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.
(PATHFINDER) Study to Evaluate Efficacy and Safety of Avapritinib (BLU-285), A Selective KIT Mutation-targeted Tyrosine Kinase Inhibitor, in Patients With Advanced Systemic Mastocytosis
This is an open-label, single arm, Phase 2 study evaluating the efficacy and safety of avapritinib (BLU-285) in patients with advanced systemic mastocytosis (AdvSM), including patients with aggressive SM (ASM), SM with associated hematologic neoplasm (SM-AHN), and mast cell leukemia (MCL)
Stanford is currently not accepting patients for this trial.
Intervention(s):
- drug: Avapritinib
Eligibility
Key Inclusion Criteria:
1. Patient must have a diagnosis of aggressive systemic mastocytosis (ASM), systemic
mastocytosis with an associated hematologic neoplasm (SM-AHN) or mast cell leukemia
(MCL) based on World Health Organization diagnostic criteria. Before enrollment, the
Study Steering Committee must confirm the diagnosis of AdvSM (based on Central
Pathology Laboratory assessment of bone marrow).
2. Patient must have a serum tryptase ≥ 20 ng/mL.
3. Patient must have Eastern Cooperative Oncology Group (ECOG) performance status (PS) of
0 to 3.
Key Exclusion Criteria:
1. Patient has received prior treatment with avapritinib.
2. Patient has received any cytoreductive therapy (including midostaurin and other TKIs,
hydroxyurea, azacitidine) or an investigational agent less than 14 days, and for
cladribine, interferon alpha, pegylated interferon and any antibody therapy (eg,
brentuximab vedotin) less than 28 days before obtaining screening BM biopsy for this
study.
3. Patient has eosinophilia and known positivity for the FIP1L1 PGDFRA fusion, unless the
patient has demonstrated relapse or PD on prior imatinib therapy. Patients with
eosinophilia (> 1.5 × 10^9/L), who do not have a detectable KIT D816 mutation, must be
tested for a PDGFRA fusion mutation by fluorescence in situ hybridization (FISH) or
polymerase chain reaction (PCR).
4. Patient has history of another primary malignancy that has been diagnosed or required
therapy within 3 years before the first dose of study drug. The following are exempt
from the 3-year limit: completely resected basal cell and squamous cell skin cancer,
curatively treated localized prostate cancer, and completely resected carcinoma in
situ of any site.
5. Patient has a QT interval corrected using Fridericia's formula (QTcF) > 480 msec.
6. Patient has a known risk or recent history (12 months before the first dose of study
drug) of intracranial bleeding (eg, brain aneurysm, concomitant vitamin K antagonist
use).
7. Platelet count < 50,000/μL (within 4 weeks of the first dose of study drug) or
receiving platelet transfusion(s).
8. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 x the upper
limit of normal (ULN); no restriction if due to suspected liver infiltration by mast
cells.
9. Bilirubin >1.5 × ULN; no restriction if due to suspected liver infiltration by mast
cells or Gilbert's disease. (In the case of Gilbert's disease, a direct bilirubin >2 ×
ULN would be an exclusion.)
10. Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2 or creatinine > 1.5 ×
ULN.
11. Patient has a primary brain malignancy or metastases to the brain.
12. Patient has a history of a seizure disorder (eg, epilepsy) or requirement for
antiseizure medication.
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
Justin Abuel
650-723-1367
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.