A Phase II Trial of Doxorubicin and Genexol-PM in Patients With Advanced Breast Cancer

Gachon University Gil Medical Center

Status and phase: Unknown; Phase 2

Conditions: Metastatic Breast Cancer

Treatments: Drug: Doxorubicin/Genexol-PM

Study type: Interventional

Funder types: Other

Identifiers

NCT01784120

2011-GIRBA-2566

Details and patient eligibility

About

To evaluate efficacy and toxicity of doxorubicin/Genexol-PM in metastatic breast cancer

1. Primary Purpose: response rate
2. Secondary purpose: toxicity, progression-free survival, overall survival

Enrollment: 48 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age or older adult women
• Instrumentation measurable lesions with histologically confirmed advanced (recurrent or metastatic) breast cancer
• ECOG 0-2
• Advanced breast cancer in the past, patients who did not receive chemotherapy
• Recurrence if adjuvant chemotherapy and adjuvant chemotherapy in the past for more than 6 months until the patient
• life expectancy more than 3 months
• Agree in writing before the party to participate in a clinical trial to patients

Exclusion criteria

• immunohistochemical staining 3 + or FISH positive anti-HER 2 therapy patients
• Severe infections requiring antibiotic therapy
• Clinically significant heart disease
• Pregnant or lactating woman
• Uncontrolled symptoms in the central nervous system (CNS) metastases
• Patients diagnosed with malignant tumors of other organs

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

doxotubicin/Genexol-PM

Experimental group

Treatment:

Drug: Doxorubicin/Genexol-PM