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.

An Open-Label Dose-Escalation Study to Evaluate XmAb24306 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors

This study will evaluate the safety, tolerability, pharmacokinetics, and activity of XmAb24306 alone or in combination with a checkpoint inhibitor treatment in participants with locally advanced or metastatic solid tumors.

Stanford is currently accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • drug: XmAb24306
  • drug: Atezolizumab
  • drug: XmAb24306

Eligibility


Key General Inclusion Criteria

   - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

   - Life expectancy >/= 12 weeks

   - Adequate hematologic and end-organ function

   - For participants receiving therapeutic anticoagulation: stable anticoagulant regimen

   - Negative serum pregnancy test for women of childbearing potential

   - Histologically confirmed locally advanced, recurrent, or metastatic incurable solid
   tumor malignancy

   - Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

   - Availability of representative tumor specimens

Key General Exclusion Criteria

   - Pregnant or breastfeeding, or intending to become pregnant during the study

   - Significant cardiovascular disease

   - Current treatment with medications that prolong the QT interval

   - Known clinically significant liver disease

   - Poorly controlled Type 2 diabetes mellitus

   - Symptomatic, untreated, or actively progressing CNS metastases

   - History of leptomeningeal disease

   - History of malignancy other than disease under study within 3 years prior to screening

   - Active or history of autoimmune disease or immune deficiency

   - Active tuberculosis, hepatitis B, hepatitis C, or known/suspected Epstein Barr virus
   infection

   - Positive for HIV infection

   - Prior allogeneic stem cell or solid organ transplantation

Ages Eligible for Study

18 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
Team Phase 1
Phase1Team@stanfordhealthcare.org
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.