A Phase I/II Trial of Temsirolimus Plus Neratinib for Subjects with Metastatic HER2-Amplified or Triple Negative Breast Cancer

Study Status

Open to Enrollment

Study Description

This clinical trial is for women with HER2-positive breast cancer

  • Whose breast cancer has grown in spite of standard treatment, and
  • Who previously received trastuzumab as treatment for breast cancer

The purpose of the study is to test the safety and benefit of the combination of a new, experimental drug called Neratinib and a drug approved for kidney cancer called Temsirolimus for the treatment of breast cancer. In addition, the study will help determine why therapy directed against HER2 sometimes stops working and what dose of Temsirolimus should be used in combination with Neratinib.

HER2 is a protein that normally appears on the surface of certain cells at low levels. If cancer cells have high levels of the HER2 protein, it is called HER-2 positive cancer. High levels of HER2 can stimulate the growth of cancer.

Neratinib blocks some of the functions of the HER2 protein and has been shown to be effective in people whose HER2-positive cancers have grown while on trastuzumab therapy. Temsirolimus blocks the signals from another protein, mTOR, that HER2 stimulates and tells cancer cells to multiply and grow.  In laboratory studies, blocking both MTOR and HER2 appears to be better at killing cancer cells than doing either alone. This approach is being tested in this study.

Treatment Plan:

  • Temsirolimus via infusion on Days 1, 8, 15 and 22 of a 28-day cycle
  • Neratinib pill by mouth once daily

All study participants will receive Neratinib and Temsirolimus; there is no placebo. Treatment will continue until disease progression. 

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Disease Status and/or Stage

HER2-Positive Metastatic Breast Cancer



Key Eligibility

  • Age 18 and older
  • HER2-positive metastatic breast cancer
  • Previously received trastuzumab as part of a regimen in the adjuvant or metastatic setting with evidence of progression
  • No more than 4 prior chemotherapy regimens for advanced disease
  • Note: Triple-negative cohort is closed to enrollment
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Linda Vahdat, MD


Healthy Volunteers


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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Erica Bersin
Tel: (646) 962-8232
[email protected]

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