Stanford APBI Trial
Clinical Trial
Overview
Accelerated, partial breast irradiation (APBI) is a potentially important new way to incorporate radiotherapy in the treatment of women with breast cancer.
Currently, women with breast cancer who undergo a lumpectomy typically have 6 1/2 weeks of radiation to the entire affected breast after surgery. Accelerated, partial breast irradiation (APBI) changes this approach in two ways. It shortens the treatment time from 6 1/2 weeks to between 1 to 5 days, and reduces the treatment area from the entire breast to the area of the breast immediately around the lumpectomy site. This is the part of the breast where most cancers are likely to recur.
In many ways APBI is to current whole breast radiotherapy what a lumpectomy is to a mastectomy. The goal is to use a less invasive more focused treatment without compromising survival.
APBI has been used in limited trials in several hundred patients over the last 10 years. These trials show that in properly selected breast cancer patients APBI worked just as well as whole breast radiotherapy. In the initial studies, investigators relied on the placement of many catheters in the breast tissue (interstial brachytherapy). Newer techniques will hopefully provide the same good results but will deliver the radiation in faster and/or more convenient ways. This could increase interest in APBI and allow additional clinical trials that test the safety and effectiveness of the newer approaches. These newer approaches could increase quality of life for many women with breast cancer.
Investigators at Stanford University Medical Center are currently offering an IRB approved clinical trial that uses three new approaches for APBI. These three approaches are:
Intraoperative Radiotherapy (IORT) - 1 day
Intracavitary Brachytherapy (MammoSite) - 5 days
3-D Conformal/External Beam Radiotherapy - 5 days
The Stanford trial is led by Dr. Frederick Dirbas, Assistant Professor of Surgery, and by Dr. Donald Goffinet, Professor of Radiation Oncology. For further information about the trial please contact Janelle Maxwell or Triona Dolphin at (650) 498-7740.
A Study of LY3154207 in Participants With Dementia Due to Lewy Body Dementia (LBD) Associated With Idiopathic Parkinson's Disease (PD) or Dementia With Lewy Bodies (DLB)
A randomized placebo-controlled trial to evaluate the safety and efficacy of three doses of study drug LY3154207 treated for 12 weeks in participants with mild-to-moderate dementia associated with LBD (PDD or DLB).
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: LY3154207
- drug: Placebo
Eligibility
Inclusion Criteria:
- Have dementia as defined by a decline in cognitive function, which in the opinion of
the investigator has resulted in functional impairment.
- Meet diagnostic criteria for PD per MDS criteria or DLB per 4th Consensus Report of
the DLB Consortium.
- Have a score on the MoCA of 10 - 23.
- Are Modified Hoehn and Yahr Stages 0 - 4.
- Have a blood pressure (BP) or pulse rate at screening and randomization, as determined
by three sequential BP/pulse rate measurements in a seated position:
- Participants <60 years old:
1. A mean systolic BP less than or equal to 140 millimeters of mercury (mmHg),
a mean diastolic BP less than or equal to 90 mmHg and a mean pulse rate less
than or equal 90 beats/minute in a seated position.
2. Each of the 3 systolic BP measurement must be less than 180 mmHg
- Participants ≥60 years old:
1. A mean systolic BP less than or equal to 150 mmHg, a mean diastolic BP less
than or equal to 90 mmHg and a mean pulse rate less than or equal to 90
beats/min in a seated position.
2. Each of the 3 systolic BP measurement must be less than 180 mmHg
- If on anti-parkinsonian agents, participants must be on stable dosage for at least 3
weeks prior to screening, and should remain on stable doses during the course of the
study.
- If on medications affecting cognition (rivastigmine, galantamine, donepezil,
memantine), participants must be on stable dosage for at least 3 weeks prior to
screening and should remain at a stable dosage during the course of the study.
- If on antidepressant medications, participants must be on stable dosage for at least 3
weeks prior to screening and should remain at a stable dosage during the course of the
study.
- If on clozapine, quetiapine, and pimavanserin to address drug induced or disease
related psychosis, participants must be on stable dosage for 3 weeks prior to
screening and should remain at a stable dosage during the course of the study.
- If on antihypertensive medications, participants must be on stable dosage for at least
3 weeks prior to screening.
- Men should use appropriate contraception.
- All participants must have a reliable caregiver who is in frequent contact with the
participant (defined as at least 10 hours per week) and will accompany the participant
to screening, baseline, day 7, day 42, day 84 and follow-up.
Exclusion Criteria:
- Are women of childbearing potential.
- Have significant central nervous system or psychiatric disease, other than PD or DLB,
that in the investigator's opinion may affect cognition or the ability to complete the
study.
- Have a history in the last 6 months of transient ischemic attacks or ischemic stroke.
- Have a history of intra cerebral hemorrhage due to hypertension.
- Have a history of hypertensive encephalopathy.
- Have atypical or secondary parkinsonism due to drugs (e.g., antipsychotics) or disease
(such as progressive supranuclear palsy, essential tremor, multiple system atrophy
(e.g. striatonigral degeneration, olivopontocerebellar atrophy), or postencephalitic
parkinsonism).
- Have a current implantable intracranial stimulator or history of intracranial ablation
surgery (e.g., subthalamic, globus pallidus-internal segment [GPi]).
- Have a history of substance abuse within the past 1 year (drug categories defined by
the Diagnostic and Statistical Manual of Mental Disorder, 5th Edition [DSM-5], and/or
substance dependence within the past 1 year, not including caffeine and nicotine.
- Have a serious or unstable medical illness, other than idiopathic LBD (PDD or DLB),
including cardiovascular, hepatic, respiratory, hematologic, endocrinologic,
neurologic, or renal disease, or clinically significant laboratory or
electrocardiogram (ECG) abnormality as determined by the investigator.
- Have a history in the last 6 months of exertional angina, unstable angina,
myocardial infarction, and acute coronary syndrome.
- Have a history of heart failure of either New York Heart Association Class III or
IV.
- A history of additional risk factors for Torsades de Pointes (TdP; [e.g., chronic
hypokalemia, family history of Long QT Syndrome]).
- Participants with acute liver disease (e.g. acute viral hepatitis, alcoholic
hepatitis); participants with a known chronic liver disease (e.g. hepatitis B, C,
alcoholic liver disease, cirrhosis); alanine aminotransferase (ALT) or aspartate
aminotransferase (AST) equal to or higher than 2X upper limit of normal (ULN); total
bilirubin (TBL) equal to or higher than 1.5X ULN; (except for participants with
Gilbert's syndrome); or alkaline phosphatase (ALP) equal to or higher than 2X ULN.
- Participants have answered 'yes' to either Question 4 (Active Suicidal Ideation with
Some Intent to Act, Without Specific Plan) or Question 5 (Active Suicidal Ideation
with Specific Plan and Intent) on the "Suicidal Ideation" portion of the Columbia
Suicide Severity Rating Scale (C-SSRS)- Children's version, or answer "yes" to any of
the suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt).
- Have used antipsychotic medications, with the exception of clozapine, quetiapine,
pimavanserin in the 6 months prior to screening and at any time during the course of
the study.
- Have used anticholinergics trihexyphenidyl and benztropine in the 4 weeks prior to
screening and at any time during the course of the study.
- Have motor conditions for which the antiparkinsonian treatment is expected to change
during the course of the study, as well as unpredictable motor fluctuations that in
the investigator's opinion would interfere with administering assessments.
- Are taking any medications or food, herbal or dietary supplements that are inhibitors
(e.g., ketoconazole, grapefruit juice), or strong/moderate inducers of cytochrome P450
3A4 (CYP3A4) (e.g., rifampicin) or are unable or unwilling to discontinue usage of
them 4 weeks prior to first dose of study drug.
Ages Eligible for Study
40 Years - 85 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Stephanie Tran
650-723-6469
Not Recruiting
What's New
Stanford’s APBI trial has now been expanded to include women with ductal carcinoma in situ (DCIS). Please call 650-498-7740 for more information.