Clinical Trial Participants Needed

BY CJ Corneliussen-James


PURPOSE OF THE TRIAL: To determine if TDM-1 combined with the oral drug Temozolomide, which is known to have the ability to cross the blood brain barrier, can prevent a return of brain metastases that have been recently treated with stereotactic surgery or surgical resection.


  • Must be HER+. (ER and PR status can be positive or negative.)
  • Must have diagnosis of brain metastasis.
  • Must have just had or be eligible for stereotactic radiosurgery or surgical resection of brain mets. (If lesions are present, removal can be done at NCI.)
  • The phase I of the trial is recruiting patients now with any number of brain metastases and recent treatment with WBRT, SRS or surgery.
  • The phase II of the trial will open after the phase I for patients with up to 10 brain metastases and recent treatment with SRS or surgery.


  • Patients with leptomeningeal metastatic disease
  • Patients with history of WBRT are disqualified for the Phase II of the trial
  • Patients unable to complete a brain MRI with contrast
  • Patients with breast tissue expanders unless removed pre-enrollment
  • HBV, HCV or HIV-positive patients

TREATMENT: There will be two groups in the trial. One group will receive TDM-1 plus Temozolomide. The other group will receive TDM-1 only. The study will be done in 3-week cycles. All participants will get T-DM1 on day 1 of each cycle. Some participants will also take TMZ capsules by mouth every day. Participants will have image-guided lumbar puncture at least 2 times. Participants will have a follow-up visit about 1 month after stopping the study drug.

SCREENING: Participants will be screened with the following

  • Medical history
  • Physical exam
  • Heart tests
  • CT and MRI scans

COST: For those qualifying for the trial, the NCI will cover the cost of the trial and the cost of transportation to and from the NIH Clinical Center in Bethesda MD for purposes of the trial. The NCI will also give a small stipend to help with hotel costs to those participating in the trial. NOTE: Travel to the NCI to determine whether you qualify for the trial must be at personal expense.

LOCATION: All tests and procedures will be performed at the NIH Clinical Center, America’s Research Hospital in Bethesda, Maryland. They are on the Washington DC Metro system. Take the Red Line and get off at the Medical Center stop.

If you are coming to Bethesda and wish to get together with the Maryland METAvivor peer-to-peer support group, please contact CJ at [email protected] or Kelly at [email protected]

Office of Patient Recruitment
TTY: 1-866-411-1010
Refer to study # 17-C-0115

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