Clinical trials: HER2-negative Metastatic Breast Cancer
Hormone Receptor Positive HER2 Negative Breast Cancer With a PIK3CA Mutation
A NIS of Alpelisib in Combination With Fulvestrant in Postmenopausal Women, and Men, With HR+,HER2- , Locally Advanced or Metastatic Breast Cancer With a PIK3CA Mutation, After Disease Progression Following Endocrine Therapy as Monotherapy, in the Real-world Setting
This was a prospective, multi-national, non-interventional study (NIS) collecting data from postmenopausal women, and adult men, with HR+, HER2- locally advanced or metastatic breast cancer whose tumor harbors a PIK3CA mutation…
- Trial name
- NCT04967248
- Testing
- Alpelisib, Fulvestrant
- Volunteers
- 4 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer, PALB2-Mutated Breast Carcinoma
Phase Ib Study of Axatilimab in Combination With Olaparib in BRCA1/2 and PALB2- Associated Metastatic HER2-negative Breast Cancer
This research is being done to evaluate the safety and tolerability of the new drug, axatilimab, in combination with olaparib (a standard of care treatment) in Breast Cancer 1/2 genes (BRCA 1/2) and PALB2 associated HER2-negative…
- Conditions
- Breast Cancer, PALB2-Mutated Breast Carcinoma, HER2-negative Breast Cancer, BRCA1 Mutation
- Trial name
- NCT06488378
- Testing
- Axatilimab, Olaparib
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- Dana-Farber Cancer Institute
Triple Negative Locally Advanced Non-resectable Breast Cancer, HR+, HER2-, Advanced Breast Cancer
A Study of Invikafusp Alfa (STAR0602), a Selective T Cell Receptor (TCR)-Targeting, Bifunctional Antibody-fusion Molecule, in Combination With Sacituzumab Govitecan in Participants With Advanced Solid Tumors
This is a Phase 1b/2, Open-label Study to Investigate the Safety and Efficacy of Invikafusp alfa (STAR0602), a Selective T Cell Receptor (TCR)-targeting, Bifunctional Antibody-fusion Molecule, in Combination with Sacituzumab…
- Trial name
- START-002 (NCT06827613)
- Testing
- STAR0602, Sacituzumab Govitecan (SG)
- Where
- 8 sites in United States, Canada
- Volunteers
- 50 people
- Sponsor
- Marengo Therapeutics, Inc.
Advanced Solid Tumors, Hematologic Neoplasms
A Study of MGD013 in Patients With Unresectable or Metastatic Neoplasms
The primary goal of this Phase 1 study is to characterize the safety and tolerability of tebotelimab and establish the maximum tolerated dose (MTD) of tebotelimab in advanced solid tumors, and tebotelimab in combination with…
- Conditions
- Advanced Solid Tumors, Hematologic Neoplasms, Ovarian Cancer, HER2-positive Advanced Solid Tumors
- Trial name
- NCT03219268
- Testing
- tebotelimab 1 mg, tebotelimab 3 mg, tebotelimab 10 mg
- Where
- 40 sites in United States, Australia and 6 more
- Volunteers
- 277 people
- Sponsor
- MacroGenics
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)
Breast Cancer
Study of Elacestrant in Combination With Onapristone in Patients With Advanced or Metastatic Breast Cancer
This is a multicenter, Phase 1b-2 study of elacestrant in combination with onapristone in patients with advanced/metastatic ER+/PgR+/HER2- breast cancer.
- Trial name
- ELONA (NCT05618613)
- Testing
- Elacestrant, Onapristone
- Where
- 3 sites in United States
- Volunteers
- 4 people
- Sponsor
- Context Therapeutics Inc.
Metastatic Breast Cancer
Pilot Study to Evaluate Reparixin With Weekly Paclitaxel in Patients With HER 2 Negative Metastatic Breast Cancer (MBC)
This is a phase I study to evaluate the safety and define the pharmacokinetic (PK) profile of orally administered reparixin in combination with paclitaxel in HER 2 (Human epidermal growth factor receptor-2) negative metastatic…
- Trial name
- NCT02001974
- Testing
- Paclitaxel+Reparixin
- Where
- 5 sites in United States
- Volunteers
- 33 people
- Sponsor
- Dompé Farmaceutici S.p.A
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.
Hormone Receptor Positive Breast Carcinoma, HER2-negative Breast Cancer
Alpelisib (BYL719) in Combination With Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer
Patients who have histologically confirmed metastatic or unresectable (not amenable to curative therapy) breast cancer may be screened for eligibility.
- Conditions
- Hormone Receptor Positive Breast Carcinoma, HER2-negative Breast Cancer, PIK3CA Mutant Metastatic Breast Cancer
- Trial name
- NCT04762979
- Testing
- Alpelisib, Fulvestrant, Aromatase inhibitor
- Where
- 4 sites in United States
- Volunteers
- 44 people
- Sponsor
- Marina N Sharifi
Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors
Study of GVV858 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
Phase I: Characterize safety and tolerability of GVV858 as a single agent and in combination with fulvestrant or letrozole. Identify dose range for optimization/recommended dose for further clinical evaluation.
- Conditions
- Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors, Metastatic Castration-resistant Prostate Cancer
- Trial name
- NCT07288359
- Testing
- GVV858, Fulvestrant, Letrozole
- Where
- 16 sites in United States, Canada and 9 more
- Volunteers
- 205 people
- Sponsor
- Novartis Pharmaceuticals
HER2-negative Breast Cancer, ER Positive Breast Cancer
D4 Choline Breast PET/CT
The aim of this study is to evaluate the effect of CDK4/6 inhibitor treatment on the tumour choline metabolism as determined by [18F]D4-FCH PET/ computed tomography(CT) in breast cancer and to determine the suitability of…
- Conditions
- HER2-negative Breast Cancer, ER Positive Breast Cancer, Metastatic Breast Cancer
- Trial name
- NCT04276272
- Testing
- Imaging scan
- Where
- United Kingdom
- Volunteers
- 6 people
- Sponsor
- Imperial College London
Breast Cancer
Metronomic Capecitabine Plus Aromatase Inhibitor for First Line Treatment in HR(+), Her2(-) Metastatic Breast Cancer
The study is designed to compare the clinical benefit following treatment with aromatase inhibitor in combination with metronomic capecitabine versus aromatase inhibitor alone in women with hormone receptor-positive…
- Trial name
- MECCA (NCT02767661)
- Testing
- Capecitabine, Aromatase Inhibitor
- Where
- China
- Volunteers
- 263 people
- Sponsor
- Sun Yat-sen University
Advanced Solid Tumor, Metastatic Solid Tumor
A Study to Evaluate the Safety and Therapeutic Activity of GI-102 As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patients with Advanced Solid Tumors (KEYNOTE-G08)
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-102 as a single agent and in combination with conventional anti-cancer drugs, pembrolizumab or trastuzumab…
- Conditions
- Advanced Solid Tumor, Metastatic Solid Tumor, Soft Tissue Sarcoma (STS), Platinum-resistant Ovarian Cancer (PROC)
- Trial name
- NCT05824975
- Testing
- GI-102 subcutaneous (SC), GI-102, doxorubicin
- Where
- 11 sites in United States, South Korea
- Volunteers
- 358 people
- Sponsor
- GI Innovation, Inc.
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
A Real-world Study Observing Treatment Patterns and Clinical Results for Patients in China With Hormone Receptor-positive, HER2-negative Metastatic Breast Cancer.
The study aims to describe demographics, clinical characteristics, genetic test diagnosis, treatment patterns, and clinical outcomes in HR+/HER2- (including HER2-low, HER2-ultralow, and HER2-null) unresectable or metastatic…
- Trial name
- VERITAS (NCT07743944)
- Where
- China
- Volunteers
- 2,000 people
- Sponsor
- AstraZeneca
Metastatic Breast Cancer
Nivolumab and Eribulin in HER2 Negative Metastatic Breast Cancer
Cancer therapeutics such as chemotherapy may modulate tumor/immune-system interactions in favor of the immune system. Chemotherapy can result in tumor cell death with a resultant increase in tumor antigen delivery to…
- Trial name
- KORNELIA (NCT04061863)
- Testing
- Nivolumab
- Where
- South Korea
- Volunteers
- 90 people
- Sponsor
- Seoul National University Hospital
Breast Cancer
Use of PRO Onc Assay to Assess HER2 in Patients With Metastatic Breast Cancer
This trial will evaluate the clinical significance of the PRO Onc assay and will assess the efficacy of HER2-targeted therapy in patients with HER2-negative breast cancer who have been identified as having HER2…
- Trial name
- NCT01048099
- Testing
- PRO Onc Assay and Treatment, Trastuzumab, Pertuzumab
- Where
- 7 sites in United States
- Volunteers
- 283 people
- Sponsor
- SCRI Development Innovations, LLC
HER2-negative Breast Cancer
Functional Precision Oncology for Metastatic Breast Cancer
This is a pilot study to assess the feasibility of comprehensive genomic characterization and drug screening in metastatic breast cancer.
- Trial name
- FORESEE (NCT04450706)
- Testing
- Precision Medicine, Physican Decision Making
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- University of Utah
Breast Cancer Metastatic
Evaluation of the Efficacy and Safety of Nal-IRI for Progressing Brain Metastases in Breast Cancer Patients
Multicenter open-label, phase II trial, to evaluate the efficacy and safety of nal-IRI in patients with HER2-negative breast cancer, who have documented Central Nervous System (CNS) progression following Whole Brain Radio Therapy…
- Trial name
- Phenomenal (NCT03328884)
- Testing
- Irinotecan (CPT-11) liposome
- Where
- 16 sites in Spain
- Volunteers
- 55 people
- Sponsor
- MedSIR
Advanced, Metastatic Breast Cancer
Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer
The primary purpose of this study was to assess the efficacy of ribociclib, as measured by progression free survival (PFS), in postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2…
- Trial name
- MONALEESA-2 (NCT01958021)
- Testing
- Ribociclib, Letrozole
- Where
- 221 sites in United States, Argentina and 27 more
- Volunteers
- 668 people
- Sponsor
- Novartis Pharmaceuticals