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.
Bintrafusp Alfa Monotherapy in Platinum-Experienced Cervical Cancer
The main purpose of this study was to evaluate clinical efficacy and safety of bintrafusp alfa in participants with advanced, unresectable cervical cancer with disease progression during or after platinum-containing chemotherapy.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Bintrafusp alfa
Eligibility
Inclusion Criteria:
- Participants who had advanced unresectable and/or metastatic cervical cancer (squamous
cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma) with disease progression
during or after the prior platinum-containing chemotherapy:
1. The prior platinum-containing chemotherapy may be a systemic treatment for
advanced unresectable, recurrent, persistent or metastatic disease or treatment
in the adjuvant or neo-adjuvant setting with disease progression or recurrence
within 6 months of completion of platinum-containing chemotherapy
2. Participants who previously only received platinum as a radiosensitizer are not
eligible
3. Participants must be naïve to checkpoint inhibitors
- Participants who had measurable disease
- Participants who provide a tumor tissue sample, either from archival tissue or newly
obtained core or excisional biopsy. If the participant received local therapy (For
example: radiation therapy or chemoradiotherapy) after the archival tissue was taken,
a new biopsy was required
- Participants who had Eastern Cooperative Oncology Group (ECOG) PS of 0 to 1
- Life expectancy greater than or equals to (>=) 12 weeks as judged by the Investigator
- Adequate hematological, hepatic and renal function as defined in the protocol
- Participants with known Human Immunodeficiency Virus (HIV) infections were in general
eligible if the following criteria are met:
1. Clinically indicated participants must be stable on antiretroviral therapy (ART)
for at least 4 weeks and agree to adhere to ART
2. had no evidence of documented multi-drug resistance that would prevent effective
ART
3. had an HIV viral load of < 400 copies per milliliter (/mL) at Screening
4. had CD4+ T-cell (CD4+) counts >= 350 cells/microliter
5. For participants with a history of an Acquired immunodeficiency syndrome
(AIDS)-defining opportunistic infection within the last 12 months, participants
may be eligible only after consultation and agreement with the study Medical
Monitor
6. If prophylactic antimicrobial drugs were indicated, participants would still be
considered eligible upon agreement with the study Medical Monitor
- Participants with hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infections
were in general eligible if the following criteria are met:
1. HBV viral load below the limit of quantification. If medically indicated,
participants infected with HBV must be treated and on a stable dose of antivirals
at study entry and with planned monitoring and management according to
appropriate labeling guidance
2. Participants with a history of HCV infection should have completed curative
antiviral treatment and require HCV viral load below the limit of quantification
3. Participants on concurrent HCV treatment should have HCV below the limit of
quantification
- Other protocol defined inclusion criteria could apply
Exclusion Criteria:
- Participants with active central nervous system (CNS) metastases causing clinical
symptoms or require therapeutic intervention are excluded. Participants with a history
of treated CNS metastases (by surgery or radiation therapy) are not eligible unless
they have fully recovered from treatment, demonstrated no progression for at least 4
weeks, and are not using steroids for at least 7 days prior to the start of study
treatment
- Participants with interstitial lung disease or has had a history of pneumonitis that
has required oral or intravenous (IV) steroids
- Participants with significant acute or chronic infections
- Participants with active autoimmune disease that might deteriorate when receiving an
immunostimulatory agent
- Participants with clinically significant cardiovascular/cerebrovascular disease
including: cerebral vascular accident/stroke, myocardial infarction, unstable angina,
congestive heart failure, or serious cardiac arrhythmia
- Other protocol defined exclusion criteria could apply
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
Female
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Bela Shah
650-723-0594
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.