Clinical trials: HER2-Negative Breast Carcinoma
Breast Cancer, Early-Stage Breast Carcinoma
SOLIS: Single-Dose Radiotherapy With Omission of Lumpectomy for Intact Small Breast Cancers
SOLIS is a prospective, single-arm, single-institution pilot trial evaluating single-fraction stereotactic radiotherapy (24 Gy to the planning target volume with a simultaneous integrated boost of 30 Gy to the clinical target…
- Conditions
- Breast Cancer, Early-Stage Breast Carcinoma, Hormone Receptor-Positive Breast Cancer, HER2-Negative Breast Cancer
- Trial name
- SOLIS (NCT07844759)
- Testing
- Stereotactic Radiation Therapy, Endocrine Therapy
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Renaissance Institute of Precision Oncology and Radiosurgery
Estrogen Receptor Negative, HER2 Positive Breast Carcinoma
Multicenter Trial for Eliminating Breast Cancer Surgery or Radiotherapy in Exceptional Responders to Neoadjuvant Systemic Therapy
This clinical trial studies eliminating surgery and/or radiation therapy in treating breast cancer patients. In HER2 positive and triple negative breast cancers, after systemic therapy, when image-guided biopsy shows no residual…
- Conditions
- Estrogen Receptor Negative, HER2 Positive Breast Carcinoma, HER2/Neu Negative, Invasive Breast Carcinoma
- Trial name
- NCT02945579
- Testing
- Undergo EBRT, Laboratory Biomarker Analysis, Quality-of-Life Assessment
- Where
- 8 sites in United States
- Volunteers
- 120 people
- Sponsor
- M.D. Anderson Cancer Center
Estrogen Receptor Status, HER2/Neu Negative
Alisertib With or Without Fulvestrant in Treating Patients With Locally Advanced or Metastatic, Endocrine-Resistant Breast Cancer
This phase II trial studies how well alisertib with or without fulvestrant works in treating patients with endocrine-resistant breast cancer that has spread to other places in the body.
- Conditions
- Estrogen Receptor Status, HER2/Neu Negative, Invasive Breast Carcinoma, Postmenopausal
- Trial name
- NCT02860000
- Testing
- Alisertib, Fulvestrant, Laboratory Biomarker Analysis
- Where
- 8 sites in United States
- Volunteers
- 96 people
- Sponsor
- Mayo Clinic
Stage I Breast Cancer, Stage II Breast Cancer
Niraparib + Dostarlimab In BRCA Mutated Breast Cancer
This research study involves pre-operative therapy that is specifically targeted for breast cancer in individuals with BRCA and PALB2 mutations.
- Conditions
- Stage I Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer, Breast Cancer
- Trial name
- NCT04584255
- Testing
- Niraparib, Dostarlimab
- Where
- 8 sites in United States
- Volunteers
- 66 people
- Sponsor
- Dana-Farber Cancer Institute
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
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
Ph2 Study for Optimization of Adjunct Systemic Therapy in HER2+ Patients, MolecularPCR Trial
This phase II trial tests reduced post surgery (adjuvant) therapy for patients with early breast cancer who have confirmed that the disease has responded completely (pathologic complete response) after pre surgical treatment…
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Early Stage HER2-Positive Breast Carcinoma, Early Stage Triple-Negative Breast Carcinoma
- Trial name
- NCT07407920
- Testing
- Biospecimen Collection, Hormone Therapy, Pembrolizumab
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- M.D. Anderson Cancer Center
ER-Positive HER2-Negative Breast Cancer
Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)
The study is intended to show superiority of AZD9833 in combination with CDK4/6 inhibitor (palbociclib, abemaciclib or ribociclib) versus aromatase inhibitors (anastrozole or letrozole) in combination with CDK4/6 inhibitor in…
- Trial name
- SERENA-6 (NCT04964934)
- Testing
- AZD9833, Anastrozole, Letrozole
- Where
- 264 sites in United States, Australia and 21 more
- Volunteers
- 315 people
- Sponsor
- AstraZeneca
Breast Cancer, Locally Advanced Breast Cancer
Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer
This phase 3 clinical trial compares the efficacy and safety of palazestrant with ribociclib to letrozole and ribociclib in women and men who have not received prior systemic anti-cancer treatment for advanced breast cancer.
- Conditions
- Breast Cancer, Locally Advanced Breast Cancer, Metastatic Breast Cancer, ER Positive Breast Cancer
- Trial name
- OPERA-02 (NCT07085767)
- Testing
- Palazestrant, Ribociclib, Letrozole
- Where
- 200 sites in United States, Australia and 21 more
- Volunteers
- 1,000 people
- Sponsor
- Olema Pharmaceuticals, Inc.
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic HER2-Negative Breast Carcinoma
Testing the Addition of Radium Therapy (Radium-223 Dichloride) to the Usual Chemotherapy Treatment (Paclitaxel) for Advanced Breast Cancer That Has Spread to the Bones
This phase II trial studies how well radium-223 dichloride and paclitaxel work in treating patients with advanced breast cancer that has spread to the bones.
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Metastatic HER2-Negative Breast Carcinoma, Metastatic Malignant Neoplasm in the Bone
- Trial name
- NCT04090398
- Testing
- Biospecimen Collection, Bone Scan, Computed Tomography
- Where
- 30 sites in United States
- Volunteers
- 70 people
- Sponsor
- National Cancer Institute (NCI)
Triple Negative Breast Cancer, HER2-positive Breast Cancer
Study of Screening Brain MRIs in Stage IV Breast Cancer
The study is a single arm, nonrandomized phase II prospective study, with the goal of investigating the role of screening brain MRIs in neurologically asymptomatic patients with metastatic breast cancer.
- Conditions
- Triple Negative Breast Cancer, HER2-positive Breast Cancer, Hormone Receptor-positive Breast Cancer
- Trial name
- NCT05115474
- Testing
- Magnetic Resonance Imaging
- Where
- 2 sites in United States
- Volunteers
- 170 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Metastatic Breast Cancer, ER-positive Breast Cancer
Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everolimus, or Atirmociclib in ER+, HER2- Breast Cancer
This is a Phase 1b open-label, 2-part study in 4 treatment groups. The 4 treatment groups are as follows: Treatment Group 1: Palazestrant (OP-1250) in combination with ribociclib (KISQALI®, Novartis Pharmaceuticals Corporation).
- Conditions
- Metastatic Breast Cancer, ER-positive Breast Cancer, HER2-negative Breast Cancer, Breast Cancer
- Trial name
- NCT05508906
- Testing
- Palazestrant, Ribociclib, Alpelisib
- Where
- 16 sites in United States, Australia
- Volunteers
- 190 people
- Sponsor
- Olema Pharmaceuticals, Inc.
Leptomeningeal Disease, Triple Negative Breast Cancer
A First in Human Dose Escalation of Dendritic Cell Vaccine (DCV)
The purpose of this study is to learn about the effects of the study treatment, Dendritic Cell Vaccine (DCV), to find the highest dose of the study treatment that can be given safely to Breast Cancer patients with Leptomeningeal…
- Conditions
- Leptomeningeal Disease, Triple Negative Breast Cancer, HER2-positive Breast Cancer
- Trial name
- NCT05809752
- Testing
- Dendritic Cell Vaccine
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Estrogen Receptor Positive, HER2/Neu Negative
Radiation Therapy Before Surgery in Treating Patients With Hormone Receptor Positive, HER2 Negative Breast Cancer
This phase II trial studies how well radiation therapy before surgery works in treating patients with hormone receptor positive, HER2 negative breast cancer.
- Conditions
- Estrogen Receptor Positive, HER2/Neu Negative, Invasive Breast Carcinoma, Progesterone Receptor Positive
- Trial name
- NCT03359954
- Testing
- Radiation Therapy, Therapeutic Conventional Surgery
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- M.D. Anderson Cancer Center
Advanced Breast Carcinoma, Anatomic Stage III Breast Cancer AJCC v8
Olaparib With Cediranib or AZD6738 for the Treatment of Advanced or Metastatic Germline BRCA Mutated Breast Cancer
This phase II trial studies how well olaparib with cediranib or AZD6738 works in treating patients with germline BRCA mutated breast cancer that has spread to other places in the body (advanced or metastatic).
- Conditions
- Advanced Breast Carcinoma, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8
- Trial name
- NCT04090567
- Testing
- Cediranib, Ceralasertib, Olaparib
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- M.D. Anderson Cancer Center
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
Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer
A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)
This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor…
- Trial name
- NCT06065748
- Testing
- Giredestrant, Fulvestrant, Abemaciclib
- Where
- 311 sites in United States, Argentina and 35 more
- Volunteers
- 1,050 people
- Sponsor
- Hoffmann-La Roche
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)