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.
Study of Atezolizumab in Combination With Cobimetinib in Participants With Locally Advanced or Metastatic Solid Tumors
This is a Phase Ib, open-label, multicenter study designed to assess the safety, tolerability, and pharmacokinetics of coadministration of intravenous (IV) dosing of atezolizumab (an engineered anti-programmed death-ligand 1 [anti-PD-L1] antibody) and oral dosing of cobimetinib in participants with metastatic or locally advanced cancer for which no standard therapy exists.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Cobimetinib
- drug: Cobimetinib
- drug: Atezolizumab
Eligibility
Inclusion Criteria:
- Solid tumor that is metastatic, locally advanced or recurrent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy greater than or equal to (>/=) 12 weeks
- Measurable disease, as defined by RECIST v 1.1
- Adequate hematologic and end organ function
- Use of highly effective contraception
- Histological tumor tissue specimen
- Participants enrolling in the indication-specific expansion cohorts in Stage 2 must
consent to tumor biopsies and must have one of the following types of cancer:
- Metatastic colorectal cancer
- Non-small cell lung cancer
- Melanoma
Exclusion Criteria:
Cancer-Specific Exclusion Criteria:
- Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3
weeks prior to initiation of study treatment
- Treatment with any other investigational agent or participation in another clinical
trial with therapeutic intent within 28 days prior to enrollment
- Known active or untreated central nervous system (CNS) metastases
- Leptomeningeal disease
- Uncontrolled tumor-related pain or uncontrolled pleural effusion, pericardial
effusion, or ascites requiring recurrent (once monthly or more frequently) drainage
procedures
- Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of
bisphosphonate therapy or denosumab
General Medical Exclusion Criteria:
- Pregnant and lactating women
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to
chimeric or humanized antibodies or fusion proteins
- Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cell or
any component of the atezolizumab formulation
- History of autoimmune disease
- Participants with prior allogeneic stem cell or solid organ transplantation
- Positive test for human immunodeficiency virus (HIV)
- Participants with active hepatitis B, hepatitis C, or tuberculosis
- Severe infections within 4 weeks prior to Cycle 1 Day 1
- Signs or symptoms of infection within 2 weeks prior to Cycle 1 Day 1
- Received therapeutic oral or IV antibiotics within 2 weeks prior to Cycle 1 Day 1
- Significant cardiovascular disease
- Major surgical procedure other than for diagnosis within 28 days prior to Cycle 1 Day
1 or anticipation of need for a major surgical procedure during the course of the
study
- Administration of a live, attenuated vaccine within 4 weeks before Cycle 1 Day 1
Exclusion Criteria Unique to Cobimetinib:
- History of prior significant toxicity from another mitogen-activated protein kinase
(MEK) pathway inhibitor requiring discontinuation of treatment
- Allergy or hypersensitivity to components of the cobimetinib formulations
- History of congenital long QT syndrome or corrected QT interval (QTc) greater than (>)
450 milliseconds at screening
- Left ventricular ejection fraction (LVEF) below institutional lower limit of normal
(LLN) or below 50%, whichever is lower, as determined by echocardiogram or Multi Gated
Acquisition Scan (MUGA) scan
- History of or evidence of retinal pathology on ophthalmologic examination that is
considered a risk factor for neurosensory retinal detachment, central serous
chorioretinopathy (CSCR), retinal vein occlusion (RVO), or neovascular macular
degeneration
- History of malabsorption syndrome or other condition that would interfere with enteral
absorption
Exclusion Criteria Related to Medications:
- Prior treatment with clusters of differentiation (CD) 137 agonists or immune
checkpoint blockade therapies, systemic immunostimulatory agents, or systemic
immunosuppressive medications
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
Lisa Zhou
650-736-4112
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.