A Clinical Trial of Paclitaxel Loaded Polymeric Micelle in Patients With Taxane-Pretreated Recurrent Breast Cancer

Recurrent Breast Cancer Clinical Trial

Official title:

A Clinical Trial of Paclitaxel Loaded Polymeric Micelle (Genexol-PM®) in Patients With Taxane-Pretreated Recurrent Breast Cancer

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00912639
• Other study ID #: KBCSG004
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: May 31, 2009
• Last updated: June 15, 2009
• Start date: May 2009
• Est. completion date: May 2011

Study information

• Verified date: June 2009
• Source: Korean Breast Cancer Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the response rate in patients with taxane-pretreated recurrent breast cancer receiving paclitaxel loaded polymeric micelle (Genexol-PM).

Description:

Genexol-PM is a novel Cremophor EL-free polymeric micelle formulation of paclitaxel. This single arm, multicenter phase IV study was designed to evaluate the response rate, toxicity, progression free survival and tumor control rate of Genexol-PM in patients with Taxane-pretreated recurrence breast cancer.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 90
• Est. completion date: May 2011
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Women aged >=18 years

2. WHO (ECOG) performance status 0-2

3. Estimated life expectancy of >=3 months

4. Have given written informed consent and are available for prolonged follow-up

Exclusion Criteria:

1. Patients with previous chemotherapy for recurrent breast cancer

2. Breast cancer recurrence within 12 months after taxane treatment

3. Her-2/neu expression

4. Patients with malignancies (other than breast cancer) within the last 5 years, except for adequately treated in situ carcinoma of the cervix or basal cell, squamous cell carcinoma of the skin.

5. Brain metastasis

6. uncontrolled infection, medically uncontrollable heart disease

7. other serious medical illness or prior malignancies

8. Pregnant or lactating women were excluded.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Recurrent Breast Cancer

Intervention

Drug:
• Paclitaxel loaded Polymeric micelle
Genexol-PM at a dose of 300mg/m2 was diluted in 500 ml of 5% dextrose solution or normal saline and infused i.v. for 3 h on day 1.Treatment was repeated every 3 weeks until either disease progression or intolerance. A minimum of 6 cycles was recommended.

Locations

Country	Name	City	State
Korea, Republic of	Department of surgery, The Catholoic university of Korea, St. Mary's hospital.	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korean Breast Cancer Study Group

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate was assessed by imaging using the RECIST (Response Evaluation Criteria In Solid Tumor) guideline		1 year	Yes
Secondary	Toxicity		1 year	Yes
Secondary	Progression Free Survival		1 year	Yes
Secondary	Tumor control rate		1 year	Yes