S1418 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 greater than / equal to 1 cm Residual Invasive Cancer or Positive Lymph Nodes (ypN+) after Neoadjuvant Chemotherapy
Johns Hopkins Kimmel Cancer Center in Baltimore
Sibley Memorial Hospital
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.
Patients with “triple-negative” breast cancer may be eligible. This means that your type of breast cancer doesn’t have receptors for estrogen, progesterone, or the protein HER2, that are found in some other types of breast cancer. Additionally, you have already had preoperative chemotherapy (also called “neoadjuvant” chemotherapy) and your breast cancer has at least partly survived that treatment.
This study has two study groups (also called study “arms”). A computer will by chance assign you to one of the two study arms. This is called randomization. This is done by chance because no one knows if one study arm is better, the same, or worse than the other arm. Once you are put on one arm, you cannot switch to the other arm. Neither you nor your doctor can choose which arm you will be in.If you are in Arm 1, you will get the usual approach used for this type of cancer: either observation or more chemotherapy as determined by your physician. Your doctors may recommend postoperative radiotherapy as part of your usual treatment. You will have visits with your physician every 12 weeks for one year. If you are in Arm 2, you will receive the usual care your physician recommends [which may include up to 6 months of adjuvant chemotherapy after your surgery before starting MK-3475 (pembrolizumab) and/or 2) postoperative radiotherapy together with MK-3475 (pembrolizumab)] and will also receive MK-3475 (pembrolizumab) by intravenous infusion over a 30 minute period. This infusion will be in the outpatient setting. You will receive MK-3475 (pembrolizumab) infusions every three weeks for one year and will be seen by your physician every 6 weeks during treatment.
12/09/2019 05:03 AM