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LY2157299 Monohydrate (LY2157299) and Radiotherapy in Metastatic Breast Cancer

Clinical Trial Details

The rationale for this trial is based on preclinical and clinical findings that radiation generates “danger” signals in tissues that, under certain conditions, enhance immune presentation of tumor antigens liberated from radiation-damaged cells, thus working as an individualized vaccine. 

This trial is open to women who have metastatic breast cancer and have progressed after at least one course of chemotherapy or hormonal therapy. In addition, patients must have at least 3 metastases with at least one measurable metastatic lesion

The purpose of this study is to investigate how effective and how safe the combination of radiation therapy targeted to one metastatic site with an investigational drug targeting TGF beta pathway known as LY2157299 in the treatment of metastatic breast cancer. This drug when given alone has demonstrated activity in brain tumors but has not shown to induce clinical objective responses in breast cancer.

In addition to toxicity, feasibility and RECIST response, an endpoint of the trial is to assess whether the combination of radiation and LY2157299 can stop the growth of tumors that are outside the field of radiation (abscopal effect). We would like see if using this combination of radiation therapy with LY2157299 could achieve clinical responses or at least help the immune system to maintain the disease stable and/or slow its growth. In addition, this study will test blood and tissue samples to further understand the immune system’s response to tumors. 

Key Eligibility: 
  • Open to women 18 years of age or older, who have biopsy proven breast cancer, which is persistent and metastatic or recurrent and metastatic
  • Patients must have failed at least one line of therapy (endocrine or chemotherapy) for metastatic disease
  • Patients must have at least 3 distinct metastatic sites with at least one measurable lesion (a more detailed review will be done at the time of enrollment)
  • At the time of enrollment patients must be ≥ 4 weeks since all of the following treatments:
    - Major surgery
    - Radiotherapy
    - Chemotherapy
    - Immunotherapy
    - Biotherapy/targeted therapies
  • Detailed eligibility reviewed when you contact the study team

Contact

Sharanya Chandrasekhar
shc2043@med.cornell.edu

Primary Investigator

Silvia Formenti, M.D.

Protocol ID: 
WCMC IRB #1505016222

Status:

Open to Enrollment

AGE GROUP

Adult

DRUG/DEVICE

STUDY TYPE