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 Study of ABI-H2158-containing Regimens in Participants With Chronic Hepatitis B Virus Infection

This Phase 2a study will assess the safety, antiviral activity, and pharmacokinetics (PK) of ABI-H2158 administered once daily for up to 72 weeks in combination with entecavir (ETV) in participants with chronic hepatitis B virus (HBV) infection.

Stanford is currently accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • drug: ABI-H2158
  • drug: Placebo
  • drug: Entecavir (ETV)

Eligibility


Inclusion Criteria:

   - Body mass index of 18 - 36 kg/m^2 and body weight ≥45 kg

   - HBeAg ≥500 IU/mL at Screening

   - In good general health except for chronic HBV infection for ≥6 months documented, for
   example, by at least two measurements of HBsAg positivity and/or detectable HBV DNA ≥6
   months apart

   - Lack of cirrhosis or advanced liver disease

Exclusion Criteria:

   - Prior treatment for chronic HBV infection with lamivudine, telbivudine, adefovir,
   standard of care nucleoside or nucleotide analogue (NrtI), HBV core inhibitors, or an
   investigational agent for HBV infection

   - History or evidence of advanced liver disease or hepatic decompensation (including
   jaundice, ascites, portal hypertension, gastrointestinal bleeding, esophageal varices,
   hepatic encephalopathy)

   - History or presence of clinically significant medical conditions requiring frequent
   medical management or pharmacologic or surgical treatment

Ages Eligible for Study

18 Years - 65 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Jennifer Smart
650-721-8517
I'm interested

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.