Stanford APBI Trial
Clinical Trial
Overview
Intraoperative Radiotherapy (IORT) is one of three approaches used for accelerated, partial breast irradiation at Stanford.
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 Multiple Ascending Dose Study to Evaluate Safety and Tolerability of BFKB8488A in Participants With Type 2 Diabetes Mellitus and Participants With Non-Alcoholic Fatty Liver Disease
This is a Phase Ib, randomized, blinded, placebo-controlled, multiple ascending-dose study of the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) effects of BFKB8488A in participants with Type 2 diabetes mellitus (T2DM) and participants with non-alcoholic fatty liver disease(NAFLD). A maximum of approximately 160 participants will be enrolled across multiple sites in the United States. Participants will be randomly assigned to receive study drug (active BFKB8488A or placebo). The study will consist of a screening period (up to 8 weeks), a 12-week treatment period, and a 6-week follow-up period. Participants may come to clinic for an optional pre-screening visit.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: BFKB8488A
- other: Placebo
Eligibility
Inclusion Criteria:
For T2DM Cohort only:
- Body mass index (BMI) ≥ 27 kg/m2 and ≤ 40 kg/m2.
- A confirmed diagnosis of Type 2 diabetes ≥ 6 months at screening
- Current stable treatment (at least 3 months) for diabetes
- Hemoglobin A1c (HbA1c) ≥ 6.8% and ≤ 9.0%.
- For women of childbearing potential, agreement to remain abstinent or use reliable
contraception during treatment period and for at least 42 days after last dose of
study drug
- For men, agreement to remain abstinent or use reliable contraception and agree to
refrain from donating sperm
- For NAFLD cohort only:
- BMI ≥ 25 kg/m2 and ≤ 40 kg/m2
- At screening, confirmed liver fat by ultrasound OR calculated Liver Fat ≥ 10% using
variables from the NAFLD liver fat score
- Hepatic steatosis on magnetic resonance imaging (MRI; ≥ 10% average liver proton
density fat fraction [PDFF]) prior to randomization.
Exclusion Criteria:
- Pregnant, lactating, or intending to become pregnant within 42 days after the last
dose of study drug is administered
- Suspected or confirmed diagnosis of Type 1 diabetes
- Significant cardiac disease
- Any psychiatric illness that increases the risk of participation in the study
- History of severe allergic, anaphylactic, or other hypersensitivity reactions, or
severe systemic bacterial, fungal, or parasitic infections
- Poor peripheral venous access
- Received blood products within 2 months before dosing
- Donation or loss of blood within 30-56 days prior to study drug administration
- Positive for hepatitis C virus (HCV) antibody, hepatitis B surface antigen (HBsAg), or
human immunodeficiency virus (HIV) antibody
- Liver enzymes greater than acceptable limits
- History of eating disorders or surgical procedures for weight loss
- Active participation in a structured weight loss or dietary program
- Treatment with investigational therapy or exposure to any biological therapy
- Illicit drug use, marijuana use, or alcohol abuse
- Current use of more than one pack of cigarettes a day or equivalent nicotine-
containing products
- Any serious medical condition or abnormality in clinical laboratory tests
Ages Eligible for Study
18 Years - 75 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
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.