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.
Zanubrutinib in Patients With IgG4-Related Disease
The aim of this clinical trial is to evaluate the safety and efficacy of zanubrutinib in treating patients with IgG4-related disease
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Zanubrutinib 80 MG
Eligibility
Inclusion Criteria:
- Men or women aged 18 to 85, inclusive, at the time of initial screening
- Have histopathologically confirmed IgG4-RD in the submandibular gland and/or the
lacrimal gland confirmed by international consensus pathology criteria
- Presence of a lymphoplasmacytic infiltrate with 10 IgG4+ plasma cells per
high-power field and/or an IgG4+/IgG+ plasma cell ratio of 40%
- All women must test negative for pregnancy and agree to use a reliable method of birth
control
- No current treatment with immunosuppressive medications other than prednisone 40mg
daily (or other glucocorticoid equivalent) with stable dosing for 28 days
Exclusion Criteria:
- Unstable prescribed dose of glucocorticoids within 28 days prior to baseline
- Any treatment with a synthetic DMARD including but not limited to hydroxychloroquine,
methotrexate, leflunomide, or sulfasalazine within 28 days prior to baseline
- Any treatment with a cytotoxic or immunosuppressive drug including but not limited to
cyclophosphamide, mycophenolic acid, azathioprine, cyclosporine, sirolimus, or
tacrolimus within 28 days prior to baseline
- Any treatment with a BTK inhibitor within 6 months before baseline
- Any treatment with a JAK inhibitor within 28 days prior to baseline
- Use of biologic agents including infliximab, abatacept, or tocilizumab within 56 days
prior to baseline
- Use of a B cell depleting therapy (such as rituximab) within 12 months prior to
baseline
- A history of, or current, inflammatory or autoimmune disease (that could affect the
interpretation of safety or efficacy outcomes) other than IgG4-related disease
- Evidence of active tuberculosis, HIV, or hepatitis B or C infection
- History of cancer other than non-melanoma skin cancer, cervical dysplasia or carcinoma
in situ (cured >1 year), prostate cancer (cured >5 years), or colon cancer (cured >5
years)
Ages Eligible for Study
18 Years - 85 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Angie Aberia
650-723-8516
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.