Clinical trials: HER2-negative Metastatic Breast Cancer
Breast Cancer
Danish Observational Study of Everolimus Plus Exemestane in Hormone Receptor (HR) Positive, Human Epidermal Growth Factor 2 (HER2) - Metastatic Breast Cancer
An observational study in patients with advanced ER+, HER2 negative breast cancer, who are treated with everolimus and exemestane in combination.
- Trial name
- NCT02023359
- Testing
- Everolimus and exemestane
- Where
- 3 sites in Denmark
- Volunteers
- 7 people
- Sponsor
- Novartis Healthcare A/S
Breast Cancer
Maximum Tolerated Dose (MTD) of Liposomal Doxorubicin in Combination With Seliciclib for Patients With Metastatic Triple Negative Breast Cancer (TNBC)
The goal of this clinical research study is to find the highest tolerable dose of seliciclib that can be given in combination with liposomal doxorubicin to patients with metastatic breast cancer.
- Trial name
- NCT01333423
- Testing
- Liposomal Doxorubicin, Seliciclib
- Sponsor
- M.D. Anderson Cancer Center
Breast Cancer
Estimation of the Prevalence of HER2 Low and Describe the SoC, Treatment Patterns, and Outcome in Real-world Practice Among Unresectable and/or Metastatic Breast Cancer Patients With HER2 Low Status
This is a worldwide, multicenter, non-interventional, retrospective study of patient medical records from metastatic breast cancer (mBC) patients previously identified as human epidermal growth factor receptor 2 negative…
- Trial name
- NCT04807595
- Testing
- None (Observational study)
- Where
- 13 sites in United States, Australia and 8 more
- Volunteers
- 798 people
- Sponsor
- AstraZeneca
Advanced Breast Cancer
Dalpiciclib With Endocrine Therapy for Advanced Breast Cancer After CDK4/6 Inhibitor Failure (DAWNA-FES)
CDK4/6 inhibitors are currently the standard treatment for female breast cancer patients with HR+ tumors. However, there is no established standard treatment for patients who experience treatment failure with CDK4/6 inhibitors.
- Trial name
- NCT05861830
- Testing
- The combination of Dalpiciclib with physician-selected endocrine therapy, Chemotherapy selected by the physician
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Peking Union Medical College Hospital
Breast Cancer, TNBC - Triple-Negative Breast Cancer
A Phase 2 Study of PCS6422 With Capecitabine in Patients With Advanced or Metastatic Breast Cancer
This is an adaptive Phase 2, open-label, randomized, multi-center study evaluating up to 2 regimens of PCS6422 with capecitabine (Cap) vs. standard dose of Cap alone in patients with advanced or metastatic breast cancer.
- Conditions
- Breast Cancer, TNBC - Triple-Negative Breast Cancer, HER2-negative Breast Cancer
- Trial name
- NCT06568692
- Testing
- PCS6422 and capecitabine, Capecitabine
- Where
- 12 sites in United States
- Volunteers
- 20 people
- Sponsor
- Processa Pharmaceuticals
Breast Cancer
Phase Ib/II Study of LY2780301 in Combination With Weekly PACLITAXEL in HER2-metastatic Breast Cancer
The overall rationale of this study evaluating tolerance and efficacy of LY2780301 in combination with paclitaxel in HER2-negative, inoperable locally advanced or metastatic breast cancer (MBC) is based on : the medical need in…
- Trial name
- TAKTIC (NCT01980277)
- Testing
- LY2780301 + paclitaxel
- Where
- 2 sites in France
- Volunteers
- 68 people
- Sponsor
- Institut Paoli-Calmettes
Metastatic Breast Cancer, Advanced Breast Cancer
Patritumab Deruxtecan (U3-1402) in Unresectable Locally Advanced or Metastatic Breast Cancer
This study aims to evaluate the efficacy and safety of U3-1402 in participants with advanced breast cancer (ABC). Participants have to be hormone-receptor positive (HR+) and have to be resistant to endocrine therapy and…
- Trial name
- ICARUS BREAST (NCT04965766)
- Testing
- U3-1402
- Where
- 11 sites in France
- Volunteers
- 139 people
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
Metastatic Hormone-Receptor-Positive (HR+) Breast Cancer, HER2-Negative Breast Cancer
Ribociclib + PDR001 in Breast Cancer and Ovarian Cancer
This clinical trial is studying the drug Ribociclib (LEE011) in combination with an immunotherapy drug called PDR001 (a therapy that uses the body's own immune system to control cancer) as a possible treatment for metastatic…
- Conditions
- Metastatic Hormone-Receptor-Positive (HR+) Breast Cancer, HER2-Negative Breast Cancer, Metastatic Epithelial Ovarian Cancer
- Trial name
- NCT03294694
- Testing
- Ribociclib, PDR001, Fulvestrant
- Where
- 3 sites in United States
- Volunteers
- 33 people
- Sponsor
- Dana-Farber Cancer Institute
Breast Cancer
Sorafenib and Paclitaxel in Treating Patients With Metastatic Breast Cancer
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
- Trial name
- NCT00622466
- Testing
- paclitaxel, sorafenib tosylate
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Texas Southwestern Medical Center
HER2-negative Breast Cancer, Hormone-receptor-positive Breast Cancer
DiviTum®TKa: A Biomarker Assay for Efficacy in HR+ Breast Cancer Patients
This study is being done to determine if there is a pattern associated with response to endocrine therapy alone and in combination with CDK4/6 inhibitor used for hormone receptor positive HER2 negative breast cancer.
- Conditions
- HER2-negative Breast Cancer, Hormone-receptor-positive Breast Cancer, Metastatic Breast Cancer, Anatomic Stage II Breast Cancer AJCC v8
- Trial name
- NCT06388122
- Testing
- Biospecimen Collection
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Mayo Clinic
Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-)
A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
The purpose of this study is to learn about the safety and effects of the study medicine when given alone or together with other anti-cancer therapies. Anti-cancer therapy is a type of treatment to stop the growth of cancer.
- Conditions
- Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-), Colorectal Cancer, Metastatic Colorectal Adenocarcinoma
- Trial name
- NCT07318805
- Testing
- PF-08032562, Fulvestrant, Cetuximab
- Where
- 13 sites in United States
- Volunteers
- 260 people
- Sponsor
- Pfizer
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma
Radiation Therapy and M7824 in Treating Patients With Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer
This phase I trial studies the side effects and best dose of anti-PD-L1/TGFbetaRII fusion protein M7824 (M7824) when given together with radiation therapy in treating patients with hormone receptor positive, HER2 negative breast…
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Prognostic Stage IV Breast Cancer AJCC v8
- Trial name
- NCT03524170
- Testing
- Bintrafusp Alfa, Radiation Therapy
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- M.D. Anderson Cancer Center
Pancreatic Adenocarcinoma Metastatic, BRCA1 Mutation
SHARON: A Clinical Trial for Metastatic Cancer Using Chemotherapy and Patients' Own Stem Cells
The clinical trial is a phase 1, single-arm trial that will evaluate the safety of the investigational treatment on metastatic pancreatic cancer and metastatic breast cancer.
- Conditions
- Pancreatic Adenocarcinoma Metastatic, BRCA1 Mutation, BRCA2 Mutation, Pancreatic Acinar Cell Carcinoma
- Trial name
- SHARON (NCT04150042)
- Testing
- Melphalan, BCNU, Vitamin B12B
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- General Oncology, Inc.
Metastatic Breast Cancer
A Randomized, Open-label, Multi-center Phase IV Study Evaluating Palbociclib Plus Endocrine Treatment Versus a Chemotherapy-based Treatment Strategy in Patients With Hormone Receptor Positive / HER2 Negative Breast Cancer in a Real World Setting (GBG 93 - PADMA Study).
The goal of the study for patients with metastatic breast cancer (MBC) is to show that palbociclib + endocrine therapy shows a significant improvement in time-to-treatment failure over chemotherapy regimen (mono-chemotherapy with…
- Trial name
- PADMA (NCT03355157)
- Testing
- Palbociclib / Chemotherapy (capecitabine, epirubicin, paclitaxel, vinorelbine) / Endocrine therapy (exemestane, fulvestrant, letrozole, tamoxifen)
- Where
- Germany
- Volunteers
- 130 people
- Sponsor
- GBG Forschungs GmbH
Metastatic Breast Cancer, Locally Advanced Breast Cancer (LABC)
JSKN016 in Combination With D-0502 for Locally Advanced or Metastatic HR-Positive, HER2-Negative Breast Cancer
This is a multicenter, open-label, Phase Ib/II randomized study designed to evaluate the safety, tolerability, dose-limiting toxicities (DLTs), and preliminary antitumor activity of JSKN016 in combination with the oral selective…
- Trial name
- NCT07336771
- Testing
- JSKN016 Q2W, JSKN016 Q3W, D-0502
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Advanced Breast Cancer
A Study of SHR6390 in Combination With Fulvestrant in Patients With HR Positive and HER2 Negative Advanced Breast Cancer
This is a phase III clinical trial to evaluate the efficacy and safety of SHR6390 in combination with Fulvestrant versus placebo combined with Fulvesrant in Patients who have HR positive and HER2 negative recurrent/metastatic…
- Trial name
- NCT03927456
- Testing
- SHR6390, Fulvestrant
- Where
- China
- Volunteers
- 357 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Inoperable Locally Advanced HER2-Negative Breast Cancer, Metastatic HER2-Negative Breast Cancer
Study of JSKN016 Combination Therapy in Inoperable Locally Advanced or Metastatic HER2-Negative Breast Cancer
This study aims to evaluate the safety and effectiveness of JSKN016 in combination with different treatments for patients with HER2-negative breast cancer that cannot be removed by surgery or has spread to other parts of the…
- Trial name
- NCT06942234
- Testing
- JSKN016, Capecitabine, Paclitaxel (albumin bound)
- Where
- China
- Volunteers
- 180 people
- Sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Metastatic Breast Cancer
Fulvestrant Versus Capecitabine as Maintenance Therapy After First-line Chemotherapy in Patients With HR+/HER2- Metastatic Breast Cancer
This phase III trial aims to compare the efficacy and safety of fulvestrant or capecitabine as maintenance therapy after first-line chemotherapy in hormone receptor-positive, human epidermal growth factor receptor-2 negative…
- Trial name
- NCT04263298
- Testing
- Fulvestrant, Capecitabine Oral Product
- Where
- 13 sites in China
- Volunteers
- 210 people
- Sponsor
- Herui Yao
Breast Cancer
Study of Ribociclib With Everolimus + Exemestane in HR+ HER2- Locally Advanced/Metastatic Breast Cancer Post Progression on CDK 4/6 Inhibitor.
The purpose of this study is determine if the triplet combination of ribociclib, everolimus and exemastane is safe and effective in the treatment of locally advanced/metastatic breast cancer following treatment with a CDK 4/6…
- Trial name
- TRINITI-1 (NCT02732119)
- Testing
- Ribociclib, Everolimus, Exemestane
- Where
- 25 sites in United States
- Volunteers
- 104 people
- Sponsor
- Novartis Pharmaceuticals
HER2-negative Breast Cancer, HER2-positive Breast Cancer
Paclitaxel With or Without Trastuzumab in Treating Patients With or Without HER-2/Neu Breast Cancer That is Inoperable, Recurrent, or Metastatic
This randomized phase III studies how well two different regimens of paclitaxel with or without trastuzumab works in treating patients with or without HER-2/Neu breast cancer that is inoperable, recurrent, or metastatic.
- Conditions
- HER2-negative Breast Cancer, HER2-positive Breast Cancer, Recurrent Breast Cancer, Stage IIIC Breast Cancer
- Trial name
- NCT00003440
- Testing
- paclitaxel, trastuzumab, quality-of-life assessment
- Where
- United States
- Volunteers
- 580 people
- Sponsor
- National Cancer Institute (NCI)