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.

Javelin Parp Medley: Avelumab Plus Talazoparib In Locally Advanced Or Metastatic Solid Tumors

Avelumab in combination with talazoparib will be investigated in patients with locally advanced (primary or recurrent) or metastatic solid tumors, including non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), hormone receptor positive (HR+) breast cancer, recurrent platinum sensitive ovarian cancer, urothelial cancer (UC), and castration resistant prostate cancer (CRPC).

Stanford is currently not accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • drug: Avelumab Phase 1b
  • drug: Talazoparib Phase 1b
  • drug: Avelumab Phase 2
  • drug: Talazoparib Phase 2

Eligibility


Inclusion Criteria:

   - Histological diagnosis of locally advanced (primary or recurrent) or metastatic solid
   tumors that are not amenable for treatment with curative intent in adult patients
   with: NSCLC, TNBC, HR+ breast cancer, recurrent platinum sensitive ovarian cancer, UC,
   CRPC, and other advanced solid tumors with a BRCA or ATM gene defect

   - Mandatory primary or metastatic tumor biopsy. If archival tumor tissue is available
   from a biopsy/surgery the tumor tissue may be submitted without repeating a tumor
   biopsy during the screening period.

   - Minimum age in Japan is 20 years.

   - ECOG performance status 0 or 1.

   - Resolved acute effects of prior therapy

   - Adequate bone marrow, renal, and liver function.

   - Negative serum pregnancy test at screening.

   - Pregnant, breastfeeding females or female patients able to have children must agree to
   use highly effective method of contraception throughout the study and for at least 30
   days after the last dose of avelumab and for at least 7 months after the last dose of
   talazoparib; fertile male patients must use a condom during treatment and for at least
   4 months after the last dose of talazoparib.

   - Signed and dated informed consent.

Exclusion Criteria:

   - Prior treatment with a PARP inhibitor.

   - Prior immunotherapy with IL-2, IFN-α, or an anti-PD-1, anti-PD-L1, anti-PD-L2,
   anti-CD137, OX 40, GITR, LAG 3, IDO, TDO,TIM 3, CTLA-4 antibody, or any other antibody
   or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
   Prior treatment with Sipuleucel-T for patients with mCRPC is allowed. For cohort A2
   NSCLC patients prior treatment with anti-PD-1/L1 is allowed

   - Prior anti-cancer therapy within 2 weeks prior to study enrollment. Prior radiation
   therapy within 2 weeks prior to enrollment. Prior palliative radiotherapy to
   metastatic lesion(s) is permitted, provided it has been completed 2 days prior to
   study enrollment and no clinically significant toxicities are expected (eg, mucositis,
   esophagitis).

   - Major surgery within 4 weeks prior to study enrollment.

   - Current use of immunosuppressive medication at the time of study enrollment.

   - Known prior or suspected hypersensitivity to investigational products.

   - Known history of immune mediated colitis, inflammatory bowel disease, pneumonitis,
   pulmonary fibrosis.

   - Active or prior autoimmune disease that might deteriorate when receiving an
   immunostimulatory agent.

   - Prior organ transplantation including allogenic stem-cell transplantation.

   - Vaccination within 4 weeks of study enrollment and while on trial is prohibited except
   for administration of inactivated vaccines.

   - Diagnosis of Myelodysplastic Syndrome.

   - Patients with known brain metastases requiring steroids.

   - Participation in other studies involving investigational drug(s) within 4 weeks prior
   to study participation and/or during study participation.

   - Persisting toxicity related to prior therapy >Grade 1

   - Known HIV or AIDs-related illness.

   - Positive HBV or HCV test indicating acute or chronic infection.

   - Active infection requiring systemic therapy.

   - Clinically significant cardiovascular disease: cerebral vascular accident/stroke or
   myocardial infarction within 6 months prior to study entry; unstable angina,
   congestive heart failure or a serious cardiac arrhythmia requiring medication.

   - Current or anticipated use within 7 days prior to first dose of study drug, or
   anticipated use during the study of a strong P-gp inhibitor.

   - Other acute or chronic medical or psychiatric conditions.

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
Wyatt Gross
650-721-4076
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.