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.
A Study Of PF-06647020 For Adult Patients With Advanced Solid Tumors
To assess the safety and tolerability at increasing dose levels of PF-06647020 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: fluconazole
- drug: PF-06647020 Q3W
- drug: PF-06647020 Q2W
- drug: PF-06647020 combined with Avelumab
Eligibility
Q2W Inclusion Criteria:
- Diagnosis of platinum resistant or refractory OVCA having received 2 or fewer prior
lines, or recurrent advanced NSCLC having received 3 or fewer prior lines
- Performance Status of 0, 1, or 2
- Adequate bone marrow, kidney, and liver function
Q2W Exclusion Criteria:
- OVCA pts excluded with any of the following: non-epithelial, including malignant mixed
mullerian tumors, unresolved bowel obstruction
- Brain metastases requiring steroids
- Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of
study treatment start
- Active and clinically significant bacterial, fungal, or viral infection
Q3W Inclusion Criteria:
- Diagnosis of solid tumor that is advanced/metastatic and resistant to standard therapy
or for whom no standard therapy is available
- Performance Status of 0 or 1
- Adequate bone marrow, kidney, and liver function
- Part 2 includes ovarian cancer, target expressing triple negative breast cancer and
non small cell lung cancer patients
Q3W Exclusion Criteria:
- OVCA pts excluded with any of the following: non-epithelial, including malignant mixed
mullerian tumors, prior radiotherapy to pelvis/abdomen, pts with CA-125 only disease,
unresolved bowel obstruction
- Brain metastases requiring steroids
- Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of
study treatment start
- Active and clinically significant bacterial, fungal, or viral infection
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
ccto
ccto-office@stanford.edu
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.