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A Randomized Phase II Trial of Genexol-PM vs Paclitaxel in Anthracycline-pretreated Metastatic Breast Cancer Patients

Phase 2
18 Years
Not Enrolling
Breast Cancer

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Trial Information

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.

Inclusion Criteria:

1. Histologically or cytologically diagnosed stage IV or recurrent breast cancer
patients according to American Joint Committee on Cancer (AJCC 6th ed.)

2. Prior chemotherapy at least one anthracycline-containing regimen, in either adjuvant
or metastatic setting is requested.

3. Previous hormonal therapy in adjuvant setting is allowed.

4. Previous adjuvant taxane chemotherapy in an adjuvant setting is allowed, if
taxane-free interval is more than 12 months

5. previous chemotherapy for metastatic disease is not allowed except for the regimen
including anthracycline.

6. Previous chemotherapy including taxane for metastatic disease is not allowed.

7. Prior radiation therapy is allowed as long as the irradiated area is not the only
source of measurable disease.

8. No other forms of cancer therapy, such as radiation, immunotherapy or chemotherapy
for at least 4 weeks before the enrollment in therapy.

9. Major surgery other than biopsy within the past two weeks.

10. At least 18 years old

11. Performance status of 0, 1 and 2 on the ECOG criteria.

12. Disease status must be that of measurable disease defined as RECIST:

Lesions that can be accurately measured in at least one dimension > 10 mm with chest
x-ray, spiral CT scan, MRI, or physical examination

13. Estimated life expectancy of at least 12 weeks.

14. Patient compliance that allow adequate follow-up.

15. Adequate major organ function including the following:

①Hematologic function: WBC ³ 3,000/mm3 or absolute neutrophil count (ANC) ³
1,500/mm3, platelet count ³ 100,000/mm3

②Hepatic function: bilirubin 1.5 x UNL , AST/ALT levels 2.5 x UNL

③Renal function: serum creatinine 1.5mg/dL

16. Grade of baseline neuropathy should not be more than grade 1 by NCI CTC v.3.0

17. Patients should sign an informed consent

18. women of childbearing age should use non-hormonal contraceptive method.

Exclusion Criteria:

1. Serious concurrent infection or nonmalignant illness that is uncontrolled or whose
control may be jeopardized by complication of study therapy

2. Other malignancy with the past 5 years except adequately treated cutaneous basal cell
carcinoma or uterine cervix in situ cancer

3. Psychiatric disorder that would preclude compliance.

4. uncontrolled CNS disease (eligible if the CNS disease is controlled with radiotherapy
or corticosteroid)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall response rate

Outcome Time Frame:


Safety Issue:


Principal Investigator

Jungsil Ro, Ph,D

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Center, Korea


Korea: Food and Drug Administration

Study ID:




Start Date:

July 2007

Completion Date:

October 2008

Related Keywords:

  • Breast Cancer
  • metastatic
  • Breast Neoplasms