
- NCT05634954
- Testing
- GEH121224 (18F) Injection, Dynamic and Static - PET/CT Scan, Static - PET/CT Scan
- Where
- United States
- Sponsor
- GE Healthcare
Breast Cancer
Dose Escalation Followed by Study of RAD001 in Combination With Trastuzumab in HER2-Positive Metastatic Breast Cancer
The purpose of this research study is to determine the safety of RAD001 and the highest dose of this drug that can be given to people with HER2-positive metastatic breast cancer safely in combination with trastuzumab.
- Trial name
- NCT00458237
- Testing
- Everolimus, Trastuzumab
- Where
- 2 sites in United States
- Volunteers
- 11 people
- Sponsor
- Beth Israel Deaconess Medical Center
Breast Neoplasms
A Study of E7090 as Monotherapy and in Combination With Other Anticancer Agents in Participants With Estrogen Receptor Positive (ER+) and Human Epidermal Growth Receptor 2 Negative (HER2-) Recurrent/Metastatic Breast Cancer
The primary purpose of this study is to evaluate the tolerability and safety of E7090 as monotherapy and in combination with other anticancer agents in participants with ER+, HER2- recurrent/metastatic breast cancer and to…
- Trial name
- NCT04572295
- Testing
- E7090, Fulvestrant, Exemestane
- Where
- 11 sites in Japan
- Volunteers
- 51 people
- Sponsor
- Eisai Co., Ltd.
Estrogen Receptor and/or Progesterone Receptor Positive, HER2/Neu Negative
Ribociclib and Aromatase Inhibitor in Treating Older Participants With Hormone Receptor Positive Metastatic Breast Cancer
This phase IIA trial studies the side effects of ribociclib and aromatase inhibitor and how well they work in treating participants with hormone receptor positive breast cancer that has spread to other places in the body.
- Conditions
- Estrogen Receptor and/or Progesterone Receptor Positive, HER2/Neu Negative, Stage IV Breast Cancer AJCC v6 and v7
- Trial name
- NCT03477396
- Testing
- Aromatase Inhibitor, Laboratory Biomarker Analysis, Pharmacokinetic Study
- Where
- 9 sites in United States
- Volunteers
- 2 people
- Sponsor
- City of Hope Medical Center
Anatomic Stage IV Breast Cancer AJCC v8, Hormone Receptor Positive Breast Adenocarcinoma
Immunotherapy (NHS-IL12 & Bintrafusp Alfa) and Radiation Therapy for the Treatment of Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer, the REINA Trial
This phase I trial is to find out the best dose, possible benefits and/or side effects of NHS-IL12 given together with bintrafusp alfa and radiation therapy in treating patients with hormone receptor positive, HER2 negative…
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Hormone Receptor Positive Breast Adenocarcinoma, Metastatic Breast Carcinoma, Metastatic HER2 Negative Breast Adenocarcinoma
- Trial name
- NCT04756505
- Testing
- Bintrafusp Alfa, Immunocytokine NHS-IL12, Radiation Therapy
- Sponsor
- M.D. Anderson Cancer Center
Breast Cancer
A First-in-Human Study of D-0502 Alone and in Combination With Palbociclib in Women With Advanced or Metastatic ER-Positive and HER2-Negative Breast Cancer
This is a phase I, open-label study of D-0502 single agent and D-0502 in combination with standard dose of palbociclib to assess the safety and tolerability, identify an MTD, and/or RP2D, evaluate the PK properties and evaluate…
- Trial name
- NCT03471663
- Testing
- D-0502, palbociclib
- Where
- 15 sites in United States, China
- Volunteers
- 200 people
- Sponsor
- InventisBio Co., Ltd
Breast Cancer Stage I, Breast Cancer Stage II
Role of Triggering Receptor Expressed on Myeloid Cells (TREM-1) as a Novel Biomarker in Human Epidermal Growth Factor Receptor -2 (HER-2) Negative Breast Cancer: a Molecular and Clinical Study
Global cancer statistics by world region for the year 2022 estimated breast cancer the 2nd cause of new cancer cases (11.6%). (1) Approximately 80% of all breast cancers (BCs) are currently categorized as human epidermal growth…
- Conditions
- Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III, Breast Cancer Invasive
- Trial name
- NCT06950671
- Where
- Egypt
- Volunteers
- 1 people, healthy volunteers welcome
- Sponsor
- Rahma Esam Salama Esawi
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
Advanced Breast Cancer, Metastatic Breast Cancer
Study of NUV-422 in Combination With Fulvestrant in Patients With HR+HER2- aBC
NUV-422-03 is a randomized, non-comparative Phase 1/2 dose escalation and expansion study designed to evaluate the safety and efficacy of NUV-422 in combination with fulvestrant relative to NUV-422 monotherapy and fulvestrant…
- Conditions
- Advanced Breast Cancer, Metastatic Breast Cancer, Breast Cancer, Breast Carcinoma
- Trial name
- NCT05191004
- Testing
- NUV-422, Fulvestrant
- Where
- 5 sites in United States
- Sponsor
- Nuvation Bio Inc.
Breast Cancer
Artificial Intelligence and Machine Learning to Guide CDK4/6 Inhibitor Rechallenge in Breast Cancer.
The goal of this clinical trial is to learn if an artificial intelligence model will be able to select patients with advanced breast cancer who may respond to a second cyclin-dependent kinase 4/6 (CDK4/6) inhibitor after they…
- Trial name
- AIM-BRIGHT (NCT07227233)
- Testing
- A CDK4/6 inhibitor different from the first that the participant had received, plus fulvestrant., Treatment of physician's choice
- Where
- United States
- Volunteers
- 105 people
- Sponsor
- University of California, San Diego
Advanced Breast Cancer, Advanced or Metastatic Breast Cancer
A Study to Learn About the Study Medicine Called PF-08165784 in People With PIK3CA-Mutated Advanced or Metastatic Solid Tumors
The purpose of this study is to learn about the safety and effects of the study medicine (called PF-08165784) when given alone or together with other anti-cancer therapies.
- Conditions
- Advanced Breast Cancer, Advanced or Metastatic Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-), Metastatic Colorectal Adenocarcinoma
- Trial name
- NCT07897721
- Testing
- PF-08165784, Fulvestrant, Atirmociclib
- Volunteers
- 268 people
- Sponsor
- Pfizer
Breast Cancer, Metastatic, Metastatic Breast Cancer
Stereotactic Ablative Body Radiotherapy (SABR) With Maintenance of Systemic Therapy Versus Physicians' Choice of Systemic Therapy for Oligoprogressive ER-positive, Her-2 Negative Breast Cancer II
The goal of this clinical trial is to assess Stereotactic Ablative Radiotherapy (SABR) as a method to delay a change in systemic therapy in patients with oligoprogressive ER-positive, HER2-negative advanced breast cancer.
- Trial name
- AVATARII (NCT06882499)
- Testing
- Stereotactic Ablative Radiotherapy, Physician's choice of systemic treatment
- Volunteers
- 74 people
- Sponsor
- Peter MacCallum Cancer Centre, Australia
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
Metastatic Breast Cancer
A Study of Lenvatinib, Pembrolizumab, and Fulvestrant in People With Breast Cancer
The purpose of this study is to test whether the combination of lenvatinib, pembrolizumab, and fulvestrant is a safe and effective treatment that causes few or mild side effects in people with ER+/HER2- metastatic breast cancer.
- Trial name
- NCT06110793
- Testing
- Lenvatinib, Pembrolizuma, Fulvestrant
- Where
- 7 sites in United States
- Volunteers
- 56 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Neoplasms, Breast
Lapatinib In Combination With Trastuzumab Versus Lapatinib Monotherapy In Subjects With HER2-positive Metastatic Breast Cancer
This study will evaluate and compare the safety and efficacy of lapatinib in combination with trastuzumab versus lapatinib monotherapy in subjects with HER2-positive metastatic breast cancer.
- Trial name
- NCT00320385
- Testing
- Lapatinib, Trastuzumab
- Where
- 145 sites in United States, Austria and 11 more
- Volunteers
- 296 people
- Sponsor
- GlaxoSmithKline
Advanced Malignant Solid Neoplasm, Estrogen Receptor Negative
Glembatumumab Vedotin, Nivolumab, and Ipilimumab in Treating Patients With Advanced Metastatic Solid Tumors That Cannot Be Removed by Surgery
This phase Ib/II trial studies the best dose of glembatumumab vedotin when giving together with nivolumab and ipilimumab in treating patients with solid tumor that has spread to other places in the body and cannot be removed by…
- Conditions
- Advanced Malignant Solid Neoplasm, Estrogen Receptor Negative, GPNMB Positive, HER2/Neu Negative
- Trial name
- NCT03326258
- Testing
- Glembatumumab Vedotin, Ipilimumab, Laboratory Biomarker Analysis
- Sponsor
- National Cancer Institute (NCI)
Breast Cancer
Safety and Efficacy Comparison of Docetaxel and Ixabepilone in Non Metastatic Poor Prognosis Breast Cancer
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
- Trial name
- TavIx (NCT00630032)
- Testing
- cyclophosphamide, Docetaxel, epirubicin hydrochloride
- Where
- 86 sites in United States, Belgium and 1 more
- Volunteers
- 762 people
- Sponsor
- UNICANCER
Breast Cancer
Phase I Study to Evaluate SIM0270 Alone or in Combination in ER+, HER2- Locally Advanced or Metastatic Breast Cancer
This study is a multi-center, open-label, Phase 1 clinical study to evaluate the safety, pharmacokinetic (PK) and anti-tumor efficacy of SIM0270 and SIM0270 in combination with palbociclib or everolimus in subjects with estrogen…
- Trial name
- NCT05293964
- Testing
- SIM0270, Palbociclib, everolimus
- Where
- China
- Volunteers
- 214 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.