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 Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR Mutation

The primary objective of the study was to evaluate the efficacy of lumacaftor in combination with ivacaftor at Week 24 in participants aged 12 years and older with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene.

Stanford is currently accepting patients for this trial.

Intervention(s):

  • drug: Ivacaftor
  • drug: Lumacaftor Plus Ivacaftor Combination
  • drug: Placebo

Eligibility


Inclusion Criteria:

   - Confirmed diagnosis of CF

   - Homozygous for the F508del CFTR mutation

   - Forced expiratory volume in 1 second (FEV1) greater than or equal to (>=) 40 percent
   (%) and less than or equal to (=<) 90% of predicted normal for age, sex, and height

   - Willing to remain on a stable CF medication regimen through Week 24 or, if applicable,
   the Safety Follow up Visit

Exclusion Criteria:

   - An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in
   therapy (including antibiotics) for pulmonary disease within 4 weeks before first dose
   of study drug

   - History of solid organ or hematological transplantation

   - History of alcohol or drug abuse in the past year

   - Ongoing or prior participation in an investigational drug study (including studies
   investigating lumacaftor and/or ivacaftor) within 30 days of screening

   - Use of strong inhibitors, moderate inducers or strong inducers of Cytochrome P450 3A
   (CYP3A) within 14 days before Day 1 of dosing

Ages Eligible for Study

12 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Angela Leung
6507235193
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.