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.
Efficacy and Safety Trial of Verubecestat (MK-8931) in Participants With Prodromal Alzheimer's Disease (MK-8931-019)
This study consists of two parts, Part 1 and Part 2. Part 1 assesses the efficacy and safety of verubecestat (MK-8931) compared with placebo administered for 104 weeks in the treatment of amnestic mild cognitive impairment (aMCI) due to Alzheimer's Disease (AD), also known as prodromal AD. Participants are randomized to receive placebo, or 12 mg or 40 mg verubecestat, once daily. The primary study hypothesis for Part 1 is that ≥1 verubecestat dose is superior to placebo with respect to the change from baseline in the Clinical Dementia Rating scale-Sum of Boxes (CDR-SB) score at 104 weeks. Participants completing Part 1 may choose to participate in Part 2, which is a long term double-blind extension to assess efficacy and safety of verubecestat administered for up to an additional 260 weeks. In Part 2, all participants receive either 12 mg or 40 mg verubecestat, once daily.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Verubecestat 12 mg (Parts 1 and 2)
- drug: Verubecestat 40 mg (Parts 1 and 2)
- other: Placebo (Part 1)
Eligibility
Inclusion Criteria:
1. Diagnosis of prodromal AD, including the following:
1. History of subjective memory decline with gradual onset and slow progression for
at least one year corroborated by an informant,
2. Objective impairment in episodic memory by memory test performed at Screening,
3. Does not meet criteria for dementia, AND
4. Positive Screening amyloid imaging PET scan using [18F]flutametamol tracer or
positive Screening CSF tau:amyloid-β42 (Aβ42) ratio (Participants with a prior
positive amyloid imaging PET scan or a Screening PET scan with florbetaben or
florbetapir may be enrolled without a Screening flutemetamol scan with Sponsor
approval)
2. Able to read at a 6th grade level or equivalent
3. If participant is receiving an acetylcholinesterase inhibitor or memantine, the dose
must have been stable for at least three months before Screening
4. Must have a reliable and competent trial partner/informant who has a close
relationship with the participant and is willing to accompany the participant to all
required trial visits, and to monitor compliance of the administration of the trial
medication
Inclusion Criteria for Extension Period (Part 2):
1. Tolerated study drug and completed the initial 104-week period of the trial (Part 1)
2. Participant must have a reliable and competent trial partner who must have a close
relationship with the subject
Exclusion Criteria:
1. History of stroke
2. Evidence of a clinically relevant neurological disorder other than the disease being
studied (i.e., prodromal AD)
3. History of seizures or epilepsy within the last 5 years
4. Evidence of a clinically relevant or unstable psychiatric disorder, excluding major
depression in remission
5. Participant is at imminent risk of self-harm or of harm to others
6. History of alcoholism or drug dependency/abuse within the last 5 years before
Screening
7. Participant does not have a magnetic resonance imaging (MRI) scan obtained within 12
months of Screening and is unwilling or not eligible to undergo an MRI scan at the
Screening Visit. With Sponsor approval, a head computed tomography (CT) scan may be
substituted for MRI scan to evaluate eligibility
8. History of hepatitis or liver disease that has been active within the 6 months prior
to Screening
9. Recent or ongoing, uncontrolled, clinically significant medical condition within 3
months of Screening
10. History of malignancy occurring within the 5 years before Screening, except for
adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer,
or localized prostate carcinoma
11. Clinically significant vitamin B12 or folate deficiency in the 6 months before
Screening
12. Use of any investigational drugs or participation in clinical trials within the 30
days before Screening
13. History of a hypersensitivity reaction to more than three drugs
14. Has human immunodeficiency virus (HIV) by medical history
15. Participant is unwilling or has a contraindication to undergo PET scanning including
but not limited to claustrophobia, excessive weight or girth
16. History or current evidence of long QT syndrome, corrected QT (QTc) interval ≥470
milliseconds (for male participants) or ≥480 milliseconds (for female participants),
or torsades de pointes
17. Close family member (including the trial partner, spouse or children) who is among the
personnel of the investigational or sponsor staff directly involved with this trial
Exclusion Criteria for Extension Period (Part 2):
1. Participant is at imminent risk of self-harm or of harm to others
2. Has developed a recent or ongoing, uncontrolled, clinically significant medical or
psychiatric condition
3. Results of safety assessments (e.g., laboratory tests) performed in participant at end
of Part 1 that are clinically unacceptable to the Investigator
4. Has developed a form of dementia that is not AD
5. Has progressed to dementia due to AD per investigator diagnosis in the initial
104-week study (Part 1).
Exclusion Criteria for NFT PET Substudy (Part 2):
1. Had one or two PET scans with MK-6240 in the initial 104-week study.
Ages Eligible for Study
50 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
Jennifer Gaudioso
650-724-4131
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.