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SWOG S1418

Status:

Recruiting | Phase III 

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 (ypN+) after Neoadjuvant Chemotherapy

Study Purpose:

To determine if adding pembrolizumab to the standard treatment for triple negative breast decrease the risk of the cancer returning (after receiving standard chemotherapy and/or radiation).

Interventions:

  • Pembrolizumab (Keytruda)
  • Lab Biomarker Analysis
  • Quality of Life questionnaires
  • ARM I: Observation (the standarad approach)
  • ARM II: Pembrolizumab every 3 weeks x 1 year

Patients should be followed every 6 months until 5 years from start of study, then annually thereafter until 10 years from start of study.

Key Participation Requirements:

Gender: 

Female

Age:

19 years and older

Diagnosis:

Breast cancer patients who have had surgery and whose cancer also has additional higher risk features (i.e. – positive lymph nodes, large size)

Marker Status:

Must be ER/PR/Her2 Negative (Triple Negative)

Prior Therapy:

Patients must have had surgery and completed chemotherapy before surgery. At least 1 cm of residual tumor tissue, or any residual positive lymph nodes, must be remaining at surgery.

Radiation (if applicable) may be done before or during study.

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Methodist Health System Trial Code:

SWOG S1418

For more information, visit the U.S. National Library of Medicine clinical trial database.

To learn more about this clinical trial please contact us today!