Evaluate the Efficacy and Safety of Genexol®-PM Compared to Genexol® in Recurrent or Metastatic Breast Cancer

Samyang Biopharmaceuticals Corporation

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Drug: Genexol®; Drug: Genexol-PM®

Study type: Interventional

Funder types: Industry

Identifiers

NCT00876486

GPMBC301

Details and patient eligibility

About

Phase III trial to evaluate the efficacy and safety of Genexol®-PM compared to Genexol® in subjects with recurrent or metastatic breast cancer.

Enrollment: 213 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Subjects should meet all of the following criteria to participate in the trial.

1. Subjects who aged 18 years or older.
2. Subjects whose written informed consent was obtained complying with the local regulatory requirements prior to their participation in the trial.
3. Subjects who have histologically or cytologically confirmed breast cancer with evidence of recurrence or metastasis.
4. If subjects have received Taxanes as neo-adjuvant or adjuvant therapy, the subjects should have relapsed with breast cancer after 12 months of completing neo-adjuvant or adjuvant therapy with Taxanes.
5. Subjects who have measurable disease in accordance with the RECIST criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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213 participants in 2 patient groups

Genexol®-PM

Experimental group

Description:

This is a open-labeled, randomized, parallel, phase III Trial. Up to 106 elgible patients will be enrolled in each treatment arm(Total 212 subjects will recruited) according to the trial design. Patients will be randomly allocated to arm A (Genexol-PM) or arm B (Paclitaxel).

Treatment:

Drug: Genexol-PM®

Genexol®

Active Comparator group

Description:

This is a open-labeled, randomized, parallel, phase III Trial. Up to 106 elgible patients will be enrolled in each treatment arm(Total 212 subjects will recruited) according to the trial design. Patients will be randomly allocated to arm A (Genexol-PM) or arm B (Paclitaxel).

Treatment:

Drug: Genexol®