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A Randomized, Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer With = 1 CM Residual Invasive Cancer or Positive Lymph Nodes (ypN1mi, ypN1-3) After Neoadjuvant Chemotherapy
Overall Recruitment Status: Enrollment on-hold
 
Official Title
A Randomized, Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer With = 1 CM Residual Invasive Cancer or Positive Lymph Nodes (ypN1mi, ypN1-3) After Neoadjuvant Chemotherapy
 
Region Sponsors
California - Northern
National Cancer Institute (NCI)
 
Acronym KP IRB No.
S62
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
 
Purpose
This randomized phase III trial studies how well pembrolizumab works in treating patients with triple-negative breast cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
 
Detailed Description
 
Gender Age Limit
Male & Female
 
Inclusion Criteria
  • Patients must have a minimum of five, available unstained formalin-fixed paraffin-embedded (FFPE) slides (4-5 micron thickness) from the residual (post-neoadjuvant) invasive tumor in primary site or lymph node
  • (these will be submitted to a central laboratory to determine PD-L1 expression)
  • the tumor tissue must be adequate for PD-L1 testing, which typically requires a minimum of 100 cancer cells per slide
  • local PD-L1 results, even if available, will not substitute for central testing NOTE: Initial order for specimen kits should be placed at least two weeks prior to registering the first patient at each site Patients must be offered the opportunity to participate in specimen banking The BAHO substudy was permanently closed to accrual on June 23, 2020, and willingness of English-speaking patients to participate in the BAHO substudy is no longer applicable
 
Exclusion Criteria
  • Patients with metastatic disease
  • Patients with prior immunotherapy with anti-PD-L1
  • Patients planning to receive concomitantly other biologic therapy

 
Keywords and/or Specific Medical Conditions
  • Obstetrics and Gynecology
  • Oncology (Adult)
 
KP Clinical Facility
  • All Kaiser Permanente Northern California Medical Centers
 
Clinical Area
  • Obstetrics and Gynecology
  • Oncology (Adult)


Principal Investigator:
Jennifer M Suga
Contact Information:
- Desiree Goldstein
-ctpcollaborate@kp.org
-All Kaiser Permanente Northern California Medical Centers


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