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 Phase II Clinical Trial of PM01183 in BRCA 1/2-Associated or Unselected Metastatic Breast Cancer
A Clinical Trial of PM01183 in Metastatic Breast Cancer to assess the antitumor activity of PM01183 ,to evaluate whether the presence of a known germline mutation in BRCA 1/2 predicts response to PM01183 in Metastatic Breast Cancer (MBC) patients, to evaluate the safety profile of this PM01183 to analyze the pharmacokinetics (PK) and PK/PD (pharmacokinetic/pharmacodynamic) correlations and to evaluate the pharmacogenomic (PGx) expression profile in tumor samples.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: PM01183
Eligibility
Inclusion Criteria:
- Women ≥ 18 and ≤ 75 years of age.
- Voluntary signed informed consent form (ICF).
- Proven diagnosis of metastatic breast cancer (MBC).
- At least one, but no more than three, prior chemotherapy regimens for MBC.
- Patients with known HER-2 overexpressing MBC must have failed at least one prior
trastuzumab-containing regimen for metastatic disease.
- Disease evaluable for response by specific appropriate criteria.
- No or minimal disease-related symptoms not affecting patient daily activities.
- Adequate major organ function (normal or minimal alteration in liver, kidney,
hematological, metabolic and cardiac function)
- Wash out periods prior to Day 1 of Cycle 1:
At least three weeks since the last chemotherapy (six weeks in some particular cases) and
At least four weeks since the last radiotherapy (RT) > 30 Gy) and At least one week since
the last hormonal therapy and At least two weeks since the last biological/investigational
therapy
- Minimal or no ongoing toxicity from immediately prior therapy according to specific
appropriate criteria. Mild ongoing toxicity is allowed in case of alopecia, skin
toxicity, fatigue and/or finger numbness or tumbling.
- Patients of child-bearing potential must agree to use a medically approved
contraception method until at least six weeks after the last study drug
administration.
- Known deleterious germline mutation of BRCA1/2 (Patients in Cohorts A and A1)
- Prior treatment with PARP inhibitors (Patients in Cohort A1)
Exclusion Criteria:
- Prior treatment with PM01183 or trabectedin.
- Extensive prior RT.
- Prior or concurrent malignant disease unless cured for more than five years.
- Exceptions are breast cancer in the other breast.
- Uncommon or rare subtypes of breast cancer.
- Symptomatic or progressive brain metastases.
- Bone-limited and exclusively metastases.
- Relevant diseases or clinical situations which may increase patient's risk:
History of cardiac disease. Moderate breathing difficulties or oxygen requirement Active
uncontrolled infection. Unhealed wound or presence of any external drainage. Chronically
active viral hepatitis. Immunocompromised patients, including those known to be infected by
human immunodeficiency virus (HIV).
Known muscular disease or functional alteration
- Pregnant or breastfeeding women.
- Impending need for immediate RT for symptomatic relief.
- Limitation of the patient's ability to comply with the treatment or to follow-up the
protocol.
Ages Eligible for Study
18 Years - 75 Years
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
CCTO
650-498-7061
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.