Question about Hereptin-MCC-DM1 trial

[Julie2]

To enter into Herceptin-DM1 trial do we need to come off Herceptin for 3 weeks? Isn't it risky to do that? I am currently on Herceptin alone but my scan shows some uptake in mediastinal nodes. So I need to decide the choices whether to restart Navelbine or Herceptin+Tykerb or DM1 trial.

Thanks,
Julie

[runtolive]

yes .. there is a washout time.. i believe it to be 30 days.. but most ladies her at the forum have found it to be worth the risk..

[runtolive]

http://www.clinicaltrials.gov/ct2/show/NCT00509769?term=dm1&rank=4&show_locs=Y#locn

Criteria

Inclusion Criteria:
<LI style="MARGIN-TOP: 0.7ex">Signed Informed Consent Form <LI style="MARGIN-TOP: 0.7ex">HER2-positive metastatic breast cancer (MBC); tissue (slides or blocks) available for HER2 confirmation <LI style="MARGIN-TOP: 0.7ex">History of progression on HER2-directed therapy for the treatment of HER2-positive breast cancer <LI style="MARGIN-TOP: 0.7ex">At least one, and no more than three, chemotherapy regimens for MBC <LI style="MARGIN-TOP: 0.7ex">Granulocyte count ≥ 1500/μL, platelet count ≥ 100,000/μL, and hemoglobin ≥ 9 g/dL <LI style="MARGIN-TOP: 0.7ex">Serum bilirubin ≤ 1.5 mg/dL; AST, ALT, and alkaline phosphatase ≤ 2.5 x the upper limit of normal (ULN) <LI style="MARGIN-TOP: 0.7ex">Serum creatinine ≤ 1.5 mg/dL, or creatinine clearance ≥ 60 mL/min
ECOG performance status of 0, 1, or 2
Exclusion Criteria:
<LI style="MARGIN-TOP: 0.7ex">Any chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or biologic therapy for the treatment of breast cancer within 2 weeks of the first study treatment <LI style="MARGIN-TOP: 0.7ex">Prior cumulative doxorubicin dose > 360 mg/m^2 or the equivalent
History of significant cardiac disease, unstable angina, CHF, myocardial infarction, or ventricular arrythmia requiring medication