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Protocol No. S1418

Principal Investigator Tevaarwerk, Amye

Phase III

Age Group Adult

Scope National

Sponsor Type National

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 Node

Objective The purpose of this study is to compare the usual approach (i.e. no more treatment or additional post-operative chemotherapy), to any effects, good and/or bad, of the experimental drug MK-3475 (also called pembrolizumab) after surgery. This study will allow the researchers to know whether treatment with MK-3475 (pembrolizumab) is better, the same, or worse than the usual approach.

Treatment
Arm 1, you will get observation with close clinical monitoring. Your doctors may recommend postoperative radiotherapy, or more post-operative chemotherapy, as part of your usual treatment. This treatment plan must be determined by you and your physician before entering the trial. If you are assigned to Arm 1, you may not receive any other treatment that is not part of the study. You will have visits with your physician every 12 weeks for one year.
Arm 2, you will receive MK-3475 (pembrolizumab) by intravenous infusion over a 30-minute period. You will not have to be hospitalized for this infusion unless your doctor feels it is needed. You will receive MK-3475 (pembrolizumab) infusions every three weeks for one year and will be seen by your physician every six weeks during treatment. Your doctors may also recommend postoperative radiotherapy
A computer will by chance assign you to one of the two study arms. This is called randomization

Description Randomized study testing MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer

Key Eligibility
  • Must have histologically confirmed ER-, PR- and HER2-negative (triple negative, TNBC) or ER, PR, and HER2 equivocal status and must not have received and not be planning to receive adjuvant anti-HER2 or endocrine therapies after completion of neoadjuvant chemotherapy
  • Patients who are HER2 positive by ASCO CAP guidelines are ineligible
  • HER2 negative and HER2 equivocal cases as per ASCO CAP guidelines that do not receive HER2-targeted therapy are eligible
  • Patients with weekly ER or PR positive disease, defined as ER and/or PR <5% by immunohistochemistry, are eligible if the treating physician considers the patient not eligible for adjuvant endocrine therapy
  • Residual disease must be ≥ 1 cm in greatest dimension, and/or have positive lymph nodes (ypN+) observed on pathologic exam
  • Patients must not have metastatic disease
  • Patients must have a minimum of five, available unstained slides from the residual (post-neoadjuvant) invasive tumor in primary site or lymph node
  • Patients must have had neoadjuvant chemotherapy followed by surgery
  • Patients may receive post-operative (adjuvant) chemotherapy for up to 24 weeks of duration
  • Patients must have resolution of adverse event(s) of the most recent prior chemotherapy to Grade 1 or less, except alopecia and ≤ Grade 2 neuropathy which are allowed
  • Patients must not have had prior immunotherapy with anti-PD-L1, anti-PD-1, antiCTLA4 or similar drugs
  • Patients must be women or men ≥ 18 years of age, Zubrod Performance Status ≤ 2.
  • Patients must not have a history of (non-infectious) pneumonitis that required steroids or evidence of active pneumonitis
  • Patients must not have active autoimmune disease that has required systemic treatment in past 2 years
  • Patients must not have known active Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection prior to registration
  • Adequate bone marrow, renal and hepatic function
  • Women of childbearing potential must have a negative urine or serum pregnancy test within 28 day prior to registration. Women/men of reproductive potential must have agreed to use an effective contraceptive method for the course of the study through 120 days after the last dose of study medication

  • Applicable Disease Sites Breast

    Status Open

    Participating Institutions Aspirus UW Cancer Center (formerly Riverview Hospital); Aspirus Wausau Hospital, Aspirus Regional Cancer Center; Johnson Creek, UW Cancer Center; Langlade Memorial Hospital, Aspirus Regional Cancer Ctr; Swedish American Hospital, Rockford ; UW Hospital and Clinics; UWCCC 1 South Park