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.
Safety and Efficacy of Oral Treprostinil in the Treatment of Calcinosis in Patients With Systemic Sclerosis
This is a prospective open-label trial that will enroll 12 patients with systemic sclerosis (SSc) and at least one calcinotic lesion of the hands that is palpable on physical examination and also measureable on hand radiographs, at one single center. Each subject will receive treprostinil orally for 12 months, and follow-up evaluations will be performed every 3 months. Our main objective is to determine whether oral treprostinil is safe, and effective in reducing calcinosis in patients with SSc. We hypothesize that calcinosis is a result of microvascular injury and ischemic damage, and that therefore treprostinil may be beneficial in the treatment of calcinosis in patients with SSc.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Oral treprostinil
Eligibility
Inclusion Criteria:
- Signed written informed consent
- Age > 18 years of age
- Diagnosis of limited or diffuse cutaneous systemic sclerosis (SSc) according to the
revised 2013 ACR/EULAR classification criteria for SSc
- Radiological and physical examination evidence of at least one subcutaneous calcium
deposition in the hands that is clinically apparent as part of routine clinical care.
- If female of childbearing potential, the patient must have a negative pregnancy test
at screening and baseline visits
- Oral corticosteroids (≤ 10 mg/day of prednisone or equivalent) and NSAIDs are
permitted if the patient is on a stable dose regimen for ≥ 2 weeks prior to screening
and throughout the study
- Calcium channel blockers, alpha-1-antagonists, ACE-inhibitors, angiotensin receptor
blockers, and protein-pump inhibitors are permitted as long as the doses are stable
for 4 weeks prior to screening and throughout the study
- Women of childbearing potential must agree to use adequate contraception when sexually
active with any combination of at least 2 effective methods of birth control (except
for women who have a partner who is sterile, i.e. due to vasectomy)
Exclusion Criteria:
- Rheumatic disease other than SSc
- Patients with pulmonary arterial hypertension (PAH), NYHA Class III or IV, as
determined by right heart catheterization or on PAH approved medications for PAH
- Patients with moderate or severe hepatic impairment (Child Pugh Class C), or
transaminase elevation (ALT or AST) > 3 x the upper limit of normal at screening visit
- Patients with diverticulosis
- Hemoglobin < 75% of the lower limit of the normal range
- Systolic blood pressure < 95 mmHg or diastolic blood pressure < 50 mmHg
- Patients who are hemodynamically unstable, or have acute renal, cardiac or pulmonary
failure, or any life-threatening condition.
- Concurrent malignancy except non-melanoma skin cancers
- Patients receiving specific (sildenafil, tadalafil) or unspecific phosphodiesterase-5
inhibitors (dipyridamole, theophylline), endothelin receptor antagonists, prostanoids,
riociguat, or NO donors (nitrates) within 4 weeks of screening
- Patients receiving bisphosphonates, warfarin, colchicine, minocycline, intravenous
immunoglobulins, or biological agents including abatacept or rituximab within 4 weeks
of screening
- Patients receiving local treatments for calcinosis including surgical removal or
intralesional steroid injections within 12 weeks of screening or throughout the study.
- Patients who have participated in another clinical trial of an investigative agent
within 30 days of screening (or 5 half-lives of the investigational drug, whichever is
longer)
- Pregnant or nursing women
- Patients with a history of drug or alcohol abuse within 6 months of screening
- Any medical condition that, in the opinion of the investigator, might interfere with
the subject's participation in the study or poses an added risk for the subject
- Inability to comply with study and follow-up procedures
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
Antonia Maria Valenzuela Vergara, MD, MS
650-723-6961
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.