Durvalumab in Patients With HER-2 Positive Metastatic Breast Cancer Receiving Trastuzumab

Official Title

A Phase 1b Pharmacodynamic Study of Durvalumab (MEDI4736) in Patients With HER-2 Positive Metastatic Breast Cancer (MBC) Receiving Trastuzumab

Summary:

The purpose of this study is to find the highest dose of durvalumab that can be tolerated without causing very severe side effects when receiving standard treatment and to see what effects the study drug has on this type of cancer. The researchers doing this study are also interested in looking for markers that will help predict which patients are most likely to be helped by durvalumab when receiving standard treatment and what effects durvalumab has on this type of cancer.

Trial Description

Primary Outcome:

  • Confirm the recommended phase II dose of durvalumab given to patients with advanced/recurrent HER-2 positive metastatic breast cancer (MBC) who are receiving treatment with trastuzumab
Secondary Outcome:
  • Number of participants with treatment related adverse events as assessed by CTCAE V 4.0
  • Measure response rate of durvalumab measured by RECIST 1.1/Immune Response Criteria) in patients receiving trastuzumab
  • Measure clinical benefit rate of durvalumab measured by RECIST 1.1/Immune Response Criteria) in patients receiving trastuzumab
  • Assess PD-L1 expression in paired biopsies pre and post treatment with durvalumab as a marker of response/benefit
The standard or usual treatment for this type of disease at this point is to receive a drug called trastuzumab that targets the HER-2 receptor. Durvalumab is a new type of drug for many types of cancer. This drug is an antibody and laboratory tests show that it works by allowing the immune system to detect your cancer and reactivating the immune response. This may help to slow down the growth of cancer or may cause cancer cells to die. Durvalumab has been shown to shrink tumours in animals and has been studied in a few people and seems promising but it is not clear if it can offer better results than standard treatment alone.

The use of durvalumab when receiving standard treatment is being studied because it is thought that one way of over-coming resistance to the standard therapy is to add a drug that activates the immune system, as durvalumab has been shown to do, thus "re-sensitizing" immune function to kill cancer cells.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society