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.

Efficacy and Safety of Pembrolizumab (MK-3475) With Platinum Doublet Chemotherapy as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (MK-3475-671/KEYNOTE-671)

This trial will evaluate the safety and efficacy of pembrolizumab (MK-3475) in combination with platinum doublet neoadjuvant chemotherapy (NAC) before surgery [neoadjuvant phase], followed by pembrolizumab alone after surgery [adjuvant phase] in participants with resectable stage II, IIIA, and resectable IIIB (T3-4N2) non-small cell lung cancer (NSCLC). The primary hypotheses of this study are that neoadjuvant pembrolizumab (vs. placebo) in combination with NAC, followed by surgery and adjuvant pembrolizumab (vs. placebo) will improve: 1) event free survival (EFS) by biopsy assessed by local pathologist or by investigator-assessed imaging using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1); and 2) overall survival (OS).

Stanford is currently not accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • biological: Pembrolizumab
  • drug: Placebo
  • drug: Cisplatin
  • drug: Gemcitabine
  • drug: Pemetrexed

Eligibility


Inclusion Criteria:

   - Have previously untreated and pathologically confirmed resectable Stage II, IIIA, or
   IIIB (N2) NSCLC.

   - If male, must agree to use contraception or practice abstinence as well as refrain
   from donating sperm during the treatment period and for the time needed to eliminate
   each study intervention after the last dose of study intervention.

   - If female, may participate if not pregnant or breastfeeding, and at least one of the
   following conditions apply: 1) not a woman of childbearing potential (WOCBP); or 2) a
   WOCBP who agrees to follow contraceptive guidance during the treatment period and for
   the time needed to eliminate each study intervention after the last dose of study
   intervention and agrees not to donate eggs (ova, oocytes) to others or freeze/store
   for her own use for the purpose of reproduction during this period.

   - Have available formalin-fixed paraffin embedded (FFPE) tumor tissue sample blocks for
   submission. If blocks are not available, have unstained slides for submission for
   central programmed death-ligand 1 (PD-L1) testing.

   - Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within
   10 days of randomization.

   - Have adequate organ function.

Exclusion Criteria:

   - Has one of the following tumor locations/types:1) NSCLC involving the superior sulcus;
   2) Large cell neuro-endocrine cancer (LCNEC); or 3) Sarcomatoid tumor.

   - Has a history of (non-infectious) pneumonitis /interstitial lung disease that required
   steroids or has current pneumonitis/interstitial lung disease that requires steroids.

   - Has an active infection requiring systemic therapy.

   - Has had an allogenic tissue/sold organ transplant.

   - Has a known severe hypersensitivity (≥ Grade 3) to pembrolizumab, its active substance
   and/or any of its excipients.

   - Has a known severe hypersensitivity (≥ Grade 3) to any of the study chemotherapy
   agents and/or to any of their excipients.

   - Has an active autoimmune disease that has required systemic treatment in past 2 years.

   - Has a known history of human immunodeficiency virus (HIV) infection.

   - Has a known history of Hepatitis B or Hepatitis C.

   - Has a known history of active tuberculosis.

   - Has a history or current evidence of any condition, therapy, or laboratory abnormality
   that might confound the results of the trial, interfere with the participant's
   participation for the full duration of the trial, or is not in the best interest of
   the participant to participate.

   - Has known psychiatric or substance abuse disorders that would interfere with
   cooperating with the requirements of the trial.

   - Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with
   an agent directed to another co-inhibitory T-cell receptor.

   - Has received prior systemic anti-cancer therapy including investigational agents for
   the current malignancy prior to randomization/allocation.

   - Has received prior radiotherapy within 2 weeks of start of trial treatment.

   - Has received a live vaccine within 30 days prior to the first dose of trial drug.

   - Is currently participating in or has participated in a trial of an investigational
   agent or has used an investigational device within 4 weeks prior to the first dose of
   trial treatment.

   - Has a diagnosis of immunodeficiency or is receiving either systemic steroid therapy or
   any other form of immunosuppressive therapy within 7 days prior the first dose of
   trial drug.

   - Has a known additional malignancy that is progressing or requires active treatment
   within the past 5 years.

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
Olga Generalova
650-498-5188
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.