Everolimus Letrozole and Trastuzumab in HR- and HER2/Neu-positive Patients

    Not Recruiting
  • participants needed
  • sponsor
    M.D. Anderson Cancer Center
Updated on 26 January 2021
monoclonal antibodies
breast cancer
growth factor
endocrine therapy
international normalized ratio
neutrophil count
hormone therapy
liver metastasis
tumor cells
monoclonal antibody therapy
chemotherapy regimen
follicle stimulating hormone
human epidermal growth factor
cancer chemotherapy
solid tumour
epidermal growth factor
estrogen receptor
antibody therapy


The goal of this clinical research study is to find the highest tolerable dose of Femara (letrozole) that can be given in combination with Afinitor (everolimus) and Herceptin (trastuzumab) to patients with advanced cancer. The safety of this drug combination will also be studied.


Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a dose level of trastuzumab and everolimus based on when you join this study. Up to 5 dose levels of trastuzumab and everolimus will be tested. Up to 3 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of trastuzumab and everolimus is found.

All participants will receive the same dose level of letrozole.

After the 4th cycle is completed, you may be considered for treatment at a dose level that is higher than the dose to which you were first assigned. In order for you to be treated at a higher dose level, you must have tolerated the lower dose for at least 4 cycles of therapy. Also, the new, higher dose that you will receive must be the same or below the highest tolerated dose seen in this study so far.

Once the highest tolerated dose of the drug combination is found, 2 groups of 12 participants will be enrolled in expansion groups. One group will include participants with breast cancer and the other group will include participants with any solid tumor.

Study Drug Administration:

You will take letrozole and everolimus by mouth 1 time every day at the same time. Both drugs should be taken either with or without food every time.

You will receive trastuzumab by vein on Day 1 of every 21-day cycle

Study Visits:

On Day 1 of every Cycle:

  • You will have a physical exam.
  • Blood (about 3 teaspoons) will be drawn for routine tests and to test for hepatitis B.
  • If you can become pregnant, you will have a urine pregnancy test.

Every 2 cycles, you will have a CT scan or MRI to check the status of the disease. If the doctor thinks it is needed, they will be performed more often.

At the end of Cycle 4 and every 4 cycles after that, you will have an ECHO or a MUGA scan to check your heart function.

Length of Study:

You may continue taking the study drugs for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation on the study will be over after you have completed the end-of-study and follow-up visits.

End-of-Study Visit:

After your last dose of study drugs, you will have an end-of-study visit. At this visit:

  • You will have a physical exam.
  • Blood (about 3 teaspoons) and urine will be collected for routine tests.

This is an investigational study. Letrozole is FDA approved and commercially available for the treatment of certain kinds of breast cancer. Everolimus is FDA approved to treat advanced renal cell carcinoma. Trastuzumab is FDA approved for certain kinds of gastric and breast cancer. The combination of these drugs is considered investigational.

Up to 42 patients will take part in this study. All will be enrolled at MD Anderson.

Condition Breast Cancer, Solid Tumors
Treatment Everolimus, Trastuzumab, Letrozole
Clinical Study IdentifierNCT02152943
SponsorM.D. Anderson Cancer Center
Last Modified on26 January 2021

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