A Study Assessing the Addition of Pembrolizumab Immunotherapy and Radiation Therapy to Standard Chemotherapy Before Surgery in People with Breast Cancer

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Full Title

P-RAD: A Randomized Study of Preoperative Chemotherapy, Pembrolizumab and No, Low or High Dose RADiation in Node-Positive, HER2-Negative Breast Cancer

Purpose

Surgery and chemotherapy followed by radiation therapy is a standard treatment for some breast cancers whose growth is driven by hormones (estrogen and progesterone) but do not make a protein called HER2. It is also the standard approach for triple-negative breast cancers, which are negative for hormone receptors and HER2. Researchers believe that adding the immunotherapy drug pembrolizumab as well as radiation therapy to standard chemotherapy before breast cancer surgery may be an effective treatment for these cancers.

Pembrolizumab works by boosting the power of the immune system to detect and destroy cancer cells. Adding radiation therapy to pembrolizumab may further boost the immune response against cancer. Participants in this study will be randomly assigned to receive one of these treatments:

  • Pembrolizumab and standard chemotherapy before surgery, but no radiation therapy before surgery, OR
  • Pembrolizumab, low-dose or medium-dose radiation therapy to the breast area, and standard chemotherapy before surgery.

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have stage I or II hormone receptor-positive HER2-negative breast cancer or triple-negative breast cancer that has a high risk of coming back after treatment.
  • Patients must be planning to have breast cancer surgery with chemotherapy.
  • At least 4 weeks must pass between the completion of any prior chemotherapy and receipt of the study treatment.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

For more information and to ask about eligibility for this study, please contact the office of Dr.  Atif Khan at 848-225-6334.

Protocol

21-376

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Diseases