A Randomized Phase II Trial of Genexol-PM vs Paclitaxel in Anthracycline-pretreated Metastatic Breast Cancer Patients
This is a prospective, two-armed, parallel group, randomized phase II study for the
evaluation of Genexol-PM and paclitaxel. Up to 42 eligible patients will be enrolled in each
treatment arm (a total of 84) according to the trial design. Patients will be randomly
allocated to arm A (Genexol-PM) or arm B (Paclitaxel). They will be stratified by ER
status(positive v negative), performance(ECOG 0 or 1 v 2), and prior adjuvant taxane (no v
yes) The treatment will be continued up to 6 cycles, or will be discontinued before 6th
cycle iin case of disease progression, unacceptable toxicity, or patient withdrawal. After
discontinuation of study therapy, patients will proceed to the post-therapy follow-up phase
of the study.
Patients may be enrolled in the study if they have documented measurable disease. Response
will be documented by physical examination prior to each treatment cycle and a CT scan every
two cycles or if disease progression is suspected. Responses will be assessed
unidimensionally according to the RECIST. All partial or complete responses require
confirmation with a second evaluation at least 4 weeks following the first documentation of
All toxicities encountered during the study will be evaluated before each cycle using the
NCI CTC (National Cancer Institute Common Toxicity Criteria) version 3.0 scale. For
peripheral neuropathy, the scale in Table 4 will be used to determine dose adjustments.
Life-threatening toxicities should be reported immediately to the Study Chairman.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
overall response rate
Jungsil Ro, Ph,D
National Cancer Center, Korea
Korea: Food and Drug Administration