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

NCT00912639 | Unknown Phase 4 DMC

• 1 other identifier: KBCSG004
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Recurrent Breast Cancer

Keywords

recurrent breast cancer; Genexol-PM

Outcome Measures

Primary Outcomes (1)

• Response rate was assessed by imaging using the RECIST (Response Evaluation Criteria In Solid Tumor) guideline

  1 year

Secondary Outcomes (3)

• Toxicity

  1 year

• Progression Free Survival

  1 year

• Tumor control rate

  1 year

Study Arms (1)

Genexol-PM

EXPERIMENTAL

All the patients are recurrent breast cancer after taxane treatment. Patients with a measurable lesion (at least 1 measurable lesion) 1. Spiral CT : lesion ≥ 10mm (unidimension) 2. X-ray, MRI, ultrasound : lesion ≥ 20 mm (unidimension)

Drug: Paclitaxel loaded Polymeric micelle

Interventions

Paclitaxel loaded Polymeric micelle DRUG

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.

Also known as: Genexol-PM®

Genexol-PM

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged \>=18 years
• WHO (ECOG) performance status 0-2
• Estimated life expectancy of \>=3 months
• Have given written informed consent and are available for prolonged follow-up

You may not qualify if:

• Patients with previous chemotherapy for recurrent breast cancer
• Breast cancer recurrence within 12 months after taxane treatment
• Her-2/neu expression
• 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.
• Brain metastasis
• uncontrolled infection, medically uncontrollable heart disease
• other serious medical illness or prior malignancies
• Pregnant or lactating women were excluded.

Sponsors & Collaborators

• Korean Breast Cancer Study Group: lead

Study Sites (1)

Department of surgery, The Catholoic university of Korea, St. Mary's hospital.

Seoul, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

genexol-PM

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Byung-Joo Song, MD.PhD.

  The Catholoic university of Korea, St. Mary's hospital.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 31, 2009
• First Posted: June 3, 2009
• Study Start: May 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2011
• Last Updated: June 16, 2009

Record last verified: 2009-06

Locations

KR (1)