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.
HORNBILL: A Study to Test Different Doses of BI 764524 in Patients Who Have Had Laser Treatment for a Type of Diabetic Eye Disease Called Diabetic Retinopathy With Diabetic Macular Ischemia
This is a study in people with a type of diabetic eye disease called diabetic retinopathy with diabetic macular ischemia. People who have had laser treatment for their diabetic retinopathy can participate in the study. The laser treatment is called panretinal photocoagulation.
The purpose of the study is to find out how well different doses of a medicine called BI 764524 are tolerated. BI 764524 is injected into the eye. The study has 2 parts. In the first part, participants get different doses of BI 764524 only once. Participants are in the first part for about 5 months and visit the study site about 8 times. In the second part, participants are put into different groups by chance. Some participants get BI 764524 injections every 4 weeks. Other participants get sham injections every 4 weeks. A sham injection means that it is not a real injection and contains no medicine. Participants cannot tell whether they get the real injection or a sham injection. For the second part, participants are in the study for about 7 months. During this time, they visit the study site about 7 times. In this study, BI 764524 is given to humans for the first time.
The doctors compare how well people tolerate the BI 764524 injections and the sham injections.
The doctors also regularly check the general health of the participants.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: BI 764524
- drug: Sham control of BI 764524
Eligibility
Inclusion Criteria:
Single rising dose (SRD) and multiple dosing (MD) part:
- Pan-retinal photo coagulation treated proliferative diabetic retinopathy (PDR)
participants with either no or inactive retinal neovascularization per investigator
judgement in the study eye
- Male or female participants of age ≥ 18 years
- HbA1c of ≤ 12.0%
- Women of childbearing potential (WOCBP) and men able to father a child must be ready
and able to use two methods of contraception with at least one of them being a highly
effective methods of birth control per ICH M3 (R2) that result in a low failure rate
of less than 1% per year when used consistently and correctly. A list of contraception
methods meeting these criteria is provided in the patient information and in the
clinical trial protocol.
--A woman is considered of childbearing potential (WOCBP), i.e. fertile, following
menarche and until becoming postmenopausal unless permanently sterile. Permanent
sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral
oophorectomy. Tubal ligation is NOT a method of permanent sterilisation. A
postmenopausal state is defined as no menses for 2 years without an alternative
medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal
range may be used to confirm a post-menopausal state in women not using hormonal
contraception or hormonal replacement therapy. However in the absence of 2 years of
menorrhea, a single FSH measurement is sufficient.
- Signed and dated written informed consent in accordance with ICH Harmonized Guideline
for Good Clinical Practice (ICH GCP) and local legislation prior to admission to the
trial
SRD part only:
- Evidence of diabetic macular ischemia (DMI) per investigator´s judgement, defined as
any degree of disruption of retinal vascularity in superficial and/or deep retinal
plexus in OCTA
- Best-corrected Visual activity (VA) in the non-study eye better than best-corrected VA
in the study-eye, if both eyes are eligible and have identical VA the investigator may
select the study eye.
- Best-corrected VA ≤55 letters (20/80) or worse
MD part only:
- Presence of significant DMI: large foveal avascular zone defined as those with ≥0.5mm2
area in superficial vascular complex (SVC) present on optical coherence tomography
angiography. If FAZ is <0.5mm2 then enlarged peri-foveal inter-capillary space in at
least 1 quadrant will be sufficient.
- If both eyes are eligible, the investigator may select either eye to be the study eye.
- Best-corrected VA ≤ 85 letters (20/20) or worse
Exclusion Criteria:
SRD part only:
- Participants receiving intravitreal (IVT) injections for active diabetic macular edema
(DME, injections: anti-vascular endothelial growth factor (VEGF), steroids) and
macular laser in the study eye in the previous 3 months prior to enrolment
- Participants receiving anti-VEGF IVT injections for active PDR in the study eye in the
previous 3 months prior to enrolment
- Current or planned use of medications known to be toxic to the retina, lens or optic
nerve (e.g. desferoximine, chloroquine/hydrochloroquine, chlorpromazine,
phenothiazines, tamoxifen, nicotinic acid, and ethambutol)
- Additional eye disease in the study eye that could compromise best corrected VA (BCVA)
with visual field loss, uncontrolled glaucoma (IOP>24), age related macular
degeneration, history of ischemic optic neuropathy or retinal vascular occlusion,
symptomatic vitreomacular traction, or genetic disorders such as retinitis pigmentosa;
history of high myopia > 8 diopters in the study eye. Anterior segment and vitreous
abnormalities in the study eye that would preclude adequate observation with SD-OCT
- Any intraocular surgery in the study eye within 3 months prior to screening
- Aphakia or total absence of the posterior capsule. Yttrium aluminium garnet (YAG)
laser capsulotomy in the study eye if performed less than 3 months prior to enrolment
- Participants not expected to comply with the protocol requirements or not expected to
complete the trial as scheduled (e.g. chronic alcohol or drug abuse or any other
condition that, in the investigator´s opinion, makes the patient an unreliable trial
participant)
- Previous participation in this trial or in other trials with IVT injections
administered within 3 months.
Further exclusion criteria apply.
MD part only:
- DME, defined as a central subfield thickness (CST) ≥305 micrometer (μm) for men and
≥290 μm women measured with optovue (Optical coherent tomography) OCT in the study eye
- Participants receiving IVT injections for active DME (anti-VEGF, steroids) and macular
laser in the study eye in the previous 3 months prior to enrolment
- Participants receiving anti-VEGF IVT injections for active PDR in the study eye in the
previous 3 months prior to enrolment
- Heavily lasered macula in the study eye per investigator's judgement
- History of vitrectomy in the study eye
- Epiretinal membrane with extended foveal contour distortion in the study eye per
investigator's judgement
- Current or planned use of medications known to be toxic to the retina, lens or optic
nerve (e.g. desferoximine, chloroquine/hydrochloroquine, chlorpromazine,
phenothiazines, tamoxifen, nicotinic acid, and ethambutol) Further exclusion criteria
apply.
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
Quan Nguyen
+001 (650) 724-4280
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.