Breast Cancer
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NCT04529044
177Lu-DOTATATE for the Treatment of Stage IV or Recurrent Breast Cancer
This phase II trial investigates how well 177Lu-DOTATATE works in treating patients with breast cancer that is stage IV or has come back (recurrent). 177Lu-DOTATATE may shrink or destroy the tumor or circulating breast cancer stem cells if they show evidence of the SSTR2. 177Lu-DOTATATE is a targeted therapy that uses DOTATATE, linked to a radioactive agent called 177Lu. DOTATATE attaches to tumor cells with SSTR2 and delivers 177Lu to kill them. Giving 177Lu-DOTATATE may help decrease the number and size of tumors and the number of circulating cancer stem cells in patient's blood for the treatment of patients with breast cancer positive for SSTR2.
Not yet recruiting • Phase II • Stage IV • ER positive • Medical Oncology • Post-Menopausal • Interventional
OHSU Knight Cancer Institute
Site Contact
SuEllen Pommier
pommiers@ohsu.edu
503-494-5034
Principal Investigator
SuEllen Pommier
Last Updated:
11/18/2021
OHSU Knight Cancer Institute
Site Contact
SuEllen Pommier
pommiers@ohsu.edu
503-494-5034
Principal Investigator
SuEllen Pommier
Last Updated:
05/25/2021
NCT02409316
[18F]FES PET/CT in Endocrine Refractory Breast Cancer
In this study, positron emission tomography (PET/CT) imaging will be used to evaluate estrogen receptor (ER) activity in sites of metastatic disease using the investigational radiotracer [18F]fluoroestradiol (FES).
Active, not recruiting • Phase NA • Stage IV • Surgical • Radiation • Post-Menopausal • Interventional
University of Pennsylvania Hospital
Principal Investigator
David Mankoff, MD. PhD
Last Updated:
05/25/2021
NCT03863457
[18F] F-GLN by PET/CT in Breast Cancer
Patients with known or suspected primary or metastatic breast cancer with one lesion that is 1.5 cm in diameter or greater may be eligible for this study. Patients may participate in this study if they are at least 18 years of age. Up to 40 evaluable subjects will participate in a single imaging cohort. Patients will be stratified for analysis by breast cancer subtype with prioritization to recruit at least 10 estrogen-receptor-expressing (ER+) and 10 triple-negative breast cancers (TNBC). This is an observational study; [18F]F-GLN PET/CT will not be used to direct treatment decisions. While patients and referring physicians will not be blinded to the [18F]F-GLN PET/CT results, treatment decisions are made by the treating physicians based upon clinical criteria. [18F]F-GLN PET/CT imaging sessions will include an injection of [18F]F-GLN. Metabolism data will be collected. Pilot data will be collected to evaluate image quality and collect preliminary information on the uptake of [18F]F-GLN in breast cancer. Uptake measures will be compared to tumor markers of glutamine metabolism, when tissue is available. The safety of [18F]F-GLN will also be evaluated in all subjects.
Recruiting • Phase I • Stage IV • Post-Menopausal • Non-interventional
University of Pennsylvania
Site Contact
Erin Schubert
erin.schubert@pennmedicine.upenn.edu
215-573-6569
Principal Investigator
Austin Pantel, MD
Last Updated:
05/25/2021
NCT02608216
[18F]FLT PET/CT in Rb+ Metastatic Breast Cancer
In this study positron emission tomography (PET/CT) imaging will be used to evaluate proliferative activity in sites of metastatic disease using the investigational radiotracer [18F]fluorothymidine (FLT).
Active, not recruiting • Phase I • Stage IV • Surgical • Post-Menopausal • Interventional
University of Pennsylvania Hospital
Principal Investigator
David Mankoff, MD, PhD
Last Updated:
05/25/2021
NCT01621906
18F-FLT-PET Imaging of the Brain in Patients With Metastatic Breast Cancer to the Brain Treated With Whole Brain Radiation Therapy With or Without Sorafenib: Comparison With MR Imaging of the Brain
The purpose of this study is to compare two different imaging methods to examine the response of brain metastases to WBRT. These two imaging methods will take pictures of the brain using : 1) a positron emission tomography (PET) scanner and 2) Magnetic Resonance Imaging (MRI) scanner. A PET scanner resembles a CT or MR scanner.PET scans use radioactive substances also called as radioactive markers to "see" cancer cells. We plan to use [18F]FLT as a radioactive marker. FLT is used to image tumor growth. FLT PET scan is a new clinical procedure. It is in the testing stage of development unlike FDG-PET which is used more commonly used. Therefore, this is considered a "research" study. This will help us evaluate whether this scan will be safe and better used in the future to evaluate tumors. The amount of radiation to the body is small. The radiation from the radiotracer drug will be gone from the body in a few hours. There is no radiation risk from the MRI scans. Additionally, we also plan to use MRI imaging of the brain. We expect that [18F]FLT PET is better when compared to MRI and will give us more information about the brain metastases after WBRT.
Completed • Phase NA • Stage IV • Surgical • Radiation • Post-Menopausal • Brain Metastases present • Interventional
Memorial Sloan Kettering Cancer Center @ Suffolk
Principal Investigator
Andrew Seidman, MD
Last Updated:
05/25/2021
Memorial Sloan Kettering at Mercy Medical Center
Principal Investigator
Andrew Seidman, MD
Last Updated:
05/25/2021
Memorial Sloan Kettering Westchester
Principal Investigator
Andrew Seidman, MD
Last Updated:
05/25/2021
Memorial Sloan Kettering Cancer Center
Principal Investigator
Andrew Seidman, MD
Last Updated:
05/25/2021
NCT04727632
[18F]Fluoroestradiol-PET/CT Companion Imaging Study to the FORESEE Trial
This protocol is a companion imaging study that will add FES-PET/CT imaging to the FORESEE trial at HCI. This study will establish the feasibility of using FES-PET/CT imaging to guide therapeutic decision making for functional precision oncology trials. The unique ability of FES-PET/CT to show absence of functional estrogen receptors throughout the entire body may improve confidence among research oncologists that an ER+ metastatic breast cancer patient is truly refractory to hormonal therapies which is a critical determination in the study design of the FORESEE trial.
Recruiting • Phase NA • Stage IV • ER positive • Post-Menopausal • Interventional
Huntsman Cancer Institute at University of Utah
Site Contact
Matt Covington, MD
matt.covington@hci.utah.edu
801-585-5942
Principal Investigator
Matthew Covington, MD
Last Updated:
05/25/2021
NCT04252859
[18F]Fluoroestradiol-PET/CT Imaging of Invasive Lobular Carcinoma
FES PET/CT imaging for invasive lobular cancer
Recruiting • Phase II • Stage IV • Surgical • Post-Menopausal • Interventional
Huntsman Cancer Institute
Site Contact
Regan Butterfield Schuchart
Regan.Butterfield@hci.utah.edu
Principal Investigator
Matthew Covington, MD
Last Updated:
05/25/2021
NCT04752267
18F-FMAU PET/CT and MRI for the Detection of Brain Tumors in Patients With Brain Cancer or Brain Metastases
This early phase I trial tests the use of a radioactive tracer (a drug that is visible during an imaging test) known as 18F-FMAU, for imaging with positron emission tomography/computed tomography (PET/CT) in patients with brain cancer or cancer that has spread to the brain (brain metastases). A PET/CT scan is an imaging test that uses a small amount of radioactive tracer (given through the vein) to take detailed pictures of areas inside the body where the tracer is taken up. 18F-FMAU may also help find the cancer and how far the disease has spread. Magnetic resonance imaging (MRI) is a type of imaging test used to diagnose brain tumors. 18F-FMAU PET/CT in addition to MRI may make the finding and diagnosing of brain tumor easier.
Active, not recruiting • Phase O • Stage IV • Post-Menopausal • Brain Metastases present • Interventional
USC / Norris Comprehensive Cancer Center
Principal Investigator
Hossein Jadvar, MD
Last Updated:
05/25/2021
NCT02284919
[18F]ISO-1 Positron Emission Tomography (PET/CT) in Primary Breast Cancer
In this study, positron emission tomography (PET/CT) imaging will be used to evaluate sigma-2 (σ2) receptor activity in sites of primary breast cancer using the investigational radiotracer [18F]ISO-1.
Active, not recruiting • Phase I • Stages 0, I, II, III, IV • Post-Menopausal • Interventional
University of Pennsylvania Hospital
Principal Investigator
Elizabeth McDonald, MD, PhD
Last Updated:
05/25/2021
NCT02624700
2nd Line Treatment With Pemetrexed and Sorafenib for Recurrent or Metastatic Triple Negative Breast Cancer
This phase 2 clinical trial will evaluate the efficacy of the combination of pemetrexed and sorafenib in patients with recurrent or metastatic Triple Negative Breast Cancer (TNBC). Candidate pharmacodynamic and predictive biomarkers will also be evaluated.
Terminated • Phase II • Stages III, IV • ER negative • PR negative • HER2 negative • Medical Oncology • Post-Menopausal • Interventional
Virginia Commonwealth University/Massey Cancer Center
Principal Investigator
Andrew S Poklepovic, MD
Last Updated:
05/25/2021
NCT04136912
3-D Super Resolution Ultrasound Microvascular Imaging
This is a 3-arm single center study of 45 patients. These cohorts will include 15 breast patients scheduled to undergo a biopsy, and 15 thyroid patients scheduled to undergo fine needle aspiration, biopsy, or thyroidectomy that consent to undergo an acoustic angiography in conjunction with b-mode ultrasound prior to their scheduled biopsy. Prior to imaging clinical patients, the third arm will include 15 healthy volunteers that will be imaged to optimize imaging parameters.
Recruiting • Phase NA • Stages 0, I, II, III, IV • ER negative • Post-Menopausal • Interventional
Univeristy of North Carolina Chapel Hill
Site Contact
Carly Sronce
carly_sronce@med.unc.edu
919-966-3262
Principal Investigator
Yueh Lee, MD, PhD
Last Updated:
05/25/2021
NCT04692818
3D Ultrasound Breast Imaging
The purpose of this research is to study the efficacy of a new ultrasound imaging method for diagnosis of breast mass.
Recruiting • Phase NA • Stages 0, I, II, III, IV • Post-Menopausal • Interventional
Mayo Clinic in Rochester
Site Contact
Bobbie Ott
ott.bobbie@mayo.edu
507-293-0922
Principal Investigator
Shigao Chen
Last Updated:
05/25/2021
NCT05704283
3D Ultrasound for the Imaging of Axillary Lymph Nodes in Patients With Breast Cancer
This early phase I studies how well a new 3D ultrasound (3D-US) imaging technology works in evaluating axillary lymph nodes in patients with breast cancer. Ultrasound uses high-frequency sound waves to generate images of the body.
Recruiting • Phase O • Stages 0, I, II, III, IV • Post-Menopausal • Interventional
Mayo Clinic in Rochester
Site Contact
Clinical Trials Referral Office
mayocliniccancerstudies@mayo.edu
855-776-0015
Principal Investigator
Shigao D Chen
Last Updated:
01/31/2023
NCT04925817
3D Ultrasound Microvessel Imaging for Breast Masses
This early phase I trial studies how well 3D ultrasound microvessel imaging works for the diagnosis of breast mass. The 3D ultrasound microvessel imaging technology demonstrates significantly increased vessel detection sensitivity over conventional doppler methods without the need of using contrast agents. This study may improve cancer diagnosis and reduce unnecessary biopsy on benign tumors.
Recruiting • Phase O • Stages 0, I, II, III, IV • Post-Menopausal • Interventional
Mayo Clinic in Rochester
Site Contact
Clinical Trial Referral Office
mayocliniccancerstudies@mayo.edu
855-776-0015
Principal Investigator
Shigao D Chen
Last Updated:
06/15/2021
NCT03364348
4-1BB Agonist Monoclonal Antibody PF-05082566 With Trastuzumab Emtansine or Trastuzumab in Treating Patients With Advanced HER2-Positive Breast Cancer
This trial studies the best dose and side effects of utomilumab (4-1BB agonist monoclonal antibody PF-05082566) with trastuzumab emtansine or trastuzumab in treating patients with HER2-positive breast cancer that has spread to other places in the body. Monoclonal antibodies, such as utomilumab, trastuzumab emtansine, and trastuzumab may interfere with the ability of tumor cells to grow and spread.
Completed • Phase I • Stages III, IV • Medical Oncology • Post-Menopausal • Interventional
Stanford University, School of Medicine
Principal Investigator
George Sledge, MD
Last Updated:
05/25/2021
NCT03542695
64 Cu-DOTA-alendronate PET Imaging in Localizing and Characterizing Breast Calcifications in Participants Before Undergoing Mastectomy
This early phase I pilot trial studies how well 64Cu-DOTA-alendronate positron emission tomography (PET) imaging work in localizing and characterizing breast calcifications (small calcium deposits) in participants before undergoing mastectomy. Diagnostic procedures, such 64Cu-DOTA-alendronate PET, may detect calcification and help doctors predict cancer associated calcification within breast tissue.
Recruiting • Phase O • Stages 0, I, II, III, IV • Post-Menopausal • Interventional
City of Hope Medical Center
Site Contact
Veronica C. Jones, MD
vjones@coh.org
626-471-7100
Principal Investigator
Veronica Jones, MD
Last Updated:
05/25/2021
NCT03831711
68-Ga-RM2 PET/MRI in Imaging Patients With Estrogen Receptor-Positive Breast Cancer
This trial studies how well 68-Ga RM2 works with PET/MRI in imaging patients with estrogen receptor-positive breast cancer. 68-Ga-RM2 is an agent used in diagnostic imaging.
Suspended • Phase I • Stages I, II, III • Post-Menopausal • Interventional
NCT03678883
9-ING-41 in Patients With Advanced Cancers
GSK-3β is a potentially important therapeutic target in human malignancies. The Actuate 1801 Phase 1/2 study is designed to evaluate the safety and efficacy of 9-ING-41, a potent GSK-3β inhibitor, as a single agent and in combination with cytotoxic agents, in patients with refractory cancers.
Recruiting • Phase II • Stages III, IV • Post-Menopausal • Interventional
INCLIVA University of Valencia
Site Contact
Andrés Cervantes, MD
andres.cervantes@uv.es
Last Updated:
05/25/2021
START Madrid-HM CIOCC Hospital Universitario
Site Contact
Emiliano Calvo, MD
emiliano.calvo@startmadrid.com
Last Updated:
05/25/2021
Netherlands Cancer Institute
Site Contact
Andrew P Mazar, PhD
amazar@actuatetherapeutics.com
(858) 922-6618
Last Updated:
11/18/2021
NCT03962647
A 2-Week Ketogenic Diet in Combination With Letrozole to Modulate PI3K Signaling in ER+ Breast Cancer
This is a neoadjuvant study to determine the feasibility and tolerability of 2 weeks of a very low carbohydrate ketogenic diet in combination with letrozole for patients with early stage operable ER+disease.
Recruiting • Phase I • Stages I, II, III • ER positive • Medical Oncology • Post-Menopausal • Brain Metastases absent • Interventional
Vanderbilt-Ingram Cancer Center
Site Contact
Vanderbilt-Ingram Service Information Program
cip@vumc.org
800-811-8480
Principal Investigator
Brent Rexer, MD, PhD
Last Updated:
05/25/2021
NCT03927768
Abbreviated Breast MRI (AB-MRI) With Golden-angle Radial Compressed-sensing and Parallel Imaging (GRASP)
The purpose of this study is to use a magnetic resonance imaging (MRI) sequence called golden-angle radial compressed sensing and parallel imaging (GRASP) as a noninvasive and fast way to measure the wash-in contrast (dye) in the breast. MRI uses a strong magnetic field and radio waves to create images of structures in the body. The goal is to determine if benign and malignant breast lesions have different patterns of contrast wash in. This study will ask woman planning to undergo a clinical breast MRI with contrast (dye) as part of their standard care.
Active, not recruiting • Phase NA • Stages 0, I, II, III, IV • Post-Menopausal • Non-interventional
NCT03664778
Abbreviated Breast MRI After Cancer Treatment
500 patients will be prospectively recruited to undergo a fast breast MRI examination. The women will be recruited for the study will meet the following criteria: 1. status post primary breast cancer treated with breast conservation therapy 3 years prior to recruitment 2. negative DBT examination six months prior to recruitment 3. all breast densities 4. clinically asymptomatic - no palpable masses, focalthickening, or clinically significant discharge We will identify these patients EPIC database utilizing the date of their last mammogram. The patients will be sent a letter explaining the study and the opportunity to enroll in the study. Interested patients may contact our research coordinators by the phone number provided in the letter. The study recruitment information will also be shared with referring physicians. Physicians may also directly refer patients to the study.
Active, not recruiting • Phase NA • Stage 0 • ER negative • Post-Menopausal • Brain Metastases absent • Non-interventional
NCT04341129
Abbreviated MRI Protocol: Initial Experience With Dotarem® (Gadoterate Meglumine)
Standard breast MRI studies often have lengthy protocols that make them inherently expensive and time-consuming. Several studies of the use of abbreviated MRI protocols have shown that the shorter protocols have diagnostic accuracy comparable to that of the conventional full MRI protocol. There are also promising results of ultrafast DCE-MRI studies with shorter breast MRI protocols that provide not only morphologic but also valuable kinetic information about a lesion. The shorter imaging times achieved with the abbreviated and the ultrafast DCE-MRI protocols have the potential to increase efficiency and lower cost by decreasing time in the MRI suite, which in turn may make breast MRI accessible for population-based mass screening. The focus of the proposed research is the investigation of an abbreviated MRI protocol with ultrafast imaging using Dotarem® (Gadoterate Meglumine).
Recruiting • Phase NA • Stages 0, I, II, III, IV • Post-Menopausal • Interventional
University of Chicago Medicine
Site Contact
Brenda Gonzales
BGonzales@radiology.bsd.uchicago.edu
773-702-1089
Principal Investigator
Hiroyuki Abe, MD
Last Updated:
05/25/2021
NCT04854304
Abbreviate or FAST Breast MRI for Supplemental Breast Cancer Screening for Black Women at Average Risk and Dense Breasts
500 patients will be prospectively recruited to undergo a fast breast MRI examination. The women will be recruited for the study will meet the following criteria: 1. African American 2. negative DBT examination 11 months prior to recruitment 3. Heterogeneously and Extremely breast densities 4. clinically asymptomatic- no palpable masses, focal thickening or clinically significant discharge. Investigators will identify these patients EPIC database utilizing the date of their last mammogram. Interested patients may contact our research coordinators by the phone number provided in the recruitment materials. The study recruitment information will also be shared with referring physicians. Physicians may also directly refer patients to the study.
Recruiting • Phase NA • Stages 0, I, II, III, IV • ER negative • PR negative • HER2 negative • Surgical • Medical Oncology • Post-Menopausal • Interventional
UPENN
Site Contact
Jessica Nunez
Jessica.Nunez@pennmedicine.upenn.edu
215-746-6788
Principal Investigator
Emily F Conant, MD
Last Updated:
12/06/2021
NCT04305834
Abemaciclib and Endocrine Therapy in Older Patients With Breast Cancer.
This phase IIa trial studies the side effects of abemaciclib monotherapy in treating patients age 70 years and older with hormone receptor positive, HER2 negative breast cancer that has spread to other places in the body.
Recruiting • Phase II • Stage IV • ER positive • PR positive • HER2 negative • Post-Menopausal • Brain Metastases present • Interventional
City of Hope Medical Center
Site Contact
Mina Sedrak
msedrak@coh.org
626-256-4673
Principal Investigator
Mina Sedrak
Last Updated:
05/25/2021
NCT04481113
Abemaciclib and Niraparib Before Surgery for the Treatment of Hormone Receptor Positive HER2 Negative Breast Cancer
This phase I trial tests the side effects and best dose of abemaciclib and niraparib in treating patients with breast cancer that is positive for estrogen or progesterone receptors (hormone receptor positive [HR+]) and HER2 negative. Abemaciclib may stop the growth of tumor cells by blocking certain proteins called cyclin-dependent kinases, which are needed for cell growth. PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as niraparib, can keep PARP from working so tumor cells can't repair themselves and grow. Giving abemaciclib and niraparib together before surgery may make the tumor smaller.
Active, not recruiting • Phase I • Stages I, II, III • ER positive • PR positive • HER2 negative • Post-Menopausal • Interventional
NCT03130439
Abemaciclib for Patients With Retinoblastoma-Positive, Triple Negative Metastatic Breast Cancer
This research study is studying a drug called Abemaciclib as a possible treatment for have metastatic triple-negative type of breast cancer.
Terminated • Phase II • Stages III, IV • ER negative • PR negative • HER2 negative • Post-Menopausal • Interventional
NCT05095207
Abemaciclib in Combination With Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer
This is an open label multicenter, Phase IB/II Study of Abemaciclib in Combination with Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer
Recruiting • Phases I, II • Stages III, IV • HER2 negative • Post-Menopausal • Interventional
Dubin breast Center
Site Contact
Atul G Joshi, MS
gargiatul.joshi@mssm.edu
212-824-7320
Principal Investigator
Amy Tiersten, MD
Last Updated:
10/28/2021
Mount Sinai Beth Israel
Site Contact
Gargi A Joshi, MS
gargiatul.joshi@mssm.edu
212-824-2333
Principal Investigator
Amy Tiersten, MD
Last Updated:
10/28/2021
Mount Sinai Beth Israel
Site Contact
Gargi A Joshi, MS
gargiatul.joshi@mssm.edu
212-824-2333
Principal Investigator
Amy Tiersten, MD
Last Updated:
11/18/2021
Mount Sinai - West
Site Contact
Gargi A Joshi, MS
gargiatul.joshi@mssm.edu
212-824-2333
Principal Investigator
Amy Tiersten, MD
Last Updated:
10/28/2021
NCT03979508
Abemaciclib in Treating Patients With Surgically Resectable, Chemotherapy Resistant, Triple Negative Breast Cancer
This phase II trial studies how well abemaciclib works in treating patients with triple negative breast cancer that can be removed by surgery (resectable) and does not respond to treatment with chemotherapy alone, or in combination with pembrolizumab. Abemaciclib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Recruiting • Phase II • Stages 0, I, II, III • ER negative • PR negative • HER2 negative • Post-Menopausal • Brain Metastases absent • Interventional
Mayo Clinic in Florida
Site Contact
Clinical Trials Referral Office
maycliniccancerstudies@mayo.edu
855-776-0015
Principal Investigator
Matthew P Goetz
Last Updated:
05/25/2021
Mayo Clinic in Rochester
Site Contact
Clinical Trials Referral Office
mayocliniccancerstudies@mayo.edu
855-776-0015
Principal Investigator
Matthew P Goetz
Last Updated:
05/25/2021
Mayo Clinic in Arizona
Site Contact
Clinical Trials Referral Office
mayocliniccancerstudies@mayo.edu
855-776-0015
Principal Investigator
Matthew P Goetz
Last Updated:
05/25/2021
NCT05169567
Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer
This study will evaluate the effect of adding abemaciclib to fulvestrant for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer that progressed or recurred after previous treatment with a type of drug known as a CDK4/6 inhibitor and endocrine therapy. Participation could last up to 5 years, depending on how you and your tumor respond.
Recruiting • Phase III • Stages III, IV • HER2 negative • Post-Menopausal • Brain Metastases absent • Interventional
H.R.U Málaga - Hospital Materno-infantil
Site Contact
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
ClinicalTrials.gov@lilly.com
1-317-615-4559
Principal Investigator
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Last Updated:
12/28/2021
Hospital Clínico Universitario Virgen de la Arrixaca
Site Contact
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
ClinicalTrials.gov@lilly.com
1-317-615-4559
Principal Investigator
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Last Updated:
12/28/2021
Hospital Infanta Cristina
Site Contact
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
ClinicalTrials.gov@lilly.com
1-317-615-4559
Principal Investigator
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Last Updated:
05/25/2022
Hospital Universitario Doctor Peset
Site Contact
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
ClinicalTrials.gov@lilly.com
1-317-615-4559
Principal Investigator
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Last Updated:
12/28/2021
Hospital Universitari Son Espases
Site Contact
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
ClinicalTrials.gov@lilly.com
1-317-615-4559
Principal Investigator
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Last Updated:
03/08/2022
NCT04523857
ABemacicliB or Abemaciclib and HydroxYchloroquine to Target Minimal Residual Disease in Breast Cancer
This is a Phase II randomized, controlled, open label breast cancer clinical trial. 66 patients will be enrolled. The drugs being studied are hydroxychloroquine (Plaquenil) and abemaciclib (also Verzenio). This research study is testing whether using these drugs to target the disseminated tumor cells in bone marrow can reduce their number or eliminate them. Both hydroxychloroquine and abemaciclib are pills that will be taken twice daily. Both are approved by the FDA
Recruiting • Phase II • Stages I, II, III • ER positive • PR positive • HER2 negative • Post-Menopausal • Interventional
Abramson Cancer Center of the University of Pennsylvania
Site Contact
Lauren Bayne, PhD
lajesse@pennmediicne.upenn.edu
215-349-5398
Principal Investigator
Amy Clark, MD
Last Updated:
05/25/2021
NCT05086692
A Beta-only IL-2 ImmunoTherapY (ABILITY) Study
This is a Phase 1/2, multi-center, open-label, dose-escalation and expansion study to evaluate safety and tolerability, PK, pharmacodynamic, and early signal of anti-tumor activity of MDNA11 alone or in combination with a checkpoint inhibitor in patients with advanced solid tumors.
Recruiting • Phases I, II • Stages III, IV • ER negative • PR negative • HER2 negative • Post-Menopausal • Interventional
Boca Raton Regional Hospital
Site Contact
Nina Merchant
nmerchant@medicenna.com
604-340-3081
Principal Investigator
Nina Merchant
Last Updated:
04/14/2022
Princess Margaret Cancer Center
Site Contact
Nina Merchant
nmerchant@medicenna.com
604-340-3081
Principal Investigator
Nina Merchant
Last Updated:
04/14/2022
Orlando Health Cancer Institute
Site Contact
Nina Merchant
nmerchant@medicenna.com
604-340-3081
Principal Investigator
Nina Merchant
Last Updated:
04/14/2022
Gabrail Cancer Center Research
Site Contact
Nina Merchant
nmerchant@medicenna.com
604-340-3081
Principal Investigator
Nina Merchant
Last Updated:
02/18/2022
Emory - Winship Cancer Institute
Site Contact
Nina Merchant
nmerchant@medicenna.com
604-340-3081
Principal Investigator
Nina Merchant
Last Updated:
08/18/2022
NCT04498520
Abexinostat, Palbociclib, and Fulvestrant for the Treatment of Breast or Gynecologic Cancer
This phase I trial investigates the side effects and best dose of abexinostat and palbociclib when given together with fulvestrant in treating patients with breast or gynecologic cancer. Abexinostat may prevent tumor cells from growing and multiplying and may kill tumor cells. Palbociclib may prevent or slow the growth of tumor cells when used with other anti-hormonal therapy. Estrogen can cause the growth of breast and gynecologic tumor cells. Fulvestrant may help fight breast or gynecologic cancer by blocking the use of estrogen by the tumor cells. Giving abexinostat, palbociclib, and fulvestrant may work better in treating patients with breast or gynecologic cancer.
Withdrawn • Phase I • Stages III, IV • ER positive • PR positive • HER2 negative • Medical Oncology • Post-Menopausal • Interventional
Moffitt Cancer Center
Site Contact
Ricardo L. Costa, MD, MSc
813-745-6100
Principal Investigator
Pamela N Munster, MD
Last Updated:
05/25/2021
University of California, San Francisco
Site Contact
Denisha Otis
Denisha.Otis@ucsf.edu
415-514-6638
Principal Investigator
Pamela N Munster, MD
Last Updated:
05/25/2021
NCT03300843
Ability of a Dendritic Cell Vaccine to Immunize Melanoma or Epithelial Cancer Patients Against Defined Mutated Neoantigens Expressed by the Autologous Cancer
Background: Exomes are the parts of deoxyribonucleic acid (DNA) that make proteins. Researchers are finding a way to read the letters in the exome. Incorrect letters are called mutations. Tumors contain specific mutations. Researchers can find these mutations in tumors to make treatments. Researchers want to use pieces of participants tumors to find the tumor-specific mutations. They also will take participants white blood cells to make a vaccine that they hope will shrink the tumors. Objectives: To see if dendritic vaccine tumor-fighting cells are safe and can cause certain cancer tumors to shrink. Eligibility: Adults ages 18-70 who have metastatic melanoma or metastatic epithelial cancer Design: The first part of this study was done under protocol 03-C-0277. In that study, white blood cells and pieces of participants' tumors were taken to make a vaccine. In this study, participants will get a vaccine every 2 weeks for 8 weeks. It will be given both in a vein and under the skin. At each visit, participants will have a physical exam and have blood taken. They will talk about any side effects they have. After treatment ends, participants will have many follow-up visits for …
Terminated • Phase II • Stage IV • Medical Oncology • Post-Menopausal • Brain Metastases present • Interventional
National Institutes of Health Clinical Center
Principal Investigator
Steven A Rosenberg, M.D.
Last Updated:
05/25/2021
NCT02788981
Abraxane® With or Without Mifepristone for Advanced, Glucocorticoid Receptor-Positive, Triple-Negative Breast Cancer
This is a randomized, placebo-controlled, double-blind, phase II trial of nab-paclitaxel with or without mifepristone for advanced, glucocorticoid receptor-positive, triple-negative breast cancer. A total of 64 patients will receive nab-paclitaxel. Patients will be randomly assigned to either receive placebo or to receive mifepristone daily on the day prior to and day of each dose of nab-paclitaxel. Patients will be enrolled over 12 months and followed for 12 months following completion of study. To expand and follow up on the investigators understanding of a potential pharmacokinetic (PK) interaction between nab-paclitaxel and mifepristone, investigators will perform PK studies in the first 20 patients enrolled at pre-specified "PK sites".
Active, not recruiting • Phase II • Stages III, IV • ER negative • PR negative • HER2 negative • Post-Menopausal • Interventional
Froedtert and the Medical College of Wisconsin
Principal Investigator
Rita Nanda, M.D.
Last Updated:
05/25/2021
NCT02823262
A Breast Cancer Treatment Decision Aid for Women Aged 70 and Older
The purpose of this research study is to evaluate a decision aid to help women aged 70 and older decide on treatment for their breast cancer.
Completed • Phase NA • Stages 0, I, II, III • ER positive • HER2 negative • Post-Menopausal • Brain Metastases absent • Interventional
Beth Israel Deaconess Medical Center
Principal Investigator
Mara Schonberg, MD MPH
Last Updated:
05/25/2021
Beth Israel Deaconess Medical Center
Principal Investigator
Mara Schonberg, MD MPH
Last Updated:
11/18/2021
NCT03544268
Academic-Industrial Partnership for Translation of Acoustic Angiography
Purpose: The primary objective of this single arm study is to compare the sensitivity and specificity of acoustic angiography with traditional b-mode ultrasound in the distinction of malignant versus benign breast lesions. Secondary objectives include a comparison of area under the curve (AUC) for acoustic angiography versus b-mode ultrasound, and comparison of radiologist preference for the two imaging techniques for each of 3 lesion characteristics. Participants: Sixty patients who are to have a clinical surgical breast biopsy based on results from pre-study standard of care (SOC) imaging will be recruited from the UNC Breast Clinic for participation in the study. Procedures (methods): This is a one arm single center study of patients with suspicious breast lesions (BIRADS 4 or 5) from the UNC Breast Clinic that consent to undergo an acoustic angiography in conjunction with b-mode ultrasound prior to their scheduled biopsy.
Recruiting • Phase IV • Stages 0, I, II, III, IV • ER negative • Surgical • Medical Oncology • Post-Menopausal • Interventional
UNC Hospitals
Site Contact
Desma Jones, CCRC
desma_jones@med.unc.edu
Principal Investigator
Lee, Yueh-Lun
Last Updated:
05/25/2021
NCT02526498
Accelerated Partial Breast Radiation Therapy Using High-Dose Rate Brachytherapy in Treating Patients With Early Stage Breast Cancer After Surgery
This phase II trial studies how well accelerated partial breast irradiation (APBI) using high-dose rate (HDR) brachytherapy works in treating patients with breast cancer that has not spread beyond the breast or the axillary lymph nodes (early-stage) after surgery. Radiation therapy uses a type of energy to kill cancer cells and shrink tumors. Brachytherapy is a type of internal radiation therapy that provides radiation inside the breast to any remaining tumor cells next to the space where the tumor was removed, and is given over a shorter amount of time than standard radiation therapy. Giving accelerated partial breast irradiation (APBI) using high-dose rate (HDR) brachytherapy may reduce the overall time that radiation is delivered to the tumor cells.
Completed • Phase II • Stages 0, I, II • ER positive • PR positive • Post-Menopausal • Brain Metastases absent • Interventional
Rutgers Cancer Institute of New Jersey
Principal Investigator
Bruce Haffty, MD
Last Updated:
11/18/2021
Rutgers Cancer Institute of New Jersey
Principal Investigator
Bruce Haffty, MD
Last Updated:
05/25/2021
RWJBarnabas Health - Robert Wood Johnson University Hospital
Principal Investigator
Bruce Haffty, MD
Last Updated:
08/17/2022
NCT03775213
Acceptability of Active Monitoring (AM) as a Treatment Option for Ductal Carcinoma in Situ (DCIS)
The purpose of this research study is to evaluate a decision support tool for patients diagnosed with ductal carcinoma in situ (DCIS).
Completed • Phase NA • Stage 0 • Post-Menopausal • Brain Metastases absent • Interventional
NCT02019303
Accuracy of FNA Versus CNB of Abnormal Axillary Lymph Nodes in Setting of Invasive Breast Cancer
To compare accuracy of ultrasound guided fine needle aspiration (FNA) to core needle biopsy (CNB) of ultrasound detected abnormal axillary lymph nodes in patients with newly diagnosed invasive breast cancer or suspected invasive breast cancer. Hypothesis: FNA and CNB have equivalent diagnostic accuracies In order to prove our hypothesis, we will perform FNA and CNB on the same lymph node in each consented patient. The two samples will be evaluated separately by different pathologists blinded to the material in the other sample. The results of the biopsies will be compared to the gold standard (lymph node excision).
Completed • Phase NA • Stages 0, I, II, III, IV • Post-Menopausal • Interventional
Huntsman Cancer Hospital
Last Updated:
11/18/2021
Huntsman Cancer Hospital
Last Updated:
05/25/2021
NCT05001347
A Clinical Study of TJ004309 With Atezolizumab (TECENTRIQ®) in Patients With Ovarian Cancer and Selected Solid Tumors
This is a multicenter, open label, Phase 2 study of TJ004309 in combination with atezolizumab in patients with advanced or metastatic solid tumors.
Active, not recruiting • Phase II • Stages III, IV • ER negative • PR negative • HER2 negative • Post-Menopausal • Interventional
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Last Updated:
02/03/2022
New York Oncology Hematology
Last Updated:
02/03/2022
Medical Oncology Hematology Consultants, PA
Last Updated:
11/16/2022
Medical Oncology Hematology Consultants
Last Updated:
02/03/2022
Virginia Cancer Specialists
Last Updated:
02/03/2022
NCT00887536
A Clinical Trial Comparing the Combination of TC Plus Bevacizumab to TC Alone and to TAC for Women With Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer
The main purpose of this study is to learn if adding bevacizumab to standard treatment with chemotherapy (docetaxel, doxorubicin, and cyclophosphamide) for early stage HER2-negative breast cancer will prevent breast cancer from returning. A second purpose of this study is to learn if adding bevacizumab to treatment with chemotherapy will help women with HER2-negative breast cancer live longer. The researchers also want to learn about the side effects of the combination of drugs used in this study.
Completed • Phase III • Stages I, II, III • HER2 negative • Medical Oncology • Post-Menopausal • Brain Metastases absent • Interventional
NCT04711252
A Comparative Study of AZD9833 Plus Palbociclib Versus Anastrozole Plus Palbociclib in Patients With ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease
The study is intended to show superiority of AZD9833 in combination with palbociclib (a CDK4/6 inhibitor) versus anastrozole (an aromatase inhibitor) and palbociclib as the initial treatment of patients with hormone receptor-positive (ER-positive), human epidermal growth factor 2-negative (HER2-negative) advanced/metastatic breast cancer. INFORMATION FOR TRIAL PARTICIPANTS In this trial, the researchers will look at how well camizestrant with palbociclib works, compared with anastrozole with palbociclib, in participants with breast cancer that has either spread into other parts of the body at the time of diagnosis, or has come back after at least 2 years of standard endocrine treatment. Participants in this trial will have breast cancer that has ER proteins but does not have overexpression of HER2 protein.
Recruiting • Phase III • Stage IV • ER positive • PR positive • HER2 negative • Post-Menopausal • Interventional
Research Site
Site Contact
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Last Updated:
11/18/2021
Research Site
Site Contact
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Last Updated:
11/18/2021
Research Site
Site Contact
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Last Updated:
11/18/2021
Research Site
Site Contact
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Last Updated:
05/31/2023
Research Site
Site Contact
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Last Updated:
11/18/2021
NCT01792726
A Comparison of Intra-operative Radiotherapy Boost With External Beam Radiotherapy Boost in Early Breast Cancer.
TARGIT-Boost is an international randomised clinical trial designed to test the hypothesis that the tumour bed boost delivered as a single dose of targeted intraoperative radiotherapy (TARGIT-B) is superior to the conventional course of external beam radiotherapy boost (EBRT-Boost), especially in women with high risk of local recurrence. It is a pragmatic trial in which each participating centre can use the local predefined inclusion/exclusion criteria for entry into the trial. Only centres with access to the Intrabeam® (Carl Zeiss) are eligible to enter patients into the trial. Eligible patients are those with a higher risk of local recurrence after breast conserving surgery. After giving consent patients are randomised to either TARGIT Boost or EBRT Boost. All patients will receive whole breast EBRT. They may receive any other adjuvant treatments as deemed necessary. The protocol recommends that patients be followed at six monthly intervals for three years and then annually. The primary endpoint is ipsilateral breast recurrence rate. Secondary endpoints are relapse-free survival, site of recurrence, overall survival (breast-cancer specific and non-breast cancer deaths) patient…
Recruiting • Phase NA • Stages I, II, III • ER negative • PR negative • Radiation • Post-Menopausal • Interventional
Hospital Universitario Dr Negrín
Site Contact
Pedro C Lara, MD
Principal Investigator
Jayant S Vaidya, MBBS FRCS
Last Updated:
06/16/2021
Netcare Milpark Hospital
Site Contact
Kyara Bergstrom
Principal Investigator
Jayant S Vaidya, MBBS FRCS
Last Updated:
06/16/2021
Institut Català d'Oncologia
Site Contact
Montse Ventura
montseventura@iconcologia.net
Principal Investigator
Jayant S Vaidya, MBBS FRCS
Last Updated:
06/16/2021
Institut Universitaire du Cancer de Toulouse - Oncopole
Site Contact
Francoise Izar, MD
Principal Investigator
Jayant S Vaidya, MBBS FRCS
Last Updated:
06/16/2021
Hôpital Nord
Site Contact
Didier Cowen, MD
Principal Investigator
Jayant S Vaidya, MBBS FRCS
Last Updated:
06/16/2021
NCT04594473
A Comprehensive Oncology Rehabilitation and Exercise (CORE) Program Among Breast Cancer Survivors
The objective of this study is to demonstrate the feasibility and acceptability of the algorithm utilized within a cancer rehab program, named Comprehensive Oncology Rehabilitation and Exercise (CORE) program, among newly diagnosed stage I-III breast cancer survivors, providers, and clinic staff. Additionally, this study aims to generate preliminary estimates on the extent to which CORE, compared with standard of care (SOC), elicits engagement in exercise and impacts changes in physical function and quality of life within this population.
Recruiting • Phase NA • Stages 0, I, II, III, IV • Post-Menopausal • Interventional
Huntsman Cancer Institute
Site Contact
Adriana Coletta, PHD, MS, RD
adriana.coletta@hci.utah.edu
801-213-6012
Last Updated:
05/25/2021
NCT02694029
Active Breathing Coordinator-based vs VisionRT-based Deep Inspiration Breath-hold for Radiation for Breast Cancer
Female patients treated with radiation for left-sided breast malignancy will undergo alternate fractions of Active Breathing Coordinator (ABC)-assisted and VisionRT-assisted Deep Inspiration Breath-Hold (DIBH).
Completed • Phase NA • Stages 0, I, II, III, IV • Radiation • Post-Menopausal • Interventional
The University of Texas Southwestern Medical Center
Principal Investigator
Asal Rahimi, MD
Last Updated:
05/25/2021
NCT05662345
ACT-MBC: A Study of Circulating Tumor Cells (CTCs) in Metastatic Breast Cancer (MBC)
ACT-MBC prospectively assesses the impact of CTCs on treatment decisions, response assessment and prognosis in MBC patients.
Recruiting • Phase NA • Stages III, IV • HER2 negative • Post-Menopausal • Non-interventional
Mayo Clinic Health System Albert Lea
Site Contact
Mina Hanna, MD
Hanna.Mina@mayo.edu
Last Updated:
02/24/2023
Mayo Clinic Health System Mankato
Site Contact
Amrit Singh, MBBS
Singh.Amrit@mayo.edu
Last Updated:
02/24/2023
NCT02946697
A Culturally Sensitive Social Support Intervention
This study is a randomized controlled trial (RCT) to assess the impact of a culturally based social support program (i.e. Joy Luck Academy, JLA) among Chinese American breast cancer survivors.
Recruiting • Phase NA • Stages 0, I, II, III • Surgical • Post-Menopausal • Brain Metastases absent • Interventional
Herald Cancer Association
Site Contact
Alice Loh
626-286-2600
Principal Investigator
Qian Lu, PhD; MD
Last Updated:
05/25/2021
NCT03091647
Acupressure for Cancer-Related Fatigue
This study develops and pilot tests the efficacy of a home-based, self-administered acupressure intervention in improving cancer-related fatigue (proximal outcome), and physical functioning and other quality of life outcomes (distal outcomes) of Chinese immigrant breast cancer survivors (versus usual care control group).
Active, not recruiting • Phase NA • Stages 0, I, II, III, IV • ER negative • Surgical • Post-Menopausal • Brain Metastases absent • Interventional
NCT03783546
Acupuncture for Hot Flashes in Hormone Receptor-Positive Breast Cancer, a Randomized Controlled Trial
This research study is evaluating acupuncture, a medical therapy in which hair-thin, stainless steel needles are shallowly inserted into specific points to help the body's natural healing process, as a possible treatment to reduce hot flashes.
Active, not recruiting • Phase NA • Stages I, II, III • ER positive • PR positive • Post-Menopausal • Brain Metastases absent • Interventional
NCT03505671
Acupuncture in Reducing Chemotherapy-Induced Peripheral Neuropathy in Participants With Stage I-III Breast Cancer
The goal of this study is to obtain preliminary evidence of the effect of 8 acupuncture treatments over 10 weeks in breast and GI cancer patients who are currently receiving or recently completed active neurotoxic chemotherapy and have clinically documented grade 1 or 2 neuropathy.
Completed • Phase NA • Stages I, II, III • Surgical • Post-Menopausal • Interventional
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