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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Korean Breast Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00912639
First received: May 31, 2009
Last updated: June 15, 2009
Last verified: June 2009

May 31, 2009
June 15, 2009
May 2009
May 2010   (final data collection date for primary outcome measure)
Response rate was assessed by imaging using the RECIST (Response Evaluation Criteria In Solid Tumor) guideline [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00912639 on ClinicalTrials.gov Archive Site
  • Toxicity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Progression Free Survival [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Tumor control rate [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Clinical Trial of Paclitaxel Loaded Polymeric Micelle in Patients With Taxane-Pretreated Recurrent Breast Cancer
A Clinical Trial of Paclitaxel Loaded Polymeric Micelle (Genexol-PM®) in Patients With Taxane-Pretreated Recurrent Breast Cancer

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).

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.

Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Recurrent Breast Cancer
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.
Other Name: Genexol-PM®
Experimental: Genexol-PM

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)
Intervention: Drug: Paclitaxel loaded Polymeric micelle
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
90
May 2011
May 2010   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00912639
KBCSG004
Yes
Byung-Joo Song, The Catholoic university of Korea, St. Mary's hospital.
Korean Breast Cancer Study Group
Not Provided
Principal Investigator: Byung-Joo Song, MD.PhD. The Catholoic university of Korea, St. Mary's hospital.
Korean Breast Cancer Study Group
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP