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.
Study to Compare Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF) in Participants With Chronic Hepatitis B Infection Who Are Positive for Hepatitis B e Antigen
The primary objective of this study is to compare the efficacy, safety, and tolerability of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive and treatment-experienced adults with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B virus (HBV) infection.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: TAF
- drug: TDF
- drug: TAF Placebo
- drug: TDF Placebo
Eligibility
Key Inclusion Criteria:
- Ability to understand and sign a written informed consent form, which must be obtained
prior to initiation of study procedures.
- Adult males and non-pregnant, non-lactating females.
- Documented evidence of chronic HBV infection.
- HBeAg-positive, chronic hepatitis B with all of the following:
- HBeAg-positive at screening.
- Screening HBV DNA ≥ 2 x 10^4 IU/mL
- Screening serum alanine aminotransferase (ALT) level > 60 U/L (males) or > 38 U/L
(females) and ≤ 10 x the upper limit of the normal range (ULN).
- Treatment-naive participants (defined as < 12 weeks of oral antiviral treatment with
any nucleoside or nucleotide analogue) OR treatment-experienced participants (defined
as participants meeting all entry criteria [including HBV DNA and serum ALT criteria]
and with ≥ 12 weeks of previous treatment with any nucleoside or nucleotide analogue).
- Previous treatment with interferon (pegylated or non-pegylated) must have ended at
least 6 months prior to the baseline visit.
- Adequate renal function.
- Normal electrocardiogram (ECG).
Key Exclusion Criteria:
- Females who are breastfeeding.
- Males and females of reproductive potential who are unwilling to use an "effective",
protocol specified method(s) of contraception during the study.
- Co-infection with hepatitis C virus, human immunodeficiency virus (HIV), or hepatitis
D virus.
- Evidence of hepatocellular carcinoma .
- Any history of, or current evidence of, clinical hepatic decompensation.
- Abnormal hematological and biochemical parameters, including aspartate
aminotransferase (AST) > 10 x ULN.
- Received solid organ or bone marrow transplant.
- History of malignancy within the past 5 years, with the exception of specific cancers
that are cured by surgical resection; individuals under evaluation for possible
malignancy are not eligible.
- Currently receiving therapy with immunomodulators (eg, corticosteroids),
investigational agents, nephrotoxic agents, or agents capable of modifying renal
excretion.
- Individuals receiving ongoing therapy with drugs not to be used with tenofovir
alafenamide or tenofovir disoproxil fumarate or individuals with a known
hypersensitivity to study drugs, metabolites, or formulation excipients.
- Current alcohol or substance abuse judged by the investigator to potentially interfere
with participant compliance.
- Any other clinical condition or prior therapy that, in the opinion of the
Investigator, would make the participant unsuitable for the study or unable to comply
with dosing requirements.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Ages Eligible for Study
18 Years - N/A
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
SPECTRUM
650-498-6474
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.