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

G

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)

48 participants in 1 patient group

doxotubicin/Genexol-PM
Experimental group
Treatment:
Drug: Doxorubicin/Genexol-PM

Trial contacts and locations

1

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Central trial contact

Hee Kyung Ahn

Data sourced from clinicaltrials.gov

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