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

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)
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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® |
- Response rate was assessed by imaging using the RECIST (Response Evaluation Criteria In Solid Tumor) guideline [ Time Frame: 1 year ]
- Toxicity [ Time Frame: 1 year ]
- Progression Free Survival [ Time Frame: 1 year ]
- Tumor control rate [ Time Frame: 1 year ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.

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
Korea, Republic of | |
Department of surgery, The Catholoic university of Korea, St. Mary's hospital. | |
Seoul, Korea, Republic of |
Principal Investigator: | Byung-Joo Song, MD.PhD. | The Catholoic university of Korea, St. Mary's hospital. |
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 |
recurrent breast cancer Genexol-PM |
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 |