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

Korean Breast Cancer Study Group

Status and phase: Unknown; Phase 4

Conditions: Recurrent Breast Cancer

Treatments: Drug: Paclitaxel loaded Polymeric micelle

Study type: Interventional

Funder types: Other

Identifiers

NCT00912639

KBCSG004

Details and patient eligibility

About

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).

Full 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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

90 participants in 1 patient group

Genexol-PM

Experimental group

Description:

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)

Treatment:

Drug: Paclitaxel loaded Polymeric micelle