Clinical trials: HER2-negative Metastatic Breast Cancer
Metastatic Breast Cancer, ER Positive Breast Cancer
To Identify Primary Resistance to CDK4/6 Inhibitors in Breast Cancer
This is a multi-center biomarkers study aiming to prospectively collect biological samples from patients with ER+ and HER2-negative metastatic breast cancer, who are candidate to first-line treatment with an aromatase inhibitor…
- Conditions
- Metastatic Breast Cancer, ER Positive Breast Cancer, HER2-negative Breast Cancer
- Trial name
- TIRESIAS (NCT04660435)
- Testing
- Thymidine kinase activity
- Where
- Italy
- Volunteers
- 150 people
- Sponsor
- Fondazione Sandro Pitigliani
Hormone-receptor-positive Breast Cancer, HER2-negative Breast Cancer
BGB-21447 (Bcl-2 Inhibitor) Combinations for Adults With Hormone-Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Metastatic Breast Cancer
This is a dose escalation and dose expansion study to assess the safety and tolerability of BGB-21447 (a B-cell leukemia/lymphoma 2 inhibitor, Bcl-2i) in combination with fulvestrant, with or without BGB-43395 (cyclin-dependent…
- Conditions
- Hormone-receptor-positive Breast Cancer, HER2-negative Breast Cancer, Metastatic Breast Cancer
- Trial name
- NCT06756932
- Testing
- BGB-21447, Fulvestrant, BGB-43395
- Where
- 14 sites in United States, Australia and 1 more
- Volunteers
- 120 people
- Sponsor
- BeOne Medicines
Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer
A Study Evaluating the Efficacy and Safety of Giredestrant Compared With Physician's Choice of Endocrine Monotherapy in Participants With Previously Treated Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (acelERA Breast Cancer)
This Phase II, randomized, open-label, multicenter study will evaluate the efficacy and safety of giredestrant compared with physician's choice of endocrine monotherapy in participants with estrogen receptor (ER)-positive, human…
- Trial name
- NCT04576455
- Testing
- Giredestrant, Fulvestrant or an Aromatase Inhibitor (Physician Choice), LHRH Agonist
- Where
- 81 sites in United States, Argentina and 15 more
- Volunteers
- 303 people
- Sponsor
- Hoffmann-La Roche
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
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma
Testing the Addition of Copanlisib to Usual Treatment (Fulvestrant and Abemaciclib) in Metastatic Breast Cancer
This phase I trial studies the effects (good and bad) of adding copanlisib to the usual therapy of fulvestrant and abemaciclib in treating patients with hormone receptor positive and HER2 negative breast cancer that has spread…
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic HER2-Negative Breast Carcinoma, Metastatic Hormone Receptor-Positive Breast Carcinoma
- Trial name
- NCT03939897
- Testing
- Abemaciclib, Biopsy Procedure, Biospecimen Collection
- Where
- 14 sites in United States
- Volunteers
- 24 people
- Sponsor
- National Cancer Institute (NCI)
Estrogen-receptor-positive Breast Cancer, HER2/Neu-Negative Breast Cancer
Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor in Patients With ERpositive/HER2-negative Advanced or Metastatic Breast Cancer
Breast cancer is not only the leading cause of cancer in women, but also the leading cause of cancer deaths in women. Estrogen receptor-positive and HER2-negative breast cancer is the most prevalent breast cancer subtype.
- Conditions
- Estrogen-receptor-positive Breast Cancer, HER2/Neu-Negative Breast Cancer, Advanced Breast Cancerv, Metastatic Breast Cancer
- Trial name
- NCT06062498
- Testing
- elacestrant, palbociclib, abemaciclib, ribociclib
- Where
- 3 sites in United States
- Volunteers
- 174 people
- Sponsor
- Northwestern University
Metastatic Breast Cancer, Triple Negative Breast Cancer
Toci +/- SOC Chemo for Metastatic Triple Negative and ER-positive, HER2-negative Breast Cancers
This is a randomized Phase II study of standard of care (SOC) chemotherapy monotherapy vs. SOC chemotherapy combined with tocilizumab biosimilar in Black and non-Black patients with metastatic triple negative and ER-positive…
- Conditions
- Metastatic Breast Cancer, Triple Negative Breast Cancer, Estrogen-receptor-low Breast Cancer, ER Positive, HER2 Negative Breast Cancer
- Trial name
- NCT05846789
- Testing
- SOC Chemotherapy, Tocilizumab/Tocilizumab Biosimilar
- Where
- 7 sites in United States
- Volunteers
- 168 people
- Sponsor
- Kathy Miller
Advanced Breast Cancer, Metastatic Breast Cancer
Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer
This is a prospective, open-label, phase 2 platform trial. The purpose of this study is to test the safety and effectiveness of the antibody-conjugated drugs (ADCs) in patients with advanced breast cancer who had previously used…
- Conditions
- Advanced Breast Cancer, Metastatic Breast Cancer, Triple Negative Breast Cancer (TNBC), HER2-negative Breast Cancer
- Trial name
- NCT06649331
- Testing
- SHR-A1811, SHR-A1921, SHR-A2009
- Where
- China
- Volunteers
- 160 people
- Sponsor
- Fudan University
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
Breast Cancer, HER2-low Breast Cancer
TReatment of ADC-Refractory Breast CancEr With Dato-DXd or T-DXd: TRADE DXd
The purpose of this study is to test the safety and effectiveness of the sequence of two investigational drugs (trastuzumab deruxtecan followed by datopotamab deruxtecan, or datopotamab deruxtecan followed by trastuzumab…
- Conditions
- Breast Cancer, HER2-low Breast Cancer, Metastatic Breast Cancer, HER2-negative Breast Cancer
- Trial name
- TRADE DXd (NCT06533826)
- Testing
- Trastuzumab Deruxtecan, Datopotamab Deruxtecan
- Where
- 11 sites in United States
- Volunteers
- 357 people
- Sponsor
- Ana C Garrido-Castro, MD
Estrogen-receptor-positive Breast Cancer, Metastatic Breast Cancer
PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA)
The goal of this research study is to compare a combination of two drugs, capecitabine and elacestrant to capecitabine alone as a treatment for advanced estrogen receptor-positive (ER+) breast cancer.
- Conditions
- Estrogen-receptor-positive Breast Cancer, Metastatic Breast Cancer, Breast Cancer, Hormone Receptor Positive Breast Cancer
- Trial name
- CAPELA (NCT07222215)
- Testing
- Capecitabine, Elacestrant
- Where
- United States
- Volunteers
- 297 people
- Sponsor
- Kristina A. Fanucci
HER2-negative Breast Cancer, Hormone Receptor Positive Tumor
A Ph II Study of the TheraBionic P1 Device in Subjects With Hormone Positive Breast Cancer
The goal of this clinical trial is to learn if the TheraBionic P1 device given to patients with advanced or metastatic HR positive, HER2 negative breast cancer who have progressed on standard of care options can affect patients…
- Conditions
- HER2-negative Breast Cancer, Hormone Receptor Positive Tumor, Advanced Breast Cancer, Metastatic Breast Cancer
- Trial name
- NCT07227831
- Testing
- TheraBionic P1
- Where
- 8 sites in United States
- Volunteers
- 82 people
- Sponsor
- Barbara Ann Karmanos Cancer Institute
Triple Negative Breast Cancer, Locally Advanced Breast Cancer
PAveMenT: Palbociclib and Avelumab in Metastatic AR+ Triple Negative Breast Cancer
This clinical study is aiming to determine the safest doses and schedule for the combination of two drugs named palbociclib and avelumab.
- Conditions
- Triple Negative Breast Cancer, Locally Advanced Breast Cancer, Recurrent Breast Cancer, Metastatic Breast Cancer
- Trial name
- PAveMenT (NCT04360941)
- Testing
- Palbociclib, Avelumab
- Where
- 9 sites in United Kingdom
- Volunteers
- 45 people
- Sponsor
- Royal Marsden NHS Foundation Trust
Breast Cancer Metastatic Breast Cancer, HER2-negative Breast Cancer
Immunologic Targeting of ESR1 Receptor for Hormone Receptor Expressing Metastatic Breast Cancer
This is a pilot study to determine feasibility and safety of the combination of Dendritic Cell (DC1) vaccines and elacestrant in patients with hormone positive HER2 negative metastatic breast cancer.
- Trial name
- NCT06691035
- Testing
- Elacestrant, DC1 native/mutated ESR1
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer)
This Phase III, randomized, double-blind, placebo-controlled, multicenter study will evaluate the efficacy and safety of giredestrant combined with palbociclib compared with letrozole combined with palbociclib in patients with…
- Trial name
- NCT04546009
- Testing
- Giredestrant, Letrozole, Palbociclib
- Where
- 255 sites in United States, Argentina and 28 more
- Volunteers
- 992 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer, Advanced Breast Cancer
OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer
This phase 3 clinical trial compares the safety and efficacy of palazestrant (OP-1250) to the standard-of-care options of fulvestrant or an aromatase inhibitor in women and men with breast cancer whose disease has advanced on one…
- Conditions
- Breast Cancer, Advanced Breast Cancer, Metastatic Breast Cancer, ER Positive Breast Cancer
- Trial name
- OPERA-01 (NCT06016738)
- Testing
- Palazestrant, Fulvestrant, Anastrozole
- Where
- 233 sites in United States, Argentina and 24 more
- Volunteers
- 510 people
- Sponsor
- Olema Pharmaceuticals, Inc.
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
Breast Cancer, Breast Cancer Female
DATO-BASE: DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs
The purpose of this study is to test the safety and effectiveness of the study drug datopotamab deruxtecan in participants with metastatic breast cancer that has spread to the brain.
- Conditions
- Breast Cancer, Breast Cancer Female, Metastatic Triple-Negative Breast Carcinoma, ER Positive Breast Cancer
- Trial name
- NCT06176261
- Testing
- Datopotamab Deruxtecan
- Where
- 3 sites in United States
- Volunteers
- 58 people
- Sponsor
- Nancy Lin, MD
Breast Cancer, HR-positive Breast Cancer
Phase III Study to Evaluate the Safety, Efficacy, and Impact on Quality of Life of Capivasertib Alongside Standard-of-care Endocrine Treatment in Patients With HR+/HER2- Advanced Breast Cancer and Progression on Prior Endocrine-based Treatment
This is a multicentre phase-III-trial to evaluate the use of capivasertib in patients with HR+/HER2- advanced breast cancer and progression on prior endocrine-based treatment. The goal of this study is 1.
- Conditions
- Breast Cancer, HR-positive Breast Cancer, Advanced Breast Cancer, Metastatic Breast Cancer
- Trial name
- CAPIcorn (NCT07281833)
- Testing
- Capivasertib
- Where
- 16 sites in Belgium, Germany and 1 more
- Volunteers
- 250 people
- Sponsor
- Women's Cancer Study Group GmbH
HR-positive, HER2-negative Metastatic Breast Cancer With Brain Metastases
Culmerciclib Plus Anlotinib and Endocrine Therapy for HR-Positive/HER2-Negative Metastatic Breast Cancer With Brain Metastases
This study aims to evaluate the efficacy and safety of adding the anti-angiogenic agent anlotinib to the combination of the CDK2/4/6 inhibitor Culmerciclib and endocrine therapy in patients with HR+/HER2- breast cancer and brain…
- Trial name
- NCT07745257
- Testing
- Culmerciclib, Anlotinib, Endocrine Therapy
- Where
- 9 sites in China
- Volunteers
- 40 people
- Sponsor
- Sun Yat-sen University