Conditions: Breast Cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 50
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Participants will receive pertuzumab, trastuzumab and a taxane (docetaxel, paclitaxel or nab-paclitaxel) once every 3 weeks (21-day cycles). Choice of taxane will be at the discretion of the investigator and administered per routine clinical practices and local prescribing instructions.

Interventions: intervention 1: Docetaxel intervention 2: Nab-paclitaxel intervention 3: Paclitaxel intervention 4: Pertuzumab intervention 5: Trastuzumab
Intervention descriptions: intervention 1: Dosing regimen to be determined by the investigator, routine clinical practices. intervention 2: Dosing regimen to be determined by the investigator, routine clinical practices. intervention 3: Dosing regimen to be determined by the investigator, routine clinical practices. intervention 4: 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. intervention 5: Trastuzumab will be administered at a fixed dose of 600 mg SC every 3 weeks.

Protocol document: