At a glance
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A Multicenter, Single Arm, Open-Label PhIV Study to Investigate the Effect of First-Line Herceptin (Trastuzumab) in Combination With a Taxane in Patients With Metastatic Breast Cancer Who Relapsed After Receiving (Neo)Adjuvant Herceptin for HER2-Positive Early Breast Cancer
In Brief
A Phase 4 clinical trial evaluating Docetaxel, Paclitaxel, and 1 other intervention for Breast Cancer. Completed, enrolled 32 participants across 17 sites.
Detailed Summary
This single arm, open-label study will evaluate the efficacy and safety of Herceptin (trastuzumab) in combination with a taxane as first line therapy in participants with HER2-positive breast cancer who relapsed after neoadjuvant or adjuvant Herceptin treatment. Participants will receive Herceptin (loading dose of 4 mg/kg intravenously \[iv\], 2 mg/kg iv weekly thereafter) with 6 3-week cycles of either docetaxel (100 mg/m2 iv every 3 weeks) or paclitaxel (90 mg/m2 every week). Herceptin treatment will be continued until disease progression or unacceptable toxicity occurs.
Study Details
Timeline
Interventions
100 mg/m2 iv every 3 weeks, 6 cycles (18 weeks)
90 mg/kg iv (+/-10%) every 3 weeks for 6 3-week cycles (18 weeks)
4 mg/kg iv loading dose on Day 1, 2 mg/kg iv on Day 8 and weekly thereafter