Stanford APBI Trial
Clinical Trial
Overview
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.
Adaptive COVID-19 Treatment Trial 3 (ACTT-3)
ACTT-3 will evaluate the combination of interferon beta-1a and remdesivir compared to remdesivir alone. Subjects will be assessed daily while hospitalized. If the subjects are discharged from the hospital, they will have a study visit at Days 15, 22, and 29. For discharged subjects, it is preferred that the Day 15 and 29 visits are in person to obtain safety laboratory tests and oropharyngeal (OP) swab and blood (serum only) samples for secondary research as well as clinical outcome data. However, infection control or other restrictions may limit the ability of the subject to return to the clinic. In this case, these visits may be conducted by phone, and only clinical data will be obtained. The Day 22 visit does not have laboratory tests or collection of samples and is conducted by phone. The primary outcome is time to recovery by Day 29.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Interferon beta-1a
- other: Placebo
- drug: Remdesivir
Eligibility
Inclusion Criteria:
1. Admitted to a hospital with symptoms suggestive of COVID-19.
2. Subject (or legally authorized representative) provides informed consent prior to
initiation of any study procedures.
3. Subject (or legally authorized representative) understands and agrees to comply with
planned study procedures.
4. Male or non-pregnant female adult > / = 18 years of age at time of enrollment.
5. Has laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain
reaction (PCR) or other commercial or public health assay in any respiratory specimen
or saliva, as documented by either of the following:
- PCR or other assay positive in sample collected < 72 hours prior to
randomization; OR
- PCR or other assay positive in sample collected >/= 72 hours but < 7 days prior
to randomization AND progressive disease suggestive of ongoing SARS-CoV-2
infection.
Note: if written documentation of the positive test result is not available at
enrollment (e.g., report from other institution), the subject may be enrolled but the
PCR should be repeated at the time of enrollment.
6. Illness of any duration, and at least one of the following:
- Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR
- SpO2 < / = 94% on room air, OR
- Requiring supplemental oxygen.
7. Women of childbearing potential must agree to either abstinence or use at least one
primary form of contraception not including hormonal contraception from the time of
screening through Day 29.
8. Agrees to not participate in another clinical trial (both pharmacologic and other
types of interventions) for the treatment of COVID-19 through Day 29.
Exclusion Criteria:
1. Anticipated discharge from the hospital or transfer to another hospital which is not a
study site within 72 hours.
2. Subject meets criteria for ordinal scale category 6 or 7 at the time of screening.
3. Subject has a positive test for influenza virus during this current hospital
admission.
4. Subjects with an estimated glomerular filtration rate (eGFR) < 30 mL/min are excluded
unless in the opinion of the PI, the potential benefit of receiving remdesivir
outweighs the potential risk of study participation.
5. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times the upper
limits of normal.
6. Total white cell blood cell count (WBC) <1500 cells/microliter.
7. Platelet count <50,000/microliter.
8. History of chronic liver disease (e.g., jaundice, ascites, hepatic encephalopathy,
history of bleeding esophageal or gastric varices). No laboratory testing is needed.
9. Pregnancy or breast feeding (lactating women who agree to discard breast milk from Day
1 until three weeks after the last study product is given are not excluded).
10. Allergy to any study medication including history of hypersensitivity to natural or
recombinant interferon beta or human albumin.
11. Patient has a chronic or acute medical condition or is taking a medication that cannot
be discontinued at enrollment, that in the judgement of the PI, places them at
unacceptable risk for a poor clinical outcome if they were to participate in the
study.
12. Received three or more doses of remdesivir, including the loading dose, outside of the
study for COVID-19.
13. Received convalescent plasma or intravenous immunoglobulin [IVIg] for the treatment of
COVID-19.
14. Received any interferon product within two weeks of screening, either for the
treatment of COVID-19 or for a chronic medical condition (e.g., multiple sclerosis,
HCV infection).
15. Received any of the following in the two weeks prior to screening as treatment of
COVID-19:
- Small molecule tyrosine kinase inhibitors (e.g. baricitinib, imatinib, gefitinib,
acalabrutinib, etc.);
- Monoclonal antibodies targeting cytokines (e.g., TNF inhibitors,
anti-interleukin-1 [IL-1], anti-IL-6 [tocilizumab or sarilumab], etc.);
- Monoclonal antibodies targeting T-cells or B-cells as treatment for COVID-19.
16. Prior enrollment in ACTT-3.
Ages Eligible for Study
18 Years - 99 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
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.