Clinical trials: HER2-negative Metastatic Breast Cancer
Female Breast Carcinoma, Breast Cancer
Trial of Anastrozole and Palbociclib in Metastatic HER2-Negative Breast Cancer
This is an open-label, pilot study designed to evaluate the safety and feasibility of combining anastrozole and palbociclib in the following two cohorts: Cohort A) as first-line therapy and Cohort B) as maintenance therapy after…
- Trial name
- NCT02942355
- Testing
- anastrozole, Palbociclib
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Wake Forest University Health Sciences
Breast Cancer
Phase III Study of BKM120/Placebo With Fulvestrant in Postmenopausal Patients With Hormone Receptor Positive HER2-negative Locally Advanced or Metastatic Breast Cancer Refractory to Aromatase Inhibitor
This study was a multi-center, randomized, double-blind, placebo controlled Phase III study to determine the efficacy and safety of treatment with buparlisib plus fulvestrant versus fulvestrant plus placebo in postmenopausal…
- Trial name
- BELLE-2 (NCT01610284)
- Testing
- Fulvestrant, BKM120
- Where
- 268 sites in United States, Argentina and 27 more
- Volunteers
- 1,147 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Breast Cancer, Bevacizumab-alone Maintenance Treatment Progression
Abrogation of Chronic Monoclonal Antibody Treatment-induced T-cell Exhaustion With DURVALUMAB in Advanced HER-2 Negative Breast Cancer
This is a single-arm pilot proof of concept, open-label clinical trial. Twenty-five subjects will be enrolled in 6 sites. Metastatic breast cancer patients with disease progression to bevacizumab maintenance treatment will be…
- Trial name
- NCT02802098
- Testing
- Durvalumab, Bevacizumab
- Where
- 6 sites in Spain
- Volunteers
- 25 people
- Sponsor
- Centro Nacional de Investigaciones Oncologicas CARLOS III
Breast Cancer
Phase Ib Trial of LEE011 With Everolimus (RAD001) and Exemestane in the Treatment of Hormone Receptor Positive HER2 Negative Advanced Breast Cancer
Dose Escalation part of the study: To estimate the MTD(s) and/ or RP2D of LEE011 in combination with everolimus + exemestane, and LEE011 in combination with exemestane, and to characterize the safety and tolerability of the…
- Trial name
- NCT01857193
- Testing
- ribociclib (LEE011), Exemestane, Everolimus (RAD001)
- Where
- 13 sites in United States, Belgium and 3 more
- Volunteers
- 132 people
- Sponsor
- Novartis Pharmaceuticals
Solid Tumor, Adult, Metastatic Breast Cancer
Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors
First in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-10203, a PI3Kα:RAS breaker, alone and in combination with other anti-cancer agents in patients with advanced solid tumors.
- Conditions
- Solid Tumor, Adult, Metastatic Breast Cancer, Advanced Breast Cancer, HER2 Mutation-Related Tumors
- Trial name
- NCT06625775
- Testing
- BBO-10203, Trastuzumab, Fulvestrant
- Where
- 44 sites in United States, Australia and 4 more
- Volunteers
- 392 people
- Sponsor
- TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
Breast Cancer
Panobinostat and Letrozole in Treating Patients With Metastatic Breast Cancer
RATIONALE: Panobinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of breast cancer cells.
- Trial name
- NCT01105312
- Testing
- letrozole, panobinostat, RNA analysis
- Where
- 172 sites in United States
- Volunteers
- 28 people
- Sponsor
- Alliance for Clinical Trials in Oncology
HER2-negative Breast Cancer, HER2 Negative Breast Carcinoma
Prospective Registry of ADC as First- and Second-line Treatment for Breast Cancer
Antibody-drug conjugates (ADCs) have demonstrated substantial improvement in progression free survival (PFS) and overall survival (OS) in phase III clinical trials in patients with metastatic triple negative breast cancer (mTNBC)…
- Conditions
- HER2-negative Breast Cancer, HER2 Negative Breast Carcinoma, Metastatic Breast Cancer, HR+ HER2 Breast Cancer
- Trial name
- ENCORE (NCT06774027)
- Testing
- Specimen collection, Non-Investigational Antibody-Drug Conjugates (ADC), Medical Record Review
- Where
- 3 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Recurrent or Metastatic Breast Cancer
A Phase III Study of SYS6010 Versus Chemotherapy in HER2-Negative, EGFR-Positive Recurrent or Metastatic Breast Cancer
This study is a multicenter, randomized, open-label, parallel-control Phase III clinical trial enrolling patients with unresectable HER2-negative, EGFR-positive recurrent/metastatic breast cancer who have previously failed first…
- Trial name
- NCT07406542
- Testing
- SYS6010, Investigator's Choice of Chemotherapy (eribulin, capecitabine, gemcitabine, or vinorelbine)
- Volunteers
- 400 people
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
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
Metastatic Pancreatic Ductal Adenocarcinoma (PDAC), Non-small Cell Lung Cancer (NSCLC)
Phase I Study of JFI447 [68Ga]Ga-DFC413 and Comparison to FFG233 [68Ga]Ga-NNS309 in Patients With Solid Tumors
The purpose of Part 1 of this study is to evaluate the imaging characteristics, safety, biodistribution and pharmacokinetics of [68Ga]Ga-DFC413, and in Part 2 compare to [68Ga]Ga-NNS309 in patients with locally advanced or…
- Conditions
- Metastatic Pancreatic Ductal Adenocarcinoma (PDAC), Non-small Cell Lung Cancer (NSCLC), HR+/HER2- Ductal Breast Cancer (BC), HR+/HER2- Lobular Breast Cancer (BC)
- Trial name
- NCT07630961
- Testing
- 68Ga-DFC413, 68Ga-NNS309
- Where
- 2 sites in Denmark, Japan
- Volunteers
- 66 people
- Sponsor
- Novartis Pharmaceuticals
Triple Negative Breast Cancer, Endometrial Cancer
ONC201 in Recurrent/Refractory Metastatic Breast Cancer and Advanced Endometrial Carcinoma
Background: The new drug ONC201 have been shown to kill breast cancer and endometrial cancer cells in the laboratory. The exact mechanism of action is not completely clear yet, but the ONC201 destroys the mitochondria inside the…
- Conditions
- Triple Negative Breast Cancer, Endometrial Cancer, Hormone Receptor Positive, HER2 Negative Breast Cancer
- Trial name
- NCT03394027
- Testing
- ONC201
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- National Cancer Institute (NCI)
Breast Cancer
Trial of BKM120/Tamoxifen-combination in Patients With HR-pos, HER2-neg Breast Cancer
This is a clinical trial with a molecularly stratified parallel cohort, single arm design to explore the efficacy and safety of BKM120 in combination with tamoxifen in patients with ER/PR-positive, HER2-negative breast cancer…
- Trial name
- PIKTAM (NCT02404844)
- Testing
- BKM120, Tamoxifen
- Where
- Germany
- Volunteers
- 48 people
- Sponsor
- University Hospital, Essen
Breast Cancer, Metastatic Cancer
Immune Therapy in HR-positive/HER2-negative Metastatic Breast Cancer(ENIGMA)-BCTOP-L-M02
This study is a prospective, open-label, phase II clinical study for patients with HR+/HER2- advanced breast cancer.
- Trial name
- NCT05205200
- Testing
- SHR-1316, SHR6390, Nab paclitaxel
- Where
- China
- Volunteers
- 338 people
- Sponsor
- Fudan University
Ductal Carcinoma
Docetaxel + Doxorubicin as Neoadjuvant Chemotherapy in Patients With Breast Cancer
Primary: To determine the pathological remission following the chemotherapy combination docetaxel and doxorubicin in large breast cancer Secondary: Clinical response rate To investigate the safety of docetaxel doxorubicin…
- Trial name
- NCT00461344
- Testing
- Docetaxel, Doxorubicin
- Volunteers
- 20 people
- Sponsor
- Sanofi
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 Neoplasms, Breast Cancer
A Study of Lapatinib in Combination With Everolimus in Patients With Advanced, Triple Negative Breast Cancer
The patient is being asked to join this clinical research study to find out if lapatinib, an agent that targets a protein, called epidermal growth factor receptor (EGFR) on the surface of cancer cells in combination with…
- Conditions
- Breast Neoplasms, Breast Cancer, Cancer of the Breast
- Trial name
- NCT01272141
- Testing
- Lapatinib and Everolimus
- Where
- 3 sites in United States
- Volunteers
- 5 people
- Sponsor
- Emory University
Metastatic Breast Cancer, Recurrent Breast Cancer
ModraDoc006/r in Patients With Breast Cancer
This is a multicenter phase IIa study to evaluate the efficacy and tolerability of ModraDoc006 in combination with ritonavir (denoted ModraDoc006/r) in patients with recurrent or metastatic HER-2 negative breast cancer, that are…
- Trial name
- NCT03890744
- Testing
- ModraDoc006/r
- Where
- 4 sites in Belgium, Denmark and 1 more
- Volunteers
- 12 people
- Sponsor
- Modra Pharmaceuticals
Breast Cancer
Pixantrone Dimaleate in Treating Patients With HER2-Negative Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as pixantrone dimaleate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
- Trial name
- NCT01086605
- Testing
- pixantrone dimaleate
- Where
- 230 sites in United States
- Volunteers
- 46 people
- Sponsor
- Alliance for Clinical Trials in Oncology
Advanced Unresectable, Metastatic
Biomarker-Guided Dual-Target CAR-T Cells for Advanced Solid Tumors
This is a multicenter, open-label, Phase 1/2 master protocol evaluating autologous dual-target CAR-T cell therapy in adults with advanced solid cancers.
- Trial name
- SELECT-2CAR (NCT07523529)
- Testing
- Autologous dual-target CAR-T cells selected from the predefined target library., Fludarabine, Cyclophosphamide
- Where
- China
- Volunteers
- 72 people
- Sponsor
- Beijing Biotech
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