Conditions: Metastatic Breast Cancer
Keywords: Metastatic breast cancer, nab paclitaxel, docetaxel,
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 302
Healthy volunteers: no

Brief summary:
This was an open-label study conducted comparing the toxicity and antitumor activity of ABI-007 (Abraxane®, nab®-paclitaxel) to docetaxel (Taxotere).

Detailed description:
This was an open-label, randomized study to compare the following regimens with respect to toxicity and antitumor activity:

* the maximum tolerated dose (MTD) of ABI-007 300 mg/m\^2 every 3 weeks;
* ABI-007 100 mg/m\^2 administered weekly for 3 weeks with a 1 week rest;
* ABI-007 150 mg/m\^2 administered weekly for 3 weeks with a 1 week rest;
* the standard dose and schedule of Taxotere (100 mg/m\^2 every 3 weeks).

Arms:
arm 1: ABI-007 300 mg/m\^2 administered once every third week (q3w). arm 2: ABI-007 100 mg/m\^2 once weekly for 3 weeks followed by 1 week of rest arm 3: ABI-007 150 mg/m\^2 once weekly for 3 weeks followed by 1 week of rest arm 4: Docetaxel (Taxotere) 100 mg/m\^2 administered once every third week (q3w).

Interventions: intervention 1: ABI-007 intervention 2: Docetaxel
Intervention descriptions: intervention 1: ABI-007 administered by intravenous infusion over 30 minutes at one of three different dosing levels (100, 150 or 300 mg/m\^2) with a treatment cycle length of either 3 or 4 weeks depending upon treatment arm assignment. intervention 2: Docetaxel dosed q3w at 100 mg/m\^2

Protocol document: