At a glance
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An Open-label, Multicentre, Phase IIIb Study With Intravenous Administration of Pertuzumab, Subcutaneous Trastuzumab, and a Taxane in Patients With HER2-positive Metastatic Breast Cancer
In Brief
A Phase 3 clinical trial evaluating Docetaxel, Nab-paclitaxel, and 3 other interventions for Breast Cancer. Completed, enrolled 50 participants across 13 sites.
Detailed Summary
This open-label, multicenter, Phase IIIb study will assess the safety, tolerability and efficacy of a combination therapy of intravenous (IV) pertuzumab (Perjeta), trastuzumab (Herceptin) SC, and taxane chemotherapy (docetaxel, paclitaxel or nab-paclitaxel) as first-line therapy in participants with HER2-positive metastatic breast cancer (mBC). All participants will be treated with 3-week cycles of pertuzumab IV (840 milligrams \[mg\] first dose; subsequent doses of 420 mg) and trastuzumab SC (600 milligrams \[mg\]). The taxane treatment regimen will be determined by the investigator. Participants will continue therapy until disease progression, unacceptable toxicity, or the participant withdraws consent, whichever occurs first.
Study Details
Timeline
Interventions
Dosing regimen to be determined by the investigator, routine clinical practices.
Dosing regimen to be determined by the investigator, routine clinical practices.
Dosing regimen to be determined by the investigator, routine clinical practices.
Pertuzumab will be administered on Day 1 of the first treatment cycle as a loading dose of 840 mg, followed by 420 mg as an IV infusion every 3 weeks.
Trastuzumab will be administered at a fixed dose of 600 mg SC every 3 weeks.