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

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ClinicalTrials.gov Identifier: NCT00912639
Recruitment Status : Unknown
Verified June 2009 by Korean Breast Cancer Study Group.
Recruitment status was:  Enrolling by invitation
First Posted : June 3, 2009
Last Update Posted : June 16, 2009
Sponsor:
Information provided by:
Korean Breast Cancer Study Group

Study Description
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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).

Condition or disease Intervention/treatment Phase
Recurrent Breast Cancer Drug: Paclitaxel loaded Polymeric micelle Phase 4

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Trial of Paclitaxel Loaded Polymeric Micelle (Genexol-PM®) in Patients With Taxane-Pretreated Recurrent Breast Cancer
Study Start Date : May 2009
Estimated Primary Completion Date : May 2010
Estimated Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Paclitaxel

Arms and Interventions
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Arm Intervention/treatment
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)
 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®


Outcome Measures
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Primary Outcome Measures :
  1. Response rate was assessed by imaging using the RECIST (Response Evaluation Criteria In Solid Tumor) guideline [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Toxicity [ Time Frame: 1 year ]
  2. Progression Free Survival [ Time Frame: 1 year ]
  3. Tumor control rate [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00912639


Locations
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Korea, Republic of
Department of surgery, The Catholoic university of Korea, St. Mary's hospital.
Seoul, Korea, Republic of
Sponsors and Collaborators
Korean Breast Cancer Study Group
Investigators
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Principal Investigator: Byung-Joo Song, MD.PhD. The Catholoic university of Korea, St. Mary's hospital.
More Information
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Responsible Party: Byung-Joo Song, The Catholoic university of Korea, St. Mary's hospital.
ClinicalTrials.gov Identifier: NCT00912639    
Other Study ID Numbers: KBCSG004
First Posted: June 3, 2009    Key Record Dates
Last Update Posted: June 16, 2009
Last Verified: June 2009
Keywords provided by Korean Breast Cancer Study Group:
recurrent breast cancer
Genexol-PM
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
 Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action