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.
B-Receptor Signaling in Cardiomyopathy
We hope to determine the importance of different genes (including B receptors) in anthracycline-induced cardiomyopathy. This has important benefits to patients exposed to anthracyclines, as this could help determine whether certain individuals have increased susceptibility to cardiac injury.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Eligibility
Inclusion Criteria:1.) Past exposure to anthracycline chemotherapy for cancer
2.) Echocardiogram at least six months after exposure to anthracyclines (in patients over
the age of 40, the echocardiogram must be obtained within 6 - 48 months of anthracycline
exposure)
3.) Ability to understand and the willingness to sign a written informed consent document.
We have no age, gender, or ethnic background limitations. Due to the increased frequency of
cardiovascular disease from other causes in adults over 40 years, we will limit enrollment
to those patients with an echocardiogram 6 - 48 months after the completion of
anthracycline exposure. Children will be included and will be eligible if they have an
echocardiogram at least 6 months after completion of anthracycline treatment..
Exclusion Criteria:1.) Congenital heart disease (other than patent foramen ovale)
2.) Pre-existing cardiomyopathy before anthracycline administration
3.) Patients with Down syndrome
4.) Patients receiving B-blocker therapy at the time of anthracycline exposure
5.) Pregnant patients (if their echocardiogram was obtained either during pregnancy or
within three months of pregnancy)
All participants will be cancer survivors. To minimize bias from post-partum
cardiomyopathy, pregnant patients will be excluded if their echocardiogram was obtained
during pregnancy or within three months of pregnancy. HIV-positive persons will not be
excluded from the study.
Of note, some patients receive a MUGA (multigated acquisition) study to evaluate left
ventricular ejection fraction. Patients who receive only a MUGA scan will NOT be included
in the study - an echocardiogram is necessary
Ages Eligible for Study
N/A - 40 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
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.